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Phys Ther. 2015 Jan;95(1):129-40. doi: 10.2522/ptj.20140218. Epub 2014 Sep 11.

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

Author information

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01888640.

PMID:
25212518
PMCID:
PMC4295083
DOI:
10.2522/ptj.20140218
[Indexed for MEDLINE]
Free PMC Article

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