Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial

Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TE...

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Veröffentlicht in:Physical therapy 2015-01, Vol.95 (1), p.129-140
Hauptverfasser: Noehren, Brian, Dailey, Dana L, Rakel, Barbara A, Vance, Carol G T, Zimmerman, Miriam B, Crofford, Leslie J, Sluka, Kathleen A
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container_issue 1
container_start_page 129
container_title Physical therapy
container_volume 95
creator Noehren, Brian
Dailey, Dana L
Rakel, Barbara A
Vance, Carol G T
Zimmerman, Miriam B
Crofford, Leslie J
Sluka, Kathleen A
description Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability. To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia. The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia. This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial. Three hundred forty-three participants with fibromyalgia will be recruited for this study. Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity. The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing. Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded. The results of this study will provide some of the first evidence from a large-scale, double-blind, placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia.
doi_str_mv 10.2522/ptj.20140218
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To date, there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation (TENS) in the management of pain and improvement in function in individuals with fibromyalgia. The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia. This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial. Three hundred forty-three participants with fibromyalgia will be recruited for this study. Participants will be randomly assigned to 1 of 3 groups: the intervention (TENS), placebo, or no treatment. After completing the randomized period, all participants will receive the intervention for 1 month. The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity. 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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection
subjects Arthritis
Care and treatment
Chronic pain
Clinical trials
Diagnosis
Double-Blind Method
Drug therapy
Exercise
Fatigue
Fatigue - physiopathology
Fatigue - therapy
FDA approval
Female
Fibromyalgia
Fibromyalgia - physiopathology
Fibromyalgia - psychology
Fibromyalgia - therapy
Health aspects
Humans
Pain
Pain management
Pain Measurement
Physical fitness
Physiology
Protocol
Quality of Life
Review boards
Rheumatic diseases
Risk factors
Skin diseases
Studies
Transcutaneous Electric Nerve Stimulation
Transcutaneous electrical nerve stimulation-TENS
title Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial
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