The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Transcutaneous Nerve Stimulation (TENS)
Cefar Primo Pro TENS device
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Transcutaneous Electrical Nerve Stimulation, Chronic pain, Neuropathic pain, Short-term efficacy, Long-term efficacy
Eligibility 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
Sites / Locations
- Skogli helse- og rehabiliteringssenter
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Reduction of pain and/or functional improvement
Secondary Outcome Measures
Compliance. Patient global impression of change
Full Information
NCT ID
NCT00716326
First Posted
July 9, 2008
Last Updated
December 17, 2008
Sponsor
Norwegian Fund for Postgraduate Training in Physiotherapy
1. Study Identification
Unique Protocol Identification Number
NCT00716326
Brief Title
The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
Official Title
The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Norwegian Fund for Postgraduate Training in Physiotherapy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Transcutaneous Electrical Nerve Stimulation, Chronic pain, Neuropathic pain, Short-term efficacy, Long-term efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
115 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Nerve Stimulation (TENS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cefar Primo Pro TENS device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of pain and/or functional improvement
Time Frame
3-4 weeks, 2 and 4 months
Secondary Outcome Measure Information:
Title
Compliance. Patient global impression of change
Time Frame
3-4 weeks, 2 and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan M Bjordal, professor
Organizational Affiliation
University of Bergen
Official's Role
Study Director
Facility Information:
Facility Name
Skogli helse- og rehabiliteringssenter
City
Lillehammer
ZIP/Postal Code
2614
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
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