Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia (LOBOTENS)
Primary Purpose
Chronic Low Back Pain, Chronic Lumbo-radiculalgia
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
CEFAR PRIMO TENS Class IIA (active)
CEFAR PRIMO TENS Class IIA (no active)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring TENS, chronic low back pain, chronic lumbo-radiculalgia, placebo, Roland scale
Eligibility 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
Sites / Locations
- CHU d'Amiens
- CHU de Grenoble
- CHU de Limoges
- Fondation Hôpital Saint Joseph - MARSEILLE
- La Timone - MARSEILLE
- Centre Catherine de Sienne - Nantes
- CHU de Saint-Etienne
- CH de Voiron
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
transcutaneous electrical nerve stimulation
No transcutaneous electrical nerve stimulation
Outcomes
Primary Outcome Measures
functional ability
Secondary Outcome Measures
pain relief
functional repercussions by Roland scale
functional repercussions by Dallas scale
quality of life
global satisfaction of cares
medical consumption
TENS observance
Full Information
NCT ID
NCT00452010
First Posted
March 23, 2007
Last Updated
July 3, 2012
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT00452010
Brief Title
Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia
Acronym
LOBOTENS
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Chronic Lumbo-radiculalgia
Keywords
TENS, chronic low back pain, chronic lumbo-radiculalgia, placebo, Roland scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
transcutaneous electrical nerve stimulation
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
No transcutaneous electrical nerve stimulation
Intervention Type
Device
Intervention Name(s)
CEFAR PRIMO TENS Class IIA (active)
Intervention Description
Active TENS. 4 sessions per day during 3 months.
Intervention Type
Device
Intervention Name(s)
CEFAR PRIMO TENS Class IIA (no active)
Intervention Description
Placebo TENS. 4 sessions per day during 3 months.
Primary Outcome Measure Information:
Title
functional ability
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
pain relief
Time Frame
Week 6 and Month 3
Title
functional repercussions by Roland scale
Time Frame
Month 3
Title
functional repercussions by Dallas scale
Time Frame
Month 3
Title
quality of life
Time Frame
Day 1 and Month 3
Title
global satisfaction of cares
Time Frame
Month 3
Title
medical consumption
Time Frame
From Day 1 to Month 3
Title
TENS observance
Time Frame
from Day 1 to Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard LAURENT, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Fondation Hôpital Saint Joseph - MARSEILLE
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
La Timone - MARSEILLE
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Centre Catherine de Sienne - Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-Etienne Cedex 2
ZIP/Postal Code
42055
Country
France
Facility Name
CH de Voiron
City
Voiron
ZIP/Postal Code
38500
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22337531
Citation
Buchmuller A, Navez M, Milletre-Bernardin M, Pouplin S, Presles E, Lanteri-Minet M, Tardy B, Laurent B, Camdessanche 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.
Results Reference
result
Learn more about this trial
Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia
We'll reach out to this number within 24 hrs