Relative effectiveness of an extension program and a combined program of manipulation and flexion and extension exercises in patients with acute low back syndrome.

With diagnoses of pathology virtually impossible in the majority of patients with low back syndrome (JBS),[1,2] classification becomes the only viable alternative for clinicians seeking guidance in managing these patients.[3] Although classification is reasonably well described for guiding both surgical 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 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.[5-8]

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 (1) manipulation combined with a program of flexion and extension exercises and (2) an extension-oriented exercise and postural program.

Method

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 manipulation/hand-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.

Rationale for the Choice of Treatment Regimens for Group Comparisons

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 effectiveness 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 exercise 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).

Subjects

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.

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).

Table 1. Demographic and Other Information

                 Group
                 Manipulation/
                 Hand-Heel        Extension
                 Rock (n=12)      (n=12)
Age(a)
  X                47
  SD               15               15

Gender
  (male/female)    8/4              7/5

Days since
  onset of
  low back
  syndrome(a)
  X                20                22
  SD               23                17

No. of subjects
  with back
  pain only        10                12

No. of subjects
with leg
symptoms(b)        2                  0

(a) p>.05.

(b) Denotes pain or paresthesia below the buttock area.

All 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 Questionnaire[10] was filled out at each visit.

Description of Classification

Patients were examined by a physical therapist and categorized as needing extension-mobilization or 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[11] 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 or paresthesia moved distally or intensified), (2) the pain improved (eg, the symptoms moved proximally or centrally or they diminished), or (3) no change in pain.

Table 2. Waddell's Tests for Symptom Magnification(9a)

I. Tenderness

II. Simulation

III. Distraction

IV. Regional

V. Overreaction

(a) Positive responses in three of the five categories denote magnified illness behavior. Isolated positive signs are ignored.

A major criterion for determining whether pain "worsens" or "improves" in patients with symptoms in their back and lower extremity is the centralization phenomenon described by McKenzie[l2] and Donelson and colleagues.[13,14] These authors relate the presence of centralization to prognosis. Our interpretation of McKenzie's description of the movement tests as well as our previous work[8] resulted in our adopting the following decision rule: For patients without distal pain or 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 (pain or 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 or 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 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.[5,11,15,16] 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 continuing 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.

Description of Treatment

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 postero-lateral-inferior thrust was administered. Immediately following the manipulation, the subject was instructed in hand-heel rocking (Appendix). On follow-up visits, the manipulation/hand-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,[12](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 assessment 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.[10] 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 Oswestry Low Back Pain Questionnaire has been shown to be responsive in studies of patients with LBS.[5,21]

The Oswestry Low Back Pain Questionnaire is an easily administered, disease-specific self-report instrument that provides an index of a patient's perceived disability based on 10 areas of limitations in performance.[10] These 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 (0-5), with 0 representing no 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 Oswestry 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.

Follow-up

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 2 x 3 (treatment group treatment period) analysis of variance (ANOVA) with treatment group as a between-group factor and treatment period as a within-group factor.[22] As a check on the randomization process, we performed a posteriori comparisons using between-group t tests of the following data: age, onset of LBS, and the initial Oswestry scores.

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

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, P<.05) and a treatment group treatment period interaction (F=20.1, P<.05). These results are illustrated in Table 3 and Figure 2. We found no difference between groups for age, time of onset of LBS, and initial Oswestry scores.

[TABULAR DATA 3 OMITTED]

At 1 week posttreatment, 9 of the 12 subjects in the manipulation/hand-heel rock group met the criterion for discharge, whereas only 2 of the 12 subjects in the extension group met the criterion for discharge. A chi-square value of 6.04 was obtained P<.05), indicating the discharge was significantly associated with group assignment (ie, treatment).

We were only able to successfully obtain follow-up assessment at 1 month posttreatment for a total of 12 subjects (6 in each group). Follow-up Oswestry scores were tabulated and used for descriptive purposes only. The results of the 1-month follow-up assessment are shown in Table 4.

[TABULAR DATA 4 OMITTED]

Discussion

The results of this study and of our previous study[5] indicate that manipulative intervention followed by a general lumbar range of motion regimen (as opposed to an extension- or flexion-oriented program without manipulation) may be the key to rapid improvement (ie, within the initial week of treatment) in patients with LBS who have signs and symptoms consistent with the need for extension/mobilization. Our conclusion was based on the observation that when the results of both studies were evaluated, rapid improvement was found only when treatment included the manipulative procedure (both studies) and not with the extension program alone (this study). We also conclude that the manipulative procedure may preclude the necessity of a specific extension program (this study) or flexion program (our previous study). Following manipulative therapy, movement itself, without regard to whether it was flexion or extension, may be the key to progressing the patient through the acute phase as rapidly as possible.

The majority of the patients in our study did not exhibit referred pain to the lower extremities. We propose that a subgroup of patients with referred pain may benefit from an extension program, particularly those with radicular symptoms. Donelson and colleagues[13,14] were able to demonstrate that patients who displayed centralization behavior had a more favorable prognosis than those who did not show centralization. In their studies, extension movements were by far more likely to produce centralization as compared with flexion movements, and those patients were placed on extension programs.

Although the subjects in the extension group showed some improvement, they did not improve as much or as rapidly as the subjects in the manipulation/hand-heel rock group. Similar short-term effects have been found in other studies involving spinal manipulation.[21] The major benefit of manipulation appears to us to be the speed at which the severity of the patient's symptoms is reduced, allowing the patient to participate more actively in his or her own management. In our study, the criterion for discharge from management for an acute condition was met more rapidly when manipulation was performed, allowing patient management to shift from a goal of pain modulation to a home program involving active patient involvement, self-care, fitness exercises, flexibility, education in body mechanics, and so forth.

The use of manipulation has been criticized because it involves passive intervention. We believed that if manipulation is overused and is the only intervention, it can be construed as a passive form of therapy. Our results, however, indicate that patient management can be expedited if manipulation is used in the initial phases of treatment with selected groups of patients with LBS. We do not believe that our results indicate a more favorable response due to the manipulation procedure itself. We believe a more plausible explanation is that the manipulation produced a short-term effect of increasing range of motion and decreasing pain, allowing patient participation in an exercise program designed to increase pain-free range of motion with the spine in a gravity-neutral position. With further improvement through home exercises, we contend that patients were able to return to normal function at a quicker pace than those patients placed on the extension program.

On 1-month follow-up assessment, we found that only two of the six patients in the extension group met the criterion for discharge, whereas all patients in the manipulation/hand-heel rock group met that criterion, with five out of six patients asymptomatic (Oswestry score=0). This finding, although based on a small number of subjects, suggests that withholding manipulative procedures because of the belief that a hands-off approach somehow allows less dependence on the therapist is unwarranted. We have found that manipulative procedures often produce dramatic relief of pain, thus enabling exercise regimens, many of which would be described as self-care" programs, to be initiated very early in the acute phase,

Conclusion

In selected patients with LBS whose signs and symptoms are consistent with the need for extension/mobilization, we were able to show that treating with a manipulative procedure directed toward the sacroiliac region, followed by an exercise program that includes both flexion and extension, results in more rapid resolution of symptoms and improvement in functional limitations than an established extension program alone. This study warrants cautious interpretation in terms of generalization due to (1) the specificity of the patient group studied, (2) the specificity of the examiners used, and (3) the small numbers of subjects included in the study.

[Figures 1-2 ILLUSTRATION OMITTED]

References

(1) Valkenburg HA, Haanen HCM. The epidemiology of low back pain. In: White AA, Gordon SL, eds. American Academy of Orthopedic Surgeons Symposium on Low Back Pain. St Louis, Mo: CV Mosby Co; 1982:9-22. (2) Nachemson AL. The natural course of low back pain. In: White AA, Gordon SL, eds. American Academy of Orthopedic Surgeons Symposium on Low Back Pain. St Louis, Mo: CV Mosby Co; 1982:46-51, (3) Spitzer WO. Diagnosis of the problem (the problem of diagnosis). In: Scientific Approach to the Assessment and Management of Activity-related Spinal Disorders: A Monograph for Clinicians. Spine. 1987;12(suppl):16-21. (4) Waddell G, Hamblen DC, The differential diagnosis of backache. Procedures in Practice. 1983;227:1167-1175. (5) Delitto A, Cibulka MT, Erhard RE, et al. Evidence for an extension/mobilization category in acute low back pain: a prescriptive validity pilot study. Phys Ther. 1993;73:216-228. (6) Delitto A, Shulman AD, Rose SJ, et al. Reliability of a clinical examination to classify patients with low back syndrome. Physical Therapy Practice. 1992;1:1-9. (7) Tenhula JA, Rose Sj, Delitto A. Association between direction of lateral lumbar shift, movement tests, and the side of symptoms in patients with low back pain. Phys Ther, 1990; 70:480-486. (8) Delitto A, Shulman AD, Rose SJ. On developing expert-based decision support systems in physical therapy: the NIOSH low back atlas. Phys Ther. 1989;69:554-558. (9) Waddell G, McCulloch JA, Kummel E, et al. Nonorganic physical signs in low-back pain. Spine. 1980;5:117-125. (10) Fairbanks JCT, Couper J, Davies JB, et al. The Oswestry Low Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271-273. (11) Cibulka MT, Delitto A, Koldehoff R. Changes in innominate tilt after manipulation

Appendix. Illustration of Hand-heel Rock Exercise Procedure From Program Handout Given to Patients

Begin in the hands-knees position. Elbows should be straight, and hands can be turned outward.

Rock backward so that your seat moves toward your heels. Try and rock back as far as you can, but if you have pain, stop.

Now rock forward. Remember to keep your elbows straight and let your hips sag downward. Try and rock forward as far as you can, but if you have pain, stop. You can move your hands forward.

Rock back and forth slowly about six to eight times. Always try and go to each extreme as far as you can, but without pain. You will find that you can go further and further with repeated tries.

You will need to perform this exercise at least three times per day: once in the morning before you get out of bed, once in the evening about 5 to 6 PM, and once before you go to bed. Feel free to do the exercise more often, especially to relieve your pain.

of the sacroiliac joint in patients with low back pain: an experimental study. Phys Ther, 1988; 68:1359-1363. [12] McKenzie RA. The Lumbar Spine: Mechanical Diagnosis and Therapy. Waikanae, New Zealand: Spinal Publications Ltd; 1989. [13] Donelson R, Silva G, Murphy K. Centralization phenomenon: its usefulness in evaluating and treating referred pain. Spine. 1990;15:211-213. [14] Donelson R, Grant W, Kamps C, et al. Pain response to sagittal end-range spinal motion: a prospective, randomized, multicentered trial. Spine. 1991;16:S206-S212. [15] NIOSH Low Back Atlas of Standardized Tests and Measurements. Washington, DC: US Dept of Health and Human Services, Public Health Service, Center for Disease Control, National Institute for Occupational Safety and Health; December 1988. [16] Magee DJ. Orthopedic Physical Assessment. 2nd ed. Philadelphia, Pa: WB Saunders Co; 1992:309-310, 320-321. [17] Porterfield JA, DeRosa C. The sacroiliac joint. In: Grould JA, ed. Orthopedic and Sports Physical Therapy. 2nd ed. St Louis, Mo: CV Mosby Co; 1990:564-573. [18] Frymoyer JW, Gordon SL. New Perspectives on Low Back Pain. Park Ridge, Ill: American Academy of Orthopedic Surgeons; 1989:240-242. [19] McGill SM. A biomechanical perspective on sacroiliac pain. Clin Biomech. 1987;2:145-151. [20] Deyo RA, Patrick DL. Barriers to the use of health status measures in clinical investigation, patient care, and policy research. Med Care. 1989;27(suppl):254-268. [21] Meade TW, Dyer S, Browne W, et al. Low back pain of mechanical origin: randomised comparison of chiropractic and hospital outpatient treatment, Br Med J. 1990;300:1431-1437. [22] Wilkinson L. SYSTAT: The System for Statistics. Evanston, Ill; SYSTAT Inc; 1988:405-418.

RE Erchard, DC, PT, is Clinical Associate Professor, Comprehensive Spine Center, University of Pittsburgh Medical Center, Pittsburgh, PA 15261. Address all correspondence to Dr Erchard at the Department of Physical Therapy, School of Health and Rehabilitation Science, University of Pittsburgh Medical Center, 101 Pennsylvania Hall, Pittsburgh, PA 15261 (USA).

A Delitto, PhD, PT, is Assistant Professor and Chair, Department of Physical Therapy, School of Health and Rehabilitation Sciences, and Clinical Assistant Professor, Comprehensive Spine Center, University of Pittsburgh Medical Center.

MT Cibulka, OCS, PT, is President, Jefferson County Rehabilitation Center, 430 S Truman Blvd, Crystal City, MO 63019.

This study was approached by the institutional review board at the University of Pittsburgh.

This article was submitted September 16, 1993, and was accepted July 8, 1994.