Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00928720|
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : August 13, 2014
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Device: CES device Device: sham device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|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|
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
- 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
- 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 ]
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
|United States, Virginia|
|University of Virginia Center for the Study of Complementary and Alternative Therapies|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Ann G Taylor, EdD, RN||University of Virginia|