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NCT Number: NCT00939107

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Back and Rehabilitation Center Copengagen

Copenhagen, Copenhagen OE, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal manipulation

Procedure

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

McKenzie exercises

Procedure

McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy

Primary outcomes

  1. Disability

    Time frame: two months after treatment

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

  2. Number of Patients With Treatment Success

    Time frame: Two months posttreatment

    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 outcomes

  1. Pain

    Time frame: twelve months posttreatment

    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).

  2. Number of Patients on Sick Leave

    Time frame: twelve months posttreatment

    Measured by self-report of beeing on sick leave at the moment because of LBP

  3. Quality of Life

    Time frame: twelve months posttreatment

    Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)

  4. Cost Effectiveness

    Time frame: twelve months posttreatment

Sponsors and collaborators

Lead sponsor

Back and Rehabilitation Center, Copenhagen

Other Gov

Collaborators

  • Foundation for Chiropractic Research and Post Graduate Education
  • The Danish Institute for Mechanical Diagnosis and Therapy.
  • The Danish Physiotherapy Organization.
  • The Danish Rheumatism Association

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jul 14, 2009
Registry last updated
Nov 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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