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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

Tracking Information
First Submitted Date  ICMJE June 24, 2009
First Posted Date  ICMJE June 26, 2009
Results First Submitted Date  ICMJE June 5, 2014
Results First Posted Date  ICMJE August 13, 2014
Last Update Posted Date July 3, 2018
Study Start Date  ICMJE June 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2009)
pain intensity using numeric rating scale and Short Form-McGill Pain Questionnaire [ Time Frame: at baseline; weekly over 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • 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
  • General Sleep Disturbance Scale [ Time Frame: Week 8 ]
  • Depression Using the CES-D [ Time Frame: Week 8 ]
  • Perceived Stress Using Numeric Rating Scale [ Time Frame: Week 8 ]
  • Functional Status Using the Fibromyalgia Index Questionnaire [ Time Frame: Week 8 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2009)
  • fatigue using Lee's Fatigue Inventory [ Time Frame: at baseline and weekly over 8 weeks ]
  • 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 ]
  • Depression Using the CES-D [ Time Frame: at baseline and weekly over 8 weeks ]
  • Perceived Stress Using Numeric Rating Scale and the Daily Stress Inventory [ Time Frame: at baseline and weekly over 8 weeks ]
  • Functional Status Using the Fibromyalgia Index Questionnaire [ Time Frame: at baseline and weekly over 8 weeks ]
  • Blood Pressure Using the Omron HEM-711DLX Upper Arm Blood Pressure Monitor [ Time Frame: at baseline and daily over 8 weeks ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
Official Title  ICMJE Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: CES device
    Participants will use the device for 60 minutes each day for 8 weeks.
    Intervention: Device: CES device
  • 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.
    Intervention: Device: sham device
  • No Intervention: Usual care alone
    No intervention; participants will receive usual medical care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2009)
57
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00928720
Other Study ID Numbers  ICMJE 14203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ann G Taylor, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ann G Taylor, EdD, RN University of Virginia
PRS Account University of Virginia
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP