Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Pain associated with fibromyalgia interferes with daily function, work, and social activities
      resulting in a decreased quality of life. People with fibromyalgia also have a significant
      amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability
      of pain neurons in the central nervous system and reduced pain inhibition. Therefore, 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. Transcutaneous electrical
      nerve stimulation is used by health professionals to deliver electrical stimulation through
      the skin for pain control. Basic science studies, from the PI's laboratory show that TENS
      activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus
      the ideal patient population for the treatment of TENS would be one in which there is
      enhanced central excitability and reduced inhibition; fibromyalgia is such a condition.

      Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve
      Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related
      pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC),
      and that this decrease in pain and/or central excitability will reduce fatigue and fear of
      movement, thereby improving function and quality of life
    

Detailed description: 
      This is a phase II randomized, double-blind, placebo controlled multi-center clinical trial
      involving a device, Transcutaneous Electrical Nerve Stimulation (TENS). TENS is a
      non-pharmacological agent which delivers electrical stimulation by a battery operated device
      via electrodes placed on the skin. TENS is considered to be a safe, inexpensive and
      non-invasive modality used to treat a variety of acute and chronic pain conditions. The
      initial phase of the study will randomly allocate subjects to receive active TENS, placebo
      TENS or standard care (No TENS). After participating in the 1 month random assignment, all
      subjects will receive active TENS for 1 month. The subjects will make 4 visits to the clinic
      approximately 2 to 3 1/2 hours each visit. Visits will entail questionnaires, functional
      tasks, accelerometry, TENS, pain and fatigue assessments.

      Study Aims:

      Aim #1: The primary aim of the study is to test the effectiveness of repeated TENS use on
      movement-related pain in people with fibromyalgia with random assignment to three treatments:
      standard care, placebo TENS and active Aim #2: A secondary aim will test if pain reduction by
      TENs results in a concomitant decrease in fatigue and fear of movement, and an increase in
      function and quality of life. Outcome measures will include physical function by directly
      assessing daily activity with an accelerometer, as well as performing specific functional
      tasks
    

Intervention name(s): TENS
Intervention type(s): Device
Intervention description(s): TENS Parameters: Active TENS and Placebo TENS
TENS Frequency - 2-125 Hz
TENS Pulse Width - 200 µs
TENS Intensity - Maximal tolerable intensity
Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
Administration - Daily
TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit No TENS - Standard Care
Other intervention name(s): Empi Select Unit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TENS; Fibromyalgia; Accelerometer