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.

Trial registration: ClinicalTrials.gov NCT01888640.

© 2015 American Physical Therapy Association.

Figures

Figure 1.

Conceptual model for effectiveness of transcutaneous electrical nerve stimulation (TENS), showing the expected outcomes and mechanisms by which those outcomes will be assessed. A combination of functional tests, pain physiology assessments, and patient-reported outcomes will be used to provide a complete picture of the effectiveness of the use of TENS in patients with fibromyalgia. BPI=Brief Pain Inventory, NRS=numeric rating scale, PROMIS=Patient Reported Outcomes Measurement Information System, SF-36=36-Item Short-Form Health Survey, FIQR=Revised Fibromyalgia Impact Questionnaire, TSK=Tampa Scale of Kinesiophobia, 6MWT=Six-Minute Walk Test, FTSTS=Five-Times-Sit-to-Stand Test, PPT=pressure pain threshold, CPM/DNIC=conditioned pain modulation (diffuse noxious inhibitory control), MAF=Multidimensional Assessment of Fatigue, QOL=quality of life, FRT=Functional Reach Test.

Figure 2.

Flowchart for the study showing the breakdown of what occurs during each visit per each group (active transcutaneous electrical nerve stimulation [TENS], placebo TENS, and no treatment). FIQR=Revised Fibromyalgia Impact Questionnaire, NRS=numeric rating scale, ACR=American College of Rheumatology, 6MWT=Six-Minute Walk Test, FTSTS=Five-Times-Sit-to-Stand Test, FRT=Functional Reach Test, PPT=pressure pain threshold, CPM=conditioned pain modulation.

Figure 3.

Inclusion and exclusion criteria for entrance into the transcutaneous electrical nerve stimulation (TENS) trial for patients with fibromyalgia.