Brian Noehren1, Dana L Dailey2, Barbara A Rakel3, Carol G T Vance4, Miriam B Zimmerman5, Leslie J Crofford6, Kathleen A Sluka7. 1. B. Noehren, PT, PhD, Division of Physical Therapy, College of Health Sciences University of Kentucky, Lexington, Kentucky. 2. D.L. Dailey, PT, PhD, Department of Physical Therapy and Rehabilitation Science, College of Medicine, University of Iowa, Iowa City, Iowa. 3. B.A. Rakel, RN, PhD, College of Nursing, University of Iowa. 4. C.G.T. Vance, PT, PhD, Department of Physical Therapy and Rehabilitation Science, College of Medicine, University of Iowa. 5. M.B. Zimmerman, PhD, Biostatistics, University of Iowa. 6. L.J. Crofford, MD, Department of Medicine, Vanderbilt University, Nashville, Tennessee. 7. K.A. Sluka, PT, PhD, FAPTA, Department of Physical Therapy and Rehabilitation Science, Carver College of Medicine, University of Iowa, Iowa City, IA 52422-1089 (USA). kathleen-sluka@uiowa.edu.
Abstract
BACKGROUND: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. OBJECTIVES: The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia. DESIGN: This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial. PARTICIPANTS: Three hundred forty-three participants with fibromyalgia will be recruited for this study. INTERVENTION: 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. MEASUREMENTS: The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing. LIMITATIONS: Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND: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. OBJECTIVES: The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia. DESIGN: This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial. PARTICIPANTS: Three hundred forty-three participants with fibromyalgia will be recruited for this study. INTERVENTION: 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. MEASUREMENTS: The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing. LIMITATIONS: Because having participants refrain from their typical medications is not practical, their usage and any change in medication use will be recorded. CONCLUSIONS: 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.
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