Fibromyalgia SyndromeFibrorilaxNCT04170387
Can a Relaxometer Improve Cognitive Impairment of Fibromyalgia Patients
A study testing Relaxometer in people with Fibromyalgia Syndrome and Fibromyalgia, run by Azienda Ospedaliera Universitaria Integrata Verona.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia Syndrome, Fibromyalgia, Pain, Chronic
- What is being tested?
- Relaxometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2019to 14 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Passive Movements of Fingers and Impact on Cognitive Impairment and Blurry Mind in Fibromyalgic Patients: Exploratory Study
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.
Read the 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.
- Being tested
- Relaxometer
- Keywords
- Relaxometer, Mini Mental State Examination, Fibromyalgia Impact Questionnaire, Cognitive Impairment, Rehabilitation, Fingers
- Medical subject headings
- Fibromyalgia, Chronic Pain, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelaxometerOther
Also called Mini-Mental State Examination (MMSE), Fibromyalgia Impairment Questionnaire revised (FIQ-R)
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)
| Study group | Role | What they receive |
|---|---|---|
| Relaxometer fibromyalgia cases | Experimental | 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 Receives: Other: Relaxometer |
| Relaxometer controls | Active comparator | 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 Receives: Other: Relaxometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 52 weeks
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
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start15 Dec 2019 (estimated)
- Primary completion15 Dec 2019 (estimated)
- Study completion14 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170387
- Sponsor's protocol ID
- Fibrorilax
- Acronym
- Fibrorilax
- Status last verified
- Dec 2019
- First submitted
- 18 Nov 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Movements of Fingers and Impact on Cognitive Impairment and Blurry Mind in Fibromyalgic Patients: Exploratory Study
- ClinicalTrials.gov ID
- NCT04170387
- Acronym / sponsor ID
- Fibrorilax / Fibrorilax
- Keywords
- Relaxometer, Mini Mental State Examination, Fibromyalgia Impact Questionnaire, Cognitive Impairment, Rehabilitation, Fingers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 15 Dec 2019 (estimated)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 14 Oct 2020 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two cohorts of 20 patients each. The first group includes patients affected by fibromyalgia and the other is the control group.
| Arm | Type | Receives |
|---|---|---|
| Relaxometer fibromyalgia cases | Experimental | Other: RelaxometerRepetition 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 |
| Relaxometer controls | Active comparator | Other: RelaxometerRepetition 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RelaxometerAlso: Mini-Mental State Examination (MMSE), Fibromyalgia Impairment Questionnaire revised (FIQ-R)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) | Other | Relaxometer controls, Relaxometer fibromyalgia cases |
Primary outcome
Assessment of differences in cognitive performance of patients affected by fibromyalgia with cognitive impairment before and after a cycle of treatment with the relaxometer.
Time frame: 4 weeks
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.
2 secondary outcomes
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.
Time frame: 52 weeks
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.
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxometer in people with Fibromyalgia Syndrome and Fibromyalgia, run by Azienda Ospedaliera Universitaria Integrata Verona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vittorio mr Schweiger, MD (045 8126666 ext. +39, vittorio.schweiger@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of differences in cognitive performance of patients affected by fibromyalgia with cognitive impairment before and after a cycle of treatment with the relaxometer. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.