Trial Outcomes & Findings for Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia (NCT NCT00928720)
NCT ID: NCT00928720
Last Updated: 2018-07-03
Results Overview
A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
week 8
Results posted on
2018-07-03
Participant Flow
Participant milestones
| Measure |
CES Device
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.
|
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.
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.
|
Usual Care Alone
No intervention; usual medical care for fibromyalgia
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
18
|
|
Overall Study
COMPLETED
|
17
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
Baseline characteristics by cohort
| Measure |
CES Device
n=17 Participants
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.
|
Sham Device
n=14 Participants
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.
|
Usual Care Alone
n=15 Participants
No intervention; participants will received usual medical care for fibromyalgia
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
46 participants
n=4 Participants
|
|
Pain Numeric Rating Scale
|
5.8 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Fatigue
|
6.12 units on a scale
STANDARD_DEVIATION 1.89 • n=5 Participants
|
6.66 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
6.85 units on a scale
STANDARD_DEVIATION 1.74 • n=5 Participants
|
6.53 units on a scale
STANDARD_DEVIATION 1.89 • n=4 Participants
|
|
Fibromyalgia impact
|
61.36 units on a scale
STANDARD_DEVIATION 18.2 • n=5 Participants
|
65.98 units on a scale
STANDARD_DEVIATION 17.9 • n=7 Participants
|
66.31 units on a scale
STANDARD_DEVIATION 16.9 • n=5 Participants
|
64.51 units on a scale
STANDARD_DEVIATION 17.5 • n=4 Participants
|
|
Depression
|
23.9 units on a scale
STANDARD_DEVIATION 11.8 • n=5 Participants
|
29.5 units on a scale
STANDARD_DEVIATION 13.7 • n=7 Participants
|
24.1 units on a scale
STANDARD_DEVIATION 14.2 • n=5 Participants
|
26.0 units on a scale
STANDARD_DEVIATION 13.3 • n=4 Participants
|
|
General sleep disturbance
|
3.75 units on a scale
STANDARD_DEVIATION 0.94 • n=5 Participants
|
4.01 units on a scale
STANDARD_DEVIATION 0.80 • n=7 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 0.86 • n=5 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 0.87 • n=4 Participants
|
|
Daily stress impact
|
3.86 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
3.05 units on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.39 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
3.44 units on a scale
STANDARD_DEVIATION 1.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: week 8A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity
Outcome measures
| Measure |
CES Device
n=17 Participants
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.
|
Sham Device
n=14 Participants
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.
|
Usual Care Alone
n=15 Participants
No intervention; participants will receive usual medical care for fibromyalgia
|
|---|---|---|---|
|
Pain Intensity Using Numeric Rating Scale
|
5.12 units on a scale
Standard Deviation 1.69
|
6.36 units on a scale
Standard Deviation 2.11
|
6.62 units on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Week 8A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale
Outcome measures
| Measure |
CES Device
n=17 Participants
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.
|
Sham Device
n=14 Participants
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.
|
Usual Care Alone
n=15 Participants
No intervention; participants will receive usual medical care for fibromyalgia
|
|---|---|---|---|
|
Fatigue Using Lee's Fatigue Scale
|
4.97 units on a scale
Standard Deviation 2.45
|
6.38 units on a scale
Standard Deviation 2.2
|
6.83 units on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: Week 8Outcome measures
| Measure |
CES Device
n=17 Participants
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.
|
Sham Device
n=14 Participants
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.
|
Usual Care Alone
n=15 Participants
No intervention; participants will receive usual medical care for fibromyalgia
|
|---|---|---|---|
|
General Sleep Disturbance Scale
|
2.79 units on a scale
Standard Deviation 1.07
|
3.86 units on a scale
Standard Deviation 1.17
|
3.53 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Week 8Outcome measures
| Measure |
CES Device
n=17 Participants
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.
|
Sham Device
n=14 Participants
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.
|
Usual Care Alone
n=15 Participants
No intervention; participants will receive usual medical care for fibromyalgia
|
|---|---|---|---|
|
Depression Using the CES-D
|
16.5 units on a scale
Standard Deviation 10.1
|
28.63 units on a scale
Standard Deviation 14.9
|
23.42 units on a scale
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Week 8Outcome measures
| Measure |
CES Device
n=17 Participants
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.
|
Sham Device
n=14 Participants
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.
|
Usual Care Alone
n=15 Participants
No intervention; participants will receive usual medical care for fibromyalgia
|
|---|---|---|---|
|
Perceived Stress Using Numeric Rating Scale
|
3.93 units on a scale
Standard Deviation 2.4
|
5.64 units on a scale
Standard Deviation 2.66
|
5.29 units on a scale
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Week 8Outcome measures
| Measure |
CES Device
n=17 Participants
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.
|
Sham Device
n=14 Participants
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.
|
Usual Care Alone
n=15 Participants
No intervention; participants will receive usual medical care for fibromyalgia
|
|---|---|---|---|
|
Functional Status Using the Fibromyalgia Index Questionnaire
|
45.05 units on a scale
Standard Deviation 16.3
|
70.1 units on a scale
Standard Deviation 22.3
|
63.2 units on a scale
Standard Deviation 19.9
|
Adverse Events
CES Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ann Gill Taylor, Professor Nursing
University of Virginia School of Nursing
Phone: 434-924-0113
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place