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.