Clinical trial NCT00928720: Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
Official title: Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
pain
sleep disturbance
fatigue
depression
functional magnetic resonance imaging
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain Intensity Using Numeric Rating Scale
timeFrame: week 8
Secondary outcomes:
measure: Fatigue Using Lee's Fatigue Scale
timeFrame: Week 8
measure: General Sleep Disturbance Scale
timeFrame: Week 8
measure: Depression Using the CES-D
timeFrame: Week 8
measure: Perceived Stress Using Numeric Rating Scale
timeFrame: Week 8
measure: Functional Status Using the Fibromyalgia Index Questionnaire
timeFrame: Week 8
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for the Study of Complementary and Alternative Therapies
state: Virginia
Study officials:
affiliation: University of Virginia
name: Ann G Taylor, EdD, RN
role: PRINCIPAL_INVESTIGATOR
References: