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

Not Applicable

Completed

• Conditions: Subacute and Chronic Non-specific Low Back Pain
• Interventions: Other: Osteopathic manipulative treatment; Other: Placebo of osteopathic manipulative treatment

• Registration Number: NCT02034864
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Study Start: 2014-02-17
• Primary Completion: 2017-10-23
• Study Completion: 2017-10-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteopathic manipulative treatment	Osteopathic manipulative treatment	6 sessions of standardized manipulative treatment
Placebo of osteopathic manipulative treatment	Placebo of osteopathic manipulative treatment	6 sessions of standardized placebo of manipulative treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pain killer and non-steroidal anti-inflammatory drug consumption	12 months after randomization	self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)
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 reduction from baseline in mean lumbar pain in the previous 48 hrs	12 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 quality of life	12 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)

Trial Locations

Locations (1)

CHU Cochin; 🇫🇷 Paris, France