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Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
NCT01888640 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DEVICE TENS
Study Locations (2)
Iowa
- University of Iowa — Iowa City
Tennessee
- Vanderbilt University — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2018-04-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01888640
The ClinicalTrials.gov registry entry for NCT01888640 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kathleen Sluka, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fibromyalgia appearing as the primary indexed condition, and to 1 intervention — of which TENS is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01888640 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Iowa, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01888640 about?
NCT01888640 is a clinical study titled "Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)". 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 th...
What is the current status of trial NCT01888640?
This trial is currently completed. It is a NA study. The enrollment target is 301 participants. The study started on 2013-09-30. Estimated completion is 2018-04-02.
What conditions does trial NCT01888640 study?
This clinical trial studies the following conditions: Fibromyalgia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01888640?
The interventions under investigation include: TENS (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01888640?
This trial is sponsored by Kathleen Sluka, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01888640 being conducted?
This trial has 2 study locations across Iowa, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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