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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Comparison of Mini-Mental State Examination (MMSE) results. 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. |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal from study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vittorio mr Schweiger, MD | Contact | 045 8126666 | +39 | vittorio.schweiger@univr.it |
| erica ms secchettin, phd | Contact | 0458126254 | +39 | erica.secchettin@univr.it |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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Two cohorts of 20 patients each. The first group includes patients affected by fibromyalgia and the other is the control group.
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|
| 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. | Fibromyalgia Impact Questionnaire revised (FIQ-R) administered before the first treatment with the relaxometer and during the last examination on the 30^ day from the first treatment. Fibromyalgia Impact Questionnaire revised (FIQ-R) explores three domains: function, overall impact, and symptoms. The score of each domain is divided by a specific number
75-100 Extreme fibromyalgia 60-74 Severe fibromyalgia 43-59 Moderate fibromyalgia 0-42 Mild fibromyalgia | 52 weeks |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |