Skip to main content
OpenTrials
Completed

NCT Number: NCT00452010

Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia

Prior studies showed contradictory results about the best type of TENS in chronic pain pathology.

Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia.

The functional ability score is evaluated by the Roland scale at 6 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Low Back Pain Chronic Lumbo-radiculalgia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU d'Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stable chronic low back pain or stable chronic lumbo-radiculalgia
  • Patients with a pain score at least superior or equal to 4
  • Patients followed in pain clinics
  • Written informed consent

Exclusion criteria

  • Prior ambulatory TENS practice
  • Lumbo-radiculalgia pathology surgery within 3 months before inclusion
  • Acute low back pain or bilateral lumbo-radiculalgia
  • Acute radiculalgia
  • Surgery planned within 6 months
  • Pacemaker
  • Symptomatic low back pain

Treatment and study plan

CEFAR PRIMO TENS Class IIA (active)

Device

Active TENS. 4 sessions per day during 3 months.

CEFAR PRIMO TENS Class IIA (no active)

Device

Placebo TENS. 4 sessions per day during 3 months.

Primary outcomes

  1. functional ability

    Time frame: Week 6

Secondary outcomes

  1. pain relief

    Time frame: Week 6 and Month 3

  2. functional repercussions by Roland scale

    Time frame: Month 3

  3. functional repercussions by Dallas scale

    Time frame: Month 3

  4. quality of life

    Time frame: Day 1 and Month 3

  5. global satisfaction of cares

    Time frame: Month 3

  6. medical consumption

    Time frame: From Day 1 to Month 3

  7. TENS observance

    Time frame: from Day 1 to Month 3

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Chronic Low Back Pain or Chronic Lumbo-radiculalgia and Followed in Pain Treatment Centers

Acronym: LOBOTENS

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 26, 2007
Registry last updated
Jul 4, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.