Fibromyalgia
Conditions
Brief 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.
Detailed description
The main objective of this clinical pilot trial was to evaluate the use of external trigeminal nerve stimulation (e-TNS) with the Cefaly® neurostimulator device as a new therapeutic treatment for fibromyalgia.
Interventions
DEVICECefaly
Sponsors
Cefaly Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged from18 to 65 years (on the day of signing the informed consent form). 2. Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010). 3. 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
1. Women: Pregnant, lactating or \<6 months post partum. 2. Episodic or Chronic Migraine according to the diagnostic criteria listed in International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine 1, having two or more attacks per month. 3. Change in any medication acting on the central nervous system (CNS) within 28 days before start of the study or during the study. 4. Severe depression i.e. having a Beck Depression Inventory-Fast Screen (BDI-FS) score \>12. 5. Botox injection within 4 months before baseline or during the study. 6. Psychiatric disorders that could interfere with study participation: bipolar disorder, psychotic disorders and dementia. 7. Suicidal behavior and/or ideation i.e. having a Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 4 during the preceding 2 years. 8. Patients currently taking any opioid medication. 9. Patients currently taking medically prescribed marijuana. 10. Current or history during the preceding year of alcohol or substance abuse including marijuana. 11. Widespread rheumatic diseases (other than fibromyalgia), evidence of inflammatory rheumatic disease. 12. Any unstable medical condition in the judgment of the investigator that would interfere with study participation or study assessments. 13. Implanted active metal or electrical devices in the head. 14. Cardiac pacemaker or implanted or wearable defibrillator. 15. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint | between baseline and 12-week timepoint | Pain intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) pain score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain). |
| Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint | between baseline and 12-week timepoint | Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGIC) at 4-week Timepoint | at 4-week timepoint | Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change). |
| Patient Global Impression of Change (PGIC) at 12-week Timepoint | at 12-week timepoint | Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change). |
| Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint | between baseline and 4-week timepoint | EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state). |
| Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint | between baseline and 12-week timepoint | EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state). |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint | between baseline and 4-week timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level. |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint | between baseline and 12-week timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level. |
| Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint | between baseline and 4-week timepoint | Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain). |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint | between baseline and 12-week timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level. |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint | between baseline and 4-week timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level. |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint | between baseline and 12-week timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level. |
| Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint | between baseline and 4-week timepoint | Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty. |
| Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint | between baseline and 12-week timepoint | Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty. |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint | between baseline and 4-week timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level. |
| Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint | between baseline and 4-week timepoint | Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cefaly Active Device 12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes) | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12-week Treatment Period | Change in medication | 1 |
| 12-week Treatment Period | Lost to Follow-up | 2 |
| 12-week Treatment Period | Withdrawal by Subject | 6 |
| 4-week Treatment Period | Change in medication | 2 |
| 4-week Treatment Period | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Cefaly Active Device | — |
|---|---|---|
| Age, Continuous | 48.10 years STANDARD_DEVIATION 11.15 | — |
| EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score | 57.49 units on a scale STANDARD_DEVIATION 17.14 | — |
| Fibromyalgia Impact Questionnaire-revised (FIQR) pain score | 6.14 score on a scale STANDARD_DEVIATION 1.29 | — |
| Fibromyalgia Impact Questionnaire-revised (FIQR) total score | 53.59 units on a scale STANDARD_DEVIATION 15.32 | — |
| Multiple Ability Self-report Questionnaire (MASQ) score | 91.28 units on a scale STANDARD_DEVIATION 16.04 | — |
| Patient Reported Outcomes Measurement Information System (PROMIS) score for depression | 17.06 units on a scale STANDARD_DEVIATION 5.24 | — |
| Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue | 31.12 units on a scale STANDARD_DEVIATION 4.9 | — |
| Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance | 25.86 units on a scale STANDARD_DEVIATION 5.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 40 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint
Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life.
Time frame: between baseline and 12-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint | -9.91 score on a scale | Standard Deviation 18.51 |
Primary
Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint
Pain intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) pain score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain).
Time frame: between baseline and 12-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint | -1.33 score on a scale | Standard Deviation 2.41 |
Secondary
Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint
EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state).
Time frame: between baseline and 12-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint | 5.60 score on a scale | Standard Deviation 17.05 |
Secondary
Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint
EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state).
Time frame: between baseline and 4-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint | 5.79 score on a scale | Standard Deviation 15.32 |
Secondary
Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint
Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life.
Time frame: between baseline and 4-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint | -11.92 score on a scale | Standard Deviation 16.18 |
Secondary
Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint
Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty.
Time frame: between baseline and 12-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint | -4.74 score on a scale | Standard Deviation 13.41 |
Secondary
Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint
Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty.
Time frame: between baseline and 4-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint | -2.55 score on a scale | Standard Deviation 10.35 |
Secondary
Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint
Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain).
Time frame: between baseline and 4-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint | -1.45 score on a scale | Standard Deviation 2.41 |
Secondary
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint
Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level.
Time frame: between baseline and 12-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint | -1.36 score on a scale | Standard Deviation 4.95 |
Secondary
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint
Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level.
Time frame: between baseline and 4-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint | -0.85 score on a scale | Standard Deviation 4.47 |
Secondary
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint
Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level.
Time frame: between baseline and 12-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint | -4.00 score on a scale | Standard Deviation 6.73 |
Secondary
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint
Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level.
Time frame: between baseline and 4-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint | -4.62 score on a scale | Standard Deviation 5.35 |
Secondary
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint
Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level.
Time frame: between baseline and 12-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint | -3.54 score on a scale | Standard Deviation 6.35 |
Secondary
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint
Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level.
Time frame: between baseline and 4-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint | -3.85 score on a scale | Standard Deviation 6.36 |
Secondary
Patient Global Impression of Change (PGIC) at 12-week Timepoint
Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change).
Time frame: at 12-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Patient Global Impression of Change (PGIC) at 12-week Timepoint | 3.33 score on a scale | Standard Deviation 1.06 |
Secondary
Patient Global Impression of Change (PGIC) at 4-week Timepoint
Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change).
Time frame: at 4-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cefaly Active Device | Patient Global Impression of Change (PGIC) at 4-week Timepoint | 3.36 score on a scale | Standard Deviation 1.11 |