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Cefaly® Device in the Treatment of Patients With Fibromyalgia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02546362
Recruitment Status : Completed
First Posted : September 10, 2015
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Cefaly Technology

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Cefaly Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Pilot, Open Trial of the Cefaly® Device in the Treatment of Patients With Fibromyalgia.
Actual Study Start Date : December 3, 2015
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Cefaly active device
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
Device: Cefaly



Primary Outcome Measures :
  1. Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint [ Time Frame: 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).

  2. Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint [ Time Frame: 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 :
  1. Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint [ Time Frame: 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).

  2. Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint [ Time Frame: 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.

  3. Patient Global Impression of Change (PGIC) at 4-week Timepoint [ Time Frame: 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).

  4. Patient Global Impression of Change (PGIC) at 12-week Timepoint [ Time Frame: 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).

  5. Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint [ Time Frame: 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).

  6. Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint [ Time Frame: 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).

  7. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint [ Time Frame: 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.

  8. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint [ Time Frame: 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.

  9. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint [ Time Frame: 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.

  10. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint [ Time Frame: 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.

  11. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint [ Time Frame: 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.

  12. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint [ Time Frame: 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.

  13. Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint [ Time Frame: 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.

  14. Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546362


Locations
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United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Cefaly Technology
Investigators
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Principal Investigator: Lesley Arnold, M.D. University of Cincinnati
Study Director: Pierre Rigaux Cefaly Technology
  Study Documents (Full-Text)

Documents provided by Cefaly Technology:
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Responsible Party: Cefaly Technology
ClinicalTrials.gov Identifier: NCT02546362    
Other Study ID Numbers: 50212
First Posted: September 10, 2015    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases