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Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00928720
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : August 13, 2014
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ann G Taylor, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: CES device Device: sham device Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
Study Start Date : June 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: CES device
Participants will use the device for 60 minutes each day for 8 weeks.
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.
Other Name: Alpha-Stim

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

No Intervention: Usual care alone
No intervention; participants will receive usual medical care



Primary Outcome Measures :
  1. Pain Intensity Using Numeric Rating Scale [ Time Frame: week 8 ]
    A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity


Secondary Outcome Measures :
  1. Fatigue Using Lee's Fatigue Scale [ Time Frame: Week 8 ]
    A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale

  2. General Sleep Disturbance Scale [ Time Frame: Week 8 ]
  3. Depression Using the CES-D [ Time Frame: Week 8 ]
  4. Perceived Stress Using Numeric Rating Scale [ Time Frame: Week 8 ]
  5. Functional Status Using the Fibromyalgia Index Questionnaire [ Time Frame: Week 8 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928720


Locations
United States, Virginia
University of Virginia Center for the Study of Complementary and Alternative Therapies
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Ann G Taylor, EdD, RN University of Virginia

Responsible Party: Ann G Taylor, Professor of Nursing, University of Virginia
ClinicalTrials.gov Identifier: NCT00928720     History of Changes
Other Study ID Numbers: 14203
First Posted: June 26, 2009    Key Record Dates
Results First Posted: August 13, 2014
Last Update Posted: July 3, 2018
Last Verified: June 2018

Keywords provided by Ann G Taylor, University of Virginia:
fibromyalgia
pain
sleep disturbance
fatigue
depression
functional magnetic resonance imaging

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases