Clinical trial NCT02034864: Comparison of the Effectiveness of 2 Manual Therapies on Functional Outcome in Sub-acute and Chronic Non-specific Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacute and Chronic Non-specific Low Back Pain
Keywords: low back pain
manual therapy
randomized controlled trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Université Paris Cité
name: University of Paris 5 - Rene Descartes
name: Institut Universitaire Romand de Sante au Travail
First posted: 2014-01-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean improvement from baseline in mean activity limitation
timeFrame: 3 months after randomization
Secondary outcomes:
measure: Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
timeFrame: 3 months after randomization
measure: Mean reduction from baseline in mean lumbar pain in the previous 48 hrs
timeFrame: 12 months after randomization
measure: Number of sick leaves
timeFrame: 12 months after randomization
measure: Duration of sick leaves
timeFrame: 12 months after randomization
measure: Recurrence of pain
timeFrame: 12 months after randomization
measure: Mean improvement from baseline in mean activity limitation
timeFrame: 12 months after randomization
measure: Mean improvement from baseline in mean quality of life
timeFrame: 3 months after randomization
measure: Mean improvement from baseline in mean quality of life
timeFrame: 12 months after randomization
measure: Pain killer and non-steroidal anti-inflammatory drug consumption
timeFrame: 3 months after randomization
measure: Pain killer and non-steroidal anti-inflammatory drug consumption
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Cochin
Study officials:
affiliation: AP-HP, Descartes University, INSERM
name: Francois Rannou, MD PhD
role: PRINCIPAL_INVESTIGATOR
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