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

July 13, 2009
November 9, 2009
September 2003
November 2008   (final data collection date for primary outcome measure)
  • 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 ]
treatment success [ Time Frame: twelve months after treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00939107 on ClinicalTrials.gov Archive Site
  • 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 ]
  • disability [ Time Frame: twelve months after treatment ] [ Designated as safety issue: No ]
  • pain [ Time Frame: twelve months posttreatment ] [ Designated as safety issue: No ]
  • return to work [ 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 ]
Not Provided
Not Provided
 
The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • Procedure: spinal manipulation
    Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care
  • Procedure: McKenzie exercises
    McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
  • Experimental: McKenzie exercises
    McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
    Intervention: Procedure: McKenzie exercises
  • Active Comparator: Spinal manipulation
    Spinal manipulation in combination with information of clinical findings and advice about back care
    Intervention: Procedure: spinal manipulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00939107
KF-01-057/03
No
Tom Petersen, research physical therapist, Back and Rehabilitation Center, Copenhagen
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.
Principal Investigator: Tom Petersen, PT,PhD Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark
Back and Rehabilitation Center, Copenhagen
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP