Status:
COMPLETED
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
Lead Sponsor:
Kathleen Sluka
Collaborating Sponsors:
Vanderbilt University
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief 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 fatig...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2018
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT01888640
Start Date
September 30 2013
End Date
April 2 2018
Last Update
October 31 2019
Active Locations (2)
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1
University of Iowa
Iowa City, Iowa, United States, 52242
2
Vanderbilt University
Nashville, Tennessee, United States, 37262-2681