Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

University of Virginia57 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Fibromyalgia

Interventions

CES deviceDEVICE

Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.

sham deviceDEVICE

The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Virginia Center for the Study of Complementary and Alternative Therapies

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

Pain Intensity Using Numeric Rating Scale

A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity

Time frame: week 8

Secondary Outcomes

Fatigue Using Lee's Fatigue Scale

A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale

Time frame: Week 8

General Sleep Disturbance Scale

Time frame: Week 8

Depression Using the CES-D

Time frame: Week 8

Perceived Stress Using Numeric Rating Scale

Time frame: Week 8

Functional Status Using the Fibromyalgia Index Questionnaire

Time frame: Week 8

Data from ClinicalTrials.gov

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