Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

Not Applicable

Completed

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.

Recruitment & Eligibility

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):

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)

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Sham device	sham device	Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.
CES device	CES device	Participants will use the device for 60 minutes each day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Pain Intensity Using Numeric Rating Scale	week 8	A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity

Secondary Outcome Measures

Name	Time	Method
Functional Status Using the Fibromyalgia Index Questionnaire	Week 8
Depression Using the CES-D	Week 8
Perceived Stress Using Numeric Rating Scale	Week 8
Fatigue Using Lee's Fatigue Scale	Week 8	A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale
General Sleep Disturbance Scale	Week 8