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Research Study Analysisby GARY L SMIDT PhD PT FAPTAEditor-In-Chief

MeadeMI DyerS Browne W TownsendJ FrankAO: Low back pain ofmechanical origin: randomised comparison of chiropractic and hospitaloutpatient treatment. Br MedJ 300: 1431 1437, 1990The analysis of the preceding paper wasperformed in a compartmentalized fashion. Withbrevity in mind, an attempt was made to presentkey points of scientific and clinical relevance.

lNTRODUCTlONIn reporting experimental research, the introduc-tion section provides the need and justification fora study. The Meade et al study (hereafter calledthis study ) provides commonly accepted state-ments concerning the high incidence of low backpain and its contribution to work absence. How-ever, no literature is cited to support these claimsor to document the need for treatment interven-tion. The main justification for the study was astatement concerning manipulation hat appearedin a cited British MedicalAssociation Report.Paragraphs two and three in the introductionare descriptions that would more appropriatelyappear in the methods section. No purpose state-ments or hypotheses are shown in the introduc-tory section.METHODSIn the methods section, the inclusion and exclu-sion criteria for patient participation and the logis-tics for carrying out the randomization process forthe two groups was commendable. The largenumber of subjects in the study was impressive.For reasons not discussed, a much higher per-centage of eligible patients referred to the hospital(80%) entered the trial compared to the low 28percent referred to chiropractors.The Oswestry Disability Index for Low BackPain was suitably used as a tool to measureoutcome in this study. The questionnaire wasused at baseline, once a week over the first six0190-6011/91/1306-0288 03.00/0THEJOURNAL OF ORTHOPAEDICND SPORTS HYSICALHERAPYCopyrightQ 1991 by The Orthopaediiand Sports PhysicalTherapySections of the American Physical TherapyAssociation

weeks, at six months, and at one and two yearspostentry. To clarify the scope of the assessmentfor this study, a copy of the current Oswestryquestionnaire is provided (Figure 1).Direct joint mobility methods for straight legraising and lumbar flexion were mentioned but notdescribed. The use of a nurse coordinator as atester with blinding was a good idea.The idea to use a pragmatic approachwhere the type, frequency, and duration of treat-ment were at the discretion of each chiropractoror hospital team was excellent. The randomizedcontrol trial appears to be an appropriate designfor this study. The acknowledged limitation wasthat specific components of treatment could notbe warranted from the results.The constraint of a 10-treatment maximumwith an intended concentration during the first

three months appeared reasonable. However, inthe end, patients treated by chiropractors re-ceived 44 percent more treatments than thosetreated in the hospital. In addition, hospital treat-ments (100%) were completed within 12 weeks,while the chiropractic group continued treatments(97%) for 30 weeks. This clear-cut disparity be-tween total number and frequency of treatmentsis a confounding factor that severely jeopardizesthe study's credibility.This paper focuses on treatment intervention,yet only two sentences are included in the treat-ment section. The data in Table 4 partially offsetthis shortcoming. The paper further suffers froma paucity of information on intervention methods.It must be pointed out that no control groupwas included in this study. For ethical reasons,the conditions for excluding patients from treat-ment are difficult to justify. Nevertheless, in theabsence of a control group, it is impossible toconclude that any of the clinical changes resultedfrom therapeutic intervention. They may simplyrepresent the natural course of the disease.

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CONFIDENTIAL THE OSWESTRY DISABILITY INDEXFOR LOW BACK PAlNSCORE l

THE ROBERT JONES AND AGNES HUNT ORTHOPAEDIC HOSPITAL, OSWESTRY, SHROPSHIREDEPARTMENT FOR SPINAL DISORDERSNAME: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATEOFBIRTH: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .DDRESS: DATE:AGE: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .CCUPATION:How long have you had back pain? . . . . . . . . . . . . . . . Years . . . . . . . . . . . . . . . Months WeeksHow long have you had leg pain? Years . . . . . . . . . . . . . . . Months. . . . . . . . . . . . . . . WeeksPLEASE READ:

This questionnaire has been designed to give the doctor information as to how your back pain has affected your ability tomanage in everyday life. Please answer every section and mark in each section only ONE BOX which applies to you. Werealise you may consider that two of the statements in any one section relate to you but please just mark the box whichmost closely describes your problem.

SECTION 1-PAIN INTENSITYMy pain is mild to moderate;l do not need pain killers.The pain is bad but I manage without taking pain killers.Pain killers give complete relief from pain.Pain killers give moderate relief from pain.Pain killers give very little relief from pain.Pain killers have no effect on the pain.

SECTION 3-LIFTINGI can lift heavy weights without extra pain.I can lift heavy weights but it gives extra pain.Pain prevents me from lifting heavy weights off the floor.but can manage if they are conveniently positioned e.g.on a table.Pain prevents m from lifting heavy weights but I canmanage light weights if they are conveniently positioned.Ican lift only very light weights.I cannot lift or cany anything at all.

SECTION 2-PERSONAL CARE Washing, Dressing, etc.Ican look after myself normally without causing extrapain.Ican look after myself normally but it causes extra pain.It is painful to look after myself andI am slow and careful.Ineed some help but manage most of my personal care.Ineed help everyday in most aspects of self care.do not dress; wash with difficulty; and stay inbed.

SECTION 4-WALKINGcan walk as far as Iwish.

Pain prevents me walking more than one mile.Pain prevents me walking more thanVZmile.Pain prevents me walking more than /4 mile.I can walk only if I use a stick or crutches.I am in bed or in a chair for most of everyday.

SECTION 5-S rnN G SECTION 6-STANDINGI can sit in any chair as long as I like. I can stand as long as I want without extra pain.cansit in my favourite chair only but for as long as Ican stand as long as I want but it gives me extra pain.like. Pain prevents me from standing for more than 1 hour.Pain prevents me from sitting more than 1 hour. Pain prevents me from standing for more than 30 minutes.Pain prevents me from sitt ing more than 12 hour. Pain prevents me from standing for more than 10 minutes.Pain prevents me from sitt ing more than10minutes. Pain prevents me from standing at all.Pain prevents me from sitt ing at all.

SECTION 7-SLEEPING SECTION 8-SEX LIFEPain does not prevent mefrom sleeping well. My sex l ie is normal and causesno extra pain.I sleep well but only by using tablets. My sex life s normal but causes some extra pain.Even when I ake tablets I have less than 6 hours sleep. My sex life is nearly normal but is very painful.Even when I take tablets have less than4 hours sleep. My sex life is severely restricted by pain.Even when I take tablets I have less than 2 hours sleep. My sex life s nearly absent because of pain.Pain prevents me from sleeping at all. Pain prevents any sex life at all.

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SECTION 9 SOCIAL LIFEMy social life is normal and causes me no extra pain.My social life is normal but increases the degree of pain.Pain affects my social life by limiting only my more ener-getic interests, dancing, etc.).Pain has restricted my social life and do not go out asoften.Pain has reshicted my social l ie to my home.Ihave no social life because of pain.

SECTION 10 TRAVELLINGIcan travel anywhere without extra pain.Ican travel anywhere but it gives me extra pain.Pain is bad, but I manage journeys over 2 hours.Pain restricts me to journeys of less than 1 hour.Pain restricts me to short necessary journeys under 30minutes.Pain prevents me travelling except to the doctor r Hos-pital.

COMMENTS. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .. . . . . . . . . .

Figure 1. From the Centre tor Spinal Studies, Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestr,r,United Kingdom.)

RESULTS AND DISCUSSION curred within the first six weeks o f treatment. Themagnitude of these changes was almost identicalThe paired tests are appropriate for analysis of for both groups. During this period, both groupsthe straight leg raising and lumbar flexion meas- were receiving approximately the same amount/ures. However, the paired t-test is inappropriate number of treatments. As such, comparisonsfor the dataObtained the Osw estry question- were valid for only the first six weeks of treatm ent.naire. In the latter case, the best statistical ap- There is a notable discrepancy in the num berproach would ave been Of of treatments between groups (the chiropracticassess interaction as well as main effects of group group received signibantly more treatment).and time. Analysis of individual questionnaireitems would have been useful. Therefore, between group comparisons at six, 12,Based on Figure 3a, small differences were and 24 months are subject to criticism. Thesenoted between groups over time for patients with tests few between group dif-low (54O0 /~ oints) Osw estry scores. For patients ferences when looking at the entire sample.with 2 4 0 percent points on the Oswestry scale, When looking at the more involved patients,the groups tend to separate at 24 months. Small i.eOl 24 0 percent points On the O swestry scale,between group differences are no ted through the the ~ ? s u ~ savored chiropractic ntetVenti0n. HOW-12-month period. Figure 2a, which represents all ever, these results are confounded since, assubjects, suggests few between group differ- shown in Table 4 (bottom entry), the chiropracticences. The difference at 24 months, although group was significantly larger than the hospitalstatistically significant, is sub ject to question and group (6 weeks: C 73 versus H 58; 6 months:has minor clinical significance based on the pre- C 69 versus H 56; 12 months: C 53 versusceding no group differences. H 44; and 24 months: C 30 versus H 19).The major changes seen in this study oc- As such, these results are also questionable.290 SMlDT JOSPT 3:6June 99


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The percentage of questionnaires returnedby the patients was laudable. Given the betweengroup inequities in number and frequency of treat-ments rendered, the between group outcome isthe same from a statistical perspective. This in-cludes the results from the Oswestry question-naire as well as the time off from work since theX result was p 0.05.

How then could the authors conclude that'obvious clinical improvement in pain and disabil-ity could be attributed to chiropractic treatment?Some might plausibly argue that the results ofthis study favor the hospital reatment group sincethe same results were obtained at considerablyless cost 165 ersus l 1 1 and patients re-quired44 percent fewer treatments. In the contextof this study, others might contend that without acontrol group, neither hospital nor chiropracticintervention was effective.The comments in the discussion section pro-vide some interesting lines of reasoning. Theycenter around the perceived clear-cut results,which, in fact, are highly tenuous. The section isreplete with bias.SUMM RYThis paper presents a clinical study involving ther-apeutic intervention on patients with low backpain of mechanical origin.

The study represents a magnanimous effort,involving arge numbers of patients and personnel.Commendable aspects of the study are the num-ber and description of subjects used, the random-ization process, the design, the use of the Os-westry questionnaire, and the data collectionprocess.On the negative side of the ledger, the studyis poorly justified, no purpose(s) was stated, andthere was inequity between the two hospital andchiropractic groups in the total number and fre-quency of treatments. Further, the treatmentmethodology was poorly described, and the sta-tistical analysis was inappropriate for the dataobtained from the Oswestry questionnaire. Therewas no control group, the interpretation of theresults and the data were mainly incongruous,and the implications of the study are grossly ov-erstated. On the Oswestry questionnaire data,there appeared to be little difference between thegroups.Although this is an interesting study withseveral noteworthy eatures, a substantial numberof critical weaknesses persist. These weaknesseswould appear to preclude any remotely definitiveconclusions regarding the effectiveness of treat-ment intervention for mechanical low back pain.

Thanks to Dr DavidNielsen for his conMbution in the areas ofresearch designand statistical analyses

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Commentary Oneby GunnarB. J. Andersson MD PhDProfessor and Associate ChairmanDepartment of Orthopedic SurgeryRush-Presbyterian-St. Luke's Medical Center

Gary L Smidt, Editor-in-Chief of The Journalof Orthopaedic and Sports Physical Therapy, hasasked me to write a short paper on clinical re-search and low back pain. This request wasprompted by a letter regarding a classical articleby James Cyriax, MD, originally published in 1950and reprinted in JOSPT 12(4):163-169, 1990, aswell as by a recent article comparing chiropracticand allopathic outpatient treatment (Meade et al,1990 .Mine is not to discuss the letter; it is obviouslynot possible for JOSPT to publish from otherscientific journals all pertinent articles on a partic-ular topic. Also, have no intention of publishingan authoritative text on clinical research. Rather,will try to address some of the problems asso-ciated with clinical studies of treatment of patientswith low back pain. To do so, let me first considerwhat evidence would convince me that a treat-ment method is effective for low back pain.The first requirement is that the study beprospective and randomized. Retrospective stud-ies are common, but often information has notbeen initially obtained with sufficient attention todetail, leaving voids when analyzing the data.Nonrandomized interventions can be comparedto historic controls or concomitant studies per-formed elsewhere. This presents a weakness,however, since time and progress in our under-standing may influence results, making historiccontrols invalid, and since results from elsewheremay reflect not only the treatment provided, butits administration and the subject population.Comparing results to the natural history isanother alternative. In low back pain, the naturalhistory of large groups of patients is reasonablywell-established; however, it varies greatly be-tween subjects. One problem with the use of thenatural history, or, for that matter, a comcomitantcontrol group, is that the intervention(s) in thecontrol group often varies greatly. Thus, we may0190-601 1/91/1306-0292 03.00/0THE JOURNALF ORTHOPAEDICND SPORTS HYSICALHERAPYCopyright 199 1 by The Orthopaedic and Sports Physical TherapySections of the American Physical Therapy Association

Gunnar B. J. Anderssonend up comparing our treatment alternative toseveral others-some that may be superior andsome that are inferior. Unfortunately then, in theglobal analysis, we may derive an erroneous con-clusion. This problem will be discussed furtherbelow. Another problem in this approach relatesto the control group patients, who may havedifferent diagnoses and disease severity levels.The second requirement is that the studypopulation be welldescribed. This means not onlyreporting on the demographic and anthropometriccharacteristics, but, more importantly, defining thepathology underlying the painful complaint as

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clearly as possible. In ow back pain this is difficult.Nonetheless, we know that certain disease cate-gories can be identified and that prognoses andnatural histories vary among them.A uniform patient group is preferable, butprovides data that are relevant only to that symptom complex (pathologic process). wider patientselection will result in data more applicable to ageneral subject population with various patholo-gies, but the study population should then pref-erably be divided into subgroups to determine ifthe intervention is more effective for a certaingroup of patients. Typically, a study will have bothinclusion and exclusion criteria for its populationthat must be carefully reported and justified.third requirement s that the interventionbewelldescribed in the treatment group and in thecontrol group. Much can be discussed about this.First, I'll address the intervention in the treat-ment group. Is it so welldescribed that it can beeasily reproduced? Is it representative of the treat-ment it reflects? Take, for example, manipulation.Is it done by an expert, or by someone withlimited experience? Did the manipulator feel thepatient had an appropriate problem to addresswith his/her technique, however defined? Is theevaluation limited to the manipulative maneuver,or is the entire care process included?Similarly, in the control group-Was it blindedto the maneuver-a very difficult proposition with,for example, manual therapy or surgery? Second,in the control population-is the treatment alter-native so poor that it has a negative influence onthe natural history? For example, a detuned short-wave alternative may actually be less effectivethan standard care, however defined (i.e. anunder-treatment or negative treatment) .Into this enters the problem of placebo effect,which, of course, is positive rom a treatment pointof view but often not specific to the intervention.Positive placebo effects are as high as 50 percentfor almost any treatment of back pain. Anotherproblem is to limit the patient group with respectto the treatment studied and its alternative. It isnot possible to remove analgesics from patientswith pain; however, pain medication can be con-trolled (type, amount) and recorded. Other careaspects such as rest, information, etc., also needto be controlled and reported.

fourth requirement is that the follow-up bedone by an unbiased observer-someone who isblinded to the intervention. This is an absoluterequirement, for obvious reasons.A fifth requirement is that the outcome meas-ures be appropriate. They must be valid, repro-ducible, and sensitive enough to distinguish between different levels of improvement. Evaluatingpain is notoriously difficult since the pain experi-ence is subjective. Function is influenced by pain,

but also by other factors. Therefore, it cannotdirectly replace pain as an outcome measure.Further, the issue of which functional abilityto evaluate needs to be addressed. In short,grading low back pain and disability is difficult.The minimum requirement s that the method usedbe valid, reproducible, and able to distinguishbetween different levels of pain and function.Another issue is when to determine outcome.Since acute low back pain has a very rapid recov-ery, studies of acute low back pain need shortobservation periods. This also allows speed ofrecovery to be determined which is essential inacute low back pain. On the other hand, a rapidrecovery with rapid recurrence is not a solution.For that reason, we must monitor the subjectsover a longer period, perhaps six to 12 months.In chronic pain, the situation is different.Longer observation periods are needed. This isalso the case when surgical procedures are eval-uated.A sixth requirement s that the follow-up eval-

uations include a sufficient percentage of thestudy population. Drop-outs must be carefullydescribed and their influence on outcome deter-mined statistically.A seventh requirement is that the data beproperly managed statistically. This often requiresinvolvement of a professional statistician to atleast select the appropriate method@).The statis-tical analyses must be described and, if unusual,motivated. If possible, independent statisticalanalysis should be considered to remove anyconcern of bias.If all these points were adhered to, and thedifference between the intervention studied andthe control group was highly statistically signifi-cant, I would be convinceable that the treatmentmethod was effective for low back pain. If thestudy was repeated with similar results, I wouldprobably be convinced.When performing clinical studies of manipu-lation in low back pain, the following elementsshould be included:a clearly stated hypothesis;strict guidelines for subject selection;a sample size sufficient for clinical and sta-tistical significance;randomized allocation;assessments that are blinded;

objective, quantitative, and statisticallymanageable treatment outcomes;precise and replicative treatment algo-rithms;long-term follow-up periods with mecha-nisms to recapture drop-out data;data analysis by independent statisticians;andresults suitable for publication in refereedjournals.OSPT 3:6 une 99 LOW BACK PAIN 293


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Commentary Twoby StanleyV Paris, PhD, PTProfessor and ChairmanInstitute of Graduate Physical Therapy1 What evidence is necessary to convinceyou that a particular treatment or cadre oftreatments is effective for low back paindisorder?

This is not a simple question to answer, butI shall attempt to do so from two perspectives:clinical esting and the results of a research study.For clinical testing, I feel I have enough clinicalexperience to be able to evaluate a new modalityor procedure on any typical condition with whichIam familiar and to compare the outcome of thatnew modality or procedure to that which I havebeen using. In fact, I constantly perform singlecase testing. If a significant and measurablechange is made in terms of objective measure-ments or sustained pain relief, then the procedureas is or with some modification should fit into myarmamentarium of treatment. I will always con-duct such a clinical test several times beforepermanently accepting the procedure into anystandard approach.As an example, I would like to offer thetreatment of positional distraction to the lumbarspine, which Ibegan using in 1971 At first, I usedit on patients with discogenic low back pain andaccompanying neurological disorders who hadnot improved with mechanical traction. Whensome of these cases showed improvement (inpain distribution and neurological assessment) ol-lowing positional distraction, I was encouraged. Ithen began to use it on cases where mechanicaltraction was expected to help. These patientsseemed to likewise improve-perhaps evenfaster. But what also influenced me to use posi-tional distraction rather than mechanical traction,which I have now totally abandoned, was thatpositional distraction did not require equipmentother than an extra pillow and a sheet for makingthe bolster over which the patient was positioned.Later, a small study with radiology suggested0190 601lpl/l306-0294 03.00/0THEJOURNAL OF ORTHOPAEDICND SPORTS HYSICALHERAPYCopyright 991 by The Orthopaedic and Sports Physical TherapySectionsof theAmerican Physical Therapy A s s o c i a t i

Stanley V Paristhat positional distraction gained a greater open-ing of the intervertebral foramen than mechanicaldistraction. I felt this was the goal of traction.Furthermore, positional distraction could beadapted to a home program. By these steps, Ibecame convinced of its value in clinical practice.Secondly, I evaluate treatment effectivenessbased on the results of a research study.Research on the effectiveness of one proce-dure or cadre of procedures is very difficult toconduct. For instance, a study contrasting backschool with physiotherapy is usually invalid-theback school proponents are enthusiastic, andphysiotherapy is usually designed to be relativelyineffective, such as ultrasound and nonspecificback exercises. The same could be said whencontrasting extension with flexion. Here again,there are extension enthusiasts but few, if any,flexion enthusiasts.Other issues are the qualifications and ex-perience of the persons on each side of the trial.A back school conducted by doctors' wives wouldprobably not be as effective as a back school

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conducted by physical therapists. A valid trialrequires a level playing field.There have been a number of studies con-trasting manipulation with a variety of treatments,such as back school, heat and massage, bed rest,etc. In all of these studies, manipulation has doneas well as or better than the procedure with whichit was contrasted. Despite this, even I a propo-nent of manipulation, say such studies are flawed.Usually the manipulation is done as a single ma-neuver, it is invariable from visit to visit, and itdoes not include supportive modalities, such asheat, massage, postural nstruction (back school),and exercises.Manipulation is rarely practiced as a single,stand-alone modality; yet most of the researchconcerning its effectiveness uses it as a stand-alone procedure. By comparison, flexion and ex-tension routines are stand-alone, more-or-lesscomplete treatments in themselves. They can eexpected to compare well with any other modalityor procedure, such as back school or manipula-tion.Research studies that would convince me oftreatment effectiveness would have to representclinically valid treatment sessions by comparableclinicians in comparable settings.2. What is your interpretation of the resultsetc. of the Mea de et al study?

The results of this study are not surprising.They show that a private practice back care spe-cialist-who in this trial is able to be more selec-tive of patients and manage them for a longerperiod-gained better results than a nonspecialistworking for the government in a busy outpatienthospital department. This is a classic example ofan unlevel playing field.However, to the referring physician, the studysuggests that referrals to chiropractors in privatepractice will likely get better results than referralsto outpatient physical therapy-in England.It would be more interesting to compare thechiropractic group with a similar physiotherapygroup, i.e., members of the Manipulative Associ-ation of Chartered Physiotherapists in privatepractice.3 To what extent does this paper satisfyconvictions expressed in your response toitem one?

It does not meet my criteria at all.The paper compares specialists in privatepractice (chiropractors) with generalists in a busyand underpaid outpatient department (physiother-apists). The quality of training and, no doubt, thelevel of enthusiasm for the study by the involvedpractitionerswould e two significant factors influ-encing outcome. The playing field was not level

on this and other factors, such as selection ofpatients, the fact that delays were experienced ingetting patients to the physiotherapists, and thefact that the chiropractors treated the patients fora longer period of time.The outcome was wholly predictable. Itproves nothing that common sense would nothave foreseen without doing the study. Therewere objections to this study by physiotherapistseven before it was begun, but these objectionswent largely unheard.However, it must eadmitted that in England,chiropractic in a private setting is more effectivethan physiotherapy in a public setting.My principal objection is that this study,which had a predictable outcome, would be usedas a propaganda tool to influence professionalsand the public. In reprinting this article at therequest of a chiropractor, JOSPT proves the va-lidity of my concern.

In a more positive light, I trust it stimulatesphysical therapists to conduct, sponsor, or sup-port similar clinical research with an improved andmore equitable design.This paper further supports the need to en-courage and recognize specialization within phys-ical therapy. Our undergraduate training is verybroad and somewhat shorter than chiropractic.We emerge as generalists, not specialists.The object of specialization, e it by physio-therapists in England or physical therapists in theUnited States, is to bring to bear the specialabilities and skills that only specialization can pro-duce. Spinal manipulation in physical therapy is agraduate skill.4. Response to Cyriax article

With regard to Cyriax's classic article, I hinkit should have been clearly published as a 'clas-sic , with perhaps invited discussion. Not allJOSPT readers are current in orthopaedics. Theymay e mislead into thinking that what Cyriaxwrote in 1950 is state-of-the-art 40 years later.The contribution of the late James H Cyriaxto orthopaedic medicine and to physical therapyremains unmatched. In recent years, his theoriesconcerning back pain have been hotly debatedand are now generally considered too simplistic.In the 1950s, Dr. Cyriax was ahead of his time.By the 1970s, his failure to recognize structuresother than the disc as sources of back pain placedhim increasingly at odds with the literature andcurrent practice.In criticizing his theories, have nothing butpraise for the man under whom I was privilegedto study and against whom I have been honoredto debate.

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CommentaryThreebyRichard E. Erhard PT DCOrthopaedic Chiropractor andPhysical Therapist

Necessary ingredients for convincing clinicalresearch on low back pain include the usual cri-teria, such as outcome measures, that are bothsubjective and objective. Some of these shouldbe functional measurements. Furthermore, thereshould be comparisons between different treat-ments. To be really convincing, one appropriatetreatment should result in improved outcomemeasurements over an inappropriate treatmentfor that particular type of problem.The Meade et al article, fulfills some of thesecriteria but falls short in others. The Oswestryquestionnaire is used throughout as a subjectivemeasure and has a functional bent. Short-termobjective outcome measurements were straightleg raising and forward flexion; however, the long-term outcome measurements, indicating fewertreatments in the chiropractic group as well asless absence from work, were somewhat poorlydefined.Essentially, this study was a comparison ofresults between high velocity, low amplitudethrusts and mobilization. The results should notbe startling. Anyone who has used both the for-mer and the latter, or has had the opportunity toobserve a competent manipulator, would not besurprised at the earlier demonstrability of improve-ment. Therefore, the long-term result is not sur-prising and, in fact, has already been demon-strated in an earlier, smaller (but better controlled)study by Nortin Hadler.The most important finding in this study, asfar as I'm concerned, is the advantage of earlyintervention. There was no attempt to categorizethese patients; therefore, there couldn't be a pos-sibility for a less appropriate treatment in thispragmatic study.We could perform a similar study on shoulderpatients who had pain from the acromioclavicular01 90-601 pl/l306-0296 O3.oO/OTHE JOURN L ORTHOP ED~CND SPORTSHYSIC LHERAPYCopyright 991 by The Orthopaedic and Sports PhysicalTherapySections of the American Physical Therapy Association

Richard E Erhardjoint to the elbow, eliminating those who hadmuscle weakness, sensory changes, or radio-graphic findings that were contraindicated. Wecould then randomly assign these patients tothree treatment categories: mobilization, modali-ties, and immobilization. One can see the obviousdifficulties-mobilization of the unstable shoulder,immobilizing he patient with tendonitis, and treat-ing a frozen shoulder with modalities. I doubt thatanyone would consider this to be a good study,no matter how well it was designed. Yet, this isessentially what the Meade et al study did for lowback pain syndrome.The problems should become obvious. First,it would be difficult to differentiate this idiopathiclow back pain syndrome into subgroups so thathypothetically appropriate treatment results couldbe compared to hypothetically nappropriate reat-ments. Secondly, in the case of the shoulder, wewould be addressing fairly well-known, patholog-ical entities. In the vast majority of low back painsyndrome cases, however, the pathology is un-known. We are confined to using clinical diag-noses, making this the most difficult obstacle toovercome.Since these diagnoses are frequently move-ment dysfunctions that change with improvementand regression, it would be necessary to build ina combination treatment. For example, would theunresponsive patients in the Meade et al studyhave responded better if there was a combinationof manipulation or mobilization and exercises?

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Would the patients that responded to manipula- to perform in a clinical laboratory. Nevertheless, iftion alone have improved even more so with ma- we are to learn clinically useful information, suchexercise pro- as when certain treatments are indicated or con-grams?These examples are remarkably easy todem- traindicated, we must become more fastidiousonstrate in the clinic setting but incredibly difficult in our re%?arch esign.

Commentary Fourby H Duane Saunders, MS, PTPresident, The Saunders GroupMinneapolis, Minnesota

am happy to respond to Dr. Siragusa's letterregarding the article by James Cyriax, MD in theOctober, 1990, issue of JOSPT.It was my understanding that the article wasintended to provide historical background to pres-ent day treatment. I was asked to provide JOSPTwith a reference that I felt was of historical signif-icance and had affected my treatment philosophyconcerning low back disorders (lumbar disc her-niation, in particular). If I had been asked to pro-vide more recent and up-to-date references,would have pointed out a paper by Onel et al 1)and a paper by Saal and Saal(3). These are twovery good references concerning current treat-ment for a diagnosis of disc herniation.Dr. Siragusa's implication that the JOSPTshould have presented the study by Meade et a1seems to be irrelevant to the issue of disc hernia-tion treatment. The Meade et al study excludedall patients who had neurological signs. Thiswould have eliminated many (if not all) of thepatients with disc herniation, or at least thoserecognized as having disc herniation. In otherwords, the Meade et al paper concerns patientswith a different type, or at least a different stage,of problem than the Cyriax article. It is like com-paring apples to oranges.That aside, I would also like to commentabout the Meade et al study. Dr. Siragusa states

that the study found chiropractic manipulationmore effective than outpatient physical therapy. . that chiropractic got patients out of low backpain faster, the relief lasted longer, and it wasmore cost effective than hospital outpatient phys-ical therapy. While the Meade et al study is0190-601 1P1/1306-0297 03.00/0THE JOURNALF ORTHOPAEO~CND SPORTS HYSICALHERAPYCopyright 1991 by The Orthopaedic and Sports Physical TherapySectionsof the American Physical Therapy Association

important and gives us a comparison of chiro-practic manipulation to hospital-based outpatientphysical therapy in England, I would certainly notbe as quick as Dr. Siragusa to assume that thebenefits of chiropractic manipulation are moreeffective than outpatient physical therapy withoutsome further understanding of the study.I have the following concerns and questionsregarding some uncontrolled variables in theMeade et a1study:1 Perhaps the study is more of a comparisonof private care to socialized care than chiropracticto physical therapy? What was the continuity ofcare in the outpatient physical therapy setting?

H. Duane SaundersJOSPT 3:6June 99 LOW BACK PAIN 297


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Did the patient see the same therapist throughhis or her entire treatment regime?Were there more waiting time and bureau-cratic problems for the patients attending theoutpatient physical therapy clinic compared to theprivate practice office of the chiropractor? Wasthe experience level of the treating physical ther-apist equivalent to that of the chiropractor? Wasthe incentive for quality care the same for thesalaried physical therapists as the private practicechiropractors?I raise these questions because any one ofthem could have considerably influenced the ef-fectiveness of the treatment. The authors ac-knowledge these possibilities on page 279 butapparently chose to leave the questions unan-swered.2 One might also view th is study as a com -parison of length of treatment time. Since thechiropractic patients were given an average 44percent more treatmen ts, one m ight conclude thatmore treatment is better than less treatment.However, according to the study, this variablewas ruled out. Perhaps another conclusion couldbe that some chiropractors treat their patientslonger, even though it apparently isn't necessary.3 The me thod of physical therapy treatmentin this study seems to differ from physical therapyin the United States. I would think that the em-phasis on exercise, especially the M cKenzie a pproach, would be much greater in the UnitedStates and that the emphasis on the Maitlandmobilization/manipulation approach would bemuch less.On the other hand, one c ould also argue thatin some physical therapy clinics, the emphasiswould have been on passive modalities. In otherwords, there is not a single physical therapyapproach. Therefore, a study of this nature reallycompared one of several physical therapy pro to-cols in one of several physical therapy practicesettings to private chiropractors' care.4) view studies that rate a patient's pe rce ption of improvement with caution. Much moreobjective criteria for comparing effectiveness aredays lost from work and total medical expensesinvolved.ind it curious that the authors were unableto determine the amount of time off from workduring the first year, but were able to track thisduring the second year. N ot to be overly skeptical,but perhaps this would have shown negativelytoward the chiropractic treatments. Would thefact that the chiropractors' patients received moretreatments over a longer period of time suggestthey were also off work longer? If so, the costeffectiveness claimed by the study would be inserious doubt.In summary, while the Meade et al study doesindicate possible benefits of chiropractic man ipu-

lation over another form of treatment, it raisesserious questions that have not been answered.Before would share Dr. Siragusa's enthusiasmfor the findings of this study, I would require moreclarification of the study resu lts and wou ld needto have the above mentioned variables eliminated.Completely neutral studies comparing the ef-fectiveness of chiropractic treatment to variousforms of physical therapy treatment on a largescale are needed. The treatment ou tcome shouldbe based on return to work, future time lost fromwork, and medical costs. These criteria are theonly legitimate outcomes.A study of this type would be difficult to puttogether, to say the least. The Meade et at study,for example, pointed out that patients went to achiropractor sooner than pa tients went t o a phys-ical therapist. This alone would bias the type ofstudy I am suggesting. Perhaps patients go tochiropractors with different types of back prob-lems than they present to physical therapists?think there would also be a difference be-tween physical therapy practice settings. For ex-ample, does the ou tpatient, private physical ther-apy clinic see the same type of patient as anoutpatient clinic owned by an orthopaedic sur-geon or a hospital-basedclinic? Do these differenttypes of physical therapy clinics treat the same?Do they have the same practice freedom andincentives? Is the experience level of the practi-tioners the same?If I may digress, can perhaps make my point.I recently attended a multidisciplinary medicalmeeting on low back pain where a chiropractorpresented a paper comparing the effectiveness ofchiropractic to medical treatment. The study, ofcourse, showed the benefit of chiropractic to besuperior. The study compared multiple visits tothe chiropractor's office for manipulation andother treatment to one visit to a medical doctorwho gave the patient exercise with only tele-phone follow-up.When questioned about the type of exercisesthe patients at the medical doctor's office weregiven, the presenter did not even know what theywere.While it can be argued that this is indeed theway some medical doc tors treat pa tients with lowback pain, is this really scientific research? Or wasthe study set up so that the outcome would beexactly what the researchers wanted it to be?I don't mean to imply that chiropractic re-search is always in question. All professions areguilty of publishing research that is of questiona-ble quality. One only has to read the Quebec TaskForce report (2) to understand my point.Good research, especially research compar-ing one treatment regime to another, is difficult toaccomplish; bad research is worse than no re-search at all because it is misleading; and the98 S UNDERS JOSPT 3:6June 99


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research that falls in between should be carefully cost and effectiveness of our treatments. After all,interpreted. isn t that what we are all interested n?I think it is important for us to continue toexchange our ideas, theories, protocols, and re- REFERENCESsults as clearly as possible so we can all benefit.am confident that this can be done, with better .and more cost-effective patient care as the objec-tive. 2.One final thought: hopefully, the insurancecompanies are monitoring all of us in our practices 3and will be able to give us information concerning

Onel D TuzlaciM. Sari H. Drnir K: Computed tomographic investigatii of the effect of tractii on lumbar disc herniation. Spine14:82-90,1989Quebec Task Force: Scientii approach to th assessment andmanagement of activity related spinal disorders. Spine 12:71S.1987Saal JA. Saal JS: Nonoperative treatment of herniated lumbarintervertebraldisc with radiculopathy-an outcome study. Spine14:432-437.1989

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