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

N/ACompletedNCT02034864

Assistance Publique - Hôpitaux de Paris400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

400

Conditions

Subacute and Chronic Non-specific Low Back Pain

Interventions

Osteopathic manipulative treatmentOTHER

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.

Placebo of osteopathic manipulative treatmentOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Cochin

Paris, France

Outcomes

Primary Outcomes

Mean improvement from baseline in mean activity limitation

Assessed with the self-administered Quebec functional scale (from 0, no limitation to 100, maximal limitation)

Time frame: 3 months after randomization

Secondary Outcomes

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)

Time frame: 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)