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Clinical Trials/NCT00452010
NCT00452010CompletedPhase 4

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

Centre Hospitalier Universitaire de Saint Etienne8 sites in 1 country236 target enrollmentStarted: September 1, 2006Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
236
Locations
8
Primary Endpoint
functional ability
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

transcutaneous electrical nerve stimulation

Intervention: CEFAR PRIMO TENS Class IIA (active) (Device)

2

Placebo Comparator

No transcutaneous electrical nerve stimulation

Intervention: CEFAR PRIMO TENS Class IIA (no active) (Device)

Outcomes

Primary Outcomes

functional ability

Time Frame: Week 6

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (8)

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