Motor control exercise for symptomaticlumbar disc herniation: protocol for asystematic review and meta-analysis

Mohammad Reza Pourahmadi,1 Morteza Taghipour,2 Ismail Ebrahimi Takamjani,1

Mohammad Ali Sanjari,3 Mohammad Ali Mohseni-Bandpei,4,5 Abbas Ali Keshtkar6

To cite: Pourahmadi MR,Taghipour M, EbrahimiTakamjani I, et al. Motorcontrol exercise forsymptomatic lumbar discherniation: protocol for asystematic review and meta-analysis. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426

▸ Prepublication history andadditional material isavailable. To view please visitthe journal (http://dx.doi.org/10.1136/bmjopen-2016-012426).

Received 25 April 2016Revised 30 August 2016Accepted 1 September 2016

For numbered affiliations seeend of article.

Correspondence toMorteza Taghipour;taghipour-morteza@hotmail.com

ABSTRACTIntroduction: Lumbar disc herniation (LDH) is acommon condition in adults and can impose a heavyburden on both the individual and society. It is definedas displacement of disc components beyond theintervertebral disc space. Various conservativetreatments have been recommended for the treatmentof LDH and physical therapy plays a major role in themanagement of patients. Therapeutic exercise iseffective for relieving pain and improving function inindividuals with symptomatic LDH. The aim of thissystematic review is to evaluate the effectiveness ofmotor control exercise (MCE) for symptomatic LDH.Methods and analysis: We will include all clinicaltrial studies with a concurrent control group whichevaluated the effect of MCEs in patients withsymptomatic LDH. We will search PubMed, SCOPUS,PEDro, SPORTDiscus, CINAHL, CENTRAL and EMBASEwith no restriction of language. Primary outcomes ofthis systematic review are pain intensity and functionaldisability and secondary outcomes are functional tests,muscle thickness, quality of life, return to work,muscle endurance and adverse events. Study selectionand data extraction will be performed by twoindependent reviewers. The assessment of risk of biaswill be implemented using the PEDro scale. Publicationbias will be assessed by funnel plots, Begg’s andEgger’s tests. Heterogeneity will be evaluated using theI2 statistic and the χ2 test. In addition, subgroupanalyses will be conducted for population and thesecondary outcomes. All meta-analyses will beperformed using Stata V.12 software.Ethics and dissemination: No ethical concerns arepredicted. The systematic review findings will bepublished in a peer-reviewed journal and will also bepresented at national/international academic andclinical conferences.Trial registration number: CRD42016038166.

INTRODUCTIONLumbar disc herniation (LDH) and disc pro-trusion are one of the most common spinaldegenerative disorders, which can lead tolow back pain (LBP) and radicular leg pain.1

It is a pathological condition that frequently

affects the spine in young and middle-agedadults.2 This condition is defined as a dis-placement of disc components (nucleus pul-posus or annulus fibrosis) beyond theintervertebral disc space.2–5 It has beenshown that LDH is the most common causeof radiculopathy (90%).6 7 The highestprevalence of disc herniation is amongadults aged 30–50 years, with a male tofemale ratio of 2:1.4 In adults aged 25–55 years, about 95% of LDH predominantlyoccurs at the L4–5 and L5–S1 spinal levels.4

Disc herniation above these levels is morecommon in adults aged over 55 years.4

However, it has been reported that LDH isnot always accompanied by clinical symptomssuch as LBP (asymptomatic LDH).1 Studiesby Boden et al8 and Jensen et al9 indicatedthat 24–27% of asymptomatic subjects havedisc herniation. In addition to the generalwear and tear (degenerative joint disease)that comes with ageing, many risk factorshave been reported for LDH, such as gender,weight, profession, smoking, psychosocial

Strengths and limitations of this study

▪ This systematic review and meta-analysis willevaluate the effectiveness of motor control exer-cise for symptomatic lumbar disc herniation.There will be no limitation by language and greyliterature will be included if identified through thesearches.

▪ This protocol was prepared according to thePreferred Reporting Items for Systematic Reviewand Meta-Analysis Protocols (PRISMA-P)recommendations.

▪ Full-text screening, data extraction and risk ofbias assessment of included primary studies willbe conducted by two reviewers independently.

▪ Some relevant unpublished trials with negativefindings that meet our inclusion criteria might bemissed (publication bias). Therefore, funnelplots will be used to detect possible publicationbias in order to reach an objective conclusion.

Pourahmadi MR, et al. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426 1

Open Access Protocol

on February 20, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012426 on 27 S

eptember 2016. D

ownloaded from

factors, exposure to vibration and sedentary lifestyle.10–12

The cardinal symptoms of symptomatic LDH includeLBP, radicular leg pain, sensory loss (paraesthesia, numb-ness and tingling), muscle weakness and incontinence(rare).13

A variety of therapeutic interventions have been pro-posed for the treatment of symptomatic LDH, includingnon-invasive treatments, minimally invasive proceduresand surgery.14 It was demonstrated that symptomaticLDH could be effectively treated both surgically andnon-surgically.15 Non-invasive (non-surgical) treatmentsare considered to be a first-line choice for most cases.16

Bed rest, physical therapy, comfortable positioning,manipulation and drug therapy (non-steroidal anti-inflammatory drugs) are the most used non-invasivetreatments.17

Physical therapy programmes are often recommendedfor the treatment of pain and restoration of functionaland neurological deficits associated with symptomaticLDH.18 Active exercise therapy, which is a type of phys-ical therapy programme, is usually preferred to passivemodalities.19 There are a number of exercise pro-grammes for the treatment of symptomatic LDH, suchas activity as usual, aerobic activity (eg, walking, cycling),directional preference (McKenzie approach), flexibilityexercises (eg, yoga and stretching), proprioception/coordination/balance (medicine ball and wobble/tiltboard), motor control and strengthening exercises.20

Motor control exercises (MCEs) or stabilisation or corestability exercises are a common type of therapeuticexercise prescribed for patients with symptomatic LDH.MCEs are designed to re-educate the co-activationpattern of abdominals, paraspinals, gluteals, pelvic floormusculature and diaphragm.21 22 The biological ration-ale for MCEs is primarily based on the idea that the sta-bility and control of the spine are altered in patientswith LBP.23 24 A MCE programme begins with recogni-tion of the natural position of the spine (mid-rangebetween lumbar flexion and extension range ofmotion), considered to be the position of balance andpower for improving performance in various sports.25

Initial low-level sustained isometric contraction oftrunk-stabilising musculature and their progressive inte-gration into functional tasks is the requirement ofMCEs.22 26 MCE is usually delivered in 1:1 supervisedtreatment sessions and sometimes includes palpation,ultrasound imaging and/or the use of pressure biofeed-back units to provide feedback on the activation of trunkmusculature.27

How the intervention might workControl of the spine is complex and depends on well-coordinated, deep-trunk musculature. The deep-trunkmusculature, which originates and inserts segmentallyon lumbar vertebrae, can maintain the stiffness of thespine by controlling intersegmental motion and spinalcurvature.28 Hodges and Richardson29 30 indicated thatpatients with LBP may have a delayed activity onset of

the deep-trunk musculature in dynamic tasks that chal-lenge control of the spine. Furthermore, a reduction ofthe cross-sectional area (CSA) of the multifidus muscleon the affected segment has been found in patients withsymptomatic LDH.31 32 Fortin et al31 also reported thatpatients with symptomatic LDH have a smaller erectorspinae functional CSA (FCSA) (lean muscle mass) andFCSA/CSA ratio on the side of herniation. Positionsense of the extensor musculature of the trunk has beenshown to be altered in patients with LBP.33 The MCEapproach uses motor learning principles to facilitatecoordination of the deep-trunk musculature of thespine. It seems that a MCE can alleviate pain, improvefunctional capacity, restore motor control, enhance thesize of the CSA and strengthen trunk, abdominal andparaspinal musculature.

Literature reviewTo date, several systematic reviews have looked at theeffects of conservative management in patients withLDH. A systematic review and meta-analysis by Hahneet al6 in 2010, which included 18 separate trials up to2008, concluded that conservative management is betterthan no treatment in reducing pain and disability. Thestudy consisted of English-language articles only.6 Inanother study, Jacobs et al34 compared the effectivenessof surgery with conservative management for LDH. Fivestudies were included up to October 2009. The findingsof the study showed that early surgery in patients withLDH results in better short-term leg pain relief than pro-longed conservative management, but no significant dif-ferences were found between surgery and usualconservative management in any of the clinical out-comes after 1- and 2-years’ follow-up.34 However, thestudies included were of low quality and a definite con-clusion could not be reached owing to their highheterogeneity.

Why it is important to do this systematic reviewSince the number of patients with LDH has increasedover the past few decades,35 and because systematicreviews on this topic are out of date, a new systematicreview of the literature is needed. The latest available sys-tematic review and meta-analysis comparing the effect-iveness of surgery with conservative treatments for LDHwas based on databases up to October 2009.34 However,it did not compare conservative treatments with eachother in adult patients with symptomatic LDH. As men-tioned earlier, active exercise therapy can provide betteroutcomes than passive modalities.19 MCEs are a popularapproach for clinicians and researchers in the treatmentof patients with LDH and many studies have been pub-lished on this topic.36–38 To the best of our knowledge,this systematic review and meta-analysis will evaluate, forthe first time, the effectiveness of MCEs for symptomaticLDH. Furthermore, no restriction of the language ofpublication will be applied in this review. The authorsbelieve that a well-conducted systematic review and

2 Pourahmadi MR, et al. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426

Open Access

on February 20, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012426 on 27 S

eptember 2016. D

ownloaded from

meta-analysis is important to better inform clinicians,therapists and patients about the effectiveness of MCEs.

ObjectivesThe objective of this investigation is to systematicallyreview the literature to determine the effectiveness ofMCEs in patients with symptomatic LDH.

METHODSThe methods adopted for this review are compliant withthe recommended PRISMA (Preferred Reporting Itemsfor Systematic Review and Meta-Analysis) checklist guide-lines for systematic reviews. In addition, the PRISMAflow diagram39 will be used to describe the number ofprimary studies that are included and excluded in eachstage of the selection process (figure 1). This protocolhas been prepared with regard to the PRISMA-P 2015guidelines and has been registered in the internationalprospective register of systematic reviews (PROSPERO;Registration No CRD42016038166; http://www.crd.york.ac.uk/PROSPERO).

Selection criteriaStudy typeStudies will be screened for selection according to thereview objectives and Participants, Interventions,Comparisons, Outcomes (PICO) criteria. We willinclude all clinical trials with concurrent control groupsin this systematic review and meta-analysis. Studies asses-sing review articles, proceedings, case studies and casereports will be excluded. No restrictions to the languageof publication will be applied in the selection of theprimary studies. Non-English articles will be translatedappropriately by free language translators on the web(Google translate, Bing, ImTranslator, Babelfish andAppliedLanguages) to assess their inclusion.

PopulationThe population will comprise non-, pre- and postsurgerygroups of adult patients with symptomatic LDH. Studieswill be included if they involve adult patients (≥18 years)of both genders with referred leg symptoms, with orwithout LBP, where at least 75% of the participants havesymptomatic LDH confirmed by MRI or CT.6 Studiesconfirming or justifying LDH only with myelography willbe excluded since disc herniations are not directly visua-lised by this technique.40 The term ‘herniation’ isdefined as displacement of the nucleus and/or annulusfibrosus through a tear of the annulus fibrosus.41 Itincludes synonymous terms such as prolapse, protrusionand sequestration, but the term disc bulging is not suffi-cient. Studies with specific pathology, such as systemicinflammatory diseases, malformations, fractures, spondy-lolisthesis, scoliosis, infections, tumours and osteopor-osis, will be excluded.

InterventionsA MCE programme could be described as facilitation ofthe deep musculature of the spine (primarily the trans-versus abdominis or multifidus) at low-level sustainedisometric contraction, integrated into exercise andfinally, progressing into functional tasks.22 26 42 A MCEprogramme improves the ability to ensure stability of theneutral spine position.21 We will consider studies inwhich MCE is described as motor control, core stabilityor a specific stabilisation exercise and/or the studydescribes exercise aiming to facilitate, activate, restore,train or improve the function of the deep musculatureof the spine.27 43 All these different names of MCEs willbe used in our search syntax. In addition, we willinclude trials evaluating Pilates, because the principlesof Pilates may overlap with the principles of a motorcontrol intervention.44 It is important that all the studiesincluded focus on specific muscle activity in their train-ing programme and if a trial consists of specific stabilisa-tion without consideration of specific muscle activity itwill be excluded.43 Furthermore, when MCEs are usedin addition to other treatments in primary studies, theyneed to represent at least 50% of the total treatmentprogramme to be included.27

ComparatorsGeneral therapeutic exercises or any other physicaltherapy intervention, surgery and placebo/sham orcontrol group.

OutcomesThe primary outcomes of interest will be pain intensityand functional disability. The secondary outcomes are asfollows: functional tests, muscle thickness, quality of life,return to work, muscle endurance and adverse events.

SEARCH METHODS FOR IDENTIFICATION OF STUDIESElectronic searchesThe first author (MRP) will perform electronic searchesin the following databases between 1 January 1990 and31 April 2016.▸ PubMed/Medline (NLM)▸ SCOPUS▸ Physiotherapy Evidence Database (PEDro)▸ SPORTDiscus (EBSCO)▸ Cumulative Index to Nursing and Allied Health

Literature (CINAHL)▸ The Cochrane Central Register of Controlled Trials

(CENTRAL)▸ EMBASE▸ ClinicalTrials.gov

PubMed search strategyThe details of the PubMed database search syntax arepresented in online supplementary appendix 1. Thesyntax of this systematic review is a combination ofMeSH terms and free text words. The syntax will be

Pourahmadi MR, et al. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426 3

Open Access

on February 20, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012426 on 27 S

eptember 2016. D

ownloaded from

adopted for other databases. We will use PubMed’s ‘MyNCBI’ (National Center for Biotechnology Information)email alert service for identification of newly publishedsystematic reviews using a basic search strategy.If we identify additional relevant keywords during any

of the electronic or other searches, we will modify theelectronic search strategies to incorporate these termsand document the changes. During searching the elec-tronic databases or reviewing reference lists in identifiedstudies, no restrictions on the language of publicationwill be imposed.

Searching other resourcesManual searches will include scanning of reference listsof included studies and similar reviews, journals thatpublish the most relevant research articles or reviewsand other grey literature for relevant references.Grey literature refers to reports that are difficult to

locate via conventional channels and include reports,theses or dissertations, conference proceedings, newspa-pers, websites, fact sheets, policy documents and unpub-lished research and data.45 46 These documents are notconsidered to be formally published in academicsources (ie, books or journals).45 The Institute ofMedicine Standards for Systematic Review and theCochrane Handbook for Systematic Reviews ofInterventions suggest incorporating grey literature in sys-tematic reviews.46 47

If we find research that seems to match our objectives,we will contact the corresponding author(s) for missing

information and enquire about the existence of furthertrials. We will use recommended strategies for electronicsurveys to enhance response rates.48 Specifically, we will(i) send an email to the corresponding author(s),explain the review objectives and request his/her/theirdata; and (ii) send reminder emails at 2-, 7-, 10- and14-week intervals after the first email. We will inform allauthors that their research will be appropriately citedand they will be acknowledged in our article. If we donot receive a response from the corresponding author(s) after five emails, we will exclude the research.

Data collection and analysisSelection of studiesFirst, two reviewers (MRP, MT) will scrutinise titles andabstracts of all primary articles that meet the search strat-egy in order to determine studies eligible for inclusion.Then, the same two reviewers will independently evalu-ate the full text of potentially relevant non-duplicatedarticles. Conflicts will be resolved by discussion to reachconsensus. When consensus is not reached, a thirdreviewer (MAS) will act as an arbitrator. Agreementbetween the two reviewers will be evaluated andreported using κ statistics and overall agreement.

Data extractionData extraction from primary articles will be performedindependently by two reviewers (MRP, MT), using aquantitative data extraction form. The data extractionform for clinical trials with concurrent control groups

Figure 1 The screening process

of the study.

4 Pourahmadi MR, et al. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426

Open Access

on February 20, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012426 on 27 S

eptember 2016. D

ownloaded from

will be piloted previously. Any discrepancies will beresolved by consensus between the two reviewers and,when this is not possible, a third reviewer (MAS) will actas an arbitrator and make a decision on the dataentered.The following data will be extracted from all theincluded studies:1. Study characteristics: first author’s name, year of publi-

cation, country in which the study was performed,study design, size of the sample and duration offollow-up.

2. Participants’ characteristics: age, gender, number, pre-/non- or postsurgery population and ethnicity.

3. Intervention and comparator details: sample size for eachtreatment group, blinding, type, surgery, frequencyand duration of the exercise programmes, withdra-wals and dropouts.

4. Outcome measures: pain intensity, scales and question-naires used to assess pain, total score of functionaldisability, disability questionnaires, type of functionaltests and their methods of assessment, instrument formeasuring muscle thickness, instruments settingparameters, name of muscles and muscles’ thickness(size), differences in changes of muscles thickness,indicators of return to work (eg, time to partial andto full return to work), return to work at differenttimes, tests used to assess muscle endurance, scalesand questionnaires used to measure quality of life.

Dealing with missing dataWe will try to contact the corresponding authors ofstudies by email, if it is necessary to obtain data missingfrom published articles. However, if the authors do notrespond to queries, we will calculate the missing datafrom other measures or estimate them from the mostsimilar study.

Assessment of risk of bias of included studiesAssessment of the risk of bias (RoB) and methodologicalquality will be implemented by two reviewers (MRP, MT)independently considering the items according to thePEDro scale.49 The PEDro scale is based on the Delphilist and has been developed by Verhagen et al.50 Maheret al49 indicated that the reliability of the total PEDroscore, based on consensus judgements, is acceptable.Therefore, they concluded that the scale can be used insystematic reviews of physical therapy clinical trials withcontrol groups.49 The PEDro scale items are illustratedin figure 2. Items 2–9 relate to the internal validity of anarticle, items 10 and 11 provide sufficient statistical infor-mation to enable appropriate interpretation of theresults. Item 1 refers to the external validity (or ‘general-isability’ or ‘applicability’ of the trial) and thus is notincluded in the total PEDro score.51 52 In addition,primary studies which attain scores of ≥6 on the PEDroscale are considered ‘high quality’. Studies with a PEDroscore of 4 or 5 are considered ‘fair quality’ and thosewith scores of ≤3 are considered ‘poor quality’. The

PEDro scale has been used in other systematicreviews.52–54

Assessment of heterogeneityAll analyses will be performed using Stata V.12 software(StataCorp LP, College Station, Texas, USA) on a per-sonal laptop. Heterogeneity among primary studies willbe evaluated by the I2 statistic and χ2 test as recom-mended by the Cochrane Handbook for SystematicReviews of Interventions.46 We will interpret the I2 statis-tic using the following guide:55

▸ 0–40%=no important heterogeneity;▸ 30–60%=moderate heterogeneity;▸ 50–90%=substantial heterogeneity;▸ 75–100%=considerable heterogeneity.We will consider heterogeneity before conducting

pooled analysis. When substantial heterogeneity(I2>50%) is evident among the studies, the results willbe presented in the text qualitatively and we will notpool them. The decision to use the random-effectsmodel will be based on our understanding of whetheror not all included trials share a common effect size andnot only on results of tests for statistical heterogeneity.56

Therefore, when I2 values are slightly higher than 50%and there is overlap between the CIs in visual inspectionof the forest plot, we will combine the results into ameta-analysis using a random-effects model.27 43 A valueof p<0.05 will be considered as statistically significant.

Assessment of publication biasWhen a sufficient number of studies (≥10) are identi-fied, publication bias will be explored by a funnel plot(ie, plots of study results against precision) and Begg’sand Egger’s tests. We will not assess publication biaswhen <10 studies are available for analysis since the testsfor publication bias yields unreliable results.

Data synthesisDescriptive analysisAll included primary studies will be read in detail andpresented in two separate tables. The first table willprovide details of the assessment of RoB amongincluded studies. The second table will consist of studycharacteristics, patient characteristics, sample size, dur-ation of complaint, intervention and setting, andoutcome data/results. Pain intensity, functional disabil-ity, functional tests, muscle thickness, return to work,muscle endurance and adverse events mean scores,together with their range (SD/95% CI) will be reported.We expect that there will be a sufficient number of clin-ical trial studies to carry out a meta-analysis for theprimary and secondary outcomes; however, the decisionto complete a meta-analysis will depend on the numberof these types of study identified in the review. Toperform a meta-analysis, a minimum of two studies willbe required.57 Stata V.12 software will be used formeta-analysis. Dichotomous data will be analysed usingthe risk ratio measure with its 95% CIs, whereas

Pourahmadi MR, et al. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426 5

Open Access

on February 20, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012426 on 27 S

eptember 2016. D

ownloaded from

continuous outcomes will be analysed using mean differ-ence or standardised mean difference, both with their95% CIs. Meta-analysis will be done separately on trialsthat evaluated the effects of MCEs in patients aftersurgery and on trials in which patients with symptomaticLDH had not undergone surgery. All data from themeta-analyses with 95% CI will be reported in forestplots.

Analysis problemsIf sufficient homogeneous studies are available for statis-tical pooling, we will conduct a meta-analysis for thetime points: short (<3 months after the baseline mea-surements were taken), intermediate (at least 3 monthsbut <12 months after the baseline measurements weretaken) and long-term (12 months or more after thebaseline measurements were taken) follow-up. If mul-tiple time points fall within the same category, we willuse the one that is closest to the end of the treatment, 6and 12 months.27

Subgroup analysisSubgroup analysis will be conducted for the population.The results will be split into two separate analyses: onepopulation with presurgery symptomatic LDH (or apopulation who had not undergone surgery) and theother with postsurgery symptomatic LDH. Furthermore,subgroup analysis will be performed for the secondaryoutcomes (functional tests, muscle thickness, quality of

life, return to work, muscle endurance and adverseevents).

Sensitivity analysisA sensitivity analysis will be performed to test the impactof the results on the RoB assessment rated by the PEDroscale.49 We will also implement sensitivity analyses toexplore the effects of methodological quality andsample size on the robustness of review conclusions.Sensitivity analyses will be reported with a summarytable.

Summary of findings tableWe will evaluate the quality of evidence for the maincomparison at the outcome level using the Grading ofRecommendations Assessment, Development andEvaluation (GRADE) approach.58 A ‘summary of find-ings’ table will be produced in our systematic review. Fivedomains will be judged for each outcome in the maincomparison: limitations in study design and execution(RoB), inconsistency of results, indirectness, imprecisionand publication bias (reporting bias). In this systematicreview and meta-analysis, limitations in the study designand execution will be assessed using the PEDro scale.49

If studies have major limitations, our confidence in theestimate of the treatment effect decreases. Therefore,the quality of evidence will be downgraded.58 We willconsider four criteria to assess inconsistency in results:point estimates, CIs, the statistical test for heterogeneity

Figure 2 The Physiotherapy Evidence Database (PEDro) scale; from Maher et al.49

6 Pourahmadi MR, et al. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426

Open Access

on February 20, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012426 on 27 S

eptember 2016. D

ownloaded from

and the I2 test.59 Indirectness will be judged by lookingat the evidence tables for the target population, inter-vention, comparison or outcome.58 In addition, resultswill be considered to be imprecise when studies includerelatively few patients and few events but have a wide CIaround the estimate of the effect.58 Finally, when a suffi-cient number of studies (≥10) are identified, publica-tion bias will be assessed by visually examining funnelplots for evidence of asymmetry. The overall quality ofthe evidence supporting each outcome will be graded ashigh, moderate, low or very low.▸ High-quality evidence will be identified when there are

consistent findings among at least 75% of includedtrials.27 43 60 No study design limitation is found andthe data are consistent, direct and precise with nopublication bias. In addition, further research isunlikely to change confidence in the estimate ofeffect.

▸ Moderate-quality evidence will be identified when one ofthe five domains is not met.27 43 60 In this level, weare moderately confident about the effect estimate.However, further research is likely to affect confi-dence in the estimated effect and may change thatestimate.

▸ Low-quality evidence will be identified when two of thefive domains are not met.27 43 60 In this level, ourconfidence in the effect estimate is limited. Furtherresearch is likely to have an important impact on con-fidence in the estimated effect and is likely to changethat estimate.

▸ Very low-quality evidence will be identified when threeof the five domains are not met.27 43 60 In this level,we have little confidence in the effect estimate. Anyestimate of the effect is uncertain.

▸ No evidence will be identified when none of the fivedomains are met.Online supplementary appendix 2 provides more

details about the five domains and the quality ofevidence.

Ethics and disseminationEthics approval is not required because this is a protocolfor a systematic review and patients will not be involvedin this research. The results of this study will be submit-ted to a peer-reviewed journal for publication and willalso be presented at national and international academicand clinical conferences.

DISCUSSIONLDH is the most common cause of activity limitation inpeople aged <45 years.61 Furthermore, this condition isamong the most common causes of LBP or sciatica(radicular leg pain) and imposes a heavy burden onboth the individual and society.62–64 Different kinds ofnon-invasive and invasive (surgical) treatment strategieshave been suggested, with varying degrees of success.63

Treatment often includes patient education, physical

therapy, alternative medicine options and pharmacother-apy. If these strategies fail, surgical intervention isusually recommended. Physical therapy is consideredimportant for the conservative management of thisproblem.16 Therapeutic exercises are physical therapyinterventions that effectively alleviate pain and improvefunction for patients with LDH.10 MCEs—one type ofactive therapeutic exercises—are a popular approach forclinicians and researchers in the conservative manage-ments of patients with LDH. To date, several systematicreviews have been published on this topic.6 34 However,existing systematic reviews are out of date and none ofthem compared MCEs with other conservative physio-therapy interventions.As stated earlier, non-invasive conservative treatment is

the first-line choice for most patients with LDH.16 Hence, asystematic review and meta-analysis is needed to evaluatethe effectiveness of MCEs for symptomatic LDH. The data-bases which will be searched in our systematic review, theprimary and secondary outcomes and the method ofmeta-analysis are clarified in this protocol. Our systematicreview with meta-analysis will help clinicians, therapists andpatients to gain a better understanding of the effectivenessof MCEs. We will try to include grey literature since somehigh-quality studies have not yet been published. In add-ition, no limitation by language will be imposed. Therefore,the limitations of this systematic review will be reduced andconclusions about the results will be improved. In thisreview, meta-analysis will be conducted on trials in whichpatients with LDH had undergone surgery and also ontrials in which the patients had not undergone surgery.Our results will be important to clarify which type of exer-cise is most effective in LDH. Implications for futureresearch can be drawn from the results.

Author affiliations1Department of Physiotherapy, School of Rehabilitation Sciences, IranUniversity of Medical Sciences and Health Services, Tehran, Iran2Student Research Committee, University of Social Welfare and RehabilitationSciences, Tehran, Iran3Department of Rehabilitation Basic Sciences, School of RehabilitationSciences, Iran University of Medical Sciences and Health Services, Tehran,Iran4Pediatric Neurorehabilitation Research Center, University of Social Welfareand Rehabilitation Sciences, Tehran, Iran5Faculty of Allied Health Sciences, University Institute of Physical Therapy,University of Lahore, Lahore, Pakistan6Department of Health Sciences Education Development, School of PublicHealth, Tehran University of Medical Sciences and Health Services, Tehran,Iran

Acknowledgements The authors acknowledge the efforts of AAK for his helpin developing this protocol. We also particularly thank the reviewers for theirvaluable comments, which helped considerably to improve the quality of themanuscript.

Contributors MRP, MT, IET, MAS, MAM-B and AAK conceived and designedthe study. MRP, MT, MAS and AAK developed the search strategies andcontributed to analysis of the studies. MRP and MT were responsible for theinitial drafting, edited the manuscript and approved the manuscript forsubmission. IET, MAM-B and AAK revised the manuscript. MRP and MT willalso screen potential studies, extract data and assess their quality. Any

Pourahmadi MR, et al. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426 7

Open Access

on February 20, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012426 on 27 S

eptember 2016. D

ownloaded from

discrepancies will be resolved by consensus between MRP and MT. Whenconsensus is not reached, MAS will act as arbitrator.

Competing interests None declared.

Provenance and peer review Not commissioned; externally peer reviewed.

Data sharing statement All recorded information from the data extractionprocess, not included in the systematic review article, will be available onrequest.

Open Access This is an Open Access article distributed in accordance withthe Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, providedthe original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

REFERENCES1. Yang H, Liu H, Li Z, et al. Low back pain associated with lumbar

disc herniation: role of moderately degenerative disc and annulusfibrous tears. Int J Clin Exp Med 2015;8:1634–44.

2. Schoenfeld AJ, Weiner BK. Treatment of lumbar disc herniation:evidence-based practice. Int J Gen Med 2010;3:209–14.

3. Anderson PA, McCormick PC, Angevine PD. Randomized controlledtrials of the treatment of lumbar disk herniation: 1983–2007. J AmAcad Orthop Surg 2008;16:566–73.

4. Jordan J, Konstantinou K, O’Dowd J. Herniated lumbar disc. BMJClin Evid 2009;3:1–34.

5. Ozkanli S, Kaner T, Efendioglu M, et al. The relation of matrixmetalloproteinase 1, 2, 3 expressions with clinical and radiologicalfindings in primary and recurrent lumbar disc herniations. TurkNeurosurg 2015;25:111–16.

6. Hahne AJ, Ford JJ, McMeeken JM. Conservative management oflumbar disc herniation with associated radiculopathy: a systematicreview. Spine (Phila Pa 1976) 2010;35:E488–504.

7. Koes BW, van Tulder MW, Peul WC. Diagnosis and treatment ofsciatica. BMJ 2007;334:1313–17.

8. Boden SD, Davis DO, Dina TS, et al. Abnormal magnetic-resonancescans of the lumbar spine in asymptomatic subjects. A prospectiveinvestigation. J Bone Joint Surg Am 1990;72:403–8.

9. Jensen MC, Brant-Zawadzki MN, Obuchowski N, et al. Magneticresonance imaging of the lumbar spine in people without back pain.N Engl J Med 1994;331:69–73.

10. Ahmed S, Hassan T, Hanif A. Effects of lumbar stabilization exercisein management of pain and restoration of function in patients withpostero lateral disc herniation. Ann King Edward Med Univ 2012;18.

11. Gregory DS, Seto CK, Wortley GC, et al. Acute lumbar disk pain:navigating evaluation and treatment choices. Am Fam Physician2008;78:835–42.

12. Zhang YG, Sun Z, Liu J, et al. Advances in susceptibility genetics ofintervertebral degenerative disc disease. Int J Biol Sci2008;4:283–90.

13. Rajagopal TS, Marshall RW. Chapter 28: Microdiscectomy. In:Bentley G, ed. European surgical orthopaedics and traumatology:the EFORT textbook. Springer Berlin Heidelberg 2014:557–80.

14. Paoloni M, Di Sante L, Cacchio A, et al. Intramuscularoxygen-ozone therapy in the treatment of acute back pain withlumbar disc herniation: a multicenter, randomized, double-blind,clinical trial of active and simulated lumbar paravertebral injection.Spine (Phila Pa 1976) 2009;34:1337–44.

15. Pearson AM, Blood EA, Frymoyer JW, et al. SPORT lumbarintervertebral disk herniation and back pain: does treatment,location, or morphology matter? Spine (Phila Pa 1976) 2008;33:428.

16. Eckel TS. Advances in spinal imaging and interventions (abstr). 40thannual meeting of the American Society of Neuroradiology,Vancouver, 2002.

17. Silby H. Conservative management of lumbar disk herniation.Postgrad Med 1988;84:157–72.

18. Brötz D, Küker W, Maschke E, et al. A prospective trial of mechanicalphysiotherapy for lumbar disk prolapse. J Neurol 2003;250:746–9.

19. Pinheiro-Franco JL, Vaccaro AR, Benzel EC, et al. Advancedconcepts in lumbar degenerative disk disease. Springer, 2015.

20. Kim Y-S, Park J, Shim JK. Effects of aquatic backward locomotionexercise and progressive resistance exercise on lumbar extensionstrength in patients who have undergone lumbar diskectomy. ArchPhys Med Rehabil 2010;91:208–14.

21. Akuthota V, Ferreiro A, Moore T, et al. Core stability exerciseprinciples. Curr Sports Med Rep 2008;7:39–44.

22. Shamsi MB, Sarrafzadeh J, Jamshidi A. Comparing core stabilityand traditional trunk exercise on chronic low back pain patientsusing three functional lumbopelvic stability tests. Physiother TheoryPract 2015;31:89–98.

23. Costa LO, Maher CG, Latimer J, et al. Motor control exercise forchronic low back pain: a randomized placebo-controlled trial. PhysTher 2009;89:1275–86.

24. Hodges PW, Richardson CA. Inefficient muscular stabilization of thelumbar spine associated with low back pain: a motor control evaluationof transversus abdominis. Spine (Phila Pa 1976) 1996;21:2640–50.

25. Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil2004;85:S86–92.

26. Richardson CA, Hodges P, Hides J. Therapeutic exercise forlumbopelvic stabilization: a motor control approach for the treatmentand prevention of low back pain. Churchill Livingstone, 2004.

27. Saragiotto BT, Maher CG, Yamato TP, et al. Motor control exercisefor chronic non-specific low-back pain. The Cochrane Library, 2016.

28. Comerford M, Mottram S. Kinetic control: the management ofuncontrolled movement. Australia: Elsevier, 2012.

29. Hodges PW, Richardson CA. Delayed postural contraction oftransversus abdominis in low back pain associated with movementof the lower limb. J Spinal Disord 1998;11:46–56.

30. Hodges PW, Richardson CA. Altered trunk muscle recruitment inpeople with low back pain with upper limb movement at differentspeeds. Arch Phys Med Rehabil 1999;80:1005–12.

31. Fortin M, Lazáry À, Varga PP, et al. Paraspinal muscle asymmetryand fat infiltration in patients with symptomatic disc herniation.Eur Spine J 2016;25:1452–9.

32. Franke J, Hesse T, Tournier C, et al. Morphological changes of themultifidus muscle in patients with symptomatic lumbar discherniation: clinical article. J Neurosurg Spine 2009;11:710–14.

33. Newcomer K, Laskowski ER, Yu B, et al. Repositioning error in lowback pain. Comparing trunk repositioning error in subjects withchronic low back pain and control subjects. Spine (Phila Pa 1976)2000;25:245–50.

34. Jacobs WC, van Tulder M, Arts M, et al. Surgery versusconservative management of sciatica due to a lumbar herniateddisc: a systematic review. Eur Spine J 2011;20:513–22.

35. Shin B-J. Risk factors for recurrent lumbar disc herniations. AsianSpine J 2014;8:211–15.

36. Bae SH, Lee HG, Kim YE, et al. Effects of trunk stabilizationexercises on different support surfaces on the cross-sectional areaof the trunk muscles and balance ability. J Phys Ther Sci2013;25:741–5.

37. Kennedy DJ, Noh MY. The role of core stabilization in lumbosacralradiculopathy. Phys Med Rehabil Clin N Am 2011;22:91–103.

38. Ostelo RW, Costa LOP, Maher CG, et al. Rehabilitation after lumbardisc surgery: an update Cochrane review. Spine (Phila Pa 1976)2009;34:1839–48.

39. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement forreporting systematic reviews and meta-analyses of studies thatevaluate health care interventions: explanation and elaboration. AnnIntern Med 2009;151:W-65–94.

40. Fagerlund MK, Thelander U. Comparison of myelography andcomputed tomography in establishing lumbar disc herniation. ActaRadiol 1989;30:241–6.

41. Fardon DF, Milette PC. Nomenclature and classification of lumbardisc pathology: recommendations of the combined task forces of theNorth American Spine Society, American Society of Spine Radiologyand American Society of Neuroradiology. Spine (Phila Pa 1976)2001;26:E93–113.

42. O’Sullivan PB, Phyty GDM, Twomey LT, et al. Evaluation of specificstabilizing exercise in the treatment of chronic low back pain withradiologic diagnosis of spondylolysis or spondylolisthesis. Spine(Phila Pa 1976) 1997;22:2959–67.

43. Macedo LG, Saragiotto BT, Yamato TP, et al. Motor control exercisefor acute non-specific low back pain. The Cochrane Library, 2016.

44. Herrington L, Davies R. The influence of Pilates training on theability to contract the transversus abdominis muscle in asymptomaticindividuals. J Bodywork Mov Ther 2005;9:52–7.

45. Godin K, Stapleton J, Kirkpatrick SI, et al. Applying systematic reviewsearch methods to the grey literature: a case study examiningguidelines for school-based breakfast programs in Canada. Syst Rev2015;4:138.

46. Higgins JP, Green S. Cochrane handbook for systematic reviews ofinterventions. Wiley Online Library, 2008.

47. Eden J, Levit L, Berg A, et al. Finding what works in health care:standards for systematic reviews. National Academies Press, 2011.

48. Dillman DA. Mail and Internet surveys: The tailored design method—2007 Update with new Internet, visual and mixed-mode guide. JohnWiley & Sons, 2011.

8 Pourahmadi MR, et al. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426

Open Access

on February 20, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012426 on 27 S

eptember 2016. D

ownloaded from

49. Maher CG, Sherrington C, Herbert RD, et al. Reliability of the PEDroscale for rating quality of randomized controlled trials. Phys Ther2003;83:713–21.

50. Verhagen AP, de Vet HC, de Bie RA, et al. The Delphi list: a criterialist for quality assessment of randomized clinical trials for conductingsystematic reviews developed by Delphi consensus. J ClinEpidemiol 1998;51:1235–41.

51. Sherrington C, Herbert RD, Maher CG, et al. PEDro. A database ofrandomized trials and systematic reviews in physiotherapy. ManTher 2000;5:223–6.

52. Smith BE, Littlewood C, May S. An update of stabilisation exercisesfor low back pain: a systematic review with meta-analysis. BMCMusculoskelet Disord 2014;15:416.

53. May S, Johnson R. Stabilisation exercises for low back pain: asystematic review. Physiotherapy 2008;94:179–89.

54. Wang XQ, Zheng JJ, Yu ZW, et al. A meta-analysis of core stabilityexercise versus general exercise for chronic low back pain. PLoSONE 2012;7:e52082.

55. Deeks J, Higgins J, Altman D. Chapter 9: analysing data andundertaking meta-analysis. In: Higgins JPT, Green S, eds. Cochranehandbook for systematic reviews. Wiley-Blackwell, 2011:243–96.

56. Borenstein M, Hedges LV, Higgins J, et al. A basic introduction tofixed-effect and random-effects models for meta-analysis. Res SynthMethods 2010;1:97–111.

57. Grimes CA, Bolhuis DP, He FJ, et al. Dietary sodium intake andoverweight and obesity in children and adults: a protocol for asystematic review and meta-analysis. Syst Rev 2016;5:7.

58. Schünemann H, Brozek J, Oxman A. GRADE handbook for gradingquality of evidence and strength of recommendation. The GRADEWorking Group, 2009.

59. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 7. Ratingthe quality of evidence—inconsistency. J Clin Epidemiol2011;64:1294–302.

60. Yamato TP, Maher CG, Saragiotto BT, et al. Pilates for low backpain: complete republication of a cochrane review. Spine (Phila Pa1976) 2016;41:1013–21.

61. Andersson GB. Epidemiological features of chronic low-back pain.Lancet 1999;354:581–5.

62. Atlas SJ, Keller RB, Wu YA, et al. Long-term outcomes of surgicaland nonsurgical management of sciatica secondary to a lumbar discherniation: 10 year results from the maine lumbar spine study. Spine(Phila Pa 1976) 2005;30:927–35.

63. Awad JN, Moskovich R. Lumbar disc herniations: surgicalversus nonsurgical treatment. Clin Orthop Relat Res2006;443:183–97.

64. Lee J, Shin JS, Lee YJ, et al. Effects of Shinbaro pharmacopuncturein sciatic pain patients with lumbar disc herniation: study protocol fora randomized controlled trial. Trials 2015;16:455.

Pourahmadi MR, et al. BMJ Open 2016;6:e012426. doi:10.1136/bmjopen-2016-012426 9

Open Access

on February 20, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012426 on 27 S

eptember 2016. D

ownloaded from