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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 4

Conditions: Chronic Low Back Pain; Chronic Lumbo-radiculalgia

Treatments: Device: CEFAR PRIMO TENS Class IIA (no active); Device: CEFAR PRIMO TENS Class IIA (active)

Study type: Interventional

Funder types: Other

Identifiers

NCT00452010

lombotens

0601001

Details and patient eligibility

About

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.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

236 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

transcutaneous electrical nerve stimulation

Treatment:

Device: CEFAR PRIMO TENS Class IIA (active)

2

Placebo Comparator group

Description:

No transcutaneous electrical nerve stimulation

Treatment:

Device: CEFAR PRIMO TENS Class IIA (no active)