Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
| Status: | Completed |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/5/2018 |
| Start Date: | June 2009 |
| End Date: | October 2010 |
The purpose of this study is to determine the effects of mild cranial electrical stimulation
on pain, fatigue, sleep disturbances, perceived stress, blood pressure, and functional status
in persons with fibromyalgia.
on pain, fatigue, sleep disturbances, perceived stress, blood pressure, and functional status
in persons with fibromyalgia.
Central pain networks in the brain are dysregulated in persons with fibromyalgia (FM). Thus,
the investigators propose that cranial electrical stimulation (CES) that works on the brain
may ameliorate symptoms of FM by interacting with the central pain networks. The specific
aims of this randomized, controlled, three-group pilot study design are to: (1) determine
differences in pain over time between the active CES, sham device, and usual care (UC)
groups; (2) explore differences in brain activity in pain processing regions (i.e.,
cingulate, insula, prefrontal and somatosensory cortices, amygdala, and thalamus) between the
active CES, sham device, and UC groups in a subset of 12 participants (6 in each device
group); (3) determine the effects of CES on other symptoms (fatigue, sleep disturbances,
depression, perceived stress) and functional status, and blood pressure over time between the
active CES, sham device, and UC groups; and (4) determine the amount of influence that
selected psychological factors (negative affect, catastrophizing, and other personality
characteristics) have on group differences in pain, other symptoms, functional status, and
brain activity.
the investigators propose that cranial electrical stimulation (CES) that works on the brain
may ameliorate symptoms of FM by interacting with the central pain networks. The specific
aims of this randomized, controlled, three-group pilot study design are to: (1) determine
differences in pain over time between the active CES, sham device, and usual care (UC)
groups; (2) explore differences in brain activity in pain processing regions (i.e.,
cingulate, insula, prefrontal and somatosensory cortices, amygdala, and thalamus) between the
active CES, sham device, and UC groups in a subset of 12 participants (6 in each device
group); (3) determine the effects of CES on other symptoms (fatigue, sleep disturbances,
depression, perceived stress) and functional status, and blood pressure over time between the
active CES, sham device, and UC groups; and (4) determine the amount of influence that
selected psychological factors (negative affect, catastrophizing, and other personality
characteristics) have on group differences in pain, other symptoms, functional status, and
brain activity.
Inclusion Criteria:
- meet the diagnostic criteria for FM established by the American College of
Rheumatology
- have initial pain level equal to or greater than 3 on a NRS 0-10
- have stable medication use related to FM for at least 4 weeks
- be able to read, write, and understand the English language
Exclusion Criteria (all participants):
- pregnant or breastfeeding
- epilepsy or history of seizures
- presence of pacemakers and/or other implanted devices
Exclusion Criteria (subset of 12 participants who wil have fMRIs):
- conditions that would not permit an fMRI (e.g., certain types of metal or metallic
objects in body, diaphragm or intrauterine device, dermal patches, ear or eye
implants, implanted electrical stimulators, artificial heart valve, implanted catheter
or tube, tattoos, claustrophobia; or weight more than 275 lbs)
We found this trial at
1
site
Charlottesville, Virginia 22908
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