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.
Footnotes
All authors provided concept/idea/study design. Dr Noehren, Dr Dailey, Dr Rakel, Dr Vance, Dr Crofford, and Dr Sluka provided writing. Dr Zimmerman provided data analysis. Dr Noehren, Dr Dailey, Dr Rakel, Dr Crofford, and Dr Sluka provided project management. Dr Crofford and Dr Sluka provided fund procurement, participants, and facilities/equipment. Dr Noehren, Dr Dailey, Dr Vance, and Dr Zimmerman provided consultation (including review of manuscript before submission).
Executive Committee: Project Director/Principal Investigator: Dr Sluka; Site Directors: Dr Rakel (Principal Investigator, University of Iowa) and Dr Crofford (Principal Investigator, Vanderbilt University); Study Statistician: Dr Zimmerman; Project Coordinator, University of Iowa: Dr Dailey; and National Institute of Arthritis and Musculoskeletal and Skin Diseases Program Officer, Dr William Tonkins.
Steering Committee: Project Director: Dr Sluka; Site Directors: Dr Rakel (Principal Investigator, University of Iowa) and Dr Crofford (Principal Investigator, Vanderbilt University); Study Coordinators: Dr Dailey (University of Iowa) and Dr Leon Darghosian (Vanderbilt University); Consultant: Dr Noehren (University of Kentucky); and Study Statistician: Dr Zimmerman (University of Iowa).
This study was approved by the institutional review boards of the University of Iowa and Vanderbilt University.
The funding of this study was provided by the National Institute of Arthritis and Musculoskeletal and Skin Diseases research grants UM1 AR063381 and R34 AR060278.
This trial is registered at ClinicalTrials.gov (trial number: NCT01888640).
- Received May 22, 2014.
- Accepted August 23, 2014.
