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Philadelphia Panel Evidence-Based Clinical Practice Guidelines on
Selected Rehabilitation Interventions for Low Back Pain
Han, Yueh-Chin
Phys Ther. 2001;81:1641-1674
Introduction
60-90% of the adult population is at risk of developing LBP at some point in their lifetime. 30% develop chronic LBP
Impact on functional ability, restricting occupational activities with marked socioeconomic repercussions.
Different practitioners treat people with LBP
Purpose– to describe the evidence-based clinical practice guidelines (EBCPGs) developed by panel about rehabilitation interventions for LBP. Target users: PT, physiatrists, orthopedic surgeons, rheumat
ologists, family physcians, and neurologists
Methods--1
Literature search: Randomized control trials (RCTs), nonrandomized control clinic
al trials (CCTs), or case control or cohort studies
Non-specific LBP: pain between the gluteal fold and he uppermost lumbar vertebrae, including postsurgery back pain
Interventions: massage, thermal therapy (hot or cold packs), ES, EMG biofeedback, TENS, therapeutic ultrasound, therapeutic exercises, and combinations.
Outcomes: functional status, pain, ability to work, clobal improvement, satisfaction and quality of life
Language: English-, French-, and Spanish-
Methods--2 Databases :
Electronic databases of MEDLINE,EMBASE,Current Contents, CINAHL,and Cochrane Controlled Trials Register up to July 1, 2000
The registries of the Cochrane Field of Rehabilitation and Related Therapies and the Cochrane Musculoskeletal Group and the Physiotherapy Evidence Database (PEDro)
2 independent reviewers:titles and abstracts (prior checklist)
2 independent reviewers:full articles Predetermined extraction forms Population characteristics, interventions. Trial design, allocation co
ncealment, and outcomes Methodological quality: 5-point validated scale– 2 points each for ra
ndomization and double-blinding and 1 points for description and withdrawals
Methods--3
Data analyzed time : 1 month, 6months, and 12 months post-therapy The closest time
3 categories of LBP Acute (< 4 weeks duration) Subacute (4-12 weeks duration) Chronic ( > 12 weeks duration) Excluded: mixed acute and chronic disease durations Subacute and chronicchronic
Statistical Analysis--1
Data analyzed using Reviews Manager (RevMan) computer program, version 4.1 for Windows
Continuous data: weight mean differences between the treatment and control groups Standardized mean differences for different scales
Dichotomous data: relative risks Heterogeneity: chi-square
Significant: random-effects models Not significant: fixed-effects models
Recommendations
Clinical improvement: 15% relative to a control
Level of evidence (I or II) Strength of evidence (A, B, C) Survey questionnaire to 324
practitioners
Results
Results
Literature Search 4981 articles related o LBP 340 considered potentially relevant based on the selection criteria
checklist 41 met the selection criteria
324 practitioner feedback survey: from the American Academy of Family Physicians (AAFP), American Academy of Orthopaedic Surgeons (AAOS), American College of Physicians (ACP), American Physical Therapy Association (APTA), American College of Rheumatology Health Professionals (ARHP), Physiatric Association of Spine, Sports, and Occupational Rehabili
tation (PASSOR) 51% response rate, 47% completed the survey
Number of included trials
Acute LBP –Therapeutic Exercises
Level I(RCT), Grade C for pain, function and return to work 4 RCTs (N=1035) McKenzie, back extension, Kendall flexio
n, and Strengthening ex. 1-3 sessions per weeks for 4-8 weeks
Efficacy: Therapeutic exercise no better than contr
ol at 1 or 12 months Pooled estimates at 1 months were not cli
nical for pain, function, or return to work No different between types of exercise
Acute LBP –Therapeutic Exercises
Strength of evidence compared with other guidelines Consistent with the Québec Task Force on Spinal Disorders (QTF),
the Agency for Health Care Policy and Research (AHCPR)
Clinical recommendations compared with other guidelines Poor evidence to include or exclude stretching or strengthening ex
ercise alone as an intervention for acute LBP Agree with AHCPR and BMJ The BMJ: increase stress from therapeutic exercise may harmful In contrast, QTF: general exercise as an option to increase strengt
h, ROM, and endurance but not discriminate between different types of exercise
Acute LBP – Continuation of Normal Activities vs. Enforced Bed Rest
Level I, Grade A for return to work, grade C for pain ad function One RCT(N=186) of continuing normal activities(CNA) versus 2 days
of enforced bed rest(EBR) Efficacy:
CNA 49% fewer sick days after 3 weeks related to EBR CAN 10% better for functional status and 5% for pain After 3 months, 51% fewer sick days, 10% better function (Oswestry scal
e), and 5% less pain (10-cm VAS)
Strength of evidence compared with other guidelines Similar to AHCPR of functional activities on return to work (level I)
Clinical recommendations compared with other guidelines Grade A for return to work, grade C for pain and function Agree with AHCPR BMJ: no discussion to normal activities as an inervention QTF: not discriminate between normal activities and stretching and streng
thening
Acute LBP – Continuation of Normal Activities vs. Enforced Bed Rest
Practitioner agreement Response rate for this EBCPG: 46% Percentage of practitioners giving comments for EBCPG: 41% Agree with recommendation: 98% Think a majority of my colleagues would agree: 98% Will (or already) follow this recommendation: 98%
Practitioner comments: Guideline should differentiate acute herniated disk,which may ben
efit from bed rest. Amount of bed rest is important—more than 72 hours is unnecess
ary. Panel’s response:
Excluded disk involvement A Cochrane review: short(2 days) or long(7 days) bed rest: no dif.
Acute LBP – Mechanical Traction
Level I(RCT), grade C for pain and global assessment 3 RCTs (N=176) of intermittent mechanical traction vs. place
bo; 1 RCT (N=16) vertical traction vs. bed rest Efficacy:
No difference at 1 month for improve pain (relative risk=0.88, 95% CI=0.50-1.55) or pain (-3.4mm on 100-mm VAS, 95% CI= -21.2-14.5)
No evidence in pain for vertical traction or global improvement
Acute LBP – Mechanical Traction
Strength of evidence compared with other guidelines QTF, no scientific evidence AHCPR moderate scientific evidence of lack of benefit
Clinical recommendations compared with other guidelines Poor evidence to include or exclude mechanical traction alone as a
n intervention for acute LBP Agree with AHCPR and BMJ BMJ reported potential harms: (not validated in trails)
• Debilitation• Loss of muscle tone• Bone demineralization• thrombophlebitis
In contrast, QTF: mechanical traction as an option to increase ROM
Acute LBP – Therapeutic Ultrasound Level II(CCT), grade C for pain One nonrandomized controlled trial(N=73) of
ultrasound vs. placebo Efficacy
No difference for pain improvement ROM of flexion and extension was improved after 1 month
Acute LBP – Therapeutic Ultrasound
Strength of evidence compared with other guidelines QTF, no scientific evidence AHCPR: agrees with this EBCPG
Clinical recommendations compared with other guidelines Poor evidence to include or exclude therapeutic ultrasound alone a
s an intervention for acute LBP Agree with AHCPR and BMJ QTF: as an option to diminish muscle spasm and pain release Thermotherapy, Pulsed US?
Acute LBP – TENS
Level I(RCT), grade C for pain or function One RCT(N=58) compared TENS and placebo
15 minutes of high-frequency TENS followed by 15 minutes of acupuncture-like TENS
Efficacy: No dif. in VAS pain, functional status, strength, or ROM at 1 month
Acute LBP – TENS
Strength of evidence compared with other guidelines Similar to AHCPR: one used electroacupunture, not TENS QTF: no scientific evidence
Clinical recommendations compared with other guidelines Poor evidence to include or exclude TENS alone as an intervention
for acute LBP Agree with AHCPR and BMJ QTF: as a useful modality for pain relief
Acute LBP – Intervention for Insufficient Data
No evidence with acceptable research design, intervention, group comparisons, and outcomes were identified for thermotherapy, ES, massage, or EMG biofeedback Lack of evidence with both QTF and AHCPR QTF recommended thermotherapy, massage, and EMG biofeedba
ck as potential interventions for acute LBP
Combination intervention: poor definitions of intervention, population r nonstandard outcomes.
Subacute LBP –Therapeutic Exercises
Level I(RCT),Grade A for pain, function and global assessment 3 RCTs (N=405) McKenzie,Kendall, and strengthening ex. Twice per weeks for 4 weeks
Efficacy: Benefit on pain relief and global condition More pain relief relative to control: 10% for strengthening ex. along, 11
% for Kendall flexion, 50 % and 57 % for McKenzie ex. Functional status improvement relative to control: 11% for McKenzie e
x. 15% for strengthening ex. Global improvement: 17 % to 24 % for McKenzie ex, not statistical diff.
Subacute LBP –Therapeutic Exercises
Strength of evidence compared with other guidelines Disagrees with QTF: no scientific evidence for general ex AHCPR: 3 trials– 1 chronic LBP, 1 with psychological intervention,
1 involving a back school
Clinical recommendations compared with other guidelines Good evidence to include extension,flexion,and strengthening ex. Not for patients with neurological or radicular pain Partial concordance with AHCPR: low-stress aerobic ex within the
first 4 weeks (acute LBP) BMJ: agreement with the EBCPG, but increase stress may harmfu
l QTF: general ex. As option to increase strength, ROM and endura
nce
Subacute LBP –Therapeutic Exercises
Practitioner agreement Response rate for this EBCPG: 49% Percentage of practitioners giving comments for EBCPG: 32% Agree with recommendation: 90% Think a majority of my colleagues would agree: 88% Will (or already) follow this recommendation: 93%
Practitioner comments Selection of exercises depends on clinical presentation; if there are
neurological or sensory deficits,exercises could exacerbate the pain Type of exercise (eg, Kendall, McKenzie) depends on patient. A combined approach with education is needed.
Panel’s response Patients with neurological/ radicular pain Individualized approach, clinical opinion but little empiric evidence Educational on posture and biomechanics (1 has, not in 2)
Subacute LBP – Mechanical Traction
Level I(RCT), grade C for global assessment and return to work
2 RCTs (N=212) of static traction vs. placebo Efficacy:
No clinical improvement for global assessment at 1 month return to work at 12 months
Subacute LBP – Mechanical Traction
Strength of evidence compared with other guidelines QTF, no scientific evidence AHCPR moderate scientific evidence of no benefit
Clinical recommendations compared with other guidelines Poor evidence to include or exclude mechanical traction alone as a
n intervention for subacute LBP Agree with AHCPR and BMJ BMJ reported potential harms: (not validated in trails)
• Debilitation• Loss of muscle tone• Bone demineralization• thrombophlebitis
In contrast, QTF: mechanical traction as an option to increase ROM
Chronic LBP –Therapeutic Exercises
Level I(RCT), Grade A for pain, function, grade C for return to work 8 RCTs (N=1035) Flexion, extension, stretching, circuit training, strength ex. with pro
gressive increases in resistance Efficacy:
Pain relief relative to control (5 RCTs); 2 RCTs—no difference Functional status: improve in 3 RCTs (N=209) related to control wi
th stretching ex., with strengthening, stretching, and aerobics, and with strengthening ex.
No different in ROM, strength, or reurn o work 1 RCTs (n=56): no difference between flexion and extension ex. f
or pain or global assessment at 1 month posttherapy
Chronic LBP –Therapeutic Exercises
Efficacy: At 6-12 months follow-up (2 RCTs) Pain relief: 60%, function improve: 0% (1 trial) Function improve: 30%(another trial)
Chronic LBP –Therapeutic Exercises
Strength of evidence compared with other guidelines QTF: no scientific evidence for general exercise (only one of
trails )
Clinical recommendations compared with other guidelines Good evidence to include stretching or strengthening, and
mobility exercise as interventions for acute LBP Agree BMJ: strengthening exercise QTF: general exercise as an option to increase strength, ROM,
and endurance but could have adverse effects due to increased stress on the spine
Chronic LBP –Therapeutic Exercises Practitioner agreement
Response rate for this EBCPG: 48% Percentage of practitioners giving comments for EBCPG: 38% Agree with recommendation: 88% Think a majority of my colleagues would agree: 91% Will (or already) follow this recommendation: 81%
Practitioner comments Evidence for functional status is not convincing Be careful about lumping different types of exercise McKenzie exercises are insufficient for chronic LBP,useful only for acute LBP Abdominal muscle re-education for spondylolisthesis should be included. Neuromotor retraining should be included in this EBCPG
Panel’s response 15% function improvement related to control group Not lumped different exercises (separately in table 9 and table 10) Educational on posture and biomechanics (1 has, not in 2) McKenzie ex. For chronic LBP in only one trail Combined heat, massage and ultrasound, but not the control No controlled studies evaluating the effectiveness of neuromotor retraining
Chronic LBP – Mechanical Traction
Level I(RCT), grade C for pain, function, global assessment, and return to work
4 RCTs (N=176)2intermittent traction and 2 static vs. placebo;
Efficacy: No difference in pain, function, global assessment
Chronic LBP – Mechanical Traction
Strength of evidence compared with other guidelines QTF, no scientific evidence
Clinical recommendations compared with other guidelines Poor evidence to include or exclude mechanical traction alone as a
n intervention for acute LBP Agree with BMJ,reported potential harms (not validated in trails)
• Debilitation• Loss of muscle tone• Bone demineralization• thrombophlebitis
In contrast, QTF: mechanical traction as an option to increase ROM
Chronic LBP – Therapeutic Ultrasound Level II(CCT), grade C for pain One RCT (N=36) of ultrasound vs. placebo Efficacy
No difference for pain improvement No data reported for ROM, strength, quality of life, function, or
return to work
Chronic LBP – Therapeutic Ultrasound
Strength of evidence compared with other guidelines Fair scientific evidence (level II) in this EBCPG QTF: no scientific evidence
Clinical recommendations compared with other guidelines Poor evidence to include or exclude therapeutic ultrasound alone
as an intervention for chronic LBP Agree with BMJ QTF: as an option to diminish muscle spasm and pain release
Chronic LBP – TENS
Level I(RCT), grade C for pain or function 4 RCT(N=235) compared TENS and placebo
Application acupuncture-like and alternate between both low- and high-frequency TENS in one
High-frequency TENS (>10 Hz) in 2 trails Low-frequency TENS (4 Hz) in 1
Efficacy: No difference in the pooled estimate of pain at 1 month post-therapy No difference for function status, ROM, or strength at 1 month
Chronic LBP – TENS
Strength of evidence compared with other guidelines Disagrees with QTF: weak scientific evidence based on a CCT
(excluded due to compare with massage )
Clinical recommendations compared with other guidelines Poor evidence to include or exclude TENS alone as an intervention
for chronic LBP Agree with BMJ QTF: as a useful modality for pain relief
Chronic LBP – EMG Biofeedback
Level I(RCT), grade C for pain or function 5 RCT(N=162) compared EMG biofeedback and placebo Efficacy:
No effect on pain relief, function, or ROM at 1 month post-therapy
Chronic LBP – EMG Biofeedback
Strength of evidence compared with other guidelines Good scientific evidence showed no clinical benefit on pain or
function with EMG Biofeedback QTF: no scientific evidence
Clinical recommendations compared with other guidelines Poor evidence to include or exclude TENS alone as an intervention
for chronic LBP BMJ: conflicting evidence QTF: as a useful modality for reduce muscle spasm
Chronic LBP – Intervention for Insufficient Data
No evidence with acceptable research design, intervention, group comparisons, and outcomes were identified for thermotherapy, ES, or massage Lack of evidence with both QTF and BMJ Both QTF and BMJ recommend massage as an intervention for chr
onic LBP
Combination intervention: poor definitions of intervention, population r nonstandard outcomes.
Deep abdominal stabilization ex. For patients with chronic spondylolisthesis improved pain and function relative to general ex., heat, massage, and therapeutic ultrasound (no placebo comparison group)
Postsurgery BP–Therapeutic Exercises
Level I (RCT), grade A for pain and function 1 RCT(N=200), 3 groups (strengthening, McKenzie, control) Efficacy:
Clinical benefit on pain and function with 2 types of ex. vs. control Function status in table 11 Exercise groups improved more on ROM and strength at 2 month Extended the re-enter treatment time for LBP
Postsurgery BP–Therapeutic Exercises
Strength of evidence compared with other guidelines QTF: no scientific evidence for general exercise
Clinical recommendations compared with other guidelines Good evidence to include stretching or strengthening, extension ex
ercise as interventions for postsurgery LBP Agree BMJ /QTF: strengthening/ therapeutic exercise BMJ: increased stress on the spine is a potential risk of therapeutic
exercise
Postsurgery BP –Therapeutic Exercises
Practitioner agreement Response rate for this EBCPG: 46% Percentage of practitioners giving comments for EBCPG: 24% Agree with recommendation: 90% Think a majority of my colleagues would agree: 83% Will (or already) follow this recommendation: 91%
Practitioner comments High-technology equipment is not practical in a clinical situation (iso
tonic or isokinetic)
Panel’s response Either high-technology exercise or low-technology (traditional stren
gthening and McKenzie exercise) be used for postsurgery LBP
Discussion
Discussion -- 1
Complex issue: certain intervention such as crytherapy, ho pack application, and massage are used for pain relief or as a treatment preparation before the main intervention
Influenced by a number of risk factors: biological, psychosocial, and occupational health indicators
Largely in agreement with previous and relatively recent EBCPGs
Feedback from the practitioners: clinical ease of use
Exercise
Continuation of normal activities for acute LBP Extension, strength or flexion exercise
For subacute, chronic and postsurgery For acute: agreement, moderate effective, advice to stay active,
negative effects of immobilization and bed rest Task-oriented activities
Future studies Clarifying types of exercise, intensity Patient-specific classification of physical dysfunction, need, reat
ment goals, and outcomes
Mechanical Traction
Static, intermittent, or vertical traction in acute, subacute, and chronic LBP: no benefit
Agree with previous systematic reviews for acute and chronic LBP management
To the patients with neurological signs Current literature does not support the suggestion
Therapeutic Ultrasound
Lacking evidence for effectiveness
Agrees with the AHCPR and BMJ guidelines
QTF: for muscle spasm and pain relief (common practice)
The available 2 trails were both of low quality (0 out of 5)
Pulsed type may be more effective than continuous type in acute condition (non-thermal effect)
TENS
No consistent benefit was shown on clinical outcomes for acute, subacute, or chronic LBP
No diff. between acute and chronic condition, low- and high- quality studies, or conventional and acupuncture-like application, or duration of TENS session
Agree with AHCPR and BMJ
QTF: for pain relief
Vibratory stimulation has been as part of the TENS (not included)
Therapeutic Massage
Insufficient data to make recommendation
Agree with AHCPR
BMJ and QTF: for relief muscle spasm
Influenced by the type of maneuvers used, therapist’s experience, number and size of muscles involved, patient position, press exerted, rhythm and progression, the frequency and duration of the treatment sessions
Thermotherapy
Insufficient evidence to make recommendation
Agree with AHCPR and QTF guidelines in chronic LBP
QTF: for acute LBP
Ice or heat were used in conjunction with other inerventions
Significant effects of crytherapy on circulatory and temperature responses on muscle spasm and inflammation translate to clinical effects? (thick muscles)
Electrical Stimulation
Insufficient evidence to make recommendation
Agree with AHCPR
BMJ and QTF: not evaluate his modality
ES to increase functional activities with intact peripheral nervous system
EMG Biofeedback
No consistent clinical benefit for EMG biofeedback for either acute or chronic LBP
Concordance with other guidelines
May be important in the relief of muscle spasm in people with acute LBP
Combined rehabilitation Interventions
QTF and BMJ: specialist use intervention in combination at their own discretion to achieve treatment goals
Difficult studies in combination of treatment
Overall
The main difficulty in determining the effectiveness of rehabilitation intervention is lack of weel-designed prospective RCTs
An appropriate placebo, adequate randomization, homogeneous sample of patients, adequate sample size to detect clinical important differences with confidence
Conclusion
There is evidence to use of continued normal activities for acute nonspecific LBP Therapeuic exercise for chronic, subacute, and postsurgery LBP
Developing with a transdisciplinary team approach, using structured methodology, including practitioner feedback
Lack of evidence of thermotherapy, therapeuic massage, EMG biofeedback, mechanical traction, therapeutic ultrasound, TENS, ES, and combined intervention (include or exclude)
Thank You!!