title: 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.
  
  
  OBJECTIVE
  The purpose of this study will be to complete a long-term, multicenter study to assess the effects of TENS in women with fibromyalgia.
  
  
  METHODS
  This will be a phase II randomized, double-blind, placebo-controlled, multicenter clinical trial.
  
  
  METHODS
  Three hundred forty-three participants with fibromyalgia will be recruited for this study.
  
  
  METHODS
  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.
  
  
  METHODS
  The primary outcome will be pain with movement, with secondary outcomes assessing functional abilities, patient-reported outcomes, and quantitative sensory testing.
  
  
  CONCLUSIONS
  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.affiliation: B. Noehren, PT, PhD, Division of Physical Therapy, College of Health Sciences University of Kentucky, Lexington, Kentucky.
authors.forename: Brian
authors.initials: B
authors.lastname: Noehren
authors.affiliation: D.L. Dailey, PT, PhD, Department of Physical Therapy and Rehabilitation Science, College of Medicine, University of Iowa, Iowa City, Iowa.
authors.forename: Dana L
authors.initials: DL
authors.lastname: Dailey
authors.affiliation: B.A. Rakel, RN, PhD, College of Nursing, University of Iowa.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Rakel
authors.affiliation: C.G.T. Vance, PT, PhD, Department of Physical Therapy and Rehabilitation Science, College of Medicine, University of Iowa.
authors.forename: Carol G T
authors.initials: CG
authors.lastname: Vance
authors.affiliation: M.B. Zimmerman, PhD, Biostatistics, University of Iowa.
authors.forename: Miriam B
authors.initials: MB
authors.lastname: Zimmerman
authors.affiliation: L.J. Crofford, MD, Department of Medicine, Vanderbilt University, Nashville, Tennessee.
authors.forename: Leslie J
authors.initials: LJ
authors.lastname: Crofford
authors.affiliation: 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.
authors.forename: Kathleen A
authors.initials: KA
authors.lastname: Sluka
mesh_terms: D004311:Double-Blind Method; D005221:Fatigue / Q000503:physiopathology / Q000628:therapy; D005260:Female; D005356:Fibromyalgia / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D010147:Pain Measurement; D011788:Quality of Life; D004561:Transcutaneous Electric Nerve Stimulation