Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)

Completed · Not applicable · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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

Key facts

Study ID

NCT01888640

Run by

Kathleen Sluka

People needed

301

Starts

2013-09-30

Expected to finish

2018-04-02

Last updated by the study team

2019-10-31

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participants will be 18 to 70 years of age
• Women may participate in the study, with the understanding that within the clinical population of fibromyalgia the there is a 7:1 ratio of female to male.
• Diagnosis of Fibromyalgia by 1990 ACR criteria (11/18 tender points)
• History of cervical or lumbar pain with fibromyalgia (this is expected in all patients since axial pain is required for diagnosis)
• Current stable treatment regimen for the last 4 weeks and projected stable treatment regimen for the next 2 months.
• English speaking

You may not qualify if…

• Current or history of cardiovascular, pulmonary, neurological, endocrine, or renal disease that would preclude the involvement in the study.
• TENS use in the last 5 years
• Pacemaker
• Uncontrolled blood pressure or diabetes
• Neuropathic pain condition
• Systemic autoimmune disorder (Lupus, PMR, RA, Psoriasis, Psoriatic arthritis)
• Spinal fusion - cervical or lumbar
• Metal implants in cervical or lumbar region
• Severe skin allergy to adhesive
• Allergy to nickel
• Pain level less than 4
• Pregnancy
• Epilepsy
• Change in or new drug or treatment program within the last month or in the next 2months, i.e. must have a stable treatment plan
• Unstable medical or psychiatric condition which in the opinion of the investigator could compromise the subject's welfare or confound the study results

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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