Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

University of Virginia

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: sham device; Device: CES device

Study type: Interventional

Funder types: Other

Identifiers

NCT00928720

14203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 3 patient groups

CES device

Active Comparator group

Description:

Participants will use the device for 60 minutes each day for 8 weeks.

Treatment:

Device: CES device

Sham device

Sham Comparator group

Description:

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.

Treatment:

Device: sham device

Usual care alone

No Intervention group

Description:

No intervention; participants will receive usual medical care