The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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Introduction: The McKenzie method as well as spinal manipulation is commonly used for the treatment of low back pain throughout the western world. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of persistent symptoms originating from a diskus in the low back. Methods: After clinical screening 350 patients with or without leg pain who presented with centralization of symptoms or signs of disc herniation were randomized to the McKenzie group or the manipulation group. The outcome measures, Roland Morris Disability Questionnaire, 11 point numerical pain scale, 6 point global perceived change scale, and quality of life (Short Form-36) were assessed at baseline, at end of treatment, and at 2 and 12 months follow-up.

Detailed Description
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In 1998, Cherkin et al. published a study showing no difference between outcomes following the McKenzie method, chiropractic manipulation, or the provision of an educational booklet for the treatment of patients with acute non-specific low back pain. Recently, the need for studies testing the effect of treatment strategies to specific diagnostic subgroups of patients has been emphasized. The present study aims to compare the effectiveness of the McKenzie method and chiropractic manipulation, information, and advice for patients with clinical signs of disc-related symptoms for duration of more than 6 Weeks.

Official Title
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The Effect of the McKenzie Method as Compared With That of Manipulation When Applied Adjunctive to Information and Advice for Patients With Clinical Signs of Disc-related Chronic Low Back Pain: Randomized Controlled Trial.

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: spinal manipulation
* Procedure: McKenzie exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 60 years of age suffering from low back pain (LBP) with or without leg pain for a period of more than 6 weeks able to speak and understand the Danish language with a presentation of clinical signs of disc-related symptoms. Exclusion Criteria: positive non-organic signs serious pathology suspected based on physical examination and/or magnetic resonance imaging application for disability pension or pending litigation pregnancy comorbidity recent back surgery problems with communication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: McKenzie exercises<br>McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy | Procedure: McKenzie exercises<br>* McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy<br>|
| Active Comparator: Spinal manipulation<br>Spinal manipulation in combination with information of clinical findings and advice about back care | Procedure: spinal manipulation<br>* Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points). | two months after treatment | 
| Number of Patients With Treatment Success | Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points) | Two months posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | The back and leg pain questionnaire included three separate 11 point box scales comprising the following items: Low Back Pain (LBP) at the moment, the worst LBP within the past two weeks, and the average level of LBP within the last two weeks. These summed to a total score ranging from 0 points (no back or leg pain at all) to 60 points (worst possible back and leg pain on all items). | twelve months posttreatment | 
| Number of Patients on Sick Leave | Measured by self-report of beeing on sick leave at the moment because of LBP | twelve months posttreatment | 
| Quality of Life | Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0) | twelve months posttreatment | 
| Cost Effectiveness |  | twelve months posttreatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, Intervertebral disc, McKenzie, Physical Therapy, Spinal manipulation, Chiropractics, Patient education, Exercise therapy, Random allocation