Abstract | BACKGROUND: 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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Authors | Brian Noehren, Dana L Dailey, Barbara A Rakel, Carol G T Vance, Miriam B Zimmerman, Leslie J Crofford, Kathleen A Sluka |
Journal | Physical therapy
(Phys Ther)
Vol. 95
Issue 1
Pg. 129-40
(Jan 2015)
ISSN: 1538-6724 [Electronic] United States |
PMID | 25212518
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Copyright | © 2015 American Physical Therapy Association. |
Topics |
- Double-Blind Method
- Fatigue
(physiopathology, therapy)
- Female
- Fibromyalgia
(physiopathology, psychology, therapy)
- Humans
- Pain Measurement
- Quality of Life
- Transcutaneous Electric Nerve Stimulation
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