search
Back to results

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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
spinal manipulation
McKenzie exercises
Sponsored by
Back and Rehabilitation Center, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, Intervertebral disc, McKenzie, Physical Therapy, Spinal manipulation, Chiropractics, Patient education, Exercise therapy, Random allocation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Back and Rehabilitation Center Copengagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

McKenzie exercises

Spinal manipulation

Arm Description

McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy

Spinal manipulation in combination with information of clinical findings and advice about back care

Outcomes

Primary Outcome Measures

Disability
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 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)

Secondary Outcome Measures

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).
Number of Patients on Sick Leave
Measured by self-report of beeing on sick leave at the moment because of LBP
Quality of Life
Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)
Cost Effectiveness

Full Information

First Posted
July 13, 2009
Last Updated
November 9, 2009
Sponsor
Back and Rehabilitation Center, Copenhagen
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.
search

1. Study Identification

Unique Protocol Identification Number
NCT00939107
Brief Title
The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Back and Rehabilitation Center, Copenhagen
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.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, Intervertebral disc, McKenzie, Physical Therapy, Spinal manipulation, Chiropractics, Patient education, Exercise therapy, Random allocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
McKenzie exercises
Arm Type
Experimental
Arm Description
McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
Arm Title
Spinal manipulation
Arm Type
Active Comparator
Arm Description
Spinal manipulation in combination with information of clinical findings and advice about back care
Intervention Type
Procedure
Intervention Name(s)
spinal manipulation
Intervention Description
Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care
Intervention Type
Procedure
Intervention Name(s)
McKenzie exercises
Intervention Description
McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
Primary Outcome Measure Information:
Title
Disability
Description
Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).
Time Frame
two months after treatment
Title
Number of Patients With Treatment Success
Description
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)
Time Frame
Two months posttreatment
Secondary Outcome Measure Information:
Title
Pain
Description
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).
Time Frame
twelve months posttreatment
Title
Number of Patients on Sick Leave
Description
Measured by self-report of beeing on sick leave at the moment because of LBP
Time Frame
twelve months posttreatment
Title
Quality of Life
Description
Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)
Time Frame
twelve months posttreatment
Title
Cost Effectiveness
Time Frame
twelve months posttreatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Petersen, PT,PhD
Organizational Affiliation
Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Back and Rehabilitation Center Copengagen
City
Copenhagen
State/Province
Copenhagen OE
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25887046
Citation
Petersen T, Christensen R, Juhl C. Predicting a clinically important outcome in patients with low back pain following McKenzie therapy or spinal manipulation: a stratified analysis in a randomized controlled trial. BMC Musculoskelet Disord. 2015 Apr 1;16:74. doi: 10.1186/s12891-015-0526-1.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs