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

Sponsor

Istituti Clinici Scientifici Maugeri SpA (Other)

Overall Status

Recruiting

CT.gov ID

NCT05748028

Collaborator

(none)

280

Enrollment

Locations

54.5

Anticipated Duration (Months)

31.1

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Multiple System Atrophy	Other: Rehabilitation Other: Administration of Clinical scales

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

280 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 15, 2019

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Parkinson Disease Patients affected by Parkinson's disease admitted for rehabilitation in Maugeri Clinical Scientific Institutes	Other: Rehabilitation 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. Other: Administration of Clinical scales 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.
Multiple System Atrophy Patients affected by Multiple System Atrophy admitted for rehabilitation in Maugeri Clinical Scientific Institutes	Other: Rehabilitation 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. Other: Administration of Clinical scales 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.

Arm

Intervention/Treatment

Parkinson Disease

Patients affected by Parkinson's disease admitted for rehabilitation in Maugeri Clinical Scientific Institutes

Other: Rehabilitation

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.

Other: Administration of Clinical scales

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.

Multiple System Atrophy

Patients affected by Multiple System Atrophy admitted for rehabilitation in Maugeri Clinical Scientific Institutes

Other: Rehabilitation

Other: Administration of Clinical scales

Outcome Measures

Primary Outcome Measures

Prevalence and Characterization of Pain [At the recruitment]
Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms through KING'S PAIN score
Prevalence and Characterization of Pain [At the end of the rehabilitation program, an average of 30 days]
Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms through KING'S PAIN score

Secondary Outcome Measures

Autonomic symptoms [At the recruitment]
Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire
Autonomic symptoms [At the end of the rehabilitation program, an average of 30 days]
Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICS Maugeri - IRCCS of Telese Terme	Telese Terme	Benevento	Italy	82037
2	ICS Maugeri - Lumezzane	Lumezzane	Brescia	Italy	25065
3	ICS Maugeri - Castelgoffredo	Castel Goffredo	Mantova	Italy	46042
4	ICS Maugeri - Mistretta	Mistretta	Messina	Italy	98073
5	ICS Maugeri - Veruno	Veruno	Novara	Italy	28010
6	ICS Maugeri - Montescano	Montescano	Pavia	Italy	27040
7	ICS Maugeri - Milano	Milano		Italy	20138
8	ICS Maugeri - Pavia Boezio	Pavia		Italy	27100
9	ICS Maugeri - Pavia	Pavia		Italy	27100