Subacute and Chronic Non-specific Low Back Pain
Conditions
Keywords
low back pain, manual therapy, randomized controlled trial
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.
Interventions
OTHEROsteopathic manipulative treatment
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.
OTHERPlacebo of osteopathic manipulative treatment
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.
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Université Paris Cité
University of Paris 5 - Rene Descartes
Institut Universitaire Romand de Sante au Travail
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean improvement from baseline in mean activity limitation | 3 months after randomization | Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean reduction from baseline in mean lumbar pain in the previous 48 hrs | 3 months after randomization | assessed with a self-administered 11-class numeric scale (from 0 no pain to 100, maximal pain) |
| Number of sick leaves | 12 months after randomization | self-reported number of sick leaves |
| Duration of sick leaves | 12 months after randomization | self-reported total duration (days) of sick leaves |
| Recurrence of pain | 12 months after randomization | self-reported number of low back pain episodes |
| Mean improvement from baseline in mean activity limitation | 12 months after randomization | Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation) |
| Mean improvement from baseline in mean quality of life | 3 months after randomization | 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) |
| Pain killer and non-steroidal anti-inflammatory drug consumption | 3 months after randomization | self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no) |
Countries
France
Outcome results
None listed