Clinical trial NCT04170387: Can a Relaxometer Improve Cognitive Impairment of Fibromyalgia Patients
Official title: Passive Movements of Fingers and Impact on Cognitive Impairment and Blurry Mind in Fibromyalgic Patients: Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia Syndrome
Fibromyalgia
Pain, Chronic
Impairment
Cognitive Impairment
Keywords: Relaxometer
Mini Mental State Examination
Fibromyalgia Impact Questionnaire
Cognitive Impairment
Rehabilitation
Fingers
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two cohorts of 20 patients each. The first group includes patients affected by fibromyalgia and the other is the control group.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
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.
timeFrame: 4 weeks
Secondary outcomes:
measure: 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.
timeFrame: 52 weeks
measure: 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.
timeFrame: 52 weeks
Other outcomes:
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Study officials:
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