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

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ClinicalTrials.gov Identifier: NCT00452010
Recruitment Status : Completed
First Posted : March 26, 2007
Last Update Posted : July 4, 2012
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE March 23, 2007
First Posted Date  ICMJE March 26, 2007
Last Update Posted Date July 4, 2012
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2008)
functional ability [ Time Frame: Week 6 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2007)
functional ability
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2007)
  • pain relief at 6 weeks and 3 months
  • functional repercussions at 3 months by Roland scale
  • functional repercussions at 3 months by Dallas scale
  • quality of life at day 1 and 3 months
  • global satisfaction of cares
  • medical consumption during 3 months
  • TENS observance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Low Back Pain
  • Chronic Lumbo-radiculalgia
Intervention  ICMJE
  • Device: CEFAR PRIMO TENS Class IIA (active)
    Active TENS. 4 sessions per day during 3 months.
  • Device: CEFAR PRIMO TENS Class IIA (no active)
    Placebo TENS. 4 sessions per day during 3 months.
Study Arms  ICMJE
  • Experimental: 1
    transcutaneous electrical nerve stimulation
    Intervention: Device: CEFAR PRIMO TENS Class IIA (active)
  • Placebo Comparator: 2
    No transcutaneous electrical nerve stimulation
    Intervention: Device: CEFAR PRIMO TENS Class IIA (no active)
Publications * Buchmuller A, Navez M, Milletre-Bernardin M, Pouplin S, Presles E, Lantéri-Minet M, Tardy B, Laurent B, Camdessanché JP; Lombotens Trial Group. Value of TENS for relief of chronic low back pain with or without radicular pain. Eur J Pain. 2012 May;16(5):656-65. doi: 10.1002/j.1532-2149.2011.00061.x. Epub 2011 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2008)
236
Original Enrollment  ICMJE
 (submitted: March 23, 2007)
206
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00452010
Other Study ID Numbers  ICMJE 0601001
lombotens
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Françoise LORCA, CHU de Saint-Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Bernard LAURENT, Professor
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP