The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Low Back Pain |
Procedure: spinal manipulation Procedure: McKenzie exercises |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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. |
- Disability [ Time Frame: two months after treatment ] [ Designated as safety issue: No ]
- Number of Patients With Treatment Success [ Time Frame: Two months posttreatment ] [ Designated as safety issue: No ]
- Pain [ Time Frame: twelve months posttreatment ] [ Designated as safety issue: No ]
- Number of Patients on Sick Leave [ Time Frame: twelve months posttreatment ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: twelve months posttreatment ] [ Designated as safety issue: No ]
- Cost Effectiveness [ Time Frame: twelve months posttreatment ] [ Designated as safety issue: No ]
| Enrollment: | 350 |
| Study Start Date: | September 2003 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: McKenzie exercises
McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
|
Procedure: McKenzie exercises
McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
|
|
Active Comparator: Spinal manipulation
Spinal manipulation in combination with information of clinical findings and advice about back care
|
Procedure: spinal manipulation
Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Denmark | |
| Back and Rehabilitation Center Copengagen | |
| Copenhagen, Copenhagen OE, Denmark, 2100 | |
| Principal Investigator: | Tom Petersen, PT,PhD | Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark |
More Information
No publications provided
| Responsible Party: | Tom Petersen, research physical therapist, Back and Rehabilitation Center, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00939107 History of Changes |
| Other Study ID Numbers: | KF-01-057/03 |
| Study First Received: | July 13, 2009 |
| Results First Received: | August 13, 2009 |
| Last Updated: | November 9, 2009 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Back and Rehabilitation Center, Copenhagen:
|
low back pain Intervertebral disc McKenzie Physical Therapy Spinal manipulation |
Chiropractics Patient education Exercise therapy Random allocation |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013