Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

NCT00928720 | Completed Results

• 1 other identifier: 14203
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; pain; sleep disturbance; fatigue; depression; functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Fatigue Using Lee's Fatigue Scale

  Week 8

• General Sleep Disturbance Scale

  Week 8

• Depression Using the CES-D

  Week 8

• Perceived Stress Using Numeric Rating Scale

  Week 8

• Functional Status Using the Fibromyalgia Index Questionnaire

  Week 8

Study Arms (3)

CES device

ACTIVE COMPARATOR

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

Device: CES device

Sham device

SHAM COMPARATOR

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.

Device: sham device

Usual care alone

NO INTERVENTION

No intervention; participants will receive usual medical care

Interventions

CES device 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.

Also known as: Alpha-Stim

CES device

sham device 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.

Sham device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant or breastfeeding
• epilepsy or history of seizures
• presence of pacemakers and/or other implanted devices
• 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)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

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

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain; Parasomnias; Fatigue; Depression

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Ann Gill Taylor, Professor Nursing
• Organization: University of Virginia School of Nursing

agt@virginia.edu

434-924-0113

Study Officials

• Ann G Taylor, EdD, RN

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 26, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 3, 2018
• Results First Posted: August 13, 2014

Record last verified: 2018-06

Locations

US (1)