Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain (TENS)

January 31, 2017 updated by: Hopital Foch

According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option.

The purpose of the study is to evaluate the impact of a therapeutic education program for patients suffering from low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

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
      • Suresnes, France, 92150
        • Hopital Foch

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Low back pain
  • Treatment with transcutaneous electrical nerve stimulation (TENS)

Exclusion Criteria:

  • Contra-indication of TENS
  • Patients with mental disorders
  • Lack of autonomy or patients living alone at home without help
  • Concomitant inclusion in another research on the treatment of pain

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
The "control" group will follow usual practice.
Other: Usual practice
Experimental: Education program
The "Education program" group benefit in addition of a therapeutic education program including nursing follow-up at 1, 3 and 6 months.
Other: Usual practice
Other: Education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 6 months
EIFEL functional disability scale (Gagnon et al, Annals Phys Med Rehab, 2009, 1, 3-16).
6 months
Quality of life
Time Frame: 6 months
DRAD questionnaire (Lawlis et al, Spine 1989;14:511-6.)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 6 months
Numerical scale
6 months
Neuropathic pain
Time Frame: 6 months
DN4 questionnaire
6 months
Social impact
Time Frame: 6 months
Changes in the employment status
6 months
Evaluation of the program
Time Frame: 6 months
Self-administered questionnaire
6 months

Collaborators and Investigators

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

Sponsor

Hopital Foch

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

September 1, 2010

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/51
  • 2009-A01193-54 (Other Identifier: ANSM)

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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