NCT04170387

Can a Relaxometer Improve Cognitive Impairment of Fibromyalgia Patients

Passive Movements of Fingers and Impact on Cognitive Impairment and Blurry Mind in Fibromyalgic Patients: Exploratory Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fibromyalgia Syndrome
• Fibromyalgia
• Pain, Chronic
• Impairment
• Cognitive Impairment

Interventions

Type	Name	Description
OTHER	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)

Timeline

• Start date: 2019-12-15
• Primary completion: 2019-12-15
• Completion: 2020-10-14
• First posted: 2019-11-20
• Last updated: 2019-12-16