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

July 3, 2012 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • CHU d'Amiens
      • Grenoble, France, 38000
        • CHU de Grenoble
      • Limoges, France, 87000
        • CHU de Limoges
      • Marseille, France, 13000
        • Fondation Hôpital Saint Joseph - MARSEILLE
      • Marseille, France, 13000
        • La Timone - MARSEILLE
      • Nantes, France, 44000
        • Centre Catherine de Sienne - Nantes
      • Saint-Etienne Cedex 2, France, 42055
        • Chu de Saint-Etienne
      • Voiron, France, 38500
        • CH de Voiron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
functional ability
Time Frame: Week 6
Week 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Bernard LAURENT, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

March 23, 2007

First Submitted That Met QC Criteria

March 23, 2007

First Posted (Estimate)

March 26, 2007

Study Record Updates

Last Update Posted (Estimate)

July 4, 2012

Last Update Submitted That Met QC Criteria

July 3, 2012

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0601001
  • lombotens

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Low Back Pain

Clinical Trials on CEFAR PRIMO TENS Class IIA (active)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe