Trial Outcomes & Findings for Cefaly® Device in the Treatment of Patients With Fibromyalgia. (NCT NCT02546362)
NCT ID: NCT02546362
Last Updated: 2019-07-19
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
between baseline and 12-week timepoint
Results posted on
2019-07-19
Participant Flow
Participant milestones
| Measure |
Cefaly Active Device
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes
|
|---|---|
|
4-week Treatment Period
STARTED
|
50
|
|
4-week Treatment Period
COMPLETED
|
47
|
|
4-week Treatment Period
NOT COMPLETED
|
3
|
|
12-week Treatment Period
STARTED
|
47
|
|
12-week Treatment Period
COMPLETED
|
38
|
|
12-week Treatment Period
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Cefaly Active Device
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes
|
|---|---|
|
4-week Treatment Period
Lost to Follow-up
|
1
|
|
4-week Treatment Period
Change in medication
|
2
|
|
12-week Treatment Period
Withdrawal by Subject
|
6
|
|
12-week Treatment Period
Lost to Follow-up
|
2
|
|
12-week Treatment Period
Change in medication
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cefaly Active Device
n=50 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
Age, Continuous
|
48.10 years
STANDARD_DEVIATION 11.15 • n=50 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=50 Participants
|
|
Fibromyalgia Impact Questionnaire-revised (FIQR) pain score
|
6.14 score on a scale
STANDARD_DEVIATION 1.29 • n=50 Participants
|
|
Fibromyalgia Impact Questionnaire-revised (FIQR) total score
|
53.59 units on a scale
STANDARD_DEVIATION 15.32 • n=50 Participants
|
|
EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score
|
57.49 units on a scale
STANDARD_DEVIATION 17.14 • n=50 Participants
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) score for depression
|
17.06 units on a scale
STANDARD_DEVIATION 5.24 • n=50 Participants
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue
|
31.12 units on a scale
STANDARD_DEVIATION 4.90 • n=50 Participants
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance
|
25.86 units on a scale
STANDARD_DEVIATION 5.10 • n=50 Participants
|
|
Multiple Ability Self-report Questionnaire (MASQ) score
|
91.28 units on a scale
STANDARD_DEVIATION 16.04 • n=50 Participants
|
PRIMARY outcome
Timeframe: between baseline and 12-week timepointPain 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).
Outcome measures
| Measure |
Cefaly Active Device
n=38 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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
|
PRIMARY outcome
Timeframe: between baseline and 12-week timepointFibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life.
Outcome measures
| Measure |
Cefaly Active Device
n=38 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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
|
SECONDARY outcome
Timeframe: between baseline and 4-week timepointPain 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).
Outcome measures
| Measure |
Cefaly Active Device
n=47 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 4-week timepointFibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life.
Outcome measures
| Measure |
Cefaly Active Device
n=47 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: at 4-week timepointPatient 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).
Outcome measures
| Measure |
Cefaly Active Device
n=47 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
Patient Global Impression of Change (PGIC) at 4-week Timepoint
|
3.36 score on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: at 12-week timepointPatient 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).
Outcome measures
| Measure |
Cefaly Active Device
n=38 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
Patient Global Impression of Change (PGIC) at 12-week Timepoint
|
3.33 score on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: between baseline and 4-week timepointEuroQol 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).
Outcome measures
| Measure |
Cefaly Active Device
n=47 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 12-week timepointEuroQol 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).
Outcome measures
| Measure |
Cefaly Active Device
n=38 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 4-week timepointPatient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level.
Outcome measures
| Measure |
Cefaly Active Device
n=47 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 12-week timepointPatient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level.
Outcome measures
| Measure |
Cefaly Active Device
n=38 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 4-week timepointPatient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level.
Outcome measures
| Measure |
Cefaly Active Device
n=47 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 12-week timepointPatient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level.
Outcome measures
| Measure |
Cefaly Active Device
n=38 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 4-week timepointPatient 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.
Outcome measures
| Measure |
Cefaly Active Device
n=47 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 12-week timepointPatient 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.
Outcome measures
| Measure |
Cefaly Active Device
n=38 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 4-week timepointMultiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty.
Outcome measures
| Measure |
Cefaly Active Device
n=47 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
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 outcome
Timeframe: between baseline and 12-week timepointMultiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty.
Outcome measures
| Measure |
Cefaly Active Device
n=38 Participants
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint
|
-4.74 score on a scale
Standard Deviation 13.41
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=50 participants at risk
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
|
|---|---|
|
Nervous system disorders
Headache
|
8.0%
4/50 • Number of events 9 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Nausea
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Neck pain
|
6.0%
3/50 • Number of events 4 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Forehead pain during the session
|
14.0%
7/50 • Number of events 9 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Persistence of sensation
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Sedative effect
|
18.0%
9/50 • Number of events 11 • The data was collected during the 12 weeks of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
14.0%
7/50 • Number of events 7 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Tooth pain
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Eye watering, tears
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Shingles outbreak
|
2.0%
1/50 • Number of events 3 • The data was collected during the 12 weeks of the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Worsening fibromyalgia
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50 • Number of events 6 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Increase in sinus pain
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Spacey feeling
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Normal sensation of the Cefaly® device
|
24.0%
12/50 • Number of events 20 • The data was collected during the 12 weeks of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Burning sensation on forehead or scalp, in eyelids or eyebrows
|
4.0%
2/50 • Number of events 7 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Heaviness in eyelids
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Forehead pressure
|
24.0%
12/50 • Number of events 15 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Sinus pressure
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Renal and urinary disorders
Worsening IBS (Irritable Bowel Syndrome)
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Low back spasms
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Infections and infestations
Flu infection, Cold virus infection, Sinus infection
|
8.0%
4/50 • Number of events 5 • The data was collected during the 12 weeks of the treatment period.
|
|
Renal and urinary disorders
Urinary tract infection
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Back pain and stiffness
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Worsening fatigue
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Sebaceous cyst
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Infections and infestations
Gastrointestinal virus
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Surgical and medical procedures
Right knee injury
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Multiple joint pain
|
2.0%
1/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back strain
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Surgical and medical procedures
Tubal ligation
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Psychiatric disorders
Increase in depression
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash on ankles
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Vertigo
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Blurred vision
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Infections and infestations
Viral respiratory illness
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Psychiatric disorders
Panic attack
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Restlessness
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Worsening right knee or foot pain
|
4.0%
2/50 • Number of events 2 • The data was collected during the 12 weeks of the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Swollen right thigh and knee
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Ear and labyrinth disorders
Ringing in the ears/Ears ache
|
6.0%
3/50 • Number of events 3 • The data was collected during the 12 weeks of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Burning sensation in both legs and right shoulder
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Body tingling
|
2.0%
1/50 • Number of events 1 • The data was collected during the 12 weeks of the treatment period.
|
|
Nervous system disorders
Cold sensation in left cheek
|
2.0%
1/50 • Number of events 3 • The data was collected during the 12 weeks of the treatment period.
|
Additional Information
Clinical Trials Department director
CEFALY Technology
Phone: +32 4 367 67 22
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 45 days from the time submitted to the sponsor for review. Sponsor may request: * deletion of any trade secret, proprietary, or confidential information of Sponsor * an additional 60 days to take measures to preserve its Intellectual Property rights Sponsor's written consent is required for results communication before trial completion.
- Publication restrictions are in place
Restriction type: OTHER