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

Phase 4

Completed

• Conditions: Chronic Lumbo-radiculalgia; Chronic Low Back Pain
• Interventions: Device: CEFAR PRIMO TENS Class IIA (active); Device: CEFAR PRIMO TENS Class IIA (no active)

• Registration Number: NCT00452010
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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 available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-03-23
• Study First Submitted QC: 2007-03-23
• Study First Posted: 2007-03-26
• Status Verified: 2008-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Last Update Submitted: 2012-07-03
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CEFAR PRIMO TENS Class IIA (active)	transcutaneous electrical nerve stimulation
2	CEFAR PRIMO TENS Class IIA (no active)	No transcutaneous electrical nerve stimulation

Primary Outcome Measures

Name	Time	Method
functional ability	Week 6

Secondary Outcome Measures

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

Trial Locations

Locations (8)

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Limoges; 🇫🇷 Limoges, France

Centre Catherine de Sienne - Nantes; 🇫🇷 Nantes, France

Fondation Hôpital Saint Joseph - MARSEILLE; 🇫🇷 Marseille, France

La Timone - MARSEILLE; 🇫🇷 Marseille, France

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne Cedex 2, France

CH de Voiron; 🇫🇷 Voiron, France

CHU d'Amiens; 🇫🇷 Amiens, France