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

Not Applicable
Completed
Conditions
Low Back Pain
Registration Number
NCT00939107
Lead Sponsor
Back and Rehabilitation Center, Copenhagen
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
350
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Disabilitytwo months after treatment

Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).

Number of Patients With Treatment SuccessTwo months posttreatment

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)

Secondary Outcome Measures
NameTimeMethod
Paintwelve months posttreatment

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).

Number of Patients on Sick Leavetwelve months posttreatment

Measured by self-report of beeing on sick leave at the moment because of LBP

Quality of Lifetwelve months posttreatment

Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)

Cost Effectivenesstwelve months posttreatment

Trial Locations

Locations (1)

Back and Rehabilitation Center Copengagen

🇩🇰

Copenhagen, Copenhagen OE, Denmark

Back and Rehabilitation Center Copengagen
🇩🇰Copenhagen, Copenhagen OE, Denmark
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