Can a Relaxometer Improve Cognitive Impairment of Fibromyalgia Patients

NCT04170387 | Unknown

• 1 other identifier: Fibrorilax
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia Syndrome; Fibromyalgia; Pain, Chronic; Impairment; Cognitive Impairment

Keywords

Relaxometer; Mini Mental State Examination; Fibromyalgia Impact Questionnaire; Cognitive Impairment; Rehabilitation; Fingers

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  52 weeks

Study Arms (2)

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

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

Other: Relaxometer

Interventions

Relaxometer OTHER

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)

Also known as: Mini-Mental State Examination (MMSE), Fibromyalgia Impairment Questionnaire revised (FIQ-R)

Relaxometer controls; Relaxometer fibromyalgia cases

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Cognitive Dysfunction

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Vittorio mr Schweiger, MD

CONTACT

045 8126666; vittorio.schweiger@univr.it

erica ms secchettin, phd

CONTACT

0458126254; erica.secchettin@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two cohorts of 20 patients each. The first group includes patients affected by fibromyalgia and the other is the control group.

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: December 15, 2019
• Primary Completion: December 15, 2019
• Study Completion: October 14, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share