Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain at 3 Months : a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subacute and Chronic Non-specific Low Back Pain
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Mean improvement from baseline in mean activity limitation
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
The purpose of this study is to determine whether a standardised osteopathic manipulative treatment is more effective than a placebo of osteopathic manipulative treatment, in sub-acute and chronic non-specific low back pain on functional recovery at 3 months.
Detailed Description
Sub-acute (4-12-week duration) and chronic (more than 3-month duration) non-specific low back pain (LBP) is frequent, disabling and costly. The effectiveness of usual treatments (including pain killers, anti-inflammatory drugs, spinal injections, physiotherapy, spinal traction, transcutaneous electrical nerve stimulation, etc) may be not sufficient, and many patients resort to alternative therapies. Manipulative treatments represent en emerging therapy in this area, although studies assessing their effectiveness are limited and often biased. The purpose of this study is to evaluate the efficacy of two manual therapies on improving functional recovery in sub-acute and chronic non-specific low back pain at 3 months. A standardised osteopathic manipulative treatment is compare to a placebo of osteopathic manipulative treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient consulting for subacute and chronic non-specific low
- •Male or female aged from 18 to 65 years (included)
- •Patient can speak and understand French
- •Patient giving his informed consent to participate in the study
- •Patient affiliated to or beneficiary of social insurance
Exclusion Criteria
- •Specific low-back pain caused by inflammatory, tumoral, infectious disease or a back traumatism in the 3 past months
- •History of back surgery and/or vertebral fracture in the previous 6 months
- •Presence of a motor impairment related to the reason for consultation
- •The patient is a student or a practitioner in manipulative therapies
- •Pregnancy
- •Inability to understand the process of the study
- •The patient is already included in another clinical study
Outcomes
Primary Outcomes
Mean improvement from baseline in mean activity limitation
Time Frame: 3 months after randomization
Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)
Secondary Outcomes
- Mean improvement from baseline in mean activity limitation(12 months after randomization)
- Duration of sick leaves(12 months after randomization)
- Pain killer and non-steroidal anti-inflammatory drug consumption(12 months after randomization)
- Mean reduction from baseline in mean lumbar pain in the previous 48 hrs(12 months after randomization)
- Number of sick leaves(12 months after randomization)
- Recurrence of pain(12 months after randomization)
- Mean improvement from baseline in mean quality of life(12 months after randomization)