PT  - JOURNAL ARTICLE
AU  - Noehren, Brian
AU  - Dailey, Dana L.
AU  - Rakel, Barbara A.
AU  - Vance, Carol G.T.
AU  - Zimmerman, Miriam B.
AU  - Crofford, Leslie J.
AU  - Sluka, Kathleen A.
TI  - Effect of Transcutaneous Electrical Nerve Stimulation on Pain, Function, and Quality of Life in Fibromyalgia: A Double-Blind Randomized Clinical Trial
AID  - 10.demo/ptj.20140218
DP  - 2015 Jan 01
TA  - Demo Journal of Physical Therapy
PG  - 129--140
VI  - 95
IP  - 1
4099  - http://demo.highwire.org/content/95/1/129.short
4100  - http://demo.highwire.org/content/95/1/129.full
AB  - 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.