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

Sponsored by:	Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by:	Norwegian Fund for Postgraduate Training in Physiotherapy
ClinicalTrials.gov Identifier:	NCT00716326

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:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compliance. Patient global impression of change [ Time Frame: 3-4 weeks, 2 and 4 months ] [ Designated as safety issue: No ]

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
1: Active Comparator 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.
2: Placebo Comparator 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.

Arms

Assigned Interventions

1: Active Comparator

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.

2: Placebo Comparator

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	8589 (REK), 15602 (NSD), 408/06-301.0 (Fondet)
Study First Received:	July 9, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00716326 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services; Norway: Norwegian Institute of Public Health

Keywords provided by Norwegian Fund for Postgraduate Training in Physiotherapy:

Transcutaneous Electrical Nerve Stimulation
Chronic pain
Neuropathic pain
Short-term efficacy
Long-term efficacy

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on September 10, 2009