Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)

Study Overview
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Brief Summary
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Fibromyalgia as a clinical syndrome is defined by chronic widespread muscular pain, fatigue and tenderness with hyperalgesia to pressure over tender points. Pain associated with fibromyalgia can interfere with daily function, work, and social activities. Thus, one of the main treatments for patients with fibromyalgia must focus on pain relief to allow the person to function more independently both at home and at work. Although the etiology of fibromyalgia is unknown, there is clearly enhanced sensitization in the central nervous system pain pathways as demonstrating by decreases in pressure pain thresholds, reduced central inhibition, and enhanced temporal summation. Reducing pain in people with fibromyalgia would help increase the patient's ability to return to work, perform activities of daily living and thus improve the quality of life for the patient. Transcutaneous electrical nerve stimulation (TENS) is a modality utilized in physical therapy that delivers electrical stimulation through the skin and is used for both acute and chronic pain. TENS works by reducing central excitability and increasing central inhibition. Thus, the investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with Fibromyalgia (FM) will reduce pain, reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and reduce temporal summation and that this decrease in pain and/or central excitability will improve function. The primary aim of the study is to test the effectiveness of TENS on pain and central excitability in a crossover design study for patients with Fibromyalgia with random assignment to three treatments: no treatment control, placebo TENS and active high frequency TENS. A secondary aim is to test the effect of decreased pain and central excitability on function in patients with Fibromyalgia.

Detailed Description
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The study will be a simple crossover design with the following three treatments (1) active TENS, (2) placebo TENS or (3) no treatment control randomly assigned. Subjects will draw the order for treatments (A, B, and C) out of a bowl at the initial testing session. This will determine the order of the testing. Each subject will receive all 3 treatments in random order. The following tools will be used to measure subject characteristics (Fibromyalgia Impact Questionnaire, Tampa Scale of Kinesiophobia), pain (McGill Pain Questionnaire and Visual Analogue Scale), central excitability (pressure pain thresholds, temporal summation and DNIC) and function (6 minute walk test, range of motion, sit to stand test).

Official Title
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Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fibromyalgia diagnosis by a physician History of cervical or lumbar pain Exclusion Criteria: TENS use in the last 5 years Pacemaker No use of opioids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active TENS Placebo TENS No TENS<br>Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor | Device: TENS<br>* Active TENS, Placebo TENS and No Treatment TENS<br>* Other names: Rehabilicare Maxima;|
| Experimental: Placebo TENS Active TENS No TENS<br>Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Participants wore a TENS unit that was turned off for blinding of the outcome assessor | Device: TENS<br>* Active TENS, Placebo TENS and No Treatment TENS<br>* Other names: Rehabilicare Maxima;|
| Experimental: No TENS Active TENS Placebo TENS<br>No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off | Device: TENS<br>* Active TENS, Placebo TENS and No Treatment TENS<br>* Other names: Rehabilicare Maxima;|
| Experimental: Active TENS No TENS Placebo TENS<br>Active TENS: 100 Hz, 200 μs at maximal tolerable intensity No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off | Device: TENS<br>* Active TENS, Placebo TENS and No Treatment TENS<br>* Other names: Rehabilicare Maxima;|
| Experimental: Placebo TENS No TENS Active TENS<br>Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity | Device: TENS<br>* Active TENS, Placebo TENS and No Treatment TENS<br>* Other names: Rehabilicare Maxima;|
| Experimental: No TENS Placebo TENS Active TENS<br>No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity | Device: TENS<br>* Active TENS, Placebo TENS and No Treatment TENS<br>* Other names: Rehabilicare Maxima;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at Rest Difference Score Pre-intervention and Post Intervention | Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention. | 3 weeks | 
| Pain With Movement Difference Score Pre-intervention and Post Intervention | Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue at Rest Difference Score Pre-intervention and Post Intervention | Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention. | 3 weeks | 
| Fatigue With Movement Difference Score Pre-intervention and Post Intervention | Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention. | 3 weeks | 
| PPT Cervical Region | Pressure pain threshold cervical region (kPa) | 3 weeks | 
| PPT Lumbar Region | Pressure pain threshold in lumbar region (kPa) | 3 weeks | 
| PPT for Anterior Tibialis | Pressure pain threshold in leg (kPa) | 3 weeks | 
| 6 Minute Walk Test Average Change (Feet) | 6 minute walk test average change (feet) before and after intervention | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Transcutaneous Electrical Nerve Stimulation (TENS)