Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928720
• Other study ID #: 14203
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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):

• 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)

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia Center for the Study of Complementary and Alternative Therapies	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	week 8
Secondary	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	Week 8
Secondary	General Sleep Disturbance Scale		Week 8
Secondary	Depression Using the CES-D		Week 8
Secondary	Perceived Stress Using Numeric Rating Scale		Week 8
Secondary	Functional Status Using the Fibromyalgia Index Questionnaire		Week 8