Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia
NCT ID: NCT00452010
Last Updated: 2012-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
236 participants
INTERVENTIONAL
2006-09-30
2008-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
transcutaneous electrical nerve stimulation
CEFAR PRIMO TENS Class IIA (active)
Active TENS. 4 sessions per day during 3 months.
2
No transcutaneous electrical nerve stimulation
CEFAR PRIMO TENS Class IIA (no active)
Placebo TENS. 4 sessions per day during 3 months.
Interventions
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CEFAR PRIMO TENS Class IIA (active)
Active TENS. 4 sessions per day during 3 months.
CEFAR PRIMO TENS Class IIA (no active)
Placebo TENS. 4 sessions per day during 3 months.
Eligibility Criteria
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Inclusion Criteria
* Patients with a pain score at least superior or equal to 4
* Patients followed in pain clinics
* Written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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CHU de Saint-Etienne
Principal Investigators
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Bernard LAURENT, Professor
Role: PRINCIPAL_INVESTIGATOR
Locations
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CHU d'Amiens
Amiens, , France
CHU de Grenoble
Grenoble, , France
CHU de Limoges
Limoges, , France
Fondation Hôpital Saint Joseph - MARSEILLE
Marseille, , France
La Timone - MARSEILLE
Marseille, , France
Centre Catherine de Sienne - Nantes
Nantes, , France
CHU de Saint-Etienne
Saint-Etienne, , France
CH de Voiron
Voiron, , France
Countries
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References
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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.
Other Identifiers
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lombotens
Identifier Type: -
Identifier Source: secondary_id
0601001
Identifier Type: -
Identifier Source: org_study_id