Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00928720
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 3
• Duration (Months): 16
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Device: CES device; Device: sham device	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• 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: Jun 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Pain Intensity Using Numeric Rating Scale [week 8]

   A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity

Secondary Outcome Measures

1. Fatigue Using Lee's Fatigue Scale [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

2. General Sleep Disturbance Scale [Week 8]

3. Depression Using the CES-D [Week 8]

4. Perceived Stress Using Numeric Rating Scale [Week 8]

5. Functional Status Using the Fibromyalgia Index Questionnaire [Week 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ann G Taylor, Professor of Nursing, University of Virginia
• ClinicalTrials.gov Identifier: NCT00928720
• Other Study ID Numbers: 14203
• First Posted: Jun 26, 2009
• Last Update Posted: Jul 3, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Ann G Taylor, Professor of Nursing, University of Virginia: fibromyalgia; pain; sleep disturbance; fatigue; depression; functional magnetic resonance imaging
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes

Study Results

Participant Flow

Arm/Group Title	CES Device	Sham Device	Usual Care Alone
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

Baseline Characteristics

Arm/Group Title	CES Device	Sham Device	Usual Care Alone	Total
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 Participants	17	14	15	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.9 (10.6)	51.5 (10.9)	48.6 (9.8)	50.8 (10.4)
Sex: Female, Male (Count of 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 (participants) [Number]
United States	17 100%	14 100%	15 100%	46 100%
Pain Numeric Rating Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.8 (1.9)	5.7 (1.6)	6.0 (2.1)	5.8 (1.8)
Fatigue (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.12 (1.89)	6.66 (2.0)	6.85 (1.74)	6.53 (1.89)
Fibromyalgia impact (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	61.36 (18.2)	65.98 (17.9)	66.31 (16.9)	64.51 (17.5)
Depression (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	23.9 (11.8)	29.5 (13.7)	24.1 (14.2)	26.0 (13.3)
General sleep disturbance (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.75 (0.94)	4.01 (0.80)	3.6 (0.86)	3.8 (0.87)
Daily stress impact (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.86 (1.2)	3.05 (1.1)	3.39 (1.3)	3.44 (1.3)

Outcome Measures

1. Primary Outcome

Title	Pain Intensity Using Numeric Rating Scale
Description	A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity
Time Frame	week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CES Device	Sham Device	Usual Care Alone
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
Measure Participants	17	14	15
Mean (Standard Deviation) [units on a scale]	5.12 (1.69)	6.36 (2.11)	6.62 (1.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care Alone
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.045
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Fatigue Using Lee's Fatigue Scale
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CES Device	Sham Device	Usual Care Alone
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
Measure Participants	17	14	15
Mean (Standard Deviation) [units on a scale]	4.97 (2.45)	6.38 (2.2)	6.83 (2.35)

3. Secondary Outcome

Title	General Sleep Disturbance Scale
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CES Device	Sham Device	Usual Care Alone
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
Measure Participants	17	14	15
Mean (Standard Deviation) [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
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CES Device	Sham Device	Usual Care Alone
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
Measure Participants	17	14	15
Mean (Standard Deviation) [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
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CES Device	Sham Device	Usual Care Alone
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
Measure Participants	17	14	15
Mean (Standard Deviation) [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
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CES Device	Sham Device	Usual Care Alone
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
Measure Participants	17	14	15
Mean (Standard Deviation) [units on a scale]	45.05 (16.3)	70.1 (22.3)	63.2 (19.9)

Adverse Events

Arm/Group Title	CES Device		Sham Device		Usual Care Alone
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CES Device		Sham Device		Usual Care Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/14 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	CES Device		Sham Device		Usual Care Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/14 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.