N/A
N=350
The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT00939107 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Disability — 6.7; 5.2 Units on a scale — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- spinal manipulation (Procedure); McKenzie exercises (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Back and Rehabilitation Center, Copenhagen
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disability |
6.7; 5.2 | >0.05 |
| PRIMARY Number of Patients With Treatment Success |
120; 95 | — |
| SECONDARY Pain |
15.0; 12.2 | — |
| SECONDARY Number of Patients on Sick Leave |
14; 6 | — |
| SECONDARY Quality of Life |
— | — |
| SECONDARY Cost Effectiveness |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00939107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.