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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: McKenzie exercises; Procedure: spinal manipulation

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 Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen OE
    • Copenhagen, Copenhagen OE, Denmark, 2100
      • Back and Rehabilitation Center Copengagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Back and Rehabilitation Center, Copenhagen
• Collaborators: The Danish Rheumatism Association; Foundation for Chiropractic Research and Post Graduate Education; The Danish Physiotherapy Organization.; The Danish Institute for Mechanical Diagnosis and Therapy.
• Investigators: Principal Investigator: Tom Petersen, PT,PhD, Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: July 13, 2009
• First Submitted That Met QC Criteria: July 13, 2009
• First Posted (Estimate): July 14, 2009

Study Record Updates

• Last Update Posted (Estimate): November 19, 2009
• Last Update Submitted That Met QC Criteria: November 9, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: low back pain; Physical Therapy; Patient education; Spinal manipulation; Exercise therapy; Intervertebral disc; McKenzie; Chiropractics; Random allocation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: KF-01-057/03