Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms

Study Overview
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Brief Summary
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The goal of this observational study is to learn about the impact of the different types of pain and of the domains involved in the autonomic disorders of inpatients and outpatients diagnosed with Parkinson disease (PD) and multiple system atrophy (MSA) admitted to Istituti Clinici Scientifici Maugeri Centers. The main aims are: Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms (MSA) Evaluate the effect of rehabilitation on pain and autonomic symptoms Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms (MSA) Assess the impact of pain and autonomic symptoms on quality of life. Participants will perform neurological examination, rehabilitation program and clinical scales. Researchers will compare the two groups of patients (PD and MSA) and the effect of the rehabilitation on pain, autonomic symptoms and quality of life.

Detailed Description
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2% of the population over 65 is affected by Parkinson's disease (PD) or parkinsonism. This represents a significant burden on the health service in countries where the elderly represent 1/5 of the general population. In recent years there has been increased attention on the presence of non-motor disorders in PD patients. Among these, pain and autonomic symptoms are more frequently present and contribute to the worsening of disability and quality of life of the affected patient. How much the presence of pain and autonomic symptoms can affect the rehabilitation outcome and how much the rehabilitation treatment itself can improve the painful or autonomic symptomatology is not known, but rehabilitation has an important role in the management of diseases where there are no real treatments capable of cure or slow down the neurodegenerative process. In the Maugeri Clinical Scientific Institutes, patients with Parkinson's disease or parkinsonism are hospitalized or followed as outpatients and a personalized rehabilitation setting is ideal for being able to evaluate the patient in a sufficiently wide time frame to be able to appreciate significant changes in clinical parameters. The greater knowledge of the impact of the different types of pain and of the domains involved in the autonomic dysfunction will help the clinician to better manage the patient's disability and will contribute to the definition of specific rehabilitation strategies aimed to improve the patient's quality of life.

Official Title
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Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms: Identification of Predictive Patterns of Rehabilitation Outcome and Evaluation of the Impact on Quality of Life

Conditions
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Parkinson Disease, Multiple System Atrophy

Intervention / Treatment
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* Other: Rehabilitation
* Other: Administration of Clinical scales


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Parkinson's Disease or Multiple System Atrophy according to current international criteria (Gilman S et al, 2008; Postuma RB et al. 2015). Mini-Mental State Examination score at least 10 Exclusion Criteria: vascular or pharmacological parkinsonism diabetes mellitus hepatic or renal dysmetabolism, hypothyroidism or hyperthyroidism assumption of potentially neurotoxic drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson Disease<br>Patients affected by Parkinson's disease admitted for rehabilitation in Maugeri Clinical Scientific Institutes | Other: Rehabilitation<br>* All patients included in the study will undergo a basic evaluation with a neurological examination, a rehabilitation program to improve strength, coordination, balance, endurance, and the ability to perform activities of daily life.<br>Other: Administration of Clinical scales<br>* All patients included in the study will be evaluated by clinical scales assessing the disease stage, clinical severity, freezing, motor and non-motor impairment, cognitive impairment, depression, quality of life, autonomic dysfunction, pain.<br>|
| Multiple System Atrophy<br>Patients affected by Multiple System Atrophy admitted for rehabilitation in Maugeri Clinical Scientific Institutes | Other: Rehabilitation<br>* All patients included in the study will undergo a basic evaluation with a neurological examination, a rehabilitation program to improve strength, coordination, balance, endurance, and the ability to perform activities of daily life.<br>Other: Administration of Clinical scales<br>* All patients included in the study will be evaluated by clinical scales assessing the disease stage, clinical severity, freezing, motor and non-motor impairment, cognitive impairment, depression, quality of life, autonomic dysfunction, pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and Characterization of Pain | Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms through KING'S PAIN score | At the recruitment | 
| Prevalence and Characterization of Pain | Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms through KING'S PAIN score | At the end of the rehabilitation program, an average of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic symptoms | Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire | At the recruitment | 
| Autonomic symptoms | Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire | At the end of the rehabilitation program, an average of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, autonomic symptoms, rehabilitation