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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Usual practice
Education program
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Education program

Arm Description

The "control" group will follow usual practice.

The "Education program" group benefit in addition of a therapeutic education program including nursing follow-up at 1, 3 and 6 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain
Numerical scale
Neuropathic pain
DN4 questionnaire
Social impact
Changes in the employment status
Evaluation of the program
Self-administered questionnaire

Full Information

First Posted
September 29, 2015
Last Updated
January 31, 2017
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02564185
Brief Title
Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain
Acronym
TENS
Official Title
Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
The "control" group will follow usual practice.
Arm Title
Education program
Arm Type
Experimental
Arm Description
The "Education program" group benefit in addition of a therapeutic education program including nursing follow-up at 1, 3 and 6 months.
Intervention Type
Other
Intervention Name(s)
Usual practice
Intervention Type
Other
Intervention Name(s)
Education program
Primary Outcome Measure Information:
Title
Quality of life
Description
EIFEL functional disability scale (Gagnon et al, Annals Phys Med Rehab, 2009, 1, 3-16).
Time Frame
6 months
Title
Quality of life
Description
DRAD questionnaire (Lawlis et al, Spine 1989;14:511-6.)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain
Description
Numerical scale
Time Frame
6 months
Title
Neuropathic pain
Description
DN4 questionnaire
Time Frame
6 months
Title
Social impact
Description
Changes in the employment status
Time Frame
6 months
Title
Evaluation of the program
Description
Self-administered questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

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

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