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

December 17, 2008 updated by: Norwegian Fund for Postgraduate Training in Physiotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lillehammer, Norway, 2614
        • Skogli helse- og rehabiliteringssenter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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.
Device: Transcutaneous Nerve Stimulation (TENS)
Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises. The TENS will be used during 3-4 weeks of hospitalization. If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months.
Device: Cefar Primo Pro TENS device

Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises.

Active TENS: high-frequency modulated pulse duration stimulation Placebo TENS: manipulated device with impulses near sensory threshold.
Placebo Comparator: 2
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.
Device: Cefar Primo Pro TENS device

Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises.

Active TENS: high-frequency modulated pulse duration stimulation Placebo TENS: manipulated device with impulses near sensory threshold.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of pain and/or functional improvement
Time Frame: 3-4 weeks, 2 and 4 months
3-4 weeks, 2 and 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Compliance. Patient global impression of change
Time Frame: 3-4 weeks, 2 and 4 months
3-4 weeks, 2 and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Fund for Postgraduate Training in Physiotherapy

Investigators

  • Study Director: Jan M Bjordal, professor, University of Bergen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8589 (REK)
  • 15602 (NSD)
  • 408/06-301.0 (Fondet)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe