N/A
Completed N=57
Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
Source: ClinicalTrials.gov NCT00928720 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Pain Intensity Using Numeric Rating Scale — 5.12; 6.36; 6.62 units on a scale — p=0.045
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Using Numeric Rating Scale |
5.12; 6.36; 6.62 | 0.045 sig |
| SECONDARY Fatigue Using Lee's Fatigue Scale |
4.97; 6.38; 6.83 | — |
| SECONDARY General Sleep Disturbance Scale |
2.79; 3.86; 3.53 | — |
| SECONDARY Depression Using the CES-D |
16.5; 28.63; 23.42 | — |
| SECONDARY Perceived Stress Using Numeric Rating Scale |
3.93; 5.64; 5.29 | — |
| SECONDARY Functional Status Using the Fibromyalgia Index Questionnaire |
45.05; 70.1; 63.2 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00928720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.