Aetna Better Health | Medicaid Health Plans - Prior Authorization … · 2019-08-07 · Prior...

Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date:06/01/2020

Policy Number: 0235 Effective Date: Revision Date: 05/07/2019

Policy Name: Plantar Fasciitis Treatments

Type of Submission – Check all that apply:

New PolicyRevised Policy* Annual Review – No Revisions Statewide PDL

*All revisions to the policy must be highlighted using track changes throughout the document.

Please provide any clarifying information for the policy below:

CPB 0235 Plantar Fasciitis Treatments

Clinical content was last revised on 05/07/2019. Additionalnon-clinical updates were made byCorporate since the last PARP submission, as documented below.

Update History since the last PARP Submission:

03/23/2020-This CPB has been updated with additional coding.

Name of Authorized Individual (Please type or print):

Benjamin Alouf, MD, MBA, FAAP

Signature of Authorized Individual:

Proprietary Revised July 22, 2019

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Plantar Fasciitis Treatments - Medical Clinical Policy Bulletins | Aetna Page 1 of 57

(https://www.aetna.com/)

Plantar Fasciitis Treatments

Policy History

Last Review

03/23/2020

Effective: 05/04/1998

Next

Review: 02/27/2020

Review History

Definitions

Ad d i t ion al Information

Clinical Policy Bulletin

Notes

Number: 0235

P o l ic y *Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Aetna considers endoscopic plantar fasciotomy medically

necessary as an alternative to conventional open plantar

fasciotomy for members with intractable plantar fasciitis or heel

spur syndrome who have failed a 6-month trial of conservative

therapy.

Aetna considers extracorporeal shock-wave therapy (ESWT)

with the OssaTron (HealthTronics, Marietta, GA), the Dornier

Epos Ultra (Dornier Medical Systems, Kennesaw, GA), the

Sonocur (Siemens Medical Solutions Inc., Iselin, NJ), the

Orbasone Pain Relief System (Orthometrix, Inc., White Plains,

NY), the Orthospec Extracorporeal Shock Wave Therapy

(Medispec, Ltd., Germantown, MD), or any other ESWT

devices experimental and investigational for plantar fasciitis

because their effectiveness has not been established.

Aetna considers the following approaches (not an all-inclusive

list) experimental and investigational for members with p lantar

fasciitis because there is a lack of reliable published literature

documenting the safety and efficacy of these techniques in the

treatment of plantar fasciitis:

https://www.aetna.com/


▪ ActiveMatrix

▪ Acupuncture

▪ Autologous blood/growth factor injection

▪ Botulinum toxin

▪ Coblation therapy (eg, Topaz MicroDebrider)

▪ Cryo-preserved human amniotic membrane injection

▪ Cryosurgery (cryotherapy)

▪ Gastrocnemius lengthening surgery (e.g., gastrocnemius

recession)

▪ Intracorporeal pneumatic shocktherapy

▪ Kinesio taping/elastic therapeutic taping

▪ Light emitting diode

▪ Local ozone (O2-O3) injection

▪ Low-level laser therapy

▪ Marrow stimulation techniques (microfracture, drilling)

▪ Micronized dehydrated amniotic/chorionic membrane

allograft

▪ Neural therapy (injection of local anesthetics)

▪ Piezoelectric focal waves application

▪ Plantar fascia partial release guided by ultrasonic energy

▪ Platelet rich plasma/platelet-poor plasma/growth factor

injection

▪ Pulsed radiofrequency electromagnetic field therapy

▪ Radiofrequency (pulsed or thermal) lesioning

▪ Radiotherapy

▪ Transcranial direct current stimulation

▪ Trigger point dry needling

▪ Ultrasound therapy.

Notes: Heel cushions/pads, night splints, shoe modifications,

or orthopedic shoes for plantar fasciitis are not covered under

plans that exclude orthopedic shoes, foot orthotics, and other

supportive devices of the feet. Members should refer to their

benefit plan documents for applicable terms and conditions.

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See

CPB 0363 - Cold Laser and High-Power Laser Therapies

(../300_399/0363.html)

, and CPB 0451 - Foot Orthotics (../400_499/0451.html).

Background

Plantar fasciitis is defined as the traction degeneration of the

plantar fascia at its origin on the heel. Plantar fasciitis is the

most common cause of chronic heel pain. It is usually caused

by bone spurs or inflammation of the foot's connective tissue

and the condition may be resistant to conservative treatment.

Conservative treatments for plantar fasciitis include rest,

physical therapy, heel cushions, non-steroidal anti-

inflammatory drugs (NSAIDs), corticosteroid injections, taping,

foot orthotics (2nd line conservative treatment), shoe

modifications, night splinting, and casting.

Surgical intervention may be indicated for patients who fail

conservative treatment. Well-designed placebo- or sham-

controlled clinical trials for plantar fasciitis are especially

important because: (i) most cases of plantar fascial pain

resolve spontaneously over time; and (ii) pain is a symptom

that is especially susceptible to placebo effects.

Radiofrequency lesioning is used to ablate pain pathways and

is generally employed for intractable pain that has not

responded to conservative measures. Radiofrequency

lesioning is not an established procedure for the treatment of

plantar fasciitis.

Most recently, extracorporeal shock wave therapy (ESWT) has

been used to treat plantar fasciitis. Extracorporeal shock wave

therapy is thought to relieve pain by disrupting scar tissue,

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causing microscopic damage to that tissue. This induces new

blood vessel formation into the injured area and facilita tes the

healing process.

The Dornier EPOS Ultra is an ESWT system that uses

electromagnetic energy to generate a shock wave, which

travels through a water-filled coupling cushion mounted to a

therapy head. The therapy head has an acoustic lens to focus

the shock wave treatment on the target tissue. The EPOS

Ultra also has an ultrasound imaging system that is used to

observe and monitor the shock wave treatment. Typically,

3,800 shock waves are delivered over 20 mins.

In support of their pre-market approval application (PMA), a

randomized, double-blind, sham-treatment-controlled study

was conducted involving 150 adult patients with chronic

plantar fasciitis enrolled at 6 clinical centers. Patients had at

least moderate pain (visual analog score [VAS] greater than 5)

for at least 6 months and a history of prior conservative

therapy (including NSAIDs and 2 other conservative

therapies). After being randomized to active or sham

treatment groups, patients underwent a single ESWT session,

and were followed for 12 months. After 3 months, patients

who received sham treatment were offered active unmasked

treatment. To maintain physician blinding during the first 3

months of the study, the treatment was administered by a

physician who did not perform the follow-up evaluations.

Although there was a modest, statistically significant difference

in improvement in VAS pain scores from baseline (the primary

study endpoint) between active and sham treatment groups

at 3 months, this was not accompanied by a significant

improvement of function. In the active group, the pain score

decreased by an average of 56.5 % by the end of 3 months; in

the sham group, the average pain score decreased by 46.6

%. Patients in the active group were more likely (56 %) than

patients in the sham group (45 %) to report an improvement in

VAS pain scores of 60 % or more from baseline; however, this

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difference was not statistically significant. There was a

statistically significant difference in patient satisfaction (Roles

and Maudsley pain scores) between treatment groups, with 62

% of active patients with good to excellent results, compared

to 40 % of sham patients. However, there was no statistically

significant difference between active and placebo groups with

respect to function (American Orthopaedic Foot and Ankle

Society [AOFAS] Ankle-Hindfoot Scale (a validated rating

scale which incorporates assessment of function (50 %), pain

(40 %), and alignment (10 %)). There was also no statistically

significant difference between active and placebo treated

groups with respect to a measure of general health status

(SF12 Health Status Questionnaire (patient's self-assessment

of general health status and mental condition)).

The most common complication was pain during treatment,

which occurred in 72.4 % of active patients and 6.8 % of sham

patients. The investigators assessed the likelihood that patient

blinding was maintained during the study, given difference in

treatment-induced pain between active and sham treatments.

After the ESWT session, the investigators asked patients in

each treatment group whether they experienced pain during

treatment, and had them guess as to whether they had been

assigned to active or sham treatment. Sixty percent of

patients in the active group correctly guessed that they

received active treatment, and 40 % were unsure. In the sham

group, 15 % of patients correctly guessed that they received

sham treatment, and 85 % believed that they received an

active treatment or were unsure. Active patients who reported

pain during treatment were more likely to have correctly

guessed their assignment than active patients who reported no

pain; however, there was no significant difference at follow-up

in change in VAS score from baseline between active patients

who believed they received active treatment and active

patients who believed they received a sham treatment.

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Other complications included pain 3 to 5 days after treatment,

which was reported in 41 % of patients in the active group;

however, there was no statistically significant difference

between active and sham groups, as 35 % of patients in the

sham group also reported pain 3 to 5 days after treatment.

Other than pain during treatment, there were no significant

differences in the nature or type of adverse events reported

between active and sham treatment groups.

The OssaTron uses an electrohydraulic method of generating

shock waves, which are focused so that they converge at a

point near the surface of the foot. Typically, 1,500 shocks are

necessary for treatment, which is performed on an outpatient

surgical center under local or general anesthesia.

In support of their pre-market application, the manufacturer of

the OssaTron submitted to the Food and Drug Administration

(FDA) the results of a clinical trial involving 300 patients with

plantar fasciitis that was not adequately responsive to

conservative treatments. Patients were randomly assigned to

the active extracorporeal shock wave therapy or sham

treatment. Patients were evaluated on the 4 following criteria:

(i) investigator assessment of heel pain, with positive

response defined as greater than 50 % improvement over

baseline and a VAS score of 4 or less on a 10-point scale; (ii)

the patient's self-assessment of pain, with a positive

response defined as greater than 50 % improvement over

baseline and a VAS score of less than 4; (iii) the patient's self-

assessment of activity, with a positive response defined as

improvement of 1 point on a 5-point scale, or maintenance

of a baseline score of 0 or 1; and (iv) use of pain medications,

with a positive response defined as no use of pain

medications for heel pain. After 12 weeks, the

only clinically significant difference between active and sham

treatments was in the investigator assessment of heel pain:

46 % of the OssaTron-treated patients and 30 % of the sham-

treated patients had an improvement of more than 5.0 units on

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a 10-unit VAS at 12 weeks, as assessed by the investigator.

However, the self-assessed pain score showed only marginal

differences between the treatment and placebo groups, and

the other 2 endpoints -- self-assessment of activity and use of

pain medications -- were not statistically different between

the 2 groups. Side effects of Ossatron ESWT included nerve

complications (nerve irritation, numbness) in 6 patients and

plantar fascial tears in 2 patients. The FDA is requiring a study

to further evaluate these adverse effects.

In a randomized controlled study (n = 160), Buchbinder et al

(2002) found no evidence to support a beneficial effect on

pain, function, and quality of life of ultrasound-guided ESWT

over placebo in patients with ultrasound-proven plantar

fasciitis 6 and 12 weeks following treatment. Commenting on

the results of the study by Buchbinder and colleagues,

Ham and Strayer (2002) stated that "[e]xtracorporeal shock

wave therapy cannot be recommended to improve pain and

function in patients with plantar fasciitis based on the results of

this study. Although previous studies do report a benefit from

ESWT, this study appears to represent a higher level of

evidence than was previously available for evaluating the

efficacy of this therapy. An updated meta-analysis combining

all the studies on ESWT will be useful".

Aetna's policy on the unproven status of ESWT for plantar

fasciitis is supported by the conclusions of more than 12

systematic evidence reviews, including those from national

and international authorities (including the Cochrane

Collaboration (Crawford and Thomson, 2010), BMJ Clinical

Evidence (Landorf and Menz, 2007), the Washington State

Department of Labor and Industries (2003), the BlueCross

BlueShield Association Technology Evaluation Center (2003,

2005), the Institute for Clinical Systems Improvement (2004),

the California Technology Assessment Forum (Tice, 2004;

CTAF, 2007; CTAF, 2009), the National Institute for Health

and Clinical Excellence (2005), BMC Musculoskeletal

Disorders (Thomson et al, 2005), the Canadian Agency for

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Drugs and Technologies in Health (Ho, 2007), and the

Galacian Agency for Health Technology Assessment (Ruano-

Ravina, 2004)), and from other investigator groups (Cole et al,

2005; Buchbinder, 2004; Burton and Overend, 2005; Boddeker

et al, 2004;and Atkins et al, 1999).

These systematic evidence reviews of ESWT for plantar

fasciitis have concluded that the effectiveness of this

intervention is unknown. Pain associated with ESWT and

differences in procedures mean that blinding in placebo- or

sham-controlled trials is probably not maintained. Rajkumar

and Schmitgen (2002) concluded that additional controlled

studies are required to define the precise role of this new

modality in the treatment of chronic plantar fasciitis.

An assessment of ESWT for plantar fasciitis conducted by the

Washington State Department of Labor and Industries (2003)

concluded that "the evidence establishing the effectiveness [o f

ESWT] for musculoskeletal conditions remainsinconclusive."

In a double-blind randomized controlled study (n = 88), Speed

et al (2003) concluded that there appears to be no treatment

effect of moderate dose ESWT in subjects with plantar

fasciitis. The investigators stated that further research is

needed to develop evidence based recommendation for the

use ESWT in musculoskeletal complaints. This is in

agreement with findings of a study by Haake et al (2003) (n =

272) who reported that ESWT is ineffective in the treatment of

chronic plantar fasciitis.

The BlueCross BlueShield Association Technology Evaluation

Center (BCBSA, 2003) re-assessed ESWT for plantar fasciitis,

and reversed position on the effectiveness of this therapy.

The 2003 TEC assessmentstated: "[i]n summary, the

available evidence consists largely of good quality studies;

there are 3 double-blind, randomized controlled trials that

included over 600 patients. Overall, the results of the trials are

inconclusive. If ESWT provided a clinically significant

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improvement in plantar fasciitis, one would expect consistent

improvement across multiple ways of measuring pain and

function (e.g., morning pain, use of pain medications, ability to

walk without pain). However, the results of various measures

within studies and across studies do not give a consistent

picture concerning the effect of ESWT on health outcomes for

plantar fasciitis.” The TEC assessment (BCBSA, 2003)

concluded that “[t]he evidence is not sufficient to permit

conclusions on the health outcome effects of ESWT” for

plantar fasciitis. The BlueCross BlueShield Association

Technology Evaluation Center re-affirmed their position in a

subsequent assessment published in 2005 (BCBSA, 2005).

In an evidence review of plantar fasciitis treatments published

in the New England Journal of Medicine, Buchbinder (2004)

concluded that “the available data do not provide substantive

support for [the] use” of ESWT for plantar fasciitis.

Although recent reports seem to provide evidence that ESWT

may be effective in the treatment of plantar fasciitis, there are

drawbacks in these studies. The study by Odgen et al (2004)

appears to be a follow-up report on the same patients in their

previous reports, providing data on 1-year and longer.

Theodore et al (2004) concluded that ESWT represents a safe

treatment option for chronic plantar fasciitis. In the study by

Theodore et al, there was a significant difference (p = 0.0435)

in VAS at 3-month between the 2 groups: 3.4 +/- 2.7 for the

treatment group and 4.1 +/- 3.1 for the control group. There

appears to be a wide overlap of VAS between the 2 groups.

Furthermore, it is unclear whether these small differences are

clinically significant as indicated by the lack of difference in

VAS during the first few mins of walking in the morning

between the 2 groups. There are also no differences in

AOFAS and SF-12 health status questionnaire scores

between the 2 groups. In addition, it is of note that there were

no differences in Roles and Maudsley Score at 6-week follow-

up between the 2 groups. Moreover, 38.4 % of patients in the

treatment group reported a fair to poor Roles and Maudsley

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Score at 3-month compared to only 6.3 % of their counterparts

in the control group. More importantly, it is unclear why the

study was unblinded at 3 months. It would have been

interesting to have the patients in the control group remained

in the original protocol and compared their results with those

from the treatment group at 12-month.

A technology assessment by the Institute for Clinical Systems

Improvement (2004) concluded that "[t]he scientific evidence,

to date, does not permit a conclusion to be reached regarding

the efficacy of ESWT for plantar fasciitis." This is in

agreement with the assessment by the BlueCross BlueShield

Association’s Technology Evaluation Center (2005), which

concluded that ESWT for chronic plantar fasciitis has not been

demonstrated to improve health outcomes in the

investigational setting.Thus,ESWT for chronic plantar

fasciitis does not meet the TEC criteria.

An assessment of ESWT for musculoskeletal disorders

prepared for the California Technology Assessment Forum

(CTAF) stated that ESWT for plantar fasciitis does not meet

CTAF’s assessment criteria (Tice, 2004). The assessment

explained that plantar fasciitis tends to improve over extended

periods of time, even for patients who have failed conservative

therapy for several months. Therefore, uncontrolled studies of

ESWT for plantar fasciitis were promising, but may represent

mainly the natural history of this disorder abetted by a strong

placebo effect. The CTAF assessment explained that studies

with pain as the primary outcome commonly are subject to

large placebo effects (Tice, 2004). The assessment observed

that, in the non-blinded randomized controlled trials of ESWT,

the placebo group usually reported minimal improvements

while the placebo group in the well-blinded studies reported 30

to 50 % improvements in pain scores. The assessment stated

that this observation highlights the need for high quality, double-

blinded, randomized trials as the minimum standard of evidence

for ESWT in plantar fasciitis. The CTAF assessment noted that

the 9 randomized controlled clinical trials of ESWT

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for plantar fasciitis illustrate this point (Tice, 2004). The

assessment found “a tremendous amount” of variability in the

quality of the randomized trials and in the interventions

studied. The assessment found that the fair to poor quality

studies demonstrated benefit compared with sham or delayed

therapy, but the trials were generally small, with inadequate

blinding, poor allocation concealment, and differential loss to

follow-up, which could have biased the study results in favor of

ESWT. In contrast, the assessment found that the 2 good

quality studies found no evidence for benefit compared with

sham ESWT.

The CTAF re-assessed the evidence for ESWT for plantar

fasciitis, and found that this does not meet CTAF criteria (Tice,

2009). The CTAF assessment explained that patients

with plantar fasciitis tend to improve over extended periods of

time, even patients who have failed conservative therapy for

months. Therefore, the uncontrolled studies of ESWT, while

promising, may represent mainly the natural history of the

disorders abetted by a strong placebo effect. Studies with

pain as the primary outcome commonly are subject to large

placebo effects. The CTAF assessment observed that, in the

non-blinded randomized controlled trials of ESWT, the placebo

group usually reported minimal improvements, while the

placebo group in the well blinded studies reported 30 to 50 %

improvements in pain scores. The CTAF assessment

concluded, therefore, that high quality, double-blinded,

randomized trials are the minimum standard of evidence (Tice,

2009).

The CTAF report stated that meta-analysis of

the 19 randomized controlled trials of ESWT for plantar

fasciitis illustrates this quite clearly (Tice, 2009). The CTAF

assessment found significant variability in the quality of the

randomized trials and in the interventions studied. However,

only the quality of the studies was significantly associated with

the magnitude of the benefit observed in the clinical trials. The

CTAF report observed that fair to poor quality studies

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demonstrated benefit compared with sham or delayed therapy,

but the trials were generally small, with inadequate blinding,

poor allocation concealment, and differential loss to follow-up,

which could have biased the study results in favor of ESWT.

However, 2 of the 4 good quality studies found no evidence for

benefit compared with sham ESWT. Furthermore, the CTAF

report found strong evidence for publication bias in the

available literature. The asymmetry of the funnel plot indicates

that many small studies with negative results have been

performed, but not published. Finally, CTAF found that many

different variations of ESWT were tried in these trials -- no

specific device or protocol was clearly superior to the others.

The CTAF report stated that there may be a form of ESWT

that effectively speeds healing of plantar fasciitis, but it

remains to be defined. The literature does not clearly support

a benefit of high energy compared with low energy ESWT nor

is it clear that the use of anesthesia blocks the benefits of

ESWT. "Until unequivocal benefit is consistently

demonstrated in high quality clinical trials, ESWT should

remain investigational" (Tice,2009).

It is interesting to note that a randomized controlled study (n =

125; Porter and Shadbolt, 2005) reported that corticosteroid

injection is more effective and multiple times more cost-

effective than ESWT in the treatment of plantar fasciopathy

that has been symptomatic for more than 6 weeks. In addition,

a recent review on the use of ESWT for the treatment of

orthopedic diseases (Trebinjac et al, 2005) found that results

on the effectiveness of ESWT are controversial. Studies that

have claimed therapeutic benefit did not fulfill scientific criteria

and randomized controlled trials were not able to confirm

significant improvement after treatment with ESWT.

An assessment by the National Institute for Health and Clinical

Excellence (NICE, 2005) about ESWT for plantar fasciitis

reached the following conclusion: "[c]urrent evidence on

extracorporeal shockwave therapy for refractory

tendinopathies (specifically tennis elbow and plantar fasciitis)

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suggests that there are no major safety concerns. Evidence

on efficacy is conflicting, and suggests that the procedure

produces little benefit apart from a placebo response in some

patients. Therefore, current evidence on efficacy does not

appear adequate to support its use without special

arrangements for consent, and for audit or research."

A systematic evidence review and metaanalysis for BMC

Musculoskeletal Disorders (Thomson et al, 2005) reported that

the results of the review did not support the use of ESWT for

plantar heel pain in clinical practice. The authors reported that

ESWT was effective for the treatment of plantar heel pain, but

the effect size was small; when only high-quality trials were

considered, this effect was not shown to be statistically

significant.

The Canadian Agency for Drugs and Technologies in Health's

report on ESWT for chronic plantar fasciitis (Ho, 2007) stated

that "the lack of convergent findings from randomized trials of

ESWT for chronic plantar fasciitis suggests uncertainty about

its effectiveness. The evidence reviewed in this bulletin does

not support the use of this technology for this condition."

A meta-analysis of ESWT for plantar fasciitis not responding to

conservative therapy (2007) conducted by the CTAF (2007)

concluded that the use of ESWT for the treatment of plantar

fasciitis does not meet CTAF's technology assessment

criteria. Meta-analysis of the 14 randomized controlled clinical

trials of ESWT for plantar fasciitis identified significant

variability in the quality of the randomized trials and in the

interventions studied. The assessment found, however, that

only the quality of the studies was significantly associated with

the magnitude of the benefit observed in the clinical trials. The

CTAF assessment found that fair to poor quality studies

demonstrated benefit compared with sham or delayed therapy,

but the trials were generally small, with inadequate blinding,

poor allocation concealment, and differential loss to follow-up,

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which could have biased the study results in favor of ESWT.

In contrast, 2 of the 3 good quality studies found no evidence

for benefit compared with sham ESWT.

Tornese and co-workers (2008) compared 2 ESWT techniques

for the treatment of painful subcalcaneal spur. A total of 45

subjects with a history of at least 6 months of heel pain were

studied. Each subject received a 3-session ultrasound-guided

ESWT (performed weekly). Perpendicular technique was used

in group A (n = 22, mean age of 59.3 +/- 12 years) and

tangential technique was used in group B (n = 23, mean age of

58.8 +/- 12.3 years). Mayo Clinical Scoring System was used

to evaluate each subject before the treatment and at 2 and 8

months follow-up. Mayo Clinical Scoring System pre-

treatment scores were homogeneous between t he groups

(group A = 55.2 +/-18.7; group B = 53.5 +/- 20; p > 0.05). In

both groups there was a significant (p < 0.05) increase in the

Mayo Clinical Scoring System score at 2 months (group A =

83.9 +/- 13.7; group B = 80 +/- 15.8) and 8 months (group A

= 90 +/- 10.5; group B = 90.2 +/- 8.7) follow-up. No significant

differences were obtained comparing the Mayo Clinical

Scoring System scores of the 2 groups at 2 and 8 months

follow-up. The authors concluded that there was no difference

between the 2 techniques of using ESWT. The tangential

technique was found to be better-tolerated regarding treatment-

induced pain, allowing higher energy dosages to be used. The

drawbacks of this study were lack of a control group, small

sample size, and a relavely short follow-up period.

In a randomizedcontrolled trial, Gerdesmeyer and

colleagues (2008) examined the effects of radial ESWT in the

treatment of chronic recalcitrant plantar fasciitis. Three

interventions of radial ESWT (0.16 mJ/mm(2); 2,000 impulses)

compared with placebo were studied in 245 patients. Primary

endpoints were changes in VAS composite score from

baseline to 12 weeks' follow-up, overall success rates, and

success rates of the single VAS scores (heel pain at first steps

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in the morning, during daily activities, during standardized

pressure force). Secondary endpoints were single changes

in VAS scores, success rates, Roles and Maudsley score, SF-

36, and patients' and investigators' global judgment of

effectiveness 12 weeks and 12 months after ESWT. Radial

ESWT proved significantly superior to placebo with a reduction

of the VAS composite score of 72.1 % compared with 44.7 %

(p = 0.0220), and an overall success rate of 61.0 % compared

with 42.2 % in the placebo group (P = .0020) at 12 weeks.

Superiority was even more pronounced at 12 months, and all

secondary outcome measures supported radial ESWT to be

significantly superior to placebo (p < 0.025, 1-sided). No

relevant side effects were observed. The authors concluded

that radial ESWT significantly improves pain, function, and

quality of life compared with placebo in patients with

recalcitrant plantar fasciitis. The positive findings of this study

need to be validated by further investigation.

Cryosurgery is also being studied for the treatment of plantar

fasciitis. In a prospective study (Allen et al, 2007), 59

consecutive patients (61 heels), who had failed prior

conservative therapy and were considered surgical candidates

were treated with cryosurgery in an office setting. Patients

were evaluated on an 11-point VAS administered pre-

operatively and up to 1 year of follow-up. The mean pain

rating (8.38) before cryosurgery (day 0) is statistically

significant to the mean pain rating (1.26) at day 365 post-

operatively. Pain decreased significantly after the procedure

(analysis of variance, p < 0.0001). These results suggested

that cryosurgery may be effective in treating patients with

recalcitrant plantar fasciitis. However, it should be noted that

this was an uncontrolled study with a small sample size. Its

findings need to be validated by well-designed studies.

Niewald and associates (2008) stated that a lot of

retrospective data concerning the effect of radiotherapy on

plantar fasciitis is available in the literature. Nevertheless, a

randomized proof of this effect is still missing. Thus, the

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GCGBD (German cooperative group on radiotherapy for

benign diseases) of the DEGRO (German Society for

Radiation Oncology) decided to start a randomized multi-

center trial in order to find out if the effect of a conventional

total dose is superior compared to that of a very low dose. In a

prospective, controlled and randomized phase III trial, 2

radiotherapy schedules were compared: (i) standard arm

-- total dose 6.0 Gy in single fractions of 1.0 Gy applied

twice-weekly, and (ii) experimental arm -- total dose 0.6 Gy

in single fractions of 0.1 Gy applied twice-weekly (acting as

a placebo). Patients aged over 40 years who have been

diagnosed clinically and radiologically to be suffering from

plantar fasciitis for at least 6 months can be included. Former

trauma, surgery or radiotherapy to the heel are not allowed nor

are patients with a severe psychiatric disease or women

during pregnancy and breast-feeding. According to the

statistical power calculation, 100 patients have to be enrolled

into each arm. After having obtaining a written informed

consenta patient is randomized by the statistician to one of

the arms mentioned above. After radiotherapy, patients are

seen first every 6 weeks, then regularly up to 48 months after

therapy; they additionally receive a questionnaire every 6

weeks after the follow-up examinations. The effect is

measured using several target variables (scores):

Calcaneodynia-score according to Rowe et al, SF-12 score,

and VAS of pain. The most important endpoint is the pain

relief 3 months after therapy. Patients with an inadequate

result are offered a second radiotherapy series applying the

standard dose (equally in both arms). This trial protocol has

been approved by the expert panel of the DEGRO as well as

by the Ethics committee of the Saarland Physicians' Chamber.

Drilling and microfracture of the subchondral

bone are techniques used to stimulate the intrinsic repair

(fibro-cartilage) process for injured/defective articular

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cartilage. However, there is a lack of evidence regarding

the effectiveness of drilling or microfracture in the treatment of

plantar fasciitis.

In a multi-center randomized clinical trial, Cleland and

colleagues (2009) compared the effectiveness of 2 different

conservative management approaches in the treatment of

plantar heel pain. Patients with a primary report of plantar

heel pain underwent a standard evaluation and completed a

number of patient self-report questionnaires, including the

Lower Extremity Functional Scale (LEFS), the Foot and Ankle

Ability Measure (FAAM), and the Numeric Pain Rating Scale

(NPRS). Patients were randomly assigned to be treated with

either an electrophysical agents and exercise (EPAX) or a

manual physical therapy and exercise (MTEX) approach.

Outcomes of interest were captured at baseline and at 4-week

and 6-month follow-ups. The primary aim (effects of treatment

on pain and disability) was examined with a mixed-model

analysis of variance (ANOVA). The hypothesis of interest was

the 2-way interaction (group by time). A total of 60 subjects

(mean [SD] age, 48.4 [8.7] years) satisfied the eligibility

criteria, agreed to participate, and were randomized into the

EPAX (n = 30) or MTEX group (n = 30). The overall group-by-

time interaction for the ANOVA was statistically significant for

the LEFS (p = 0.002), FAAM (p = 0.005), and pain (p = 0.043).

Between-group differences favored the MTEX group at both

4-week (difference in LEFS, 13.5; 95 % confidence i nterval

[CI]: 6.3 to 20.8) and 6-month (9.9; 95 % CI: 1.2 to 18.6)

follow-ups. The authors concluded that the results of this

study provided evidence that MTEX is a superior management

approach over an EPAX approach in the management of

individuals with plantar heel pain at both the short- and long-

term follow-ups.

Rompe et al (2010) tested the null hypothesis of no difference

in the effectiveness of plantar fascia-specific stretching and

shock-wave therapy for patients who had unilateral plantar

fasciopathy for a maximum duration of 6 weeks and which had

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not been treated previously. A total of 102 patients with acute

plantar fasciopathy were randomly assigned to perform an

8-week plantar fascia-specific stretching program (group I, n =

54) or to receive repetitive low-energy radial shock-wave

therapy without local anesthesia, administered weekly for 3

weeks (group II, n = 48). All patients completed the 7-item

pain subscale of the validated Foot Function Index and a

patient-relevant outcome questionnaire. Patients were

evaluated at baseline and at 2, 4, and 15 months after

baseline. The primary outcome measures were a mean

change in the Foot Function Index sum score at 2 months after

baseline, a mean change in item 2 (pain during the first few

steps of walking in the morning) on this index, and satisfaction

with treatment. No difference in mean age, sex, weight, or

duration of symptoms was found between the groups at

baseline. At 2 months after baseline, the Foot Function Index

sum score showed significantly greater changes for the

patients managed with plantar fascia-specific stretching than

for those managed with shock-wave therapy (p < 0.001), as

well as individually for item 2 (p = 0.002). Thirty-five patients

(65 %) in group I versus 14 patients (29 %) in group II were

satisfied with the treatment (p < 0.001). These findings

persisted at 4 months. At 15 months after baseline, no

significant between-group difference was measured. The

authors concluded that a program of manual stretching

exercises specific to the plantar fascia is superior to repetitive

low-energy radial shock-wave therapy for the treatment of

acute symptoms of proximal plantar fasciopathy.

In a pilot study, Dogramaci et al (2010) examined the clinical

efficacy of intracorporeal pneumatic shock therapy (IPST)

application for the treatment of chronic plantar fasciitis using a

pneumatic lithotripter. A total of 50 patients with clinically and

radiologically confirmed plantar fasciitis were randomly

allocated to either an active (treatment) (n = 25) or inactive

(placebo) (n = 25) group. Under local anesthesia and

posterior tibial nerve block, a rigid probe was directly

introduced into the calcaneal spur under fluoroscopic control; a

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standard protocol of 1,000 shocks was applied during a single

session into the calcaneal spur. The main outcome measure

was patients' subjective assessment of pain by means of a

VAS and the Roles and Maudsley Score before the treatment

and 6 months later. At the 6 months, the rate of successful

outcomes (excellent + good results) in the treatment group (92

%) were significantly higher comparing to the control group (24

%) (p < 0.001). Heel pain measured 6 months after using the

VAS were 2.04 +/- 1.67 in the treatment group and 7.16 +/-

1.57 in the control group as compared to 8.92 +/- 1.22 and

9.12 +/- 1.23, respectively before the commencement of the

treatment. No complications attributable to the procedure

such as rupture of the planter fascia, hematoma, or infection

were observed during the study. The authors concluded that

these findings showed that IPST is a safe and effective

method in the treatment of patients with chronic plantar

fasciitis not responding to conservative measures. It should

be considered before surgical intervention when ESWT is not

available for daily practice. Moreover, they stated that further

evaluation of this novel treatment is necessary to understand

the exact mechanism of action.

Peerbooms et al (2010) described the design of a multi-center

randomized controlled trial to study the use of platelet rich

plasma in the treatment of plantar fasciitis. The study

population consists of 120 patients aged 18 years and older.

Patients with chronic plantar fasciitis will be allocated randomly

to have a steroid injection or an autologous platelet

concentrate injections. Data will be collected before the

procedure,4,8, 12, 26 weeks and 1 year after the procedure.

The main outcome measures of this study are pain and

function measured with questionnaires.

Cotchett et al (2011) described the design of a randomized

controlled trial to evaluate the effectiveness of dry needling for

plantar heel pain. A total of 80 community-dwelling men and

woman aged over 18 years with plantar heel pain (who satisfy

the inclusion and exclusion criteria) will be recruited. Eligible

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participants with plantar heel pain will be randomized to

receive either 1 of 2 interventions, (i) real dry needling, or (ii)

sham dry needling. The protocol (including needling details

and treatment regimen) was formulated by general consensus

(using the Delphi research method) using 30 experts

worldwide that commonly use dry needling for plantar heel

pain. Primary outcome measures will be the pain subscale of

the Foot Health Status Questionnaire and "first step" pain as

measured on a VAS. The secondary outcome measures will

be health-relatedquality of life (assessed using the Short Form-

36 questionnaire - Version Two) and depression, anxiety and

stress (assessed using the Depression, Anxiety and Stress

Scale - short version). Primary outcome measures will be

performed at baseline, 2, 4, 6 and 12 weeks and secondary

outcome measures will be performed at baseline, 6 and 12

weeks. Data will be analyzed using the intention-to-treat

principle. The authors concluded that this study is the first

randomized controlled trial to evaluate the effectiveness of dry

needling for plantar heel pain. The trial will be reported in

accordance with the Consolidated Standards of Reporting

Trials and the Standards for Reporting Interventions in Clinical

Trials of Acupuncture guidelines. The findings from this trial

will provide evidence for the effectiveness of trigger point dry

needling for plantar heel pain.

Zhang et al (2011) examine the efficacy of botulinum toxin

type A (BoNTA) in reducing chronic musculoskeletal pain.

Studies for inclusion in this report were identified using

MEDLINE, EMBASE, PUBMED, Cochrane Central Register of

Controlled Trials, CINAHL, and reference lists of relevant

articles. Studies were considered eligible for inclusion if they

were randomized controlled trials (RCTs), evaluating the

efficacy of BoNTA injections in pain reduction. All studies

were assessed and data were abstracted independently by

paired reviewers. The outcome measures were baseline and

final pain scores as assessed by the patients. The internal

validity of trials was assessed with the Jadad scale.

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Disagreements were resolved through discussions. A total of

21 studies were included in the systematic review and 15 of

them were included in the final meta-analysis. There was a

total of 706 patients in the meta-analysis, represented from

trials of plantar fasciitis (n = 1), tennis elbow (n = 2), shoulder

pain (n = 1), whiplash (n = 3), and myofascial pain (n = 8).

Overall, there was a small to moderate pain reduction among

BoNTA patients when compared to control (standardized

mean difference [SMD] = -0.27, 95 % CI: -0.44 to -0.11).

When the results were analyzed in subgroups, only tennis

elbow (SMD = -0.44, 95 % CI: -0.86 to -0.01) and plantar

fasciitis (SMD = -1.04, 95 % CI: -1.68 to -0.40) demonstrated

significant pain relief. Although not in the meta-analysis, 1

back pain study also demonstrated positive results for BoNTA.

Lastly, BoNTA was effective when used at greater than or

equal to 25 units per anatomical site or after a period greater

than or equal to 5 weeks. In this meta-analysis, BoNTA had a

small to moderate analgesic effect in chronic musculoskeletal

pain conditions. It was particularly effective in plantar fasciitis,

tennis elbow, and back pain, but not in whiplash or shoulder

pain patients. However, more evidence i s required before

definitive conclusions can be drawn. On the other hand, there

is convincing evidence that BoNTA lacks strong analgesic

effects in patients with myofascial pain syndrome.

Diaz-Llopis et al (2012) examined the effectiveness of BoNTA

in chronic plantar fasciitis compared to the local injection of a

corticosteroid plus local anesthetic. Patients with a clinical

diagnosis of plantar fasciitis made at least 6 months earlier

were selected to enter a randomized, single-blind study of

treatment with injections of botulinum toxin type A or

corticosteroid. There were 28 patients in each treatment

group. Patients were evaluated at 1 month using the Foot

Health Square Questionnaire and those with no clinical

response subsequently received a 2nd injection with the drug

of the other arm of the study, creating 2 new treatment

groups. Re-evaluation was performed at 6 months. One

month after injection there was a clear clinical improvement in

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both treatment groups but it was greater in the botulinum toxin

group, with a significant difference for the pain item (p =

0.069), though not in other items. At 6 months, patients

treated with botulinum toxin type A had continued to improve

in all items, whereas the corticosteroid group lost part of the

improvement achieved at 1 month (improvement with

botulinum toxin versus corticosteroid: pain 19.10/-6.84 ( p =

0.001), function 16.00/-8.80 (p < 0.001), footwear 13.48/-7.95

(p = 0.004), self-perceived f oot health 25.44/-5.41 ( p < 0.001).

The authors concluded that BoNTA should be considered for

the treatment of chronic plantar fasciitis in view of the

improvement found at 1 month, and particularly at 6 months,

when this treatment clearly has better results than

corticosteroid injections. They stated that further studies with

larger samples are necessary to confirm these results.

In a double-blind, multi-center, randomized, placebo-controlled

study, Brook et al (2012) evaluated the clinical value of pulsed

radiofrequency electromagnetic field (PREF) therapy as a

potential novel treatment of plantar fasciitis. A small,

wearable, extended-use PRFE device was employed in this

study. A total of 70 subjects diagnosed with plantar fasciitis

were enrolled in the present study. The subjects were

randomly assigned a placebo or active PRFE device. Subjects

were instructed to wear the PRFE device over-night, record

their morning and evening pain using a 0- to 10-pointVAS,

and log any medication use. The primary outcome measure

for the present study was morning pain, a hallmark of plantar

fasciitis. The study group using the active PRFE device

showed progressive decline in morning pain. The day 7 AM-

VAS score was 40 % lower than the day 1 AM-VAS score.

The control group, in comparison, showed a 7 % decline. A

significantly different decline was demonstrated between the 2

groups (p = 0.03). The PM-VAS scores declined by 30 % in

the study group compared to 19 % in the control group,

although the difference was non-significant. Medication use in

the study group also showed a trend downward, but the use in

the control group remained consistent with the day 1 levels.

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The authors concluded that PRFE therapy worn on a nightly

basis appears to offer a simple, drug-free, non-invasive

therapy to reduce the pain associated with plantar fasciitis.

The findings of this study need to be validated by further

investigations especially since there were no significant

differences in VAS score between the study and control

groups.

The National Institute for Health and Clinical Excellence

assessment on “Autologous blood injection for plantar

fasciitis” (NICE, 2013) concluded that “The evidence on

autologous blood injection for plantar fasciitis raises no major

safety concerns. The evidence on efficacy is inadequate in

quantity and quality. Therefore, this procedure should only be

used with special arrangements for clinical governance,

consent and audit or research...........NICE encourages further

research comparing autologous blood injection (with or without

techniques to produce platelet-rich plasma) against

established treatments for managing plantar fasciitis. Trials

should clearly describe patient selection, including duration of

symptoms and any prior treatments. Outcomes should include

specific measures of pain and function”.

Morris et al (2013) examined the effect of Kinesio Tex tape

(KTT) from RCTs in the management of clinical conditions. A

systematic literature search of CINAHL; MEDLINE; OVID;

AMED; SCIENCE DIRECT; PEDRO; SPORT DISCUS;

BRITISH NURSING INDEX; COCHRANE CENTRAL

REGISTER OF CLINICAL TRIALS; and PROQUEST was

performed up to April 2012. The risk of bias and quality of

evidence grading was performed using the Cochrane

collaboration methodology. A total of 8 RCTs met the full

inclusion/exclusion criteria; 6 of these included patients with

musculoskeletal conditions; 1 included patients with breast-

cancer-related lymphedema; and 1 included stroke patients

with muscle spasticity. Six studies included a sham or usual

care tape/bandage group. There was limited to moderate

evidence that KTT is no more clinically effective than sham or

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usual care tape/bandage. There was limited evidence from 1

moderate quality RCT that KTT in conjunction with

physiotherapy was clinically beneficial for plantar fasciitis

related pain in the short-term; however, there were serious

questions around the internal validity of this RCT. The authors

concluded that there currently exists insufficient evidence to

support the use of KTT over other modalities in clinical

practice.

Zelen et al (2013) reported the results of a feasibility study

examining the effectiveness of micronized dehydrated human

amniotic/chorionic membrane (mDHACM) injection as a

treatment for chronic refractory plantar fasciitis. An

institutional review board-approved, prospective, randomized,

single-center clinical trial was performed. A total of 45 patients

were randomized to receive injection of 2 cc 0.5 % Marcaine

plain, then either 1.25 cc saline (controls), 0.5 cc mDHACM, or

1.25 cc mDHACM. Follow-up visits occurred over 8 weeks to

measure function, pain, and functional health and well-being.

Significant improvement in plantar fasciitis symptoms was

observed in patients receiving 0.5 cc or 1.25 cc mDHACM

versus controls within 1 week of treatment and throughout the

study period. At 1 week, AOFAS Hindfoot scores increased by

a mean of 2.2 ± 17.4 points for controls versus 38.7 ± 11.4

points for those receiving 0.5 cc mDHACM (p < 0.001) and

33.7 ± 14.0 points for those receiving 1.25 cc mDHACM (p <

0.001). By week 8 AOFAS Hindfoot scores increased by a

mean of 12.9 ± 16.9 points for controls versus 51.6 ± 10.1 and

53.3 ± 9.4 for those receiving 0.5 cc and 1.25 cc mDHACM,

respectively (both p < 0.001). No significant difference in

treatment response was observed in patients receiving 0.5 cc

versus 1.25 cc mDHACM. The authors concluded that in

patients with refractory plantar fasciitis, mDHACM is a viable

treatment option. Moreover they stated that larger studies are

needed to confirm these findings.

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In a meta-analysis, Yin et al (2014) examined the

effectiveness of ESWT and provided clinicians with an

evidence base for their clinical decision-making. PubMed,

MEDLINE, Embase, Cochrane Central Register of Controlled

Trials, and Evidence-Based Medicine Reviews served as data

sources. All randomized or quasi-randomized controlled trials

of ESWT for chronic recalcitrant plantar fasciitis were

searched. Searching identified 108 potentially relevant

articles; of these, 7 studies with 550 participants met inclusion

criteria. Number of patients, population, body mass index

(BMI), duration of symptoms, adverse effects, blinding method,

and details of shockwave therapy were extracted. For

intervention success rate, ESWT of low intensity was more

effective than control treatment of low intensity. For pain relief,

the pooled data showed a significant difference between the

ESWT and control groups. For function, only low-intensity

ESWT was significantly superior over the control treatment.

The authors concluded that the effectiveness of low-intensity

ESWT is worthy of recognition. The short-term pain relief and

functional outcomes of this treatment are satisfactory.

However, they noted that owing to the lack of a long-term

follow-up, its long-term effectiveness remains unknown.

In a systematic review, Sandrey (2014) evaluated the literature

to critically consider the effects of growth factors delivered

through autologous whole-blood and platelet-rich-plasma

(PRP) injections in managing wrist-flexor and -extensor

tendinopathies, plantar fasciopathy, and patellar tendinopathy.

The primary question was, according to the published

literature, is there sufficient evidence to support the use of

growth factors delivered through autologous whole-blood and

PRP injections for chronic tendinopathy? The authors

performed a comprehensive, systematic literature search in

October 2009 using PubMed, MEDLINE, EMBASE, CINAHL,

and the Cochrane library without time limits. The following key

words were used in different combinations: tendinopathy,

tendinosis, tendinitis, tendons, tennis elbow, plantar fasciitis,

platelet rich plasma, platelet transfusion, and autologous blood

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or injection. The search was limited to human studies in

English. All bibliographies from the initial literature search

were also viewed to identify additional relevant studies.

Studies were eligible based on the following criteria: (i) Articles

were suitable (inclusion criteria) if the participants had

been clinically diagnosed as having chronic tendinopathy;

(ii) the design had to be a prospective clinical study, RCT,

non-RCT, or prospective case series; (iii) a well-described

intervention in the form of a growth factor injection with

either PRP or autologous whole blood was used; and (iv)

the outcome was reported in terms of pain or function (or

both). All titles and abstracts were assessed by 2

researchers, and all relevant articles were obtained. Two

researchers independently read the full text of each article to

determine if it met the inclusion criteria. If opinions differed on

suitability, a third reviewer was consulted to reach consensus.

The data extracted included number of participants, study

design, inclusion criteria, intervention, control group, primary

outcome measures (pain using a v isual analog or ordinal scale

or function), time of follow-up, and outcomes for intervention

and control group (percentage improvement) using a

standardized data-extraction form. Function was evaluated in

9 of the 11 studies using (i) the Nirschl scale (elbow function)

or the modified Mayo score for wrist flexors and extensors,

(ii) the Victorian Institute of Sports Assessment-Patella

score, a validated outcome measure for patellar

tendinopathy, or the Tegner score for patellar

tendinopathy, and (iii) the rear-foot score from the

American Orthopaedic Foot and Ankle Scale for plantar

fasciopathy. The Physiotherapy Evidence Database (PEDro)

scale contains 11 items; items 2 to 11 receive 1 point each for

a yes response. Reliability is sufficient (0.68) for the PEDro

scale to be used to assess physiotherapy trials. A score of 6

or higher on the PEDro scale is considered a high-quality

study; below 6 is considered a low-quality study. The PEDro

score results determined the quality of the RCT, non-RCT, or

prospective ca se se ries (greater than or equal to 6 or less than

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6). A qualitative analysis was used with 5 levels of evidence

(strong, moderate, limited, conflicting, or no evidence) to

determine recommendations for the use of the intervention.

The number of high-quality or low-quality RCT or non-

randomized clinical trial studies with consistent or inconsistent

results determined the level of evidence (1 to 5). Using the

specific search criteria, the authors identified 418 potential

sources. After screening of the title or abstract (or both), they

excluded 405 sources, which left 13 studies. After viewing the

full text, they excluded 2 additional sources (a case report and

a study in which the outcome measure was remission of

symptoms and not pain or function), leaving 11 studies for

analysis. Six of the 11 studies were characterized by an

observational, non-controlled design; the remaining 5 studies

were controlled clinical trials, 2 of which had proper

randomization. The mean number of participants included in

the studies was 40.5 (range of 20 to 100). Three of the

studies were on "tennis elbow", 1 on "golfer's elbow", 1 on

wrist extensor or flexor tendinopathy, 3 on plantar fasciopathy,

and 3 on chronic patellar tendinopathy. Based on the

information reported, there was no standardization of

frequency or method of growth factor injection treatment or of

preparation of the volume, and an optimal mixture was not

described. Autologous whole-blood injections were used in 8

studies; in 5 studies, the autologous whole-blood injection was

combined with a local anesthetic. In contrast, a local

anesthetic was used in only 1 of the 3 PRP injection studies.

The authors of the other 2 studies did not report whether a

local anesthetic was used. The number of autologous whole-

blood and PRP injections varied, ranging from 1 to 3. The

centrifuging process was single or double for the PRP

injections. In 2 studies, calcium was added to activate the

platelets. A visual analog or ordinal pain scale was used in 10

of the 11 studies. Function was evaluated in 9 of the 11

studies using (i) the Nirschl scale in 4 elbow studies or the

modified Mayo score at baseline in 1 elbow study, (ii) the

Victorian Institute of Sports Assessment-Patella score for 1

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study and the Tegner score for 2 of the patellar

tendinopathy studies, and (iii) the rear-foot score of the

American Orthopaedic Foot and Ankle Scale for 1 plantar

fasciopathy study. Only 1 study used an appropriate,

disease-specific, validated tendinopathy measure (Victorian

Institute of Sports Assessment-Patella). All intervention

groups reported a significant improvement in pain or function

score (or both), with a mean improvement of 66 % over a

mean follow-up of 9.4 months. The control groups in these

studies also showed a mean improvement of 57 %. None of

the pain benefits among the intervention groups were greater

than those for the control group at final follow-up. In 4 of the

studies, the control group and the autologous growth factor

injection group had similar results in pain or function or both,

whereas in 2 studies, the control group had greater relief in

pain than the injection group. Eleven studies were assessed

using the PEDro scale. The PEDro scores for these studies

ranged from 1 to 7, with an average score of 3.4. Only 3

studies had PEDro scores of ≥6 and were considered high

quality. The 3 high-quality plantar fasciopathy studies used

autologous growth factor injections but did not show a

significant improvement over the control group. One of the

studies that showed no beneficial effect for the autologous

growth factor injections was compared with corticosteroids.

Compared w ith other treatments, level 1 (strong) evidence

demonstrated that autologous growth factor injections did not

improve pain or function in plantar fasciopathy. The PRP

injection results were based on 3 low-quality studies, 2 for the

patellar tendon and 1 for the wrist flexors-extensors; level 3

(limited) evidence suggested that PRP injections improve pain

or function. The authors concluded that strong evidence

indicated that autologous growth factor injections do not

improve plantar fasciopathy pain or function when c ombined

with anesthetic agents or when compared with corticosteroid

injections, dry needling, or exercise therapy treatments.

Furthermore, limited evidence suggested that PRP injections

are beneficial. Except for 2 high-quality RCT studies, the rest

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were methodologically flawed. They stated that additional

studies should be conducted using proper control groups,

randomization, blinding, and validated disability outcome

measures for pain and function. Until then, the results remain

speculative because autologous whole-blood and PRP

injection treatments are not standardized.

Jastifer et al (2014) stated that a newly emerging technology,

low-level laser therapy (LLLT), has demonstrated promising

results for the treatment of acute and chronic pain. In a

prospective study examining the effects of LLLT for the

treatment of chronic plantar fasciitis, a total of 30 patients were

administered LLLT and completed 12 months of follow-up.

Patients were treated twice-weekly for 3 weeks for a total of 6

treatments and were evaluated at baseline, 2 weeks post-

procedure, and 6 and 12 months post-procedure. Patients

completed the VAS and Foot Function Index (FFI) at study

follow-up periods. Patients demonstrated a mean

improvement in heel pain VAS from 67.8 out of 100 at baseline

to 6.9 out of 100 at the 12-month follow-up period. Total FFI

score improved from a mean of 106.2 at baseline to 32.3 at 12

months post-procedure. The authors concluded that although

further studies are warranted, this study showed that LLLT is a

promising treatment of chronic plantar fasciitis.

ActiveMatrix

ActiveMatrix is a pre-mixed, ambient temperature human

placental connective tissue matrix intended to replace or

supplement damaged or inadequate integumental tissue. An

UpToDate review on “Plantar fasciitis” (Buchbinder, 2016)

does not mention ActiveMatrix, placenta, or allograft.

Cryo-Preserved Human Amniotic Membrane Injection

In a randomized, controlled, double-blind, pilot study,

Hanselman and colleagues (2015) compared a novel

treatment, cryo-preserved human amniotic membrane

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(c-hAM), to a traditional treatment, corticosteroid. The

hypothesis was that c-hAM would be safe and comparable to

corticosteroids for plantar fasciitis in regard to patient

outcomes. Patients were randomized into 1 of 2 treatment

groups: (i) c-hAM or (ii) corticosteroid. Patients received an

injection at their initial baseline visit with an option for a second

injection at their first 6-week follow-up. Total follow-up was

obtained for 12 weeks after the most recent injection. The

primary outcome measurement was the Foot Health Status

Questionnaire (FHSQ). The secondary outcome

measurements were the VAS and verbally reported

percentage improvement. Data were analyzed between

groups for the 2 different cohorts (1 injection versus 2

injections). A total of 23 patients had complete follow-up; 14

were randomized to receive corticosteroid and 9 were

randomized to receive c-hAM. Three patients in each group

received second injections. With the numbers available, the

majority of outcome measurements showed no statistical

difference between groups. The corticosteroid did, however,

have greater FHSQ shoe fit improvement (p = 0.0244) at 6

weeks, FHSQ general health improvement (p = 0.0132) at 6

weeks, and verbally reported improvement (p = 0.041) at 12

weeks in the 1-injection cohort. Cryo-preserved hAM had

greater FHSQ foot pain improvement (p = 0.0113) at 18 weeks

in the 2-injection cohort. The authors concluded that cryo-

preserved hAM injection may be safe and comparable to

corticosteroid injection for treatment of plantar fasciitis. They

stated that this was a pilot study and requires further

investigation.

L ight-Emitting Diode

Higgins et al (2015) compared the application of the light

emitting diode (LED) to sham LED in the treatment of plantar

fasciitis. A total of 18 subjects met the inclusion criteria and

were randomly assigned into 2 groups: (i) LED or (ii) sham

LED. The subjects received either the LED at 12 J/cm(2) or

sham LED along 2 points of the plantar fascia. Subjects in

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both groups received a 10 minute transverse friction massage

and participated in 4 plantar fascia stretching exercises. All

subjects received a total of 6 treatments over 3 weeks.

Progress was assessed using the lower extremity functional

and analog pain scale. No significant difference was found

between treatment groups (p = 0.845). There was a significant

difference in pain and outcome scores over time within both

groups (p < 0.35). The authors concluded that among patients

with plantar fasciitis, the use of LED did not result in greater

improvement in function or pain compared with sham

treatment.They stated that these findings suggested that

manual intervention and passive stretching activities may have

provided significant pain relief and improvement in functional

outcome scores.

Plantar Fascia Partial Release Guided by Ultrasonic Energy

Patel (2015) noted that chronic plantar fasciitis is a major

health care problem worldwide and affects nearly 10 % of the

US population. Although most cases resolve with conservative

care, the numerous treatments for refractory plantar fasciitis

attest to the lack of consensus regarding these cases. The

emerging goals for this condition are a minimally invasive

percutaneous intervention that is safe, effective, and well-

tolerated and has minimal morbidity and a low complication

rate. These researchers conducted a prospective study in

which patients were allowed either to continue with non-

invasive treatment or to undergo focal aspiration and partial

fasciotomy with an ultrasonic probe. They stated that this was

the first report of a plantar fascia partial release guided by

ultrasonic energy delivered by a percutaneously inserted

probe under local anesthesia. The author concluded that this

procedure appeared to be a safe, effective, well-tolerated

treatment for a condition that is refractory to other options.

These preliminary findings need to be validated by well-

designed studies.

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Transcranial Direct Current Stimulation

In an open-label, single-arm, pilot study, Concerto et al (2016)

examined if primary motor cortex anodal transcranial direct

current stimulation (tDCS) reduces chronic foot pain intensity

and improves depression and pain-related anxiety symptoms

in patients with chronic plantar fasciitis. A total of 10 patients

with symptomatic treatment-resistant plantar fasciitis were

enrolled in the study. The treatment consisted of anodal tDCS

over the motor area of the leg contralateral to the symptomatic

foot for 20 minutes, at 2 mA for 5 consecutive days. Pre-tDCS

(T0), post-tDCS (T1), 1 week (T2), and 4 weeks (T3) post-

treatment assessments were conducted consisting of the VAS

for pain intensity, the FFI, the Pain Anxiety Symptom Scale

(PASS-20), and the Hamilton Rating Scale for Depression

(HDRS-17 items). Anodal tDCS treatment induced a

significant improvement in pain intensity; FFI and PASS scores

that were maintained up to 4 weeks post-treatment. In

addition, patients reported taking fewer pain medication tablets

following the treatments. The authors concluded that these

findings indicated that anodal tDCS may be a viable treatment

to control pain and psychological comorbidity in elderly

patients with treatment-resistant foot pain. These preliminary

findings need to be validated by well-designed studies.

Ultrasound Therapy

An UpToDate review on “Plantar fasciitis” (Buchbinder, 2016)

states that “Exercises may be beneficial, although evidence is

limited. Home exercises include plantar and calf-plantar fascia

stretches, foot-ankle circles, toe curls, toe towel curls and

unilateral heel raises with toe dorsiflexion. Ultrasound therapy,

ice massage, and deep friction massage may be used prior to

exercise, although their effectiveness is unknown”.

In a prospective, randomized, double-blind, placebo-controlled

clinical trial,, Katzap and colleagues (2018) examined the

additive effect of therapeutic US in the treatment of plantar

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fasciitis in terms of pain, function, and quality of life (QOL). A

total of 54 patients with plantar fasciitis, aged 24 to 80 years,

who met the inclusion criteria were randomized into an active

intervention and a control group. Individuals in the active

intervention group were treated with self-performed stretching

of the plantar fascia and calf muscles and with therapeutic US.

Individuals in the control group were treated with the same

stretching exercises and sham US. Both groups received 8

treatments, twice-weekly. Outcome measures included a

numeric pain-rating scale, the computerized adaptive test for

the foot and ankle, and an algometric test. Both groups

showed statistically significant improvement in all outcome

measures (p < 0.001, both groups). At the completion of the

study, no statistically significant differences were found

between the groups in any of the outcomes. The authors

concluded that the addition of therapeutic US did not improve

the efficacy of conservative treatment for plantar fasciitis.

Thus, these investigators recommended excluding therapeutic

US from the treatment of plantar fasciitis and agreed with

results of previous studies that stretching may be an effective

treatment for healing plantar fasciitis. Level of Evidence = 1b

Platelet-Rich Plasma/Platelet-Poor Plasma

Chiew and associates (2016) reviewed to the effectiveness

and relevant factors of PRP treatment in managing plantar

fasciitis (PF). These investigators performed a search in

electronic databases, including PubMed, Scopus, and Google

Scholar using different keywords. Publications in English-

language from 2010 to 2015 were included; 2 reviewers

extracted data from selected articles after the quality

assessment was done. A total of 1,126 articles were retrieved,

but only 12 articles met inclusion and exclusion criteria. With a

total of 455 patients, a number of potentially influencing factors

on the effectiveness of PRP for PF was identified. In all these

studies, PRP had been injected directly into the plantar fascia,

with or without ultrasound (US) guidance. Steps from

preparation to injection were found equally crucial. Amount of

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collected blood, types of blood anti-coagulant, methods in

preparing PRP, speed, and numbers of time the blood

samples were centrifuged, activating agent added to the PRP

and techniques of injection, were varied between different

studies. Regardless of these variations, superiority of PRP

treatment compared to steroid was reported in all studies. The

authors concluded that PRP therapy might provide an effective

alternative to conservative management of PF with no obvious

side effect or complication; and the onset of action after PRP

injection also greatly depended on the degree of

degeneration. Major drawback of these studies were: (i) small

sample sizes, (ii) absence of placebo, diagnosis of PF, and

duration of follow-up. In addition, when selecting a

preparation system, many factors must be taken into account,

such as volume of autologous blood drawn, centrifuge

rate/time, leukocyte concentration, delivery method, activating

agent, final PRP volume and final platelet and growth-factor

concentration. The authors noted that due to differences in

PRP characteristics, reported evidence for the clinical

effectiveness of PRP cannot be generalized to all of these

systems. Furthermore, variation of hematologic parameters

between patients may also affect the final PRP preparation.

Controversies regarding the optimal quantity of platelets and

growth factors required for muscle and tendon healing still

persist. Vahdatpour and colleagues (2016) compared PRP

and whole blood (WB) for the treatment of chronic PF. Patients

with chronic PF received either an intralesional injection of 3 cc

PRP prepared by double centrifuge technique or WB (n = 17 in

each group). Overall, morning and walking pain severity were

assessed by 11-point numerical rating scale, and function was

assessed by the Roles and Maudsley score (RMS) at baseline

and 1-month and 3 months after treatment. Ultrasonography

was performed to measure plantar fascia thickness at baseline

and 3 months after treatment. Pain scores were reduced over

the study in the PRP (mean change of -5.00 ± 1.17 to -5.47 ±

1.46) and WB groups (mean change of -5.29 ± 2.56 to -6.47 ±

2.83), with no difference between groups (p > 0.05). One

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month and 3 months after treatment, successful treatment

(RMS of less than or equal to 2) was respectively observed in

29.4 % and 82.3 % of the PRP and in 47.1 % and 76.4 % of

the WB groups (p > 0.05). Also, fascia thickness was

decreased in both the PRP and WB groups (mean change of

-1.74 ± 1.11 versus -1.21 ± 0.73 mm, respectively, p = 0.115).

The authors concluded that significant improvement in pain

and function, as well as decrease in plantar fascia thickness,

was observed by intralesional injection of the PRP and WB in

patients with chronic PF. They noted that the study results

indicated similar effectiveness between PRP and WB for the

treatment of chronic PF in short-term. This study had several

major drawbacks: (i) the sample size was small (n= 17 in

each group), which affected the randomization quality as

well, (ii) the follow-up was only for 3 months, (iii) due to the

nature of the interventions, blinding of patients and

treatment providers were not easily possible though the

outcome assessors were not aware of the assigned

treatments in the study, (iv) the study had no placebo

control group and the observed therapeutic effects in the

study cannot be completely attributed to the ABDPs

injection, and (v) the decrease in plantar fascia thickness

after active interventions has not been observed by

placebo in previous studies. Moreover, the authors stated

that these findings need to be confirmed by further studies with

a larger sample of patients and longer follow-up duration.

Yang and colleagues (2017) evaluated the current evidence

concerning the efficacy and safety of PRP as a treatment for

PF compared with the safety and efficacy of steroid

treatments. Databases (PubMed, Embase, and The Cochrane

Library) were searched from their establishment to January 30,

2017, for RCTs comparing PRP with steroid injections as

treatments for PF. The Cochrane risk of bias (ROB) tool was

used to assess the methodological quality. Outcome

measurements were the VAS, Foot and Ankle Disability Index

(FADI), AOFAS scale,and the RMS. The statistical analysis

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was performed with RevMan 5.3.5 software. A total of 9 RCTs

(n = 430) were included in this meta-analysis. Significant

differences in the VAS were not observed between the 2

groups after 4 [weighted mean difference (WMD) = 0.56, 95 %

CI: -1.10 to 2.23, p = 0.51, I = 89 %] or 12 weeks of treatment

(WMD = -0.49, 95 % CI: -1.42 to 0.44, p = 0.30, I = 89 %).

However, PRP exhibited better efficacy than the steroid

treatment after 24 weeks (WMD = -0.95, 95 % CI: -1.80 to

-0.11, p = 0.03, I = 85 %). Moreover, no significant differences

in the FADI, AOFAS, and RMS were observed between the 2

therapies (p > 0.05). The authors concluded that limited

evidence supported the conclusion that PRP is superior to

steroid treatments for long-term pain relief; however,

significant differences were not observed between s hort and

intermediate effects. They stated that because of the small

sample size and the limited number of high-quality RCTs,

additional high-quality RCTs with larger sample sizes are

needed to validate these findings.

Malahias and colleagues (2018) stated that there are

conflicting reports regarding the therapeutic effect of PRP

versus autologous whole-blood (platelet poor plasma, PPP)

injections for plantar fasciitis. in a double-blinded,

randomized, prospective study, these researchers compared

the effectiveness of a single ultrasound (US)-guided PRP

versus PPP injection in patients with chronic plantar fasciitis.

A total of 36 patients were recruited with clinical and

sonographic evidence of chronic (greater than 6 months)

plantar fasciitis, refractory to analgesics and physical therapy.

Subjects were randomly allocated into 2 groups with a sealed

envelope method. Group A included 18 patients who

underwent a single US-guided PRP injection and group B

included another 18 patients who underwent PPP injection

with the same technique. Follow-up was set at 3 and 6

months; no patient was lost to follow-up. Pain, function and

satisfaction were assessed using VAS, and occurrence of

complications. All scores statistically significantly improved for

both groups from baseline at the 3- and 6-month follow-up

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evaluation, without, however, any statistically significant

differences between the 2 groups with respect to pain, function

and satisfaction scores. Complications were not observed.

The authors concluded that a single US-guided PRP injection

yielded similar results with PPP injection in patients with

chronic plantar fasciitis. Both treatments provided significant

improvement at 6-month follow-up after the injection. These

investigators stated that these findings questioned the

superiority of the PRP injection for these patients. They stated

that further studies with longer term follow-up would be

welcomed. Also, this was relative small study (n = 18 for the

PRP; and n = 18 for the PPP).

Furthermore, an UpToDate review on “Plantar

fasciitis” (Buchbinder, 2018) lists autologous whole blood or

PRP injections, botulinum toxin injection, cryosurgery, ESWT,

low-level laser therapy, and radiotherapy as unproven

treatments.

Radiofrequency Lesioning

In a prospective, comparative study, Osman and colleagues

(2016) evaluated the effect of applying pulsed radiofrequency

(PRF) for 6 minutes versus thermal radiofrequency (TRF) for

90 seconds to the medial calcaneal nerve for treatment of

chronic refractory plantar fasciitis pain. A total of 20 patients

with refractory chronic bilateral plantar fasciitis received PRF

to the medial calcaneal nerve for 6 minutes for 1 heel and TRF

to the same nerve on the other heel (as their own control) for

90 seconds. Numerical verbal rating scale (NVRS) at waking

up from bed and after prolonged walking, and satisfaction

score were used for assessment of studied patients at 1, 3, 6,

12, and 24 weeks from the intervention. All studied patients

showed significant improvement in their pain scale after the

intervention that lasted for 24 weeks; however, the PRF heels

had significantly better pain scale and satisfaction scores at

the 1st and 3rd weeks assessments when compared to the

TRF heels. Effective analgesia was achieved after 1 week or

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less after PRF compared to 3 weeks for the TRF (p < 0.001).

The authors concluded that PRF to the medial calcaneal nerve

is a safe and effective method for treatment of chronic plantar

fasciitis pain. The onset of effective analgesia can be

achieved more rapidly with PRF compared to TRF on the

same nerve. Moreover, they stated that further randomized

trials are needed to confirm the therapeutic effect and

optimizing the dose of RF needed.

Acupuncture

In a systematic review, Thiagarajah (2017) determined the

effectiveness of acupuncture in reducing pain due to plantar

fasciitis. Online literature searches on the PubMed and

Cochrane Library databases were done for studies on the use

of acupuncture for pain due to plantar fasciitis. Studies

designed as RCTs and which compared acupuncture with

standard treatments or had real versus sham acupuncture

arms were selected. The Delphi List was used to assess the

methodological quality of the studies retrieved. A total of 3

studies that compared acupuncture with standard treatment

and 1 study on real versus sham acupuncture were found.

These showed that acupuncture significantly reduced pain

levels in patients with plantar fasciitis, as measured on the

VAS and the Plantar Fasciitis Pain/Disability Scale. These

benefits were noted between 4 and 8 weeks of treatment, with

no further significant reduction in pain beyond this duration.

Side effects were found to be minimal. The authors concluded

that although acupuncture may reduce plantar fasciitis pain in

the short-term, there is insufficient evidence for a definitive

conclusion regarding its effectiveness in the longer term. They

stated that further research is needed to strengthen its

acceptance among healthcare providers.

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An UpToDate review on “Plantar fasciitis” (Buchbinder, 2016)

lists ESWT, cryosurgery, autologous whole blood or PRP

injections, botulinum toxin injection, low-level laser therapy,

and radiotherapy as unproven treatments. Furthermore, it

does not mention acupuncture as a therapeutic option.

Ex tracorporeal Shock Wave Therapy

Sun and associates (2017) performed a meta-analysis to

compare the efficacy of general ESWT, focused shock wave

(FSW), and radial shock wave (RSW) with placebo, to assess

their effectiveness in chronic PF. The PubMed, Medline,

EmBase, Web of Science, and Cochrane library databases

were searched for studies comparing FSW or RSW therapy

with placebo in chronic PF. Clinical outcomes included the

odds ratios (ORs) of pain relief, pain reduction, and

complications. Relevant data were analyzed using R evMan

v5.3. A total of 9 studies involving 935 patients were included;

ESWT had higher improvement rates than the placebo group

(OR 2.58, 95 % CI: 1.97 to 3.39, p < 0.00001); ESWT had

markedly lower standardized mean difference than placebo,

with heterogeneity observed (SMD 1.01, 95 % CI: -0.01 to

2.03, p = 0.05, I = 96 %, p < 0.00001). FSW and RSW therapies

had greater therapeutic success in pain relief than the placebo

group (OR 2.17, 95 % CI: 1.49 to 3.16, p < 0.0001; OR 4.63, 95

% CI: 1.30 to 16.46, p = 0.02), but significant heterogeneity was

observed in RSW therapy versus placebo (I = 81 %, p = 0.005).

The authors concluded that this meta-analysis suggested that

FSW therapy can relieve pain in chronic PF as an ideal

alternative option; meanwhile, no firm conclusions of general

ESWT and RSW effectiveness can be drawn. Moreover, they

stated that due to variations in the included studies, additional

trials are needed to validate these conclusions.

Salvioli and colleagues (2017) stated that plantar heel pain is

one of the most common causes of pain and musculoskeletal

pathologies of the foot. These researchers identified the most

effective, conservative and non-pharmacological treatments

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regarding pain in patients with plantar heel pain. They

searched 5 databases and included only RCTs that examined

the efficacy of a conservative,non-pharmacological treatment

compared to the placebo, for the outcome of pain. Study

selection, data collection and risk of bias assessment were

conducted independently by 2 authors, and consensus was

reached with a 3rd author. Results were quantitatively

summarized in meta-analyses, by separating homogeneous

subgroups of trials by type of intervention. A total of 20

studies that investigated the efficacy of 9 different types of

interventions were included, with a total of 4 meta-analyses

carried out. The interventions: shock waves, laser therapy,

orthoses, pulsed radiofrequency, dry-needling, and calcaneal

taping resulted in being effective treatments for the outcome

pain in patients with plantar heel pain when compared to the

placebo. However, the authors stated that considering that the

improvements were very small, and the quality of evidence

was mostly low or moderate for many of the interventions, it

was not possible to give definitive conclusions for clinical

practice.

Local Ozone (O2-O3) Injection

In a randomized clinical trial, Babaei-Ghazani and colleagues

(2018) compared the effects of ozone (O2-O3) injection to

corticosteroid injection ( CSI) under US-guidance for the

treatment of patients with chronic PF (n = 30). Subjects were

randomly divided into 2 groups receiving methylprednisolone

(n = 15) versus ozone (O2-O3; n = 15). The following outcome

measures were assessed before injection and t hen 2 weeks

and 12 weeks after the injection in each group; morning and

daily pain via VAS, daily life and exercise activities via the Foot

and Ankle Ability Measure, and plantar fascia thickness at

insertion and 1 cm distal to its insertion into the calcaneus via

US imaging. Intra-group changes showed significant

improvement in pain, functional parameters, and sonographic

findings in both groups (p < 0.05). Pain reduction (both daily

and morning) and daily activity improvement were better in the

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corticosteroid group 2 weeks after injection; however, at 12 weeks ,

the ozone (O2-O3) group had significantly more

improvement (p = 0.003, p = 0.001, and p = 0.017,

respectively). The authors concluded that both methods were

effective in the treatment of chronic PF; CSI provided a more

rapid and short-term therapeutic effect. However, ozone (O2-

O3) injection results in a slow and longer-lasting treatment

outcome. This was a small (n = 15 for the ozone group) with

short-term follow-up (12 weeks). These preliminary findings

need to be validated by well-designed studies.

Neural Therapy (Injection of Local Anesthetics)

In a case-report, Fleckenstein and colleagues (2018)

examined the role of inflammation as a contributor to pain in

plantar fasciitis and its cure by neural therapy (injection of local

anesthetics). This was a case report on a 24-year old man, a

middle-distance runner, with chronic unilateral plantar fasciitis

and perceived heel pain for almost 1.5 years. He was treated

with neural therapy (injection of less than 1 ml procaine 1 %

which is a local anesthetic with strong anti-inflammatory

properties) of the surgical scar and along the surgical puncture

channel. The follow-up period from the time of 1st

presentation until publication was 2.5 years. At admission,

pain intensity (VAS) in the affected leg was severe (10 cm,

VAS; range of 0 to 10 cm) when walking and moderate (5 cm,

VAS) when standing. After the 1st session of injections the

subject could stand pain-free and pain when w alking w as

markedly reduced ( - 90 %). After the 3rd session, the subject

reported no pain in the affected leg and could return to sports

at his former level (no difference in training load compared to

non-injured state). There was no recurrence of inflammatory

signs or heel pain despite intense athletics training up t o the

date of publication. The authors concluded that in prolonged

cases of plantar fasciitis, inflammation is an important

component in the development of persistent pain. The results

of this case described the effects of 3 neural therapy sessions

that abolished inflammation and associated heel pain. They

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stated that neural therapy might be an effective and time-

efficient approach in the treatment of plantar fasciitis, enabling

an early return-to-sports. These preliminary observations

need to be validated by well-designed studies.

Piezoelectric Focal Waves Application

Vaamonde-Lorenzo and colleagues (2018) evaluated the

effectiveness of Piezoelectric focal Shock waves with

echographic support in the treatment of PF. A total of 90

patients, 36.6 % men and 63.3 % women, with a mean age of

52 years, diagnosed with PF enrolled in this trial; 3 sessions (1

weekly for 3 weeks) of shock wave therapy (PiezoWave F10

G4 generator) were performed, with echographic support and

weekly revision and at 3 and 6 months. Main outcome

measures were pain, using VAS before and after each session

and at 3 and 6 months and Roles and Maudsley Scale at the

end of treatment and at 3 and 6 months. A total of 2,000

pulses per session were applied, medium energy intensity

0.45 mJ/mm2, median frequency 8 MHz and median depth of

focus of 15 mm. Statistically significant improvement was

observed in the VAS between the 3 treatment sessions and

after 3 and 6 months post-treatment, obtaining a statistically

significant improvement in all values (p < 0.05). The authors

concluded that treatment with piezoelectric focal shock waves

in PF may reduce pain from the 1st session and achieved a

subjective perception of improvement, maintaining these

results at 6 months post -treatment. These preliminary

findings need to be validated by well-designed studies with

larger sample sizes and longer follow-up.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

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Code Code Description

CPT codes covered if selection criteria are met:

29893 Endoscopic plantar fasciotomy

CPT codes not covered for indications listed in the CPB:

Low-Level Laser Therapy, Micronized dehydrated amniotic/chorionic membrane allograft, piezoelectric focal waves application - no specific code :

0232T Injection(s), platelet rich plasma, any tissue,

including image guidance, harvesting and

preparation when performed

0481T Injection(s), autologous white blood cell

concentrate (autologous protein solution), any

site, including image guidance, harvesting and

preparation, when performed

20552 Injection(s); single or multiple trigger point(s), 1

or 2 muscle(s)

20553 Injection(s); single or multiple trigger point(s), 3

or more muscle(s)

20560 Needle insertion(s) without injection(s); 1 or 2

muscle(s)

20561 3 or more muscles

27687 Gastrocnemius recession (e.g., Strayer

procedure)

28890 Extracorporeal shock wave, high energy,

performed by a physician or other qualified

healthcare professional, requiring anesthesia

other than local, including ultrasound gui dance,

involving the plantar fascia

64642 -

64645

Chemodenervation of one extremity

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77401 -

77417

Radiation treatment delivery

97035 Application of a modality to 1 or more areas;

ultrasound, each 15 minutes

97810 -

97814

Acupuncture without/with electrical stimulation

Other CPT codes related to the CPB:

28008 Fasciotomy, foot and/or toe [not covered when

guided by ultrasonic energy]

28060 Fasciectomy, plantar fascia; partial (separate

procedure) [not covered when guided by

ultrasonic energy]

28062 radical (separate procedure) [not covered

when guided by ultrasonic energy]

28250 Division of plantar fascia and muscle (eg,

Steindler stripping) (separate procedure) [not

covered when guided by ultrasonic energy]

HCPCS codes not covered for indications listed in the CPB:

Kinesio Tex taping, local ozone (O2-O3) injection - no specific code:

C 9290 Injection, bupivacaine liposome, 1 mg

E0761 Non-thermal pulsed high frequency radiowaves,

high peak power electromagnetic energy

treatment device

E0769 Electrical stimulation or electromagnetic wound

treatment device, not otherwise classified

G6001 -

G6014

Radiation treatment delivery

J 0585 Injection, onabotulinumtoxina A, 1 unit

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J0586 Injection, abolotulinumtoxina A, 5 units

J0587 Injection, rimabotulinumtoxin B, 100 units

J0588 Injection, incobotulinumtoxin A, 1 unit

J1030 Injection, methylprednisolone acetate, 40 mg

J2001 Injection, lidocaine HCl for intravenous infusion,

10 mg

P9020 Platelet rich plasma, each unit

Q4139 Amniomatrix or biodmatrix, injectable, 1 cc

Q4155 Neoxflo or clarixflo 1 mg

S8948 Application of modality (requiring constant

provider attendance) to one or more areas; low-

level laser; each 15 minutes

Other HCPCS codes related to the CPB:

A4570 Splint

L3000 -

L3265

Orthopedic shoes

L3300 -

L3649

Shoe modifications

L4350 -

L4398

Splint, ankle, foot, leg

S8451 Splint, prefabricated, wrist or ankle

ICD- 10 codes covered if selection criteria are met:

M72.2 Plantar fascial fibromatosis

M77.30 -

M77.32

Calcaneal spur

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chronic plantar fasciitis/heel spur syndrome: Surgical

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors

in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely

responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is

subject to change.

Copyright © 2001-2020 Aetna Inc.

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0235 Plantar Fasciitis

Treatments

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania updated 03/23/2020

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http://www.aetnabetterhealth.com/pennsylvania

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