Clinical trial NCT00452010: Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Low Back Pain
Chronic Lumbo-radiculalgia
Keywords: TENS
chronic low back pain
chronic lumbo-radiculalgia
placebo
Roland scale
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2007-03-26
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: functional ability
timeFrame: Week 6
Secondary outcomes:
measure: pain relief
timeFrame: Week 6 and Month 3
measure: functional repercussions by Roland scale
timeFrame: Month 3
measure: functional repercussions by Dallas scale
timeFrame: Month 3
measure: quality of life
timeFrame: Day 1 and Month 3
measure: global satisfaction of cares
timeFrame: Month 3
measure: medical consumption
timeFrame: From Day 1 to Month 3
measure: TENS observance
timeFrame: from Day 1 to Month 3
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Grenoble
country: France
facility: CHU de Grenoble
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille
country: France
facility: Fondation Hôpital Saint Joseph - MARSEILLE
city: Marseille
country: France
facility: La Timone - MARSEILLE
city: Nantes
country: France
facility: Centre Catherine de Sienne - Nantes
city: Saint-Etienne Cedex 2
country: France
facility: CHU de Saint-Etienne
city: Voiron
country: France
facility: CH de Voiron
Study officials:
name: Bernard LAURENT, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.