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Can a Relaxometer Improve Cognitive Impairment of Fibromyalgia Patients (Fibrorilax)

Primary Purpose

Fibromyalgia Syndrome, Fibromyalgia, Pain, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Relaxometer
Sponsored by
Azienda Ospedaliera Universitaria Integrata Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia Syndrome focused on measuring Relaxometer, Mini Mental State Examination, Fibromyalgia Impact Questionnaire, Cognitive Impairment, Rehabilitation, Fingers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Fibromyalgic Syndrome diagnosed according to the criteria of American College of Rheumatology 2016 (ACR 2016)
  • moderate-severe cognitive impairment according to the Symptoms Severity Score (SS)
  • informed consent gathered

Exclusion Criteria:

  • contraindication to passive handling of fingers (severe arthritis, fractures or unconsolidated traumatic outcomes, not healed wounds, finger amputations, contact allergies to substances contained in the relaxometer)
  • informed consent not gathered
  • drug addiction
  • brain stroke

Withdrawal from study

  • withdrawal of informed consent
  • treatment non completed

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Relaxometer fibromyalgia cases

    Relaxometer controls

    Arm Description

    Repetition 6 minutes pre-set programme with the relaxometer 60 seconds 34 movements/minute 3 seconds 55 movements/minute 60 seconds 34 movements/minute 60 seconds 55 movements/minute 90 seconds 34 movements/minute 5 seconds 55 movements/minute 90 seconds 34 movements/minute

    Repetition 6 minutes pre-set programme with the relaxometer 60 seconds 34 movements/minute 3 seconds 55 movements/minute 60 seconds 34 movements/minute 60 seconds 55 movements/minute 90 seconds 34 movements/minute 5 seconds 55 movements/minute 90 seconds 34 movements/minute

    Outcomes

    Primary Outcome Measures

    Assessment of differences in cognitive performance of patients affected by fibromyalgia with cognitive impairment before and after a cycle of treatment with the relaxometer.
    Mini-Mental State Examination (MMSE) administered before the first treatment with the relaxometer (T0), after the last treatment with the relaxometer (T1, on the 10^ day from the first treatment) and on the 30^ day from the first treatment (T2). Mini-Mental State Examination is a 30 point questionnaire used to measure cognitive impairment. Normal cognition 24-30 points Mild cognitive impairment 19-23 points Moderate cognitive impairment 10-18 points Severe cognitive impairment <9 points The score is corrected for educational attainment and age, according to MMSE guidelines.

    Secondary Outcome Measures

    Evaluate the differences in cognitive performance obtained at the end of treatment, between the case group (patients affected by fibromyalgia with cognitive impairment) and the control group.
    Comparison of Mini-Mental State Examination (MMSE) results. Mini-Mental State Examination is a 30 point questionnaire used to measure cognitive impairment. Normal cognition 24-30 points Mild cognitive impairment 19-23 points Moderate cognitive impairment 10-18 points Severe cognitive impairment <9 points The score is corrected for educational attainment and age, according to MMSE guidelines.
    Evaluate the differences in quality of life (QoL) of patients affected by fibromyalgia before and after a cycle of treatment with the relaxometer, comparing them with the control group.
    Fibromyalgia Impact Questionnaire revised (FIQ-R) administered before the first treatment with the relaxometer and during the last examination on the 30^ day from the first treatment. Fibromyalgia Impact Questionnaire revised (FIQ-R) explores three domains: function, overall impact, and symptoms. The score of each domain is divided by a specific number Function domain sum (0-90) divided by 3 (upper limit 30) Overall impact domain sum (0-20) divided by one (0-20) Symptom domain sum (0-100) divided by 2 (upper limit 50) The three resulting domain scores are added together to obtain the total score of the Fibromyalgia Impact Questionnaire revised (FIQ-R) range 0-100. 75-100 Extreme fibromyalgia 60-74 Severe fibromyalgia 43-59 Moderate fibromyalgia 0-42 Mild fibromyalgia

    Full Information

    First Posted
    November 18, 2019
    Last Updated
    December 12, 2019
    Sponsor
    Azienda Ospedaliera Universitaria Integrata Verona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04170387
    Brief Title
    Can a Relaxometer Improve Cognitive Impairment of Fibromyalgia Patients
    Acronym
    Fibrorilax
    Official Title
    Passive Movements of Fingers and Impact on Cognitive Impairment and Blurry Mind in Fibromyalgic Patients: Exploratory Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 15, 2019 (Anticipated)
    Primary Completion Date
    December 15, 2019 (Anticipated)
    Study Completion Date
    October 14, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Azienda Ospedaliera Universitaria Integrata Verona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate the differences in cognitive performance and quality of life, after a cycle of treatment with the relaxometer, between a group of patients affected by fibromyalgia and a control group.
    Detailed Description
    The relaxometer is a device designed for the physical rehabilitation of patients with functional problems of upper limbs. It works by moving passively the patient's fingers in a gradual way (with different speeds) in all directions of space, which is innovative compared to similar machines already on the market. The device consists of an electrical supply unit and two handling units made of 10 silicone tips of different sizes for the placement of fingers and it works with a six-minute pre-set program. It has obtained patent and certification mark and it has been used in the rehabilitation of patients with joint stiffness induced by specific working activities, as musicians. After the treatment these patients reported a remarkable improvement of motor skills and articulation of fingers, in addition to a parallel improvement of cognitive abilities such as concentration, visual acuity and mnemonic learning. In sight of this, the aim of the study is to establish whether the application of this treatment in a small group patients affected by fibromyalgia and cognitive impairment is able to improve some aspects of the cognitive dysfunction measured with appropriate functional tests and comparing the results with a control group of patients not affected by this condition.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia Syndrome, Fibromyalgia, Pain, Chronic, Impairment, Cognitive Impairment
    Keywords
    Relaxometer, Mini Mental State Examination, Fibromyalgia Impact Questionnaire, Cognitive Impairment, Rehabilitation, Fingers

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two cohorts of 20 patients each. The first group includes patients affected by fibromyalgia and the other is the control group.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Relaxometer fibromyalgia cases
    Arm Type
    Experimental
    Arm Description
    Repetition 6 minutes pre-set programme with the relaxometer 60 seconds 34 movements/minute 3 seconds 55 movements/minute 60 seconds 34 movements/minute 60 seconds 55 movements/minute 90 seconds 34 movements/minute 5 seconds 55 movements/minute 90 seconds 34 movements/minute
    Arm Title
    Relaxometer controls
    Arm Type
    Active Comparator
    Arm Description
    Repetition 6 minutes pre-set programme with the relaxometer 60 seconds 34 movements/minute 3 seconds 55 movements/minute 60 seconds 34 movements/minute 60 seconds 55 movements/minute 90 seconds 34 movements/minute 5 seconds 55 movements/minute 90 seconds 34 movements/minute
    Intervention Type
    Other
    Intervention Name(s)
    Relaxometer
    Other Intervention Name(s)
    Mini-Mental State Examination (MMSE), Fibromyalgia Impairment Questionnaire revised (FIQ-R)
    Intervention Description
    Day 1: signing of informed consent, medical history, physical examination, Mini-Mental State Examination (MMSE), Fibromyalgia Impairment Questionnaire revised (FIQ-R), repetition of 6 minutes relaxometer pre-set programme for 3 times Day 2: repetition of 6 minutes relaxometer pre-set programme for 3 times Day 3: repetition of 6 minutes relaxometer pre-set programme for 3 times Day 8: 6 minutes relaxometer pre-set programme once Day 10: 6 minutes relaxometer pre-set programme once, Mini-Mental State Examination Day 30: Mini-Mental State Examination (MMSE), Fibromyalgia Impairment Questionnaire revised (FIQ-R)
    Primary Outcome Measure Information:
    Title
    Assessment of differences in cognitive performance of patients affected by fibromyalgia with cognitive impairment before and after a cycle of treatment with the relaxometer.
    Description
    Mini-Mental State Examination (MMSE) administered before the first treatment with the relaxometer (T0), after the last treatment with the relaxometer (T1, on the 10^ day from the first treatment) and on the 30^ day from the first treatment (T2). Mini-Mental State Examination is a 30 point questionnaire used to measure cognitive impairment. Normal cognition 24-30 points Mild cognitive impairment 19-23 points Moderate cognitive impairment 10-18 points Severe cognitive impairment <9 points The score is corrected for educational attainment and age, according to MMSE guidelines.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Evaluate the differences in cognitive performance obtained at the end of treatment, between the case group (patients affected by fibromyalgia with cognitive impairment) and the control group.
    Description
    Comparison of Mini-Mental State Examination (MMSE) results. Mini-Mental State Examination is a 30 point questionnaire used to measure cognitive impairment. Normal cognition 24-30 points Mild cognitive impairment 19-23 points Moderate cognitive impairment 10-18 points Severe cognitive impairment <9 points The score is corrected for educational attainment and age, according to MMSE guidelines.
    Time Frame
    52 weeks
    Title
    Evaluate the differences in quality of life (QoL) of patients affected by fibromyalgia before and after a cycle of treatment with the relaxometer, comparing them with the control group.
    Description
    Fibromyalgia Impact Questionnaire revised (FIQ-R) administered before the first treatment with the relaxometer and during the last examination on the 30^ day from the first treatment. Fibromyalgia Impact Questionnaire revised (FIQ-R) explores three domains: function, overall impact, and symptoms. The score of each domain is divided by a specific number Function domain sum (0-90) divided by 3 (upper limit 30) Overall impact domain sum (0-20) divided by one (0-20) Symptom domain sum (0-100) divided by 2 (upper limit 50) The three resulting domain scores are added together to obtain the total score of the Fibromyalgia Impact Questionnaire revised (FIQ-R) range 0-100. 75-100 Extreme fibromyalgia 60-74 Severe fibromyalgia 43-59 Moderate fibromyalgia 0-42 Mild fibromyalgia
    Time Frame
    52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Fibromyalgic Syndrome diagnosed according to the criteria of American College of Rheumatology 2016 (ACR 2016) moderate-severe cognitive impairment according to the Symptoms Severity Score (SS) informed consent gathered Exclusion Criteria: contraindication to passive handling of fingers (severe arthritis, fractures or unconsolidated traumatic outcomes, not healed wounds, finger amputations, contact allergies to substances contained in the relaxometer) informed consent not gathered drug addiction brain stroke Withdrawal from study withdrawal of informed consent treatment non completed
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vittorio mr Schweiger, MD
    Phone
    045 8126666
    Ext
    +39
    Email
    vittorio.schweiger@univr.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    erica ms secchettin, phd
    Phone
    0458126254
    Ext
    +39
    Email
    erica.secchettin@univr.it

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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