The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin

Not Applicable

Completed

• Conditions: Neuropathic Pain
• Interventions: Device: Transcutaneous Nerve Stimulation (TENS); Device: Cefar Primo Pro TENS device

• Registration Number: NCT00716326
• Lead Sponsor: Norwegian Fund for Postgraduate Training in Physiotherapy

Brief Summary

The aim of this study is to investigate the effectiveness of TENS in addition to routine care in patients with chronic pain of predominantly neuropathic origin, compared to treatment with routine care alone."

Hypothesis:

An eventually neuropathic pain component is needed to be identified and alleviated in chronic pain patients to improve the quality of rehabilitation.

0-hypothesis:

* TENS is not better than than placebo, medication or standard rehabilitation program.

* A neuropathic pain component does not demand special considerations in rehabilitation of chronic pain patients.

Detailed Description

Setting:

Skogli helse- og rehabiliteringssenter, Lillehammer, Norway. Center of Rehabilitation for chronic pain patients, rheumatic diseases and orthopedic postoperative patients.

Duration:

Until 18 months of intervention + 6 months of follow up and preparation.

Intervention:

Use of TENS during 3-4 weeks of hospitalization connected to multimodal rehabilitation (short-term efficacy). TENS or placebo-TENS is added to routine care.

Follow-up:

If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months. Questionnaires will be send at 2 and 4 months, both for the active group, the placebo group and for the group of patients who discontinued the use of TENS/placebo-TENS (long-term efficacy).

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-07-09
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Primary Completion: 2008-09
• Status Verified: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2008-12-17
• Last Update Posted: 2008-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• Adult patients with chronic pain of predominantly neuropathic origin

Exclusion Criteria

• Pain less than 3 months
• Surgery or lesion within 3 months
• Central neuropathic pain
• Fibromyalgia
• Primary headaches
• Primary psychiatric diagnosis
• Patients with pacemaker
• Formerly treated with TENS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Transcutaneous Nerve Stimulation (TENS)	Subjects in this study arm will receive active treatment with Cefar TENS device which delivers therapeutic electrical currents 2-3x over sensory threshold in the area of pain.
1	Cefar Primo Pro TENS device	Subjects in this study arm will receive active treatment with Cefar TENS device which delivers therapeutic electrical currents 2-3x over sensory threshold in the area of pain.
2	Cefar Primo Pro TENS device	Subjects in this study arm will receive placebo treatment with manipulated Cefar TENS device which delivers electrical currents just below sensory threshold in the area of pain.

Primary Outcome Measures

Name	Time	Method
Reduction of pain and/or functional improvement	3-4 weeks, 2 and 4 months

Secondary Outcome Measures

Name	Time	Method
Compliance. Patient global impression of change	3-4 weeks, 2 and 4 months

Trial Locations

Locations (1)

Skogli helse- og rehabiliteringssenter; 🇳🇴 Lillehammer, Norway