Back to resultsCefaly® Device in the Treatment of Patients With Fibromyalgia.
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cefaly
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
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 <6 months post partum.
- 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.
- Change in any medication acting on the central nervous system (CNS) within 28 days before start of the study or during the study.
- Severe depression i.e. having a Beck Depression Inventory-Fast Screen (BDI-FS) score >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).
Sites / Locations
- University of Cincinnati College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cefaly active device
Arm Description
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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).
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02546362
Brief Title
Cefaly® Device in the Treatment of Patients With Fibromyalgia.
Official Title
A Single Center, Pilot, Open Trial of the Cefaly® Device in the Treatment of Patients With Fibromyalgia.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2015 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cefaly Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cefaly active device
Arm Type
Experimental
Arm Description
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
Intervention Type
Device
Intervention Name(s)
Cefaly
Primary Outcome Measure Information:
Title
Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint
Description
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
Title
Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint
Description
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
Secondary Outcome Measure Information:
Title
Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint
Description
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
Title
Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint
Description
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
Title
Patient Global Impression of Change (PGIC) at 4-week Timepoint
Description
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
Title
Patient Global Impression of Change (PGIC) at 12-week Timepoint
Description
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
Title
Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint
Description
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
Title
Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint
Description
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
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint
Description
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
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint
Description
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
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint
Description
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
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint
Description
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
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint
Description
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
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint
Description
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
Title
Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint
Description
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
Title
Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 <6 months post partum.
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.
Change in any medication acting on the central nervous system (CNS) within 28 days before start of the study or during the study.
Severe depression i.e. having a Beck Depression Inventory-Fast Screen (BDI-FS) score >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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley Arnold, M.D.
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Rigaux
Organizational Affiliation
Cefaly Technology
Official's Role
Study Director
Facility Information:
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cefaly® Device in the Treatment of Patients With Fibromyalgia.
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