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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00939107
First received: July 13, 2009
Last updated: November 9, 2009
Last verified: November 2009
  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.

Resource links provided by NLM:


Further study details as provided by Back and Rehabilitation Center, Copenhagen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939107

Locations
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
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:
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014