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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716326
First Posted: July 16, 2008
Last Update Posted: December 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Norwegian Fund for Postgraduate Training in Physiotherapy
  Purpose

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.

Condition Intervention
Neuropathic Pain Device: Transcutaneous Nerve Stimulation (TENS) Device: Cefar Primo Pro TENS device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin

Resource links provided by NLM:


Further study details as provided by Norwegian Fund for Postgraduate Training in Physiotherapy:

Primary Outcome Measures:
  • Reduction of pain and/or functional improvement [ Time Frame: 3-4 weeks, 2 and 4 months ]

Secondary Outcome Measures:
  • Compliance. Patient global impression of change [ Time Frame: 3-4 weeks, 2 and 4 months ]

Estimated Enrollment: 115
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716326


Locations
Norway
Skogli helse- og rehabiliteringssenter
Lillehammer, Norway, 2614
Sponsors and Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators
Study Director: Jan M Bjordal, professor University of Bergen
  More Information

ClinicalTrials.gov Identifier: NCT00716326     History of Changes
Other Study ID Numbers: 8589 (REK)
15602 (NSD)
408/06-301.0 (Fondet)
First Submitted: July 9, 2008
First Posted: July 16, 2008
Last Update Posted: December 18, 2008
Last Verified: December 2008

Keywords provided by Norwegian Fund for Postgraduate Training in Physiotherapy:
Transcutaneous Electrical Nerve Stimulation
Chronic pain
Neuropathic pain
Short-term efficacy
Long-term efficacy

Additional relevant MeSH terms:
Chronic Pain
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases