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NCT01888640 · ClinicalTrials.gov registry record · NA
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
A NA study of Fibromyalgia, sponsored by Kathleen Sluka.
- Completed
- Registry status
- NA
- Development phase
- 301
- Enrollment target
- 2
- Study locations
NCT01888640: Completed NA study of Fibromyalgia, sponsored by Kathleen Sluka.
NCT01888640 is a NA study of Fibromyalgia that has completed, run by Kathleen Sluka. The registered enrollment target is 301 participants, above the 175-participant average among 76 other Fibromyalgia trials with a reported enrollment target (72% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01888640, a NA study of Fibromyalgia, has completed, sponsored by Kathleen Sluka.
- COMPLETED
- Registry status
- NA
- Development phase
- 301 participants
- Enrollment target
- 2
- Study locations
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
Primary Outcome
Numeric rating scale of 0-10 (low to high scale) for pain with movement during six minute walk test; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from ba
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 |
What the finished NCT01888640 record still lists
NCT01888640 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, above the 175-participant average among 76 other Fibromyalgia trials with a reported enrollment target (72% higher).
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.
NCT01888640 reports a single indexed study location in Iowa, Tennessee.
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.
What interventions are being tested in trial NCT01888640?
The interventions under investigation include: TENS (DEVICE).
Who is sponsoring clinical trial NCT01888640?
This trial is sponsored by Kathleen Sluka, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01888640's enrollment target sits among peer trials
301 12th of 76 higher than 65 of 76 other Fibromyalgia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fibromyalgia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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