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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00939107
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : November 19, 2009
Last Update Posted : November 19, 2009
Sponsor:
Collaborators:
The Danish Rheumatism Association
The Danish Physiotherapy Organization.
Foundation for Chiropractic Research and Post Graduate Education
The Danish Institute for Mechanical Diagnosis and Therapy.
Information provided by:
Back and Rehabilitation Center, Copenhagen

Study Description
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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.


Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: spinal manipulation Procedure: McKenzie exercises Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (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.
Study Start Date : September 2003
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Disability [ Time Frame: two months after treatment ]
    Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).

  2. Number of Patients With Treatment Success [ Time Frame: Two 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 :
  1. Pain [ Time Frame: twelve 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).

  2. Number of Patients on Sick Leave [ Time Frame: twelve months posttreatment ]
    Measured by self-report of beeing on sick leave at the moment because of LBP

  3. Quality of Life [ Time Frame: twelve months posttreatment ]
    Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)

  4. Cost Effectiveness [ Time Frame: twelve months posttreatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939107


Locations
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Denmark
Back and Rehabilitation Center Copengagen
Copenhagen, Copenhagen OE, Denmark, 2100
Sponsors and Collaborators
Back and Rehabilitation Center, Copenhagen
The Danish Rheumatism Association
The Danish Physiotherapy Organization.
Foundation for Chiropractic Research and Post Graduate Education
The Danish Institute for Mechanical Diagnosis and Therapy.
Investigators
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Principal Investigator: Tom Petersen, PT,PhD Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tom Petersen, research physical therapist, Back and Rehabilitation Center, Copenhagen
ClinicalTrials.gov Identifier: NCT00939107    
Other Study ID Numbers: KF-01-057/03
First Posted: July 14, 2009    Key Record Dates
Results First Posted: November 19, 2009
Last Update Posted: November 19, 2009
Last Verified: November 2009
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:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations