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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Fibromyalgia
Interventions Device: CES device
Device: sham device
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CES Device Sham Device Usual Care Alone
Hide Arm/Group Description cranial electrical stimulation (CES) device (Alpha-Stim): 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.

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.

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 medical care for fibromyalgia
Period Title: Overall Study
Started 19 20 18
Completed 17 14 15
Not Completed 2 6 3
Arm/Group Title CES Device Sham Device Usual Care Alone Total
Hide Arm/Group Description cranial electrical stimulation (CES) device (Alpha-Stim): 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.

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.

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; participants will received usual medical care for fibromyalgia Total of all reporting groups
Overall Number of Baseline Participants 17 14 15 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 14 participants 15 participants 46 participants
51.9  (10.6) 51.5  (10.9) 48.6  (9.8) 50.8  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 15 participants 46 participants
Female
16
  94.1%
13
  92.9%
14
  93.3%
43
  93.5%
Male
1
   5.9%
1
   7.1%
1
   6.7%
3
   6.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 14 participants 15 participants 46 participants
17 14 15 46
Pain Numeric Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 14 participants 15 participants 46 participants
5.8  (1.9) 5.7  (1.6) 6.0  (2.1) 5.8  (1.8)
[1]
Measure Description: A Numeric Rating Scale to capture average pain. The scales ranges from 0 (no pain) to 10 (worst pain imaginable).
Fatigue   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 14 participants 15 participants 46 participants
6.12  (1.89) 6.66  (2.0) 6.85  (1.74) 6.53  (1.89)
[1]
Measure Description: A Numeric Rating Scale to capture present fatigue. The scales ranges from 0 (no fatigue) to 10 (worst fatigue imaginable).
Fibromyalgia impact   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 14 participants 15 participants 46 participants
61.36  (18.2) 65.98  (17.9) 66.31  (16.9) 64.51  (17.5)
[1]
Measure Description: The Fibromyalgia Impact Questionnaire is a brief assessment and evaluation instrument consisting of 19 items to measure patient status, progress, and outcomes of patients with fibromyalgia over the past week. The measure is self-administered and takes approximately 5 minutes to complete. Total scores range from 0 to 80, with 0 indicating no impact and 80 indicating maximum impact, thus a higher score indicating more negative impact.
Depression   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 14 participants 15 participants 46 participants
23.9  (11.8) 29.5  (13.7) 24.1  (14.2) 26.0  (13.3)
[1]
Measure Description: The Center for Epidemiological Studies-Depression (CES-D) scale is a 20-item measure that asks the individual to rate how often over the past week s/he has experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The CES-D also provides cutoff scores (e.g., 16 or greater) that aid in identifying individuals at risk for clinical depression.
General sleep disturbance   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 14 participants 15 participants 46 participants
3.75  (0.94) 4.01  (0.80) 3.6  (0.86) 3.8  (0.87)
[1]
Measure Description: The General Sleep Disturbance Scale (GSDS) is a subjective measure of sleep disturbance that contains 21 items rating the frequency of specific sleep problems during the past week from 0 to 7. Each item is rated on a numeric rating scale ranging from 0 to 7 and the total 21 items are summed to calculate total score ranging from 0 (no disturbance) to 147 (extreme disturbance); higher scores indicate greater sleep disturbances.
Daily stress impact   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 14 participants 15 participants 46 participants
3.86  (1.2) 3.05  (1.1) 3.39  (1.3) 3.44  (1.3)
[1]
Measure Description: The Daily Stress Inventory is a 58-item measure designed to quantify individuals' perceived daily stress by rating the stressfulness of the events identified on a Likert-type scale from 1 to 7. Three daily scores are derived for each individual: (1) number of events that are scored as having occurred (Frequency), (2) sum of the total of the impact rating of these events (Summary, and (3) average impact rating of the events (the AIR, which is obtained by dividing the Summary score by the Frequency Score). Scores range from 1 to 58, with higher scores indicating higher levels of stress.
1.Primary Outcome
Title Pain Intensity Using Numeric Rating Scale
Hide Description A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity
Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CES Device Sham Device Usual Care Alone
Hide Arm/Group Description:
cranial electrical stimulation (CES) device (Alpha-Stim): 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.

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.

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; participants will receive usual medical care for fibromyalgia
Overall Number of Participants Analyzed 17 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.12  (1.69) 6.36  (2.11) 6.62  (1.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care Alone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Fatigue Using Lee's Fatigue Scale
Hide Description A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CES Device Sham Device Usual Care Alone
Hide Arm/Group Description:

Participants will use the device for 60 minutes each day for 8 weeks.

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.

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.

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; participants will receive usual medical care
Overall Number of Participants Analyzed 17 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.97  (2.45) 6.38  (2.2) 6.83  (2.35)
3.Secondary Outcome
Title General Sleep Disturbance Scale
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CES Device Sham Device Usual Care Alone
Hide Arm/Group Description:
cranial electrical stimulation (CES) device (Alpha-Stim): 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.

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.

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 medical care for fibromyalgia
Overall Number of Participants Analyzed 17 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.79  (1.07) 3.86  (1.17) 3.53  (1.14)
4.Secondary Outcome
Title Depression Using the CES-D
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CES Device Sham Device Usual Care Alone
Hide Arm/Group Description:
cranial electrical stimulation (CES) device (Alpha-Stim): 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.

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.

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 medical care for fibromyalgia
Overall Number of Participants Analyzed 17 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.5  (10.1) 28.63  (14.9) 23.42  (13.2)
5.Secondary Outcome
Title Perceived Stress Using Numeric Rating Scale
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CES Device Sham Device Usual Care Alone
Hide Arm/Group Description:
cranial electrical stimulation (CES) device (Alpha-Stim): 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.

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.

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 medical care for fibromyalgia
Overall Number of Participants Analyzed 17 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.93  (2.4) 5.64  (2.66) 5.29  (2.61)
6.Secondary Outcome
Title Functional Status Using the Fibromyalgia Index Questionnaire
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CES Device Sham Device Usual Care Alone
Hide Arm/Group Description:
cranial electrical stimulation (CES) device (Alpha-Stim): 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.

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.

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 medical care for fibromyalgia
Overall Number of Participants Analyzed 17 14 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
45.05  (16.3) 70.1  (22.3) 63.2  (19.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CES Device Sham Device Usual Care Alone
Hide Arm/Group Description cranial electrical stimulation (CES) device (Alpha-Stim): 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.

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.

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; participants will receive usual medical care for fibromyalgia
All-Cause Mortality
CES Device Sham Device Usual Care Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
CES Device Sham Device Usual Care Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/14 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CES Device Sham Device Usual Care Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/14 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ann Gill Taylor, Professor Nursing
Organization: University of Virginia School of Nursing
Phone: 434-924-0113
EMail: agt@virginia.edu
Layout table for additonal information
Responsible Party: Ann G Taylor, University of Virginia
ClinicalTrials.gov Identifier: NCT00928720    
Other Study ID Numbers: 14203
First Submitted: June 24, 2009
First Posted: June 26, 2009
Results First Submitted: June 5, 2014
Results First Posted: August 13, 2014
Last Update Posted: July 3, 2018