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

Integrated University Hospital Trust of Verona

Status: Unknown

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

Treatments: Other: Relaxometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04170387

Fibrorilax

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Relaxometer fibromyalgia cases

Experimental group

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

Treatment:

Other: Relaxometer

Relaxometer controls

Active Comparator group

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

Treatment:

Other: Relaxometer