N/A N=57 Randomized Triple-blind Supportive Care

Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT00928720 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Pain Intensity Using Numeric Rating Scale — 5.12; 6.36; 6.62 units on a scale — p=0.045

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CES device (Device); sham device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Virginia
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Intensity Using Numeric Rating Scale	5.12; 6.36; 6.62	0.045 sig
SECONDARY Fatigue Using Lee's Fatigue Scale	4.97; 6.38; 6.83	—
SECONDARY General Sleep Disturbance Scale	2.79; 3.86; 3.53	—
SECONDARY Depression Using the CES-D	16.5; 28.63; 23.42	—
SECONDARY Perceived Stress Using Numeric Rating Scale	3.93; 5.64; 5.29	—
SECONDARY Functional Status Using the Fibromyalgia Index Questionnaire	45.05; 70.1; 63.2	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00928720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.