Clinical trial NCT00939107: The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
Intervertebral disc
McKenzie
Physical Therapy
Spinal manipulation
Chiropractics
Patient education
Exercise therapy
Random allocation
Lead sponsor: Back and Rehabilitation Center, Copenhagen
Sponsor class: OTHER_GOV
Collaborators: name: The Danish Rheumatism Association
name: The Danish Physiotherapy Organization.
name: Foundation for Chiropractic Research and Post Graduate Education
name: The Danish Institute for Mechanical Diagnosis and Therapy.
First posted: 2009-07-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Disability
timeFrame: two months after treatment
measure: Number of Patients With Treatment Success
timeFrame: Two months posttreatment
Secondary outcomes:
measure: Pain
timeFrame: twelve months posttreatment
measure: Number of Patients on Sick Leave
timeFrame: twelve months posttreatment
measure: Quality of Life
timeFrame: twelve months posttreatment
measure: Cost Effectiveness
timeFrame: twelve months posttreatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Back and Rehabilitation Center Copengagen
state: Copenhagen OE
Study officials:
affiliation: Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark
name: Tom Petersen, PT,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.