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    Philadelphia Panel Evidence-Based

    Clinical Practice Guidelines onSelected Rehabilitation Interventions

    for Low Back Pain

    APTA is a sponsor of the Decade, an international,multidisciplinary initiativeto improve health-relatedquality of life for people withmusculoskeletal disorders.

    Introduction. A structured and rigorous methodology was developed for theformulation of evidence-based clinical practice guidelines (EBCPGs), thenwas used to develop EBCPGs for selected rehabilitation interventions for themanagement of low back pain. Methods. Evidence from randomized con-trolled trials (RCTs) and observational studies was identified and synthesizedusing methods defined by the Cochrane Collaboration that minimize bias byusing a systematic approach to literature search, study selection, data extrac-tion, and data synthesis. Meta-analysis was conducted where possible. Thestrength of evidence was graded as level I for RCTs or level II for nonran-domized studies. Developing Recommendations. An expert panel was formedby inviting stakeholder professional organizations to nominate a representa-tive. This panel developed a set of criteria for grading the strength of both theevidence and the recommendation. The panel decided that evidence ofclinically important benefit (defined as 15% greater relative to a control basedon panel expertise and empiric results) in patient-important outcomes wasrequired for a recommendation. Statistical significance was also required, butwas insufficient alone. Patient-important outcomes were decided by consensusas being pain, function, patient global assessment, quality of life, and returnto work, providing that these outcomes were assessed with a scale for whichmeasurement reliability and validity have been established. Validating theRecommendations. A feedback survey questionnaire was sent to 324 practitio-ners from 6 professional organizations. The response rate was 51%. Results.Four positive recommendations of clinical benefit were developed. Therapeu-tic exercises were found to be beneficial for chronic, subacute, and postsur-gery low back pain. Continuation of normal activities was the only interven-tion with beneficial effects for acute low back pain. These recommendationswere mainly in agreement with previous EBCPGs, although some were notcovered by other EBCPGs. There was wide agreement with these recommen-dations from practitioners (greater than 85%). For several interventions andindications (eg, thermotherapy, therapeutic ultrasound, massage, electrical stim-

    ulation), there was a lack of evidence regarding efficacy. Conclusions. Thismethodology of developing EBCPGs provides a structured approach to assessingthe literature and developing guidelines that incorporates clinicians feedbackand is widely acceptable to practicing clinicians. Further well-designed RCTs arewarranted regarding the use of several interventions for patients with low backpain where evidence was insufficient to make recommendations. [PhiladelphiaPanel Evidence-Based Clinical Practice Guidelines on Selected RehabilitationInterventions for Low Back Pain. Phys Ther. 2001;81:16411674.]

    Key Words: Clinical practice guidelines, Evidence-based practice, Low back pain, Meta-analysis, Physical

    therapy, Practitioner feedback survey, Rehabilitation, Systematic reviews.

    Physical Therapy . Volume 81 . Number 10 . October 2001 1641

    SpecialIssue

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    INTRODUCTION

    Low back pain (LBP) is the largest cause ofworkers compensation in the United States andCanada. Sixty to 90% of the adult population is atrisk of developing LBP at some point in their

    lifetime.14 Of those who develop acute LBP, 30%develop chronic LBP.5 Low back pain has a significant

    impact on functional ability, restricting occupationalactivities with marked socioeconomic repercussions.6,7

    A number of different practitioners treat people withLBP. These include physicians, physical therapists, chi-ropractors, massage therapists, psychologists, kinesiolo-gists, rehabilitation technicians, and others. The treat-

    ment goals are to relieve pain, reduce muscle spasm,improve range of motion (ROM) and strength, correctpostural problems, and ultimately improve functionalstatus.

    A number of rehabilitation interventions are used in themanagement of people with LBP. Among current mus-

    culoskeletal interventions specific for LBP available torehabilitation specialists, there are body mechanics andergonomics training, posture awareness training,strengthening exerises, stretching exercises, activities ofdaily living (ADL) training, organized functional train-ing programs, therapeutic massage, joint mobilizationsand manipulations, mechanical traction, biofeedback,

    Philadelphia Panel Members:

    Clinical Specialty Experts:

    John Albright, MD (Orthopaedic Surgeon), American Academy of Orthopaedic Surgeons, USA

    Richard Allman, MD (Internist, Rheumatologist), American College of Physicians, USA

    Richard Paul Bonfiglio, MD (Physiatrist)

    Alicia Conill, MD (Internist), University of Pennsylvania, Philadelphia. USA

    Bruce Dobkin, MD (Neurologist), American Academy of Neurology, USA

    Andrew A Guccione, PT, PhD (Physical Therapist), American Physical Therapy Association, USA

    Scott M Hasson, PT, EdD (Physical Therapist), American College of Rheumatology, Association of Health Professionals, USA

    Randolph Russo, MD (Physiatrist), American Academy of Physical Medicine and Rehabilitation, USA

    Paul Shekelle, PhD (Internist), Cochrane Back Group

    Jeffrey L Susman, MD (Family Practice), American Academy of Family Physicians, USA

    Ottawa Methods Group:

    Lucie Brosseau, PhD (Public Health, specialization in epidemiology), Career Scientist, Ministry of Ontario Health (Canada), and Assistant

    Professor, Physiotherapy Program, School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada

    Peter Tugwell, MD, MSc (Epidemiology), Chair, Centre for Global Health, Institute of Population Health

    George A Wells, PhD (Epidemiology and Biostatistics), Professor and Chairman, Department of Epidemiology and Community Medicine,

    University of Ottawa, Ottawa, Ontario, Canada

    Vivian A Robinson, MSc (Kinesiology), Research Associate, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Civic Hospital,

    Ottawa, Ontario, Canada

    Ian D Graham, PhD (Medical Sociology), Medical Research Council Scholar, Clinical Epidemiology Unit, Ottawa Health Research Institute,

    Ottawa Hospital, Civic Campus, Ottawa, Ontario, Canada

    Beverley J Shea, MSc (Epidemiology), Research Associate, Department of Medicine, University of Ottawa, and Clinical Epidemiology Unit, Ottawa

    Health Research Institute, Ottawa Hospital, Civic Campus, Ottawa, Ontario, Ontario, Canada

    Jessie McGowan, Director of the Medical Library, Ottawa Hospital, Ottawa, Ontario, Canada

    Joan Peterson, Research Associate, Department of Medicine, Clinical Epidemiology Unit, Ottawa Health Research Institute, Ottawa Hospital, CivicCampus, Ottawa, Ontario, Canada

    Michel Tousignant. PhD, Lucie Poulin, MSc, Helene Corriveau, PhD, Michelle Morin, BSc, Lucie Pelland, PhD, Lucie Laferriere, MHA, Lynn

    Casimiro, Louis E Tremblay, Program of Physiotherapy, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa,

    Ontario, Canada

    Address all correspondence and requests for reprints to: Peter Tugwell, MD, MSc, Chair, Centre for Global Health, Institute of Population Health,

    1 Stewart St, Rm 312, Ottawa, Ontario, Canada K1N 6N5 ([email protected]).

    This study was financially supported by an unrestricted educational grant from the Cigna Foundation, Philadelphia, Pa, USA, the Ministry of

    Human Resources and Development, Government of Canada (Summer Students Program), and the Ontario Ministry of Health and Long-Term

    Care (Canada). Ian Graham is a Medical Research Council Scholar, Canadian Institutes of Health Research (Canada).

    Acknowledgments: Summer students: Sarah Milne, Michael Saginur, Marie-Josee Noel, Melanie Brophy, Anne Mailhot

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    electrical muscle stimulation, transcutaneous electricalnerve stimulation (TENS), athermal modalities, cryo-therapy, deep thermal modalities, superficial thermalmodalities, and work hardening.8

    The Philadelphia Panel (see article titled Evidence-Based Clinical Practice Guidelines on Selected Rehabil-

    itation Interventions: Overview and Methodology) wasconvened to evaluate 9 selected rehabilitation interven-tions for LBP: thermotherapy, therapeutic massage,therapeutic exercises, electromyographic (EMG)biofeedback, mechanical traction, ultrasound, TENS,electrical stimulation, and combined rehabilitationinterventions.

    The purpose of this article is to describe the evidence-based clinical practice guidelines (EBCPGs) developedby the panel about rehabilitation interventions for LBP.The aim of developing the guidelines was to improveappropriate use of rehabilitation interventions for lowback pain. The target users of these guidelines arephysical therapists, physiatrists, orthopedic surgeons,rheumatologists, family physicians, and neurologists.

    METHODSThe detailed methods of the EBCPGs developmentprocess are summarized in an accompanying article inthis issue (Evidence-Based Clinical Practice Guidelineson Selected Rehabilitation Interventions: Overview andMethodology). Briefly, an a priori protocol was definedthat was followed for the conduct of separate systematicreviews for each intervention.

    Studies were eligible if they were randomized controlledtrials (RCTs), nonrandomized controlled clinical trials(CCTs), or case control or cohort studies that evaluatedthe intervention of interest in a population with non-specific LBP. Nonspecific LBPwas defined as pain betweenthe gluteal fold and the uppermost lumbar vertebraeand included postsurgery back pain. The outcomes ofinterest were functional status, pain, ability to work,patient global improvement, patient satisfaction, andquality of life. The interventions included massage,thermal therapy (hot or cold packs), electrical stimula-

    tion, EMG biofeedback, TENS, therapeutic ultrasound,therapeutic exercises, and combinations of these reha-bilitation interventions. Studies whose control groupsreceived active treatments were included. Concurrenttreatments (eg, home exercises, educational booklets,advice on posture) were allowed if they were given in thesame way to both the experimental and control groups.However, concurrent therapy that was given to onegroup but not to the other group was not accepted(eg, education by means of lectures for the control group

    were not accepted). No limitations based on methodolog-ical quality were imposed. Only English-, French-, andSpanish-language articles were accepted. Abstracts werenot included.

    A structured literature search was developed based onthe sensitive search strategy for RCTs recommended by

    the Cochrane Collaboration9

    and modifications pro-posed by Haynes et al.10 The search strategy wasexpanded to identify case control, cohort, and non-randomized studies. The search was conducted in theelectronic databases of MEDLINE, EMBASE, CurrentContents, CINAHL, and the Cochrane Controlled TrialsRegister up to July 1, 2000. In addition, the registries ofthe Cochrane Field of Rehabilitation and Related Ther-apies and the Cochrane Musculoskeletal Group and thePhysiotherapy Evidence Database (PEDro) weresearched. The references of all included trials weresearched for relevant studies. Content experts werecontacted for additional studies.

    Two independent reviewers (VAR, JP) appraised thetitles and abstracts of the literature search, using achecklist with the a priori defined selection criteria.Relevant studies were retrieved and the full articles wereassessed by 2 independent reviewers for inclusion. Data were extracted by 2 independent reviewers fromincluded articles, using predetermined extraction formsregarding the population characteristics, details of theinterventions, trial design, allocation concealment, andoutcomes. Methodological quality was assessed by a5-point validated scale that assigns 2 points each for

    randomization and double-blinding and 1 point fordescription of withdrawals.11,12 Differences in dataextraction and quality assessment were resolved byconsensus.

    Data were analyzed at 3 approximate time points post-therapy: 1 month, 6 months, and 12 months. If outcomeswere reported at different intervals, the closest time wasused for these time points.

    Because prognosis is widely thought to be dependent ondisease duration, the analysis was conducted for 3 cate-

    gories of LBP: acute (

    4 weeks duration), subacute(4 12 weeks duration), and chronic (12 weeks dura-tion). If the population contained individuals withmixed acute and chronic disease durations, the study wasexcluded. If the population included individuals withmixed subacute and chronic disease durations, the studywas classified as chronic.

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    STATISTICAL ANALYSISData were analyzed using the Review Manager (RevMan)computer program, Version 4.1 for Windows.* Continu-ous data were analyzed using weighted mean differences(WMDs) between the treatment and control groups atthe end of the study, where the weight is the inverse ofthe variance. Where an outcome was measured withdifferent scales (eg, pain, functional status), the datawere analyzed with standardized mean differences, cal-culated using the mean and standard deviation. Dichot-omous data were analyzed using relative risks. Heteroge-neity was tested using the chi-square statistic. Whenheterogeneity was not significant, fixed-effects models were used. With significant heterogeneity, random-effects models were used.

    To calculate clinical improvement (defined as 15%improvement relative to a control), the absolute benefit

    and the relative difference in the change from baselinewere calculated. Absolute benefit was calculated as theimprovement in the treatment group less the improve-ment in the control group, in the original units. Relativedifference in the change from baseline was calculated asthe absolute benefit divided by the baseline mean(weighted for the treatment and control groups). Fordichotomous data, the relative percentage of improve-ment was calculated as the difference in the percentageof improvement between the treatment and controlgroups.

    The recommendations were graded by their level ofevidence (I or II) and by the strength of evidence (A, B,or C). This grading system is shown in Table 1 and isdescribed more fully elsewhere (see article titledEvidence-Based Clinical Practice Guidelines onSelected Rehabilitation Interventions: Overview andMethodology). Briefly, grade A recommendations indi-cate that a clinically important benefit was shown in oneor more RCTs. Grade B recommendations were assignedfor interventions with a clinically important benefit

    shown in nonrandomized trials. Because there is lessconfidence in the results of nonrandomized studies,grade B recommendations required that the study beassigned a quality score of 3 or more out of 5. Grade Crecommendations were assigned to interventions thathave been compared with a control and have shown noevidence of effect in controlled trials. A master gridshowing each rehabilitation intervention assessed and

    the strength and level of evidence is shown in Table 2.The report follows the same order as this grid, from leftto right, top to bottom.

    Clinically important benefit was shown for therapeuticexercise across subacute, chronic, and postoperativeLBP as well as for the continuation of normal activities(Tab. 3). No clinically important benefit was demon-strated for 4 other interventions (Tab. 4). Insufficientdata were available for 4 interventions (Tab. 5). ThePhiladelphia Panel guidelines are compared with otherpublished guidelines in Appendix 1.

    * Oxford, England: The Cochrane Collaboration, 2000.

    Table 1.Details of Philadelphia Panel Classification System

    Clinical ImportanceStatisticalSignificance Study Designa

    Grade A 15% P.05 RCT (single or meta-analysis)Grade B 15% P.05 CCT or observational (single or meta-analysis), with a quality score

    of 3 or more on the 5-point Jadad methodologic quality checklistGrade C 15% Not significant RCT or CCT or observational (single or meta-analysis)Grade C 15% Unimportantb Any study designGrade D 0% (favors control) Well-designed RCT with 100 patients

    a RCTrandomized controlled trial, CCTcontrolled clinical trial.b For grade C, statistical significance is unimportant (ie, clinical importance is not met; therefore, statistical significance is irrelevant).

    Table 2.Master Grid of Low Back Pain (LBP) Guidelinesa

    AcuteLBP

    SubacuteLBP

    ChronicLBP

    Post-surgeryLBP

    Exercise C, I A, I A, I A, IContinue normal

    activities A, I ID ID ID

    Traction C, I C, I C, I ndTherapeutic ultrasound C, II nd C, II ndTENS C, I nd C, I ndMassage ID nd ID ndThermotherapy nd nd ID ndElectrical stimulation nd nd ID ndEMG biofeedback ID nd C, I ndCombined rehabilitation

    interventionsID nd ID nd

    a TENStranscutaneous electrical nerve stimulation,

    EMGelectromyographic, ndno data, IDinsufficient data, Abenefit

    demonstrated, Cno benefit demonstrated, level Irandomized controlledtrial evidence, level IIevidence from controlled clinical trials.

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    A survey questionnaire was sent to 324 practitioners forfeedback on the 4 grade A or B recommendations. Theircomments were reviewed by the Philadelphia Panel and

    were incorporated in this EBCPG document.

    RESULTS

    Literature SearchThe literature search identified 4,981 articles related toLBP. Of these, 340 were considered potentially relevantbased on the selection criteria checklist. Of these, 41 metthe selection criteria and were included (Appendix 2).The number of included trials is shown for each of theinterventions for nonspecific back pain in the cityscapeshown in Figure 1.

    Practitioner Feedback SurveyOf the 324 practitioners surveyed from the American Academy of Family Physicians (AAFP), American Acad-

    emy of Orthopaedic Surgeons (AAOS), American Col-lege of Physicians (ACP), American Physical TherapyAssociation (APTA), American College of RheumatologyHealth Professionals (ARHP), and Physiatric Associationof Spine, Sports, and Occupational Rehabilitation(PASSOR), 9 were inappropriately sampled (wrong spe-cialty) and 21 could not be reached due to incorrectaddresses. Of the 294 practitioners who were appropri-ately sampled and received the questionnaire, 149responded (51% response rate). Of these, 11 (4%) refusedto participate and 138 (47%) completed the survey.

    Table 3.Grade A Guidelines: Clinically Important Benefit Demonstrateda

    Guideline Recommendation Outcomes Relative Difference Study Design

    Continue normal activity versus enforcedbed rest for acute (4 wk) low backpain

    Grade A, I Sick leave, 12 wk 3.5 d (49% difference) RCT (N186)Grade C Function, 3, 12 wk 10%Grade C Pain 10%

    Therapeutic exercises for subacute(412 wk) low back pain Grade A Pain 10%57% 3 RCTs (N

    405)Grade A Function 1115%Grade A Patient global assessment 1724%

    Therapeutic exercises for chronic(12 wk) low back pain

    Grade A Pain 18%60% 6 RCTs (N563)Grade A Function 7%47%

    Therapeutic exercises for back painpostsurgery

    Grade A Function 51%56% 1 RCT (N200)

    a RCTrandomized controlled trial.

    Table 4.Grade C Rehabilitation Interventions: Clinically Important Benefit Not Demonstrateda

    Guideline Recommendation Outcome

    Relative

    Difference Study Design

    Therapeutic exercises versus controlfor acute low back pain

    Grade C Pain No effect 4 RCTs (N549)Grade C FunctionGrade C Return to work

    Mechanical traction for acute lowback pain

    Grade C Pain No effect 3 RCTs (N176)

    Ultrasound for acute low back pain Grade C Pain No effect 1 CCT (N73)TENS for acute low back pain Grade C Pain No effect 1 RCT (N58)

    Grade C FunctionMechanical traction for subacute low

    back pain (412 wk)Grade C Pain No effect 3 RCTs (N212)Grade C Patient global assessmentGrade C Return to work

    Mechanical traction for chronic lowback pain

    Grade C Pain No effect 2 RCTs (N176)Grade C Function

    Grade C Return to workTherapeutic ultrasound for chroniclow back pain

    Grade C Pain No effect 1 CCT (N36)

    TENS for chronic low back pain Grade C Pain No effect 5 RCTs (N317)Grade C Function

    EMG biofeedback for chronic lowback pain

    Grade C Pain 3% to 50% 4 RCTs (N96)Grade C Function

    a RCTrandomized controlled trial, CCTcontrolled clinical trial, TENStranscutaneous electrical nerve stimulation, EMGelectromyography.

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    ACUTE LBP (

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    This is consistent with the Quebec Task Force on SpinalDisorders (QTF)20 and the Agency for Health CarePolicy and Research (AHCPR),21 which found no scien-tific evidence for general exercises.

    Clinical Recommendations Compared With OtherGuidelines: The Philadelphia Panel recommendedthere is poor evidence to include or exclude stretchingor strengthening exercises alone (grade C for pain,function, and return to work) as an intervention foracute LBP. This recommendation agrees with theAHCPR21 and BMJ22 guidelines. In contrast, the QTF20

    recommended the prescription of general exercises asan option to increase strength, ROM, and endurance

    but did not discriminate between different types ofexercise. The BMJ22 reported that increased stress fromtherapeutic exercises may be harmful in acute condi-tions based on the RCT by Malmivaara et al15 that wasincluded in our study.

    Continuation of Normal Activities VersusEnforced Bed Rest for Acute LBP (

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    Table 6.Continue Normal Activities for Acute Low Back Pain: Pain, Function, and Return to Work at 3 Weeks a

    StudyTreatmentGroup

    Outcome(Units)

    No. ofPatients

    BaselineMean

    End-of-StudyMean Absolute Benefit

    RelativeDifferencein ChangeFromBaseline

    Malmivaara et al,15

    1995E: normal activity Return to work (d) 67 NA 4.1 3.4 (I) d difference

    after 3 wk49% (I)

    C: bed rest 67 NA 7.5Malmivaara et al,15

    1995E: normal activity Function, Oswestry

    scale (0100)67 32 10 3.40 (I) on 100-point

    scale10% (I)

    C: bed rest 67 34.6 16Malmivaara et al,15

    1995E: normal activity Pain, VAS 10 cm 67 5.7 1.9 0.30 (I) on 10-cm

    VAS5% (I)

    C: bed rest 67 5.9 2.4

    a Eexercise group, Ccontrol group, NAnot available, VASvisual analog scale.

    Figure 3.Normal activities versus bed rest for acute low back pain: return to workat 1 and 3 months. CIconfidence interval.

    Figure 4.Continue normal activity versus bed rest for acute low back pain:function at 1 and 3 months. CI confidence interval.

    Figure 5.Continue normal activities versus bed rest for acute low back pain: painat 1 and 3 months. CIconfidence interval.

    Figure 6.Traction versus placebo for acute low back pain: patient and clinicianglobal assessment at 1 month. CIconfidence interval.

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    Mechanical Traction for Acute LBP (

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    for acute LBP. This EBCPG agrees with AHCPR21 and

    BMJ22 guidelines, even though they make general state-ments to consider physical interventions, including ther-apeutic ultrasound. In contrast, the QTF20 recom-mended therapeutic ultrasound as an option to diminishmuscle spasm and relieve symptomatic pain. However,ultrasound was classified as thermotherapy, which ismisleading, because pulsed ultrasound does not pro-duce thermal effects. There is insufficient informationregarding adverse effects.22

    TENS for Acute LBP (

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    2. Type of exercise (eg, Kendall, McKenzie) depends onpatient.

    3. A combined approach with education is needed.

    4. Length of follow-up in Davies et al study32 is insufficient.

    Panels Response: The guideline has been modified tospecify that we did not assess the use of these interven-tions for patients with neurological/radicular pain. Theindividualized approach to exercise prescription is a widespread clinical opinion but has little empiric evi-dence. The effects of individualized approaches couldnot be assessed, because the trials report group out-comes. Education was not assessed by the PhiladelphiaPanel. An educational booklet on posture and biome-chanics was provided to the patients in both groups of 1trial,31 but not to the other 2 trials. When the Davies etal study32 was excluded from the analysis, the results

    remained the same; therefore, exclusion of this studywould not change the recommendation.

    Mechanical Traction for Subacute LBP (4 12Weeks), Level 1 (RCT), Grade C for PatientGlobal Assessment and Return to Work (NoBenefit Demonstrated)

    Summary of Trials: Two RCTs (N212) of static trac-tion compared with a placebo were included.33,34 Onetrial was excluded due to lack of a control group(traction was compared with heat).35 Both trialsincluded patients with radiating pain.

    Efficacy: None demonstrated. There was no clinicallyimportant benefit for patient global assessment at 1month (Fig. 11) or for return to work at 12 months(Fig. 12).34

    Strength of Published Evidence in Comparison With OtherGuidelines: The Philadelphia Panel found level I evi-

    dence of no clinically important benefit of mechanicaltraction for subacute LBP. In contrast, the AHCPR21

    found moderate scientific evidence of no benefit, andthe QTF20 reported no scientific evidence. The AHCPR21

    included the same trials as our research team except forone, did not use the same classification for scientificevidence, and included a trial involving clients withchronic LBP conditions.

    Clinical Recommendations Compared With OtherGuidelines: The Philadelphia Panel recommends thatthere is poor evidence to include or exclude mechanicaltraction alone (grade C for patient global assessmentand return to work) as an intervention for subacute LBP.This EBCPG agrees with AHCPR21 and BMJ22 recom-mendations. The QTF20 recommended mechanical trac-tion as an option to increase ROM. The BMJ22 reportedthe following potential harms of traction: (1) debilita-tion, (2) loss of muscle tone, (3) bone demineralization,and (4) thrombophlebitis.

    Table 8.Therapeutic Exercises for Subacute Low Back Pain: Patient Global Assessment at 1 Month a

    Study Treatment Group OutcomeNo.Improved

    No. ofPatients

    Risk (% ofOccurrence)

    RiskDifference

    Davies et al,32 1979 E1: McKenzie exercises Patient global assessment 9 14 64% 24%E2: Kendall exercises 8 14 57% 17%

    C: control 6 15 40%a Eexercise group, Ccontrol group.

    Figure 11.Mechanical traction for subacute low back pain: patient global assess-ment at 1 month. CIconfidence interval.

    Figure 12.Mechanical traction versus placebo for subacute low back pain: returnto work at 12 months. CIconfidence interval.

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    CHRONIC LBP (>12 WEEKS)

    Therapeutic Exercises for Chronic LBP (>12Weeks), Level I (RCT), Grade A for Pain andFunction (Clinically Important Benefit), Grade Cfor Return to Work (No Benefit Demonstrated)

    Summary of Trials: Seven trials were excluded due tolack of an appropriate control group.3642 One studycould not be analyzed because standard deviations were

    not reported.43 Eight RCTs wereincluded.4451 The exercises includedflexion, extension,44 stretching, circuittraining,45,49,50 and strength exercises with progressive increases in resis-tance.4648

    Efficacy: Clinically important benefit

    was demonstrated for pain relief andfunctional status. Five RCTs (N361)demonstrated percentage reductionsin pain relative to the control group of7%,50 20%,44 23%,45 26%,46 and 60%47

    (Tab. 9, Fig. 13). Two RCTs of nursingaides with back pain showed no differ-ence in number of patients with painimprovement after 1 month (RR1.45, 95% CI0.59 3.56).48,49 Func-tional status was improved in 3 RCTs(N209) relative to the control group

    by 7% with stretching exercises50

    ; 17% with strengthening, stretching, andaerobics45; and 47% with strengthen-

    ing exercises46 (Tab. 10). The pooled meta-analysisresults were statistically significant for function (stan-dardized mean difference [SMD]0.36, 95% CI0.10.6). There was no difference in ROM, strength, orreturn to work. One RCT (N56)52 found no differencebetween flexion and extension exercises for pain orpatient global assessment at 1 month posttherapy.

    Table 9.Therapeutic Exercises for Chronic Low Back Pain: Pain at 1 Montha

    Study Treatment Group Outcome (Scale)No. ofPatients

    BaselineMean

    End-of-StudyMean

    AbsoluteBenefit

    RelativeDifferencein ChangeFromBaseline

    Frost et al,45

    1995E: strengthening, stretching,

    aerobic exercisesSensory pain

    (0100 VAS)36 20.9 12.1 5.30 (I) on 100-

    point VAS23% (I)

    C: control 35 25.6 22.1Deyo et al,50

    1990E: stretching exercises Pain improvement

    (0100)63 NA 47.9 7 (I) on 100-point

    scale7% (I)

    C: control 63 NA 40.9Spratt et al,44

    1993E: McKenzie exercise Pain (010 cm VAS) 21 5.6 6.85 1.12 (I) on 10-cm

    VAS20% (I)

    C: control 17 5.84 5.97Hansen et al,47

    1993E: strengthening exercises Pain (09 VAS) 44 5.0 4.1 3.00 (I) on 9-point

    Likert scale60% (I)

    C: control 28 5.0 7.1Risch et al,46

    1993E: strengthening, stretching

    exercisesPain (West-Haven Yale

    scale, 025)31 3.4 2.9 0.90 (I) on 25-

    point scale26% (I)

    C: control 23 3.7 4.1a Eexercise group; Ccontrol group; VASvisual analog scale; NAnot available; (I) indicates improvement better in treatment group than in control group,

    negative or positive depending on anchors for the scales.

    Figure 13.

    Exercises for chronic low back pain: pain at 1 month. CIconfidence interval.

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    At 6 to 12 months follow-up (not shown in the table), therelative reduction in pain was 60%47 and the relativeimprovements in function were 0% in one trial50 and30% in another trial.45 Two RCTs were pooled andshowed no difference in sick days over 12 months(WMD0.5 days, 95% CI 1.5 to 2.5 days).47,51

    Strength of Published Evidence in Comparison With OtherGuidelines: The Philadelphia Panel found good scien-

    tific evidence (level I) of clinically important benefit onpain and function with stretching or strengtheningexercises. In contrast, the QTF20 found no scientificevidence for general exercises. The QTF20 reviewed onlyone of the trials that was included in our meta-analysis.

    Clinical Recommendations Compared With OtherGuidelines: The Philadelphia Panel recommends thatthere is good evidence to include stretching, strength-ening, and mobility exercises (grade A for pain andfunction, grade C for return to work) as interventions forchronic LBP. The BMJ22 is in agreement with this

    EBCPG concerning strengthening exercises. The QTF20

    also recommended the prescription of general exercisesas an option to increase strength, ROM, and endurance.The BMJ22 reported that exercise could have adverseeffects due to increased stress on the spine.

    Practitioner Agreement

    Response rate for this EBCPG: 48% Percentage of practitioners giving comments for

    this EBCPG: 38% Agree with recommendation: 88%

    Think a majority of my colleagues would agree:91%

    Will (or already) follow this recommendation: 81%

    Practitioner Comments

    1. Evidence for functional status is not convincing.

    2. Be careful about lumping different types of exercise

    (eg, McKenzie and strengthening).

    3. McKenzie exercises are insufficient for chronic LBP,useful only for acute LBP.

    4. Article by OSullivan et al53 on abdominal musclere-education for spondylolisthesis should beincluded.

    5. Neuromotor retraining should be included in thisEBCPG.

    Panels Response: The evidence for functional status isbased on 3 RCTs, 2 of which demonstrated greater than15% improvement in function relative to the controlgroup. Different exercises were not lumped; each articleis presented separately in Tables 9 and 10. The McKen-zie approach was evaluated for chronic LBP by one trial, which showed a 20% relative improvement in paincompared with the control, thus meeting the Philadel-phia Panel criteria for clinically important improve-ment.44 The study by OSullivan et al53 was excludedbecause neuromotor retraining was compared with acombined approach using exercises, heat, massage, and

    Table 10.Therapeutic Exercises for Chronic Low Back Pain: Function After 1 Montha

    Study Treatment Group OutcomeNo. ofPatients

    BaselineMean

    End-of-StudyMean

    AbsoluteChangeas % ofBaseline

    DifferenceinAbsoluteChange

    Relative% ofChange

    Deyo et al,50

    1990 E: stretching exercises Function: modifiedSIP score (0100,100worst)

    63 10.1 5.6

    45% (I)

    0.70 (I) on100-pointscale

    7% (I)

    C: control 62 10.1 6.3 38% (I)Frost et al,45

    1995E: strengthening,

    stretching, aerobicexercises

    Disability:Oswestry scale(0100,100worst)

    36 23.6 17.6 25% (I) 4.10 (I) on100-pointscale

    17% (I)

    C: control 35 23.6 21.7 8% (I)Risch et al,46

    1993E: strengthening,

    stretching exercisesSIP, physical

    component (0100,100worst)

    31 9.1 7.7 15% (I) 5.50 (I) on100-pointscale

    47% (I)

    C: control 23 15.2 19.3 27% (W)

    a Eexercise group, Ccontrol group, SIPSickness Impact Profile.

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    ultrasound, but not the control. The panel was not ableto make any recommendations about neuromotorretraining, as there are no controlled studies evaluatingthe effectiveness of this intervention.

    Mechanical Traction for Chronic LBP(>12 Weeks), Level I (RCT), Grade C for Pain,Function, Patient Global Assessment, andReturn to Work (No Benefit Demonstrated)

    Summary of Trials: Four RCTs (N176) of mechanicaltraction (2 intermittent and 2 static) versus placebo oruntreated were included.5457 One RCT was excludedbecause it was impossible to separate the data for eachtreatment group.58 One RCT was excluded because thetraction force was only 10% of body weight and consid-ered a placebo therapy.47

    Efficacy: None demonstrated.There was no difference in pain,function, or patient global assess-ment. The point estimate for pain at3 months favored the control groupin the pooled analysis (WMD 6.3, 95% CI15.8 to 3.1)

    (Fig. 14). However, work absence was shorter in the traction groupafter 6 months (35 days with tractionversus 45 days without traction, butthis was not statistically significant).

    Strength of Published Evidence inComparison With Other Guidelines:We found good evidence (level I) ofno important benefit on pain, func-tion, or patient-rated improvementof mechanical traction. In contrast,the QTF20 found no scientific evi-dence.

    Clinical Recommendations Compared With OtherGuidelines: The Philadelphia Panel recommends thatthere is poor evidence to include or exclude mechanicaltraction alone (grade C for pain, function, patient globalassessment, and return to work) as an intervention forchronic LBP. This EBCPG is in accordance with BMJ22

    clinical recommendations compared with otherEBCPGs, but not the QTF,20 which recommendedmechanical traction as an option to increase ROM.According to the BMJ,22 potential harms, not validated

    in trials, include (1) debilitation, (2) loss of muscle tone,(3) bone demineralization, and (4) thrombophlebitis.

    Therapeutic Ultrasound for Chronic LBP (>12Weeks), Level II (CCT), Grade C for Pain (NoBenefit Demonstrated)

    Summary of Trials: One RCT (N36) of continuoustherapeutic ultrasound versus a placebo59 was included.

    Efficacy: None demonstrated. There was no differencein pain improvement between continuous therapeutic

    ultrasound and sham therapeutic ultrasound after 1month of therapy (Fig. 15).59 No data were reported forfunctional status, ROM, strength, quality of life, orreturn to work, and no data were available beyond 1month.

    Strength of Published Evidence in Comparison With OtherGuidelines: We found fair scientific evidence (level II)that showed no clinically important benefit on pain withtherapeutic ultrasound. The QTF20 found no scientificevidence.

    Figure 14.Traction for chronic low back pain: pain at 1, 3, and 6 months. VASvisual analog scale,CIconfidence interval.

    Figure 15.Therapeutic ultrasound for chronic low back pain: pain (numberimproved at 1 month). CIconfidence interval.

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    Clinical Recommendations Compared With OtherGuidelines: The Philadelphia Panel recommends thatthere is poor evidence to include or exclude therapeuticultrasound alone (grade C for pain) as an interventionfor chronic LBP. This EBCPG is in concordance withBMJ22 guidelines, despite a general statement on physi-cal interventions, including therapeutic ultrasound. In

    contrast, the QTF20 recommended the prescription oftherapeutic ultrasound grouped with thermotherapy asan option to diminish muscle spasm and relieve symp-tomatic pain. There is insufficient information regard-ing adverse effects.22

    TENS for Chronic LBP (>12 Weeks), Level I(RCT), Grade C for Pain and Function (NoBenefit Demonstrated)

    Summary of Trials: Four CCTs (N235) of TENS versusa placebo were included.50,6062 One observational study

    (N

    78) was included, although some patients did nothave LBP (but had other pain syndromes such as cervi-calgia or phantom limb pain).63 This study also allowedpatients to self-select TENS based on its perceived effec-tiveness during 2 weeks of in-hospital therapy. One CCTwas excluded because, of the 16 patients assigned to thetreatment group, only 6 had LBP.64 One RCT wasexcluded because the patient population was people with chronic myalgia and the etiology was notdescribed.65 Two RCTs were excluded due to lack of anappropriate control group (both used a form of massageas the comparison intervention).66,67 Two crossover

    RCTs were excluded because both thetreatment and placebo groups receivedacupuncture needles. Acupuncture isthought to have an effect of its own and was excluded from the scope of thisreview.68,69

    The method of application wasacupuncture-like in one RCT.50 Twotrials used high-frequency (10 Hz)TENS,60,61 2 trials used low-frequency(4 Hz) TENS,62 1 trial alternatedbetween both low- and high-frequencyTENS,50 and the other trial did notreport the characteristics in sufficientdetail.63

    Efficacy: None demonstrated (Fig.16). There was no difference in thepooled estimate of patient-rated painat 1 month posttherapy (SMD0.2,95% CI0.4 to 0.1). This SMD isequivalent to a difference betweentreatment and control groups of 4 mmon a 100-mm VAS for pain. In addition,

    there were no differences between placebo and TENSfor functional status, ROM, or strength at 1 monthposttherapy. At 3 to 6 months posttherapy, there was nodifference in self-rated pain or activity level in any study.The pooled results were not affected by the quality of thetrial, the frequency of TENS, or whether acupuncture ortraditional TENS was applied. No side effects were

    reported for TENS.

    Strength of Published Evidence in Comparison With OtherGuidelines: The Philadelphia Panel found good evi-dence (level I) of no clinically important benefit on painwith TENS. This finding disagrees with the QTF,20whichfound weak scientific evidence based on a CCT.67 Thistrial was excluded from our analysis due to lack ofplacebo (the comparison intervention was massage).

    Clinical Recommendations Compared With Other Guide-lines: The Philadelphia Panel recommends that there

    is poor evidence to include or exclude TENS alone(grade C for pain and function) as an intervention forchronic LBP. This EBCPG is in concordance with theBMJ22 recommendations. In contrast, the QTF20 recom-mended TENS as a rehabilitation modality for symptom-atic pain relief, but this recommendation may includeother forms of electroanalgesia. Insufficient informationregarding adverse effects was reported by the BMJ.22

    Figure 16.Transcutaneous electrical nerve stimulation for chronic low back pain: pain at 1 and 6 months.VASvisual analog scale, TENStranscutaneous electrical nerve stimulation, CIconfidenceinterval.

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    EMG Biofeedback for Chronic LBP (>12Weeks), Level I (RCT), Grade C for Pain andFunction (No Benefit Demonstrated)

    Summary of Trials: Five RCTs (N162) of EMGbiofeedback versus a control for chronic LBP wereincluded.7276

    Efficacy: None demonstrated. Meta-analysis showed noeffect on pain relief, functional status, or ROM after 1month of therapy (Fig. 17). There were no data forquality of life or return to work. There were no databeyond 1 month.

    Strength of Published Evidence in Comparison With OtherGuidelines: The Philadelphia Panel found good scien-tific evidence (level I), which showed no clinically impor-tant benefit on pain or function with EMG biofeedback,but no scientific evidence. When no evidence was found,we rated it insufficient data regarding postural exer-

    cises. The QTF20

    found no scientific evidence.

    Clinical Recommendations Compared With OtherGuidelines: The Philadelphia Panel recommends thatthere is poor evidence to include or exclude EMGbiofeedback alone (grade C for pain and function) asintervention for chronic LBP. The BMJ22 made norecommendation due to conflicting evidence related toEMG biofeedback. The QTF20 recommended EMGbiofeedback as an option to reduce muscle spasm.Postural exercises were not studied by the QTF.20 There

    is insufficient information regardingadverse effects for EMG biofeedback.22

    Interventions for Chronic LBPWith Insufficient DataNo eligible studies were found on which to base recommendations for

    thermotherapy, massage, or electricalstimulation (Tab. 5). This lack of evi-dence was also reported by the BMJ22

    and QTF20 guidelines. However, boththe QTF20 and BMJ22 recommend mas-sage as an intervention for chronicLBP. Massage may have beneficialeffects, as shown in an RCT publishedin abstract format.75

    Combinations of rehabilitation inter-ventions were classified by the Philadel-phia Panel as having insufficient data tomake a recommendation due to differ-ent combinations, unvalidated out-comes, and poor description of theactual interventions. This is in disagree-

    ment with the BMJ22 and the QTF,20 which both makegeneral statements about the use of physical interven-tions in combination at the discretion of the rehabilita-tion specialist.

    Deep abdominal stabilization exercises for patients withchronic spondylolisthesis improved pain and functionrelative to general exercises, heat, massage, and thera-

    peutic ultrasound in one RCT (N42), but no placebocomparison group was available.53

    POSTSURGERY BACK PAIN

    Therapeutic Exercises Post-Back Surgery,Level I (RCT), Grade A for Pain and Function(Clinically Important Benefit)

    Summary of Trials: One RCT (N200) with 3 groups was included that compared strengthening exercises

    versus McKenzie exercise versus no therapy.79

    One RCTof vigorous lumbar stabilizing exercises compared withmild exercises was excluded due to lack of a controlgroup.77

    Efficacy: Clinically important benefit was shown onpain and function with both types of exercise versus notherapy. Both the resisted exercises and the McKenzieprogram improved functional status by 51% relative tothe control group (Tab. 11). The exercise groupsimproved more on ROM (flexion increased by 45%and extension increased by 109%) and strength (by

    Figure 17.

    Electromyographic biofeedback for chronic low back pain: pain and function at 1 month.ADLactivities of daily living, VASvisual analog scale, CIconfidence interval.

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    97%) at 2 months. Both exercise programs alsoextended the time to re-enter treatment for LBP by 51weeks (95% CI50 52) and 89 weeks (95% CI69 110), respectively.76

    Strength of Published Evidence in Comparison With OtherGuidelines: The Philadelphia Panel found good scien-tific evidence (level I) of clinically important benefit onpain and function with back extension and strengthen-ing exercises. In contrast, the QTF20 found no scientificevidence for general exercises postsurgery.

    Clinical Recommendations Compared With OtherGuidelines: The Philadelphia Panel recommends thatthere is good evidence to include strengthening andextension exercises (grade A for pain and function) asan intervention for postsurgery LBP. This is in agree-

    ment with the BMJ,22

    which recommends strengtheningexercises, and the QTF,20 which recommends therapeu-tic exercises. The BMJ22 guidelines reported thatincreased stress on the spine is a potential risk oftherapeutic exercises.

    Practitioner Agreement

    Response rate for this EBCPG: 46% Percentage of practitioners giving comments for

    this EBCPG: 24% Agree with recommendation: 90% Think a majority of my colleagues would agree:

    83% Will (or already) follow this recommendation: 91%

    Practitioner Comments

    1. High-technology equipment (isotonic and isokinetic)is not practical in a clinical situation.

    Panels Response. The EBCPG recommends that eitherhigh-technology exercise or low-technology (traditionalstrengthening and McKenzie exercises) be used forpostsurgery LBP.

    DISCUSSIONEvidence-based practice is rapidly growing in the reha-bilitation domain,78 especially for LBP.6 This systematicreview demonstrates that there are a number of rehabil-itation interventions for LBP that have been shown in

    one or more controlled trials to provide a clinicallyimportant benefit. Such evidence is still needed for theother interventions.

    However, as with all such reviews, there are a number oflimitations. Methodologic issues such as the potential forpublication bias, variations in the methodologic qualityof the included trials, and lack of standardized outcomesare discussed in the Philadelphia Panel article on meth-odology in this issue (Evidence-Based Clinical PracticeGuidelines on Selected Rehabilitation Interventions:Overview and Methodology).

    The effectiveness of conservative management of peoplewith LBP is a complex issue.6,79 Physical rehabilitation isdefined as a combination of physical agents. Rehabilita-tion specialists often use concomitant interventions intheir daily practice.80 Each intervention is usually used asan adjunct. Certain interventions such as cryotherapy,hot pack application, and massage are used for painrelief or as a treatment preparation before the mainintervention. The use of a single and specific interven-tion does not reflect the complexity of the globalapproach adopted by rehabilitation specialists in real-lifeclinical situations.

    The effectiveness of physical rehabilitation interventionsfor LBP are thought to be influenced by a number of riskfactors,4,8184 including biological,85 psychosocial,8689

    and occupational9094 health indicators. A multidimen-sional clinical evaluation is recommended in LBP man-agement.95,96 It was not possible to examine these riskfactors in this review.

    The Philadelphia Panel EBCPGs for the management ofLBP are largely in agreement with previous and relativelyrecent EBCPGs21,22 for LBP shown in Appendix 1. The

    Table 11.Exercises for Postsurgery Back Pain at 1 Montha

    Study Treatment Group OutcomeNo. ofPatients

    BaselineMean

    End-of-studyMean Absolute Benefit

    RelativeDifferencein ChangeFromBaseline

    Timm,76 1994 E1: high-tech resistedexercises

    Function: Oswestry scale,0100

    50 33.17 15.06 17.93 (I) on 100-pointscale

    51% (I)

    E2: low-tech, McKenzieexercises

    50 34.96 14.46 20.32 (I) on 100-pointscale

    56% (I)

    C: control 50 37.22 37.04

    a Eexercise group, Ccontrol group.

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    Philadelphia Panel EBCPGs for LBP were developedbased on a systematic grading of the evidence deter-mined by an expert panel, and the evidence was derivedfrom systematic reviews and meta-analyses using theCochrane Collaboration methodology. The finalizedguidelines were circulated for feedback from practitio-ners to verify their applicability and ease of use for

    practicing clinicians. This additional procedure providescredibility for rehabilitation specialists who intend to usethese EBCPGs for LBP management in their daily practice.

    ExercisesOur recommendations are in agreement with those ofthe AHCPR guidelines that continuation of normalactivities (such as walking) is more effective than bedrest for the management of acute LBP.15

    Extension, Strengthening, or Flexion Exercises: Our sys-tematic review3032,39,4447,51,52,76,97101 also showed thatextension, flexion, or strengthening exercises are effec-tive for subacute and chronic LBP and for postsurgeryLBP. The results for acute LBP are in full agreementwith guidelines and other reviews6,102 concerning mod-erate effectiveness of stretching or strengthening exer-cises, but highly effective advice to stay active.103 Cer-tain authors recommend return to functional and workactivities as soon as possible after lumbar injury to avoidthe negative effects of immobilization and bed restprescription.104,105 Task-oriented activities are recog-nized in rehabilitation. Patients with LBP benefit fromthese activities as they improve ADL. For chronic LBP,our results are concordant with the summary by van

    Tulder et al6 on the effects of exercise therapy (flexion,extension, strengthening). Exercise therapy for subacuteand for postsurgery LBP was not considered by vanTulder et al.6 For subacute and chronic LBP conditions,our conclusions are in full agreement with the results ofFaas.106 In future studies, it will be important to look atclarifying types of exercises used, adequate exerciseintensity, and progression according to patient-specificclassification of physical dysfunction, needs, treatmentgoals, and outcomes.95,107110

    Mechanical Traction

    Eleven RCTs of static, intermittent, or vertical tractionhave been conducted in acute, subacute, and chronicLBP.2427,3335,54,56,58,111 None of these RCTs showed evi-dence of clinically important benefit56 on any of theoutcomes identified as patient-important outcomes bythe Philadelphia Panel; thus, neither static nor intermit-tent mechanical traction was shown to be of clinicallyimportant benefit. This lack of important benefit wasconsistent for acute, subacute, and chronic LBP as wellas for static and intermittent traction. These resultsagree with previous systematic reviews for acute andchronic LBP management,6 even though those reviews

    did not clearly distinguish between manual and mechan-ical traction.

    It would have been of great interest to pool the results ofdifferent subgroups in order to evaluate whether thepresence or absence of neurological signs influenced theresults. Unfortunately, subgroup analyses across the dif-

    ferent trials according to specific clinical characteristicswere not possible due to noncomparable outcome mea-sures. Our systematic review included a mix of patients with and without neurological signs in 4 out of 11trials.23,34,54,58 Therefore, our results appear to be robustacross mixed conditions. However, as none of these 4trials included patients with disk involvement, no con-clusions can be drawn about effects in patients with diskinvolvement.

    Some have claimed that the clinical indication for staticor sustained traction is the presence of a nuclear diskprotrusion.112,113 Of the 11 trials, 2 included populationsin which all patients had disk involvement,25,26 and 2included a mix of patients with and without nuclear diskprotrusions.50,57 The results of these 3 trials were consis-tent with the others, showing no evidence of clinicalbenefit. This point shows the importance of identifyinghomogenous subgroups of patients with LBP based onprecise differential physical dysfunction diagnosticclasses, such as nerve root adhesion, hypomobility dys-function, and sacroiliac hypermobility.114 However, cur-rent literature does not support the suggestion thatlumbar traction has a beneficial effect on LBP111,115 byrepairing disk herniations.

    Therapeutic UltrasoundTherapeutic ultrasound has not been shown to provideclinically important benefit for acute LBP28 or chronicLBP.59 The Philadelphia Panel recommendation (levelII, grade C) agrees with the AHCPR21 and BMJ22 guide-lines that evidence for the effectiveness of therapeuticultrasound is lacking. Comparison with the results of vanTulder and colleagues6 systematic review was not possi-ble because they found no RCTs that met their criteria.However, the QTF20 recommended therapeutic ultra-sound for muscle spasm and pain relief. This QTF

    recommendation was based on common practice ratherthan any evidence from clinical trials. Furthermore, thisrecommendation grouped therapeutic ultrasound withthermotherapy.

    The only 2 trials available were both of low quality (0 outof 5 on the Jadad scale11,12). Furthermore, the type oftherapeutic ultrasound was continuous in the study byRoman59 and not specified in the other trial.28 A pulsedtherapeutic ultrasound type may be more effective thancontinuous therapeutic ultrasound in acute conditionsbecause of a nonthermal effect.116 These results concur

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    with a previous systematic review,80 even though it wasconducted for all musculoskeletal conditions.

    TENSDespite several RCTs of TENS, no consistent benefit wasshown on clinically relevant outcomes (eg, pain, func-tional status, patient global assessment) for acute, sub-

    acute, or chronic LBP.29,50,60

    64

    Subgroup analysesrevealed no significant differences between acute andchronic conditions, low- and high-quality studies, orconventional and acupuncture-like application or dura-tion of the TENS session. These results are in concor-dance with previous systematic reviews for acute andchronic LBP.6,117 The Philadelphia Panel EBCPGs (levelI, grade C) are in agreement with AHCPR21 and BMJ22

    guidelines, which do not recommend TENS for LBP, butthey are in conflict with the QTF20 guidelines, whichrecommend TENS for pain relief. However, the QTF20

    guidelines do not differentiate between electroanalgesiaand TENS. Specific therapeutic application of TENS isof key importance. Vibratory stimulation has been rec-ommended as part of the TENS application, especiallyfor chronic pain relief.65,118,119 None of the trialsincluded in our review considered vibratory stimulation.There is a need for strict and rigorous RCTs of TENSusing combined vibratory stimulation.

    Therapeutic MassageThere were insufficient data for the Philadelphia Panelto make a recommendation for therapeutic massage asan intervention for acute, subacute, or chronic LBP. Thecurrent results are in full agreement with 2 recent

    systematic reviews.6,120 However, a recent, large unpub-lished trial suggests that massage may have a clinicallyimportant benefit.75

    The Philadelphia Panel recommendation agrees withthe AHCPR,21 which concluded that insufficient evi-dence regarding massage was available. However, thePhiladelphia Panel disagrees with both the BMJ22 andQTF20 recommendations that massage should be consid-ered as a therapeutic option in LBP, particularly for therelief of muscle spasm. The QTF20 and BMJ22 recom-mendations were made based on common practice

    rather than any evidence from controlled clinical trials.

    Massage is a global intervention involving a number ofconfounding variables related to the therapeutic appli-cation. For example, the effectiveness of massage isinfluenced by the types of maneuvers used, the massageapproach adopted, years of experience of the therapist,the number and the size of the muscles involved, thepatient position used, the pressure exerted, the rhythmand progression, and the frequency and duration of thetreatment sessions.120

    ThermotherapyThere was insufficient evidence to make a recommenda-tion regarding thermotherapy as an intervention foracute or chronic LBP. These results are in agreement with a recent systematic review6 for chronic LBP andwith the evidence ratings of the AHCPR21 and QTF20

    guidelines. However, the QTF20 recommended thermo-

    therapy as an intervention for acute LBP.

    Only comparative trials56,66,121 were identified forchronic LBP. In these trials, the separate effects of ice orheat could not be determined because they were used inconjunction with other interventions or compared withother interventions of unknown therapeutic benefit.

    Physiological studies have shown significant effects ofcryotherapy on circulatory and temperature responsesand on muscle spasm and inflammation,122,123 but themechanism of action has not yet been fully elucidated.123

    It is unknown whether these physiological effects trans-late to important effects on clinical outcomes (such aspain and functional status). Back muscles may be toothick to benefit from the penetrating effects of superfi-cial, local ice application for pain relief.123

    Electrical StimulationThe Philadelphia Panel was unable to make a recom-mendation regarding electrical stimulation due to insuf-ficient evidence. There are some head-to-head stud-ies,61,124 but in the absence of placebo controls, efficacycannot be established. This is in agreement withAHCPR21 guidelines. The BMJ22 and QTF20 did not

    evaluate this modality.

    Electrical stimulation is thought to increase functionalactivity if the peripheral nervous system is intact.125 OnlyPope et al124 excluded patients with LBP who hadneurological deficits. It has been recommended forphysical rehabilitation in the upper and lower extremi-ties in patients with LBP.125 To our knowledge, no othersystematic reviews have studied this specific therapeuticintervention.

    EMG Biofeedback

    No consistent clinically important benefit was found forEMG biofeedback for either acute LBP126 or chronicLBP.70,7274 Two trials used EMG biofeedback for backmuscle relaxation.72,74 The other trials70,73,126 used EMGbiofeedback to improve muscle activation control. Only2 trials70,126 excluded patients with root and peripheralnerve entrapment. Electromyographic biofeedback126

    may be important in the relief of muscle spasms inpeople with acute LBP.127 Our results are in concor-dance with other guidelines and the review by vanTulder et al.6

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    Combined Rehabilitation InterventionsFor both acute and chronic LBP, the Philadelphia Panelconcluded that insufficient evidence was availableregarding rehabilitation interventions when several arecombined. This differs from the QTF20 and BMJ22 guide-lines, which both recommend that rehabilitation special-ists use interventions in combination at their own discre-

    tion to achieve treatment goals. The extent to whichmultiple interventions are redundant needs to beassessed in the same fashion as individual interventions.

    The studies of combinations that were found used hetero-geneous modalities, many of which were not described insufficient detail to allow replication.41,42,56,128130 Further-more, comparisons among studies are difficult becausethe investigators did not select the same combination ofrehabilitation interventions. Methodological quality waslow in these studies.

    OverallThe main difficulty in determining the effectiveness ofrehabilitation interventions is the lack of well-designedprospective RCTs. Future research in physical therapyshould adopt rigorous methods such as the use of anappropriate placebo (and double-blind procedure), ade-quate randomization, homogeneous sample of patientsbased on rigorous selection and diagnosis criteria, andadequate sample size to detect clinically important dif-ferences with confidence.

    CONCLUSIONThere is evidence to support and recommend the use of

    continued normal activities for acute nonspecific LBPand therapeutic exercises for chronic, subacute, andpostsurgery LBP. These EBCPGs were developed with atransdisciplinary team approach, using a structuredmethodology for guideline development that includespractitioner feedback. There is a lack of evidence atpresent regarding whether to include or exclude the useof thermotherapy, therapeutic massage, EMG biofeed-back, mechanical traction, therapeutic ultrasound,TENS, electrical stimulation, and combined rehabilitationinterventions in the daily practice of physical rehabilitation.

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    Appendix1.

    Continued

    Rehabilitation

    Intervention

    PhiladelphiaPanel(20

    01)

    QuebecTaskForce20

    (1987)

    AHCP

    R21

    (1994)

    BMJ22

    (2000)

    EMGbiofeedback

    Strengthofp

    ublished

    evidenceincomparison

    withother

    guidelines

    Insufficientscientificevidence

    (levelID)forEMG

    biofeedback

    Commonpractice,butno

    scientificevidence

    N/C

    N/R

    Clinicalreco

    mmendations

    compared

    withother

    guidelines

    Insufficientevidencetoinclude

    orexclude(gradeID)EM

    G

    biofeedbackaloneasan

    interventionforacuteLBP

    EMGbiofeedbackis

    listedasanoptionto

    diminishmusclespasm

    N/C

    Insufficient

    evidenceoftheeffects

    ofEMG

    biofeedbackinacute

    LBP

    Therapeuticmassage

    Strengthofp

    ublished

    evidenceincomparison

    withother

    guidelines

    Insufficientscientificevidence

    (levelID)fortherapeutic

    massage

    Commonpractice,butno

    scientificevidence

    Limitedresearch-basedevidence

    (atleastoneadequatescientific

    stud

    y)

    N/R

    Clinicalreco

    mmendations

    compared

    withother

    guidelines

    Insufficientevidencetoinclude

    orexclude(gradeID)

    therapeuticmassagealo

    neas

    aninterventionforacute

    LBP

    Therapeuticmassageis

    listedasanoptionto

    diminishmusclespasm

    Useofphysicalagentsisofpoorly

    substantiatedbenefittojustify

    theircostinacuteLBP

    Insufficient

    evidenceoftheeffects

    ofphysicalinterventionsin

    acuteLBP

    Thermotherapy

    Strengthofp

    ublished

    evidenceincomparison

    withother

    guidelines

    N/A

    Commonpractice,butno

    scientificevidence

    Limitedresearch-basedevidence

    (atleastoneadequatescientific

    stud

    y)

    N/R

    Clinicalreco

    mmendations

    compared

    withother

    guidelines

    Nodatafound

    Thermotherapyislisted

    asanoptionto

    diminishmusclespasm

    andinflammationand

    torelievesymptomatic

    pain

    Useofphysicalagentsisofpoorly

    substantiatedbenefittojustify

    theircostinacuteLBP

    Insufficient

    evidenceoftheeffects

    ofphysicalinterventionsin

    acuteLBP

    Electricalstimulation

    Strengthofp

    ublished

    evidenceincomparison

    withother

    guidelines

    N/A

    N/C

    N/C

    N/C

    Clinicalreco

    mmendations