Fibromyalgia
Conditions
Keywords
fibromyalgia, pain, sleep disturbance, fatigue, depression, functional magnetic resonance imaging
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.
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.
Interventions
DEVICECES 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.
DEVICEsham 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.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| General Sleep Disturbance Scale | Week 8 | — |
| Depression Using the CES-D | Week 8 | — |
| Perceived Stress Using Numeric Rating Scale | Week 8 | — |
| Functional Status Using the Fibromyalgia Index Questionnaire | Week 8 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 14 |
| Usual Care Alone No intervention; participants will received usual medical care for fibromyalgia | 15 |
| Total | 46 |
Baseline characteristics
| Characteristic | CES Device | Sham Device | Usual Care Alone | Total |
|---|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 10.6 | 51.5 years STANDARD_DEVIATION 10.9 | 48.6 years STANDARD_DEVIATION 9.8 | 50.8 years STANDARD_DEVIATION 10.4 |
| Daily stress impact | 3.86 units on a scale STANDARD_DEVIATION 1.2 | 3.05 units on a scale STANDARD_DEVIATION 1.1 | 3.39 units on a scale STANDARD_DEVIATION 1.3 | 3.44 units on a scale STANDARD_DEVIATION 1.3 |
| Depression | 23.9 units on a scale STANDARD_DEVIATION 11.8 | 29.5 units on a scale STANDARD_DEVIATION 13.7 | 24.1 units on a scale STANDARD_DEVIATION 14.2 | 26.0 units on a scale STANDARD_DEVIATION 13.3 |
| Fatigue | 6.12 units on a scale STANDARD_DEVIATION 1.89 | 6.66 units on a scale STANDARD_DEVIATION 2 | 6.85 units on a scale STANDARD_DEVIATION 1.74 | 6.53 units on a scale STANDARD_DEVIATION 1.89 |
| Fibromyalgia impact | 61.36 units on a scale STANDARD_DEVIATION 18.2 | 65.98 units on a scale STANDARD_DEVIATION 17.9 | 66.31 units on a scale STANDARD_DEVIATION 16.9 | 64.51 units on a scale STANDARD_DEVIATION 17.5 |
| General sleep disturbance | 3.75 units on a scale STANDARD_DEVIATION 0.94 | 4.01 units on a scale STANDARD_DEVIATION 0.8 | 3.6 units on a scale STANDARD_DEVIATION 0.86 | 3.8 units on a scale STANDARD_DEVIATION 0.87 |
| Pain Numeric Rating Scale | 5.8 units on a scale STANDARD_DEVIATION 1.9 | 5.7 units on a scale STANDARD_DEVIATION 1.6 | 6.0 units on a scale STANDARD_DEVIATION 2.1 | 5.8 units on a scale STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 17 participants | 14 participants | 15 participants | 46 participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 14 Participants | 43 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 17 | 0 / 14 | 0 / 15 |
Outcome results
Primary
Pain Intensity Using Numeric Rating Scale
A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity
Time frame: week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CES Device | Pain Intensity Using Numeric Rating Scale | 5.12 units on a scale | Standard Deviation 1.69 |
| Sham Device | Pain Intensity Using Numeric Rating Scale | 6.36 units on a scale | Standard Deviation 2.11 |
| Usual Care Alone | Pain Intensity Using Numeric Rating Scale | 6.62 units on a scale | Standard Deviation 1.94 |
p-value: 0.045Mixed Models Analysis
Secondary
Depression Using the CES-D
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CES Device | Depression Using the CES-D | 16.5 units on a scale | Standard Deviation 10.1 |
| Sham Device | Depression Using the CES-D | 28.63 units on a scale | Standard Deviation 14.9 |
| Usual Care Alone | Depression Using the CES-D | 23.42 units on a scale | Standard Deviation 13.2 |
Secondary
Fatigue Using Lee's Fatigue Scale
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CES Device | Fatigue Using Lee's Fatigue Scale | 4.97 units on a scale | Standard Deviation 2.45 |
| Sham Device | Fatigue Using Lee's Fatigue Scale | 6.38 units on a scale | Standard Deviation 2.2 |
| Usual Care Alone | Fatigue Using Lee's Fatigue Scale | 6.83 units on a scale | Standard Deviation 2.35 |
Secondary
Functional Status Using the Fibromyalgia Index Questionnaire
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CES Device | Functional Status Using the Fibromyalgia Index Questionnaire | 45.05 units on a scale | Standard Deviation 16.3 |
| Sham Device | Functional Status Using the Fibromyalgia Index Questionnaire | 70.1 units on a scale | Standard Deviation 22.3 |
| Usual Care Alone | Functional Status Using the Fibromyalgia Index Questionnaire | 63.2 units on a scale | Standard Deviation 19.9 |
Secondary
General Sleep Disturbance Scale
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CES Device | General Sleep Disturbance Scale | 2.79 units on a scale | Standard Deviation 1.07 |
| Sham Device | General Sleep Disturbance Scale | 3.86 units on a scale | Standard Deviation 1.17 |
| Usual Care Alone | General Sleep Disturbance Scale | 3.53 units on a scale | Standard Deviation 1.14 |
Secondary
Perceived Stress Using Numeric Rating Scale
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CES Device | Perceived Stress Using Numeric Rating Scale | 3.93 units on a scale | Standard Deviation 2.4 |
| Sham Device | Perceived Stress Using Numeric Rating Scale | 5.64 units on a scale | Standard Deviation 2.66 |
| Usual Care Alone | Perceived Stress Using Numeric Rating Scale | 5.29 units on a scale | Standard Deviation 2.61 |