Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ann G Taylor, University of Virginia
ClinicalTrials.gov Identifier:
NCT00928720
First received: June 24, 2009
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Fibromyalgia
Device: CES device
Device: sham device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Pain Intensity Using Numeric Rating Scale [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity


Secondary Outcome Measures:
  • Fatigue Using Lee's Fatigue Scale [ Time Frame: at baseline and weekly over 8 weeks ] [ Designated as safety issue: No ]
    A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale

  • Sleep Disturbances and Sleep Quality Using Wrist Actigraph and Sleep Diary, General Sleep Disturbance Scale, and Pittsburgh Sleep Quality Index [ Time Frame: wear actigraph and keep sleep diary for 96 hrs at baseline and weeks 4 and 8; GSDS at baseline and weekly over 8 weeks; PSQI at baseline and weeks 4 and 8 ] [ Designated as safety issue: No ]
  • Depression Using the CES-D [ Time Frame: at baseline and weekly over 8 weeks ] [ Designated as safety issue: No ]
  • Perceived Stress Using Numeric Rating Scale and the Daily Stress Inventory [ Time Frame: at baseline and weekly over 8 weeks ] [ Designated as safety issue: No ]
  • Functional Status Using the Fibromyalgia Index Questionnaire [ Time Frame: at baseline and weekly over 8 weeks ] [ Designated as safety issue: No ]
  • Blood Pressure Using the Omron HEM-711DLX Upper Arm Blood Pressure Monitor [ Time Frame: at baseline and daily over 8 weeks ] [ Designated as safety issue: Yes ]
  • Differences in Brain Activity in Pain Processing Regions Between the Active CES and Sham Device Groups in a Subset of 12 Participants (6 in Each Device Group) Using fMRI [ Time Frame: at baseline and week 8 ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: June 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ann G Taylor, Professor of Nursing, University of Virginia
ClinicalTrials.gov Identifier: NCT00928720     History of Changes
Other Study ID Numbers: 14203
Study First Received: June 24, 2009
Results First Received: June 5, 2014
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 27, 2014