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Relative Effectiveness of an Extension Program and a Combined Program of Manipulation and Flexion and Extension Exercises in Patients With Acute Low Back Syndrome

Background a d Purpose. The relative effectiveness of an extension program and a manipulation program with flexion and extension exercises was examined in patients with low back syndrome. Subjects. Forty-ninepatients with less than a 3-month hktory of low back pain were seen at physical therapy clinics in western Pennsylvania, southern Mississippi, and eastern Missouri during a 6-month period. Twenty-seven of the 49 patients were class@ed a prion' into a treatment-oriented category of extmion/mobilization and were then randomly assigned to participate in an extm'on program or a program of manipulationfollowed by bandheel rocks flexion and extension). Two patients dmpped out of the study (I patient returned to work, and the other patient was unable to comply with the treatment schedule), and 1 patient was eliminatedfiom the study because of magnijied illness behavior. The remaining 24 patients (15 male, 9 female; mean age=& years, SD= 15, range=14-73) were assigned randomly and equally to the two groups. EEig pbsical therapists participated in the study. Metbods. A randomized clinical trial comparing the two regimens was conducted for a I-week period. Outcome was assessed using an Oswestry Low Back Pain Questionnaire initially roefore treatment) and at 3 and 5 days posttreatment, and data were analyzed using a 2 x 3 (groupX time) analysis of variance. Results. A sigrtijicant interaction of the group and time variables was demonstrated, indicating that the rate of positive response was greater in the manipulation/hand-heel rock group than in the extension group. Conclusion and D d s d o n . In this category of patients with low back pain, the use of manipulation as an adjunct to an ongoing exercise program appears to be warranted. [Erhard RE, Delitto A, Cibulka MT, Relative efictiveness of an extension program and a combined program of manipulation andJexion and extension exercises in patients with acute low back syndrome. Phys Ther. 1994;74:1093-1100.1

Richard E Erhard Anthony Delltto Mlchael T Clbulka

Key Words: Back pain; Exercise, spec@c lumbav Manipulation; Outcome, functional.

With diagnoses of pathology virtually impossible in the majority of patients with low back syndrome (LBS),l,Z classification becomes the only viable alternative for clinicians seeking guidance in managing these patients3 Although classification is reasonably well described for guiding both surgi-

10 / 1093

cal management and diagnostic testing (eg, imaging),4 there is very little written in the peer-reviewed literature that would offer the clinician guidance in the nonsurgical management of patients with LBS. Instead, once the decision to manage conservatively is made, treatment is often described in

nonspecific terms such as "exercise," "rest," "graded increase in activity," and so forth. A useful classification system that would guide conservative management requires (1) that clear operational definitions exist for testing

Physical Therapy / Volume 74, Number 12/ December 1994

procedures and that there be decision rules that can be used for the classification of the patient, (2) that reasonably well-trained clinicians can carry out both assessment and treatment procedures, and (3) that using the classification system results in effective management when compared to some standard of practice. Members of our group have been able to document, to some extent, the presence of all three of these conditions in a system that we use.* We recently reported positive results using a classification approach with previously unclassified LBS in which a subtype of patient was identified and a treatment of manipulation and an extension-oriented exercise program was indicated.5 In that study, we found that treating the patients classified as needing extension and mobilization resulted in more rapid improvement, as demonstrated by patient self-report. We were not able, however to differentiate the effect of the manipulation from that of the extension program. To further refine our approach, we undertook this study, the purpose of which was to compare the effects of (I) manipulation combined with a program of flexion and extension exercises and (2) an extension-oriented exercise and postural program.

We used a method similar to that of our previous study.5 Eight physical therapists from five different physical therapy clinics participated in this study as compared with one physical therapist performing the treatment in

one location in the previous study. We first classified patients as belonging to an extension/mobilization group. All others were excluded from the study. Next, we randomly assigned patients (via flip of a coin) to a group that followed an extension-oriented exercise program (extension group) or a group that underwent manipulation followed by an exercise program that incorporated both flexion and extension of the trunk (hand-heel rocking), hereafter referred to as the manipulationhand-heel rock group. We followed the patients for about 1 week, with an outcome evaluation done initially, approximately at the midpoint, and at the conclusion of the week.

cise program with the manipulation because in our clinical experience we rarely use manipulation as a sole treatment for patients with LBS. We felt that including an exercise program that incorporated flexion as well as extension would not confound the study, because the use of flexion exercises and positions of flexion is discouraged in the early phases of treatment by proponents of the extension regimen. Finally, we chose a hand-heel rock because, in our experience, it is easier to teach patients to perform this technique than other combined flexion and extension regimens (eg, the cat-horse).

Rationale for the Choice of Treatment Reglmens for Group Comparisons

Over a 6-month period, we examined 49 patients for admittance to this study. After examination, we found that 27 patients fit the criteria necessary for classification into extension and mobilization. Two patients subsequently dropped out of the study (1 patient became asymptomatic and returned to full-time work, and the other patient was unable to comply with the treatment schedule), and another patient was not admitted because of magnified illness behavior. Demographic and other information for the remaining 24 subjects, by group, is presented in Table 1.

Our rationale for the two treatment programs was partially based on our previous result in which we found that a group that underwent manipulation and an extension-oriented treatment regimen obtained a better short-term outcome than did a group that underwent a flexion-oriented exercise program.5 In that study, we recognized our inability to differentiate the effec?iveness of the manipulation versus the extension exercise regimen because patients were administered both treatments. In this study, we therefore had one group receiving only the extension-oriented program. For the other group, we used manipulation followed by exercises that incorporated both flexion and extension movements of the lumbar spine. We included the exer-

RE Erhard, DC, FT,is Clinical Associate Professor, Comprehensive Spine Center, Universiry of Pittsburgh Medical Center, Pittsburgh, PA 15261. Address all correspondence to Dr Erhard at the Department o f Physical Therapy, School of Health and Rehabilitation Sciences, Universiry of Pittsburgh Medical Center, 101 Pennsylvania Hall, Pittsburgh, PA 15261 (USA). A Delitto, PhD, FT,is Assistant Professor and Chair, Department of Phrjical Therapy, School of Health and Rehabilitation Sciences, and Clinical Assistant Professor, Comprehensive Spine Center, University of Pittsburgh Medical Center. MT Cibulka, OCS, FT,is President, Jefferson County Rehabilitation Center, 430 S Truman Blvd, Crystal City, MO 63019. This study was approved by the institutional review board at the Universiry of Pittsburgh.

This article was submitted September IG, 1993, and was acceptedJuly 8,I 9 9 4

Physical. TherapyIVolume 74, Number 121December 1994

Examiners Eight examiners from five different clinics in three geographic regions participated. The clinics were located in southern Mississippi, eastern Missouri, and western Pennsylvania and were outpatient settings in which primarily orthopedic disorders were treated. The therapists had an average age of 35 years (SD= 13, range=25-51) and an average of 12 years of experience (SD=8, range=2-29). Five of the 8 therapists have advanced clinical credentials (1 is a chiropractor, 2 are certified as orthopedic physical therapy specialists, and 2 are certified as orthopedic manual therapists).

Description of Ciassification

Table 1 . Danographic a d Other Information

Group Manlpulatlon/ Hand-Heel Extension Rock (n=12) (n=12)

Agea

x

47

41

SD

15

15

Gender (rnalelfemale) 814

715

Days since onset of low back syndromea

X

20

22

SD

23

17

No. of subjects with back pain only

10

12

No. of subjects with leg symptomsb

2

0

'P>.05. '~enotespain or paresthesia below the buttock area.

AU participating therapists were trained in the examination, evaluation, and treatment procedures by the principal author (REE). In addition, all participating clinicians were provided with written instructions describing the inclusion and classification criteria, the randomization procedure (flip of a coin), the treatment regimens, and the follow-up procedures.

Procedure Patients who reported low back pain with an onset of less than 3 months prior to appearance at the clinic were assessed, and they were admitted to the study if it was decided that they met our previously published criteria for needing extension/mobilization.5 Waddell's tests for symptom magnification9 were administered during the initial visit, and patients who showed signs of symptom magnification were eliminated from the study (Tab. 2). An Oswestry Low Back Pain QuestionnaireI0 was filled out at each visit.

Patients were examined by a physical therapist and categorized as needing extension-mobilization o r some other program based on our criteria. Patients who did not meet the criteria for the extension-mobilization group were excluded as subjects. Although the classification system we used has six different categories, we selected only subjects categorized as needing extension-mobilization. Therefore, for the purpose of this report, we describe extension-mobilization criteria only. The variables used to classify the patients can be divided into two major groups: (1) physical signs and tests" that focus on pelvic landmarks and (2) movement testing using the patients' response to movement as a guide to classification. Patients were asked to describe their symptoms regarding location and intensity in the standing position (establishing a baseline level). They were then asked to perform various movements and to report any changes in symptoms. After returning to the starting position, each patient was asked to compare symptoms that occurred with movement with those he or she experienced in the starting position. The possible responses were (1) the pain worsened with movement (eg, the pain o r paresthesia moved distally o r intensified), (2) the pain improved (eg, the symptoms moved proximally o r centrally o r they diminished), o r (3) no change in pain.

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Table 2. Waddell's Testsfor Symptom MagniJication9" I. Tenderness II. Simulation III. Distraction IV. Regional V. Overreaction

aPositive responses in three of the five categories denote magnified illness behavior. Isolated positive signs are ignored.

A major criterion for determining

whether pain "worsens" o r "improves" in patients with symptoms in their back and lower extremity is the centralization phenomenon described by McKenzie12and Donelson and ~ o l l e a g u e s . These ~ 3 ~ ~ authors ~ relate the presence of centralization to prognosis. Our interpretation of McKenzie's description of the movement tests as well as our previous work8 resulted in our adopting the following decision rule: For patients without distal pain o r paresthesia below the buttock, judgments would be made according to the change in lumbar/ buttock symptom intensity after the movement. A patient whose symptoms improved (eg, intensity decreased with movement) with at least two variables related to extension movements or worsened with at least one flexion movement was placed in the extension category (eg, the patient reported centralization of symptoms during extension in standing and repeated extension in the prone position while reporting peripheralization with flexion in the supine position). For patients with referred pain or root symptoms @ain o r paresthesia) below the buttock, we used the centralization phenomenon to judge status. A patient had to improve (achieve centralization) in at least two extension movements o r worsen with at least one flexion movement to be placed in the extension category. The second category of variables used for classification involves signs that have been related to sacroiliac joint region pain.15.16 Manipulative techniques, also purportedly directed to the sacroiliac joint, are indicated when such signs are positive.17 The etiology of pain arising from the sacroiliac joint is an extremely controversial topic.18 The presence of pain in the sacroiliac region (eg, dull pain over the posterior superior iliac spine [PSIS]), however, is described by many patients and may be explained by a variety of non-joint-related causes.19 Rather than implicate the sacroiliac joint in the etiology of such pain, we prefer to label the signs and symptoms as indicative of sacroiliac regional pain and, if a composite (a

Physical Therapy/Volume 74, Number 12/December 1994

Description of Treatment

Flgure 1. The manipulative technique. (Reprinted by permission of the American Pbysical Therapy Association from Cibulka MT. The treatment of the sacroiliac joint component to low back pain: a case report. Pbys Ther. 1992;72:917-922.) group of such signs is positive), as indicative of a specific manipulative technique. For the assessment of sacroiliac regional pain, four tests were used and are described in detail elsewhere.5J1J5J6 The first test conducted is used to assess heights of the PSISs with the patient in a sitting position. Bilateral comparisons are made, and PSISs of equal heights constitute a negative finding. A standing flexion test is conducted next. The patient is in the standing position, and the examiner palpates the PSISs bilaterally. The patient then bends forward, with the examiner coritinuing to palpate the PSISs. A positive finding is present if a change in relationship is detected between the beginning.and end of motion. The third test is a comparison of medial malleoli from a supine to a long-sitting position. With the patient initially positioned supine, the examiner palpates the inferior aspect of the medial malleoli bilaterally and notes relative lower-extremity lengths. The patient

then sits up, and the lengths are again compared. A change in relative lower-extremity lengths is a positive finding. Our fourth test is a prone knee flexion test. With the patient initially positioned prone with shoes on, the relative leg lengths are assessed visually. The patient's knees are then flexed passively to approximately 90 degrees, and the lower-extremity lengths are again observed. A change in relative lengths between the two positions is a positive finding. To place a patient in a manipulation category, at least three of the four tests must be positive. Past work has shown a percentage of agreement beyond chance (kappa= .88).11 The final examination procedure included Waddell's tests for nonorganic physical signs.9 If these test results were positive (three or more of the five categories were positive), the patients were not used as subjects in the study.

*OrthopedicPhysical Therapy Products, PO Box 47009, Minneapolis, MN 55447-0009. Physical Therapy /Volume 74, Number 12/ December 1994

Subjects were randomly assigned to either of the treatment groups by the flip of a coin. The manipulation procedure is purported to affect the sacroiliac joint (Fig. 1). Facing the supine subject with the spine laterally flexed away from the therapist, the subject was instructed to clasp his or her hands behind the neck. One of the therapist's arms was threaded through the subject's far elbow from lateral to medial and, using the subject's arms for leverage, the subject's upper trunk was rotated toward the therapist. The therapist's other hand was placed on the subject's anterior superior iliac spine on the side farthest away, and a postern-lateral-inferior thrust was administered. Immediately following the manipulation, the subject was instructed in hand-heel rocking (Appendix). On follow-up visits, the manipulationhand-heel rock group were reassessed, and if three or more of the signs were present, a second manipulation was administered. No postural instruction was afforded, nor were any props used other than a handout illustrating the exercise. The extension group was treated by an extension-oriented treatment regimen as proposed by McKenzie,l2(pp93-94,107-108, 129-136) including press-ups, use of a lumbar roll, and postural instruction. The use of flexed postures was discouraged, and a handout with illustrations of extension exercises was provided. Each subject was provided with a lumbar roll.* Subjects in both groups were supervised by the treating therapist within the physical therapy setting on a three-times-per-week schedule. Sometimes, the treatment period continued over a weekend, and those subjects who were treated over a weekend were assessed at 4 and 6 days posttreatment instead of at 3 and 5 days posttreatment. Every effort was made to have the third visit within a 7-day window from the initial visit. No third visit occurred greater than 9 days from the initial visit. During return visits, the therapist focused on assess-

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of LBS, and the initial Oswestry scores.

Table 3. Analpis of Variance Results df

Treatment group

Error Treatment time Group x time Error

SS

MS

1

1128

1128

22

10146

461

2

9582

2 44

F

P

2.45

,132

4791

91.70

.OoO

2095

1048

20.05

.OoO

2298

52

In addition, using the criterion for discharge from the acute treatment intervention as a score of below 11 on the Oswestry questionnaire, we counted those patients ready for discharge by group and conducted a chi-square analysis. The alpha level for all analyses was set at .05.

Results ment of the subject's compliance with the exercise/posture routine. Exercise proficiency was evaluated by asking the subjects to perform their exercises on follow-up visits. If a subject performed the exercise without need of correction or assistance, minimal supervision was offered. If a subject was not able to perform the exercises correctly and independently, the exercises were demonstrated. All subjects were able to perform their exercises correctly by their third visit.

Outcome Measure We decided to use a self-report questionnaire as the measure of outcome because (1) it is easy to administer; (2) there is no participation by the treating clinician, and bias of the clinician is therefore eliminated as a factor; (3) the items reflect functional activities that would be logistically impossible to replicate in the clinic or to predict from indexes based on physical examination; and (4) there is documented reliability for the measure.1° Limitations of self-reports include their susceptibility to patient bias. There is, however, good support for self-report measures of health status in clinical investigations involving patients with LBS,20 and the 0 s westry Low Back Pain Questionnaire has been shown to be responsive in studies of patients with LBS.5121 The Oswestq Low Back Pain Questionnaire is an easily administered, disease-specificself-repon instrument that provides an index of a patient's perceived disability based on 10 areas of limitations in perforrnance.I0 These 14 / 1097

areas are pain intensity; changes in the status of pain; and the ability to perform personal hygiene, lifting, walking, sitting, standing, sleeping, social activity, and travel. Each section is scored on a six-point scale (&5), with 0 representing n o limitation and 5 representing a maximal limitation. The subscales added together yield a maximum score of 50. The score is then doubled and interpreted as a percentage of the patient-perceived disability (the higher the score, the greater the disability). We use the Oswestty questionnaire as both a patient-oriented outcome assessment and a guide to know when to progress the patient from the acute treatment phase. In our practice, a score below 11 on the Oswestry questionnaire indicates the patient should be discharged or prepared for return to work.

We attempted follow-up with all subjects after 1 month by mail. Follow-up was with an Oswestry questionnaire only.

Data Analysis Data from the Oswestry questionnaire were analyzed with a 2x3 (treatment group treatment period) analysis of variance (ANOVA) with treatment group as a between-group factor and treatment period as a within-group factor.Z2As a check on the randomization process, we performed a posteriori comparisons using between-group t tests of the following data: age, onset

Of the 49 patients initially entered into the study, 27 met the criteria for extension/mobilization. Three patients were eliminated from the study. The remaining 24 patients were assigned randomly and equally to the two treatment groups. Results of the ANOVA revealed a main effect of treatment period (F=91.7, Pc.05) and a treatment group treatment period interaction (F=20.1, P