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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00928720 |
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Date of registration:
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24/06/2009 |
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Primary sponsor: |
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Public title:
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Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
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Scientific title:
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Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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57 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00928720 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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Ann G Taylor, EdD, RN |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibromyalgia
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Intervention(s)
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Device: cranial electrical stimulation (CES) device (Alpha-Stim)
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Device: sham device
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Primary Outcome(s)
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pain intensity using numeric rating scale and Short Form-McGill Pain Questionnaire
[Time Frame: at baseline; weekly over 8 weeks]
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Secondary Outcome(s)
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blood pressure using the Omron HEM-711DLX upper arm blood pressure monitor
[Time Frame: at baseline and daily over 8 weeks]
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depression using the CES-D
[Time Frame: at baseline and weekly over 8 weeks]
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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]
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fatigue using Lee's Fatigue Inventory
[Time Frame: at baseline and weekly over 8 weeks]
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functional status using the Fibromyalgia Index Questionnaire
[Time Frame: at baseline and weekly over 8 weeks]
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perceived stress using numeric rating scale and the Daily Stress Inventory
[Time Frame: at baseline and weekly over 8 weeks]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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