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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 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.

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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

Conditions Studied

Fibromyalgia

Interventions

  • DEVICE TENS

Study Locations (2)

Iowa

  • University of Iowa - Iowa City

Tennessee

  • Vanderbilt University - Nashville

Trial Details

FieldValue
Enrollment Target 301 participants
Start Date 2013-09-30
Est. Completion 2018-04-02
Phase NA

Sponsor

Kathleen Sluka

2 total trials

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What the Registry Record Tells You About NCT01888640

The ClinicalTrials.gov registry entry for NCT01888640 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 175-participant average among 76 other Fibromyalgia trials with a reported enrollment target (72% higher). The listed sponsor is Kathleen Sluka, which has 2 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.