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

NCT00939107 | Completed Results

• 1 other identifier: KF-01-057/03
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; Intervertebral disc; McKenzie; Physical Therapy; Spinal manipulation; Chiropractics; Patient education; Exercise therapy; Random allocation

Outcome Measures

Primary Outcomes (2)

• Disability

  Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).

  two months after treatment

• 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)

  Two months posttreatment

Secondary Outcomes (4)

• Pain

  twelve months posttreatment

• Number of Patients on Sick Leave

  twelve months posttreatment

• Quality of Life

  twelve months posttreatment

• Cost Effectiveness

  twelve months posttreatment

Study Arms (2)

McKenzie exercises

EXPERIMENTAL

McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy

Procedure: McKenzie exercises

Spinal manipulation

ACTIVE COMPARATOR

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

Procedure: spinal manipulation

Interventions

spinal manipulation PROCEDURE

Spinal manipulation to the lumbopelvic spine in combination with information about examination findings and advice about back care

Spinal manipulation

McKenzie exercises PROCEDURE

McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy

McKenzie exercises

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Back and Rehabilitation Center, Copenhagen: lead
• The Danish Rheumatism Association: collaborator
• The Danish Physiotherapy Organization.: collaborator
• Foundation for Chiropractic Research and Post Graduate Education: collaborator
• The Danish Institute for Mechanical Diagnosis and Therapy.: collaborator

Study Sites (1)

Back and Rehabilitation Center Copengagen

Copenhagen, Copenhagen OE, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 25887046 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Tom Petersen
• Organization: Back and Rehabilitation Center Copenhagen

tom.petersen@suf.kk.dk

+45 35304974

Study Officials

• Tom Petersen, PT,PhD

  Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: September 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 19, 2009
• Results First Posted: November 19, 2009

Record last verified: 2009-11

Locations

DK (1)