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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Device: Transcutaneous Nerve Stimulation (TENS)
* Device: Cefar Primo Pro TENS device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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)<br>* 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.<br>Device: Cefar Primo Pro TENS device<br>* 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.<br>|
| Placebo Comparator: 2<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous Electrical Nerve Stimulation, Chronic pain, Neuropathic pain, Short-term efficacy, Long-term efficacy