Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Subacute and Chronic Non-specific Low Back Pain

Intervention / Treatment
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* Other: Osteopathic manipulative treatment
* Other: Placebo of osteopathic manipulative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic manipulative treatment<br>6 sessions of standardized manipulative treatment | Other: Osteopathic manipulative treatment<br>* A standardized manipulative treatment according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized manipulative treatment.<br>|
| Sham Comparator: Placebo of osteopathic manipulative treatment<br>6 sessions of standardized placebo of manipulative treatment | Other: Placebo of osteopathic manipulative treatment<br>* A standardized placebo of manipulative treatment consisting in light touch and according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized placebo of manipulative treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean improvement from baseline in mean activity limitation | Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation) | 3 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction from baseline in mean lumbar pain in the previous 48 hrs | assessed with a self-administered 11-class numeric scale (from 0 no pain to 100, maximal pain) | 3 months after randomization | 
| Mean reduction from baseline in mean lumbar pain in the previous 48 hrs | assessed with a self-administered 11-class numeric scale (from 0, no pain to 100, maximal pain) | 12 months after randomization | 
| Number of sick leaves | self-reported number of sick leaves | 12 months after randomization | 
| Duration of sick leaves | self-reported total duration (days) of sick leaves | 12 months after randomization | 
| Recurrence of pain | self-reported number of low back pain episodes | 12 months after randomization | 
| Mean improvement from baseline in mean activity limitation | Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation) | 12 months after randomization | 
| Mean improvement from baseline in mean quality of life | Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life) | 3 months after randomization | 
| Mean improvement from baseline in mean quality of life | Assessed with the physical and mental components of the self-administered MOS SF-12 questionnaire (from 0, worse quality of life to 100, best quality of life) | 12 months after randomization | 
| Pain killer and non-steroidal anti-inflammatory drug consumption | self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no) | 3 months after randomization | 
| Pain killer and non-steroidal anti-inflammatory drug consumption | self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no) | 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, manual therapy, randomized controlled trial