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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00452010
First Posted: March 26, 2007
Last Update Posted: July 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
  Purpose

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.


Condition Intervention Phase
Chronic Low Back Pain Chronic Lumbo-radiculalgia Device: CEFAR PRIMO TENS Class IIA (active) Device: CEFAR PRIMO TENS Class IIA (no active) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • functional ability [ Time Frame: Week 6 ]

Secondary Outcome Measures:
  • pain relief [ Time Frame: Week 6 and Month 3 ]
  • functional repercussions by Roland scale [ Time Frame: Month 3 ]
  • functional repercussions by Dallas scale [ Time Frame: Month 3 ]
  • quality of life [ Time Frame: Day 1 and Month 3 ]
  • global satisfaction of cares [ Time Frame: Month 3 ]
  • medical consumption [ Time Frame: From Day 1 to Month 3 ]
  • TENS observance [ Time Frame: from Day 1 to Month 3 ]

Enrollment: 236
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
transcutaneous electrical nerve stimulation
Device: CEFAR PRIMO TENS Class IIA (active)
Active TENS. 4 sessions per day during 3 months.
Placebo Comparator: 2
No transcutaneous electrical nerve stimulation
Device: CEFAR PRIMO TENS Class IIA (no active)
Placebo TENS. 4 sessions per day during 3 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452010


Locations
France
CHU d'Amiens
Amiens, France, 80000
CHU de Grenoble
Grenoble, France, 38000
CHU de Limoges
Limoges, France, 87000
Fondation Hôpital Saint Joseph - MARSEILLE
Marseille, France, 13000
La Timone - MARSEILLE
Marseille, France, 13000
Centre Catherine de Sienne - Nantes
Nantes, France, 44000
CHU de Saint-Etienne
Saint-Etienne Cedex 2, France, 42055
CH de Voiron
Voiron, France, 38500
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Bernard LAURENT, Professor
  More Information

Publications:
Responsible Party: Françoise LORCA, CHU de Saint-Etienne
ClinicalTrials.gov Identifier: NCT00452010     History of Changes
Other Study ID Numbers: 0601001
lombotens
First Submitted: March 23, 2007
First Posted: March 26, 2007
Last Update Posted: July 4, 2012
Last Verified: September 2008

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
TENS
chronic low back pain
chronic lumbo-radiculalgia
placebo
Roland scale

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms