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

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.

• 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)
• 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