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OpenTrials
Completed

NCT Number: NCT02564185

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual practice

Other

Education program

Other

Primary outcomes

  1. Quality of life

    Time frame: 6 months

    EIFEL functional disability scale (Gagnon et al, Annals Phys Med Rehab, 2009, 1, 3-16).

  2. Quality of life

    Time frame: 6 months

    DRAD questionnaire (Lawlis et al, Spine 1989;14:511-6.)

Secondary outcomes

  1. Pain

    Time frame: 6 months

    Numerical scale

  2. Neuropathic pain

    Time frame: 6 months

    DN4 questionnaire

  3. Social impact

    Time frame: 6 months

    Changes in the employment status

  4. Evaluation of the program

    Time frame: 6 months

    Self-administered questionnaire

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: TENS

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2015
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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