Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia as a clinical syndrome is defined by chronic widespread muscular pain, fatigue
      and tenderness with hyperalgesia to pressure over tender points. Pain associated with
      fibromyalgia can interfere with daily function, work, and social activities. Thus, one of the
      main treatments for patients with fibromyalgia must focus on pain relief to allow the person
      to function more independently both at home and at work. Although the etiology of
      fibromyalgia is unknown, there is clearly enhanced sensitization in the central nervous
      system pain pathways as demonstrating by decreases in pressure pain thresholds, reduced
      central inhibition, and enhanced temporal summation. Reducing pain in people with
      fibromyalgia would help increase the patient's ability to return to work, perform activities
      of daily living and thus improve the quality of life for the patient. Transcutaneous
      electrical nerve stimulation (TENS) is a modality utilized in physical therapy that delivers
      electrical stimulation through the skin and is used for both acute and chronic pain. TENS
      works by reducing central excitability and increasing central inhibition. Thus, the
      investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation
      (TENS) to patients with Fibromyalgia (FM) will reduce pain, reduce central excitability by
      restoring diffuse noxious inhibitory controls (DNIC), and reduce temporal summation and that
      this decrease in pain and/or central excitability will improve function. The primary aim of
      the study is to test the effectiveness of TENS on pain and central excitability in a
      crossover design study for patients with Fibromyalgia with random assignment to three
      treatments: no treatment control, placebo TENS and active high frequency TENS. A secondary
      aim is to test the effect of decreased pain and central excitability on function in patients
      with Fibromyalgia.
    

Detailed description: 
      The study will be a simple crossover design with the following three treatments (1) active
      TENS, (2) placebo TENS or (3) no treatment control randomly assigned. Subjects will draw the
      order for treatments (A, B, and C) out of a bowl at the initial testing session. This will
      determine the order of the testing. Each subject will receive all 3 treatments in random
      order.

      The following tools will be used to measure subject characteristics (Fibromyalgia Impact
      Questionnaire, Tampa Scale of Kinesiophobia), pain (McGill Pain Questionnaire and Visual
      Analogue Scale), central excitability (pressure pain thresholds, temporal summation and DNIC)
      and function (6 minute walk test, range of motion, sit to stand test).
    

Intervention name(s): TENS
Intervention type(s): Device
Intervention description(s): Active TENS, Placebo TENS and No Treatment TENS
Other intervention name(s): Rehabilicare Maxima
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Fibromyalgia; Transcutaneous Electrical Nerve Stimulation (TENS)