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NCT02564185 Clinical Trial

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

Low Back Pain Clinical Trial

— TENS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02564185
Other study ID # 2009/51
Secondary ID 2009-A01193-54
Status Completed
Phase N/A
First received September 29, 2015
Last updated January 31, 2017
Start date September 2010
Est. completion date October 2015

Study information
Verified date January 2017
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Usual practice

• Education program

Locations
Country Name City State
France Hopital Foch Suresnes

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life EIFEL functional disability scale (Gagnon et al, Annals Phys Med Rehab, 2009, 1, 3-16). 6 months
Primary Quality of life DRAD questionnaire (Lawlis et al, Spine 1989;14:511-6.) 6 months
Secondary Pain Numerical scale 6 months
Secondary Neuropathic pain DN4 questionnaire 6 months
Secondary Social impact Changes in the employment status 6 months
Secondary Evaluation of the program Self-administered questionnaire 6 months
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