N/A
Completed N=50
Cefaly® Device in the Treatment of Patients With Fibromyalgia.
Source: ClinicalTrials.gov NCT02546362 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint — -1.33 score on a scale
Summary
The objective of this pilot open trial was to assess the efficacy and safety of external trigeminal nerve stimulation (e-TNS) with the Cefaly® device in fibromyalgia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint |
-1.33 | — |
| PRIMARY Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint |
-9.91 | — |
| SECONDARY Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint |
-1.45 | — |
| SECONDARY Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint |
-11.92 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at 4-week Timepoint |
3.36 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at 12-week Timepoint |
3.33 | — |
| SECONDARY Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint |
5.79 | — |
| SECONDARY Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint |
5.60 | — |
| SECONDARY Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint |
-0.85 | — |
| SECONDARY Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint |
-1.36 | — |
| SECONDARY Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint |
-4.62 | — |
| SECONDARY Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint |
-4.00 | — |
| SECONDARY Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint |
-3.85 | — |
| SECONDARY Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint |
-3.54 | — |
| SECONDARY Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint |
-2.55 | — |
| SECONDARY Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint |
-4.74 | — |
Eligibility Criteria
Inclusion Criteria
- Aged from18 to 65 years (on the day of signing the informed consent form).
- Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010).
- Having a minimum pain score of at least 4 on the 0-10 Fibromyalgia Impact Questionnaire-revised (FIQR) pain scale at screening and baseline.
Exclusion Criteria
- Women: Pregnant, lactating or 12.
- Botox injection within 4 months before baseline or during the study.
- Psychiatric disorders that could interfere with study participation: bipolar disorder, psychotic disorders and dementia.
- Suicidal behavior and/or ideation i.e. having a Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 4 during the preceding 2 years.
- Patients currently taking any opioid medication.
- Patients currently taking medically prescribed marijuana.
- Current or history during the preceding year of alcohol or substance abuse including marijuana.
- Widespread rheumatic diseases (other than fibromyalgia), evidence of inflammatory rheumatic disease.
- Any unstable medical condition in the judgment of the investigator that would interfere with study participation or study assessments.
- Implanted active metal or electrical devices in the head.
- Cardiac pacemaker or implanted or wearable defibrillator.
- Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program).
Data sourced from ClinicalTrials.gov (NCT02546362). 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.