MedDataX Logo

Can a Relaxometer Improve Cognitive Impairment of Fibromyalgia Patients

NCT ID: NCT04170387

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2020-10-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia Syndrome Fibromyalgia Pain, Chronic Impairment Cognitive Impairment

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Two cohorts of 20 patients each. The first group includes patients affected by fibromyalgia and the other is the control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Relaxometer fibromyalgia cases

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

Group Type EXPERIMENTAL

Relaxometer

Intervention Type 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)

Relaxometer controls

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

Group Type ACTIVE_COMPARATOR

Relaxometer

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Relaxometer

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)

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mini-Mental State Examination (MMSE) Fibromyalgia Impairment Questionnaire revised (FIQ-R)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vittorio mr Schweiger, MD

Role: CONTACT

Phone: 045 8126666

Email: [email protected]

erica ms secchettin, phd

Role: CONTACT

Phone: 0458126254

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Fibrorilax

Identifier Type: -

Identifier Source: org_study_id