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

January 18, 2019 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • CHU Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Osteopathic manipulative treatment
6 sessions of standardized manipulative treatment
Other: Osteopathic 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.
Sham Comparator: Placebo of osteopathic manipulative treatment
6 sessions of standardized placebo of manipulative treatment
Other: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean improvement from baseline in mean activity limitation
Time Frame: 3 months after randomization
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
Time Frame: 3 months after randomization
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
Time Frame: 12 months after randomization
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
Time Frame: 12 months after randomization
self-reported number of sick leaves
12 months after randomization
Duration of sick leaves
Time Frame: 12 months after randomization
self-reported total duration (days) of sick leaves
12 months after randomization
Recurrence of pain
Time Frame: 12 months after randomization
self-reported number of low back pain episodes
12 months after randomization
Mean improvement from baseline in mean activity limitation
Time Frame: 12 months after randomization
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
Time Frame: 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)
3 months after randomization
Mean improvement from baseline in mean quality of life
Time Frame: 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)
12 months after randomization
Pain killer and non-steroidal anti-inflammatory drug consumption
Time Frame: 3 months after randomization
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
Time Frame: 12 months after randomization
self-reported consumption of pain killer and non-steroidal anti-inflammatory drugs since last contact ( yes/no)
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
University of Paris 5 - Rene Descartes
Université Paris Cité
Institut Universitaire Romand de Sante au Travail

Investigators

  • Principal Investigator: Francois Rannou, MD PhD, AP-HP, Descartes University, INSERM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2014

Primary Completion (Actual)

October 23, 2017

Study Completion (Actual)

October 23, 2017

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P110142

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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