CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 301 enrolled
Drug / intervention
TENSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01888640
NCT01888640N/ACompleted

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation

Kathleen Sluka·interventional·Posted Jun 28, 2013·Updated Oct 31, 2019

In Brief

A clinical study evaluating TENS for Fibromyalgia. Completed, enrolled 301 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 28, 2013
Enrollment StartSep 30, 2013
Primary CompletionApr 2, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.0 years ago

Interventions

TENSdevice

TENS Parameters: Active TENS and Placebo TENS * TENS Frequency - 2-125 Hz * TENS Pulse Width - 200 µs * TENS Intensity - Maximal tolerable intensity * Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes. * Administration - Daily * TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region. Placebo TENS Unit Active TENS unit No TENS - Standard Care