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

Recruiting

• Conditions: Parkinson Disease; Multiple System Atrophy
• Interventions: Other: Rehabilitation; Other: Administration of Clinical scales

• Registration Number: NCT05748028
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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.

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 Timeline

• Study Start: 2019-06-15
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson Disease	Administration of Clinical scales	Patients affected by Parkinson's disease admitted for rehabilitation in Maugeri Clinical Scientific Institutes
Multiple System Atrophy	Rehabilitation	Patients affected by Multiple System Atrophy admitted for rehabilitation in Maugeri Clinical Scientific Institutes
Parkinson Disease	Rehabilitation	Patients affected by Parkinson's disease admitted for rehabilitation in Maugeri Clinical Scientific Institutes
Multiple System Atrophy	Administration of Clinical scales	Patients affected by Multiple System Atrophy admitted for rehabilitation in Maugeri Clinical Scientific Institutes

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (9)

ICS Maugeri - Castelgoffredo; 🇮🇹 Castel Goffredo, Mantova, Italy

ICS Maugeri - Mistretta; 🇮🇹 Mistretta, Messina, Italy

ICS Maugeri - Pavia Boezio; 🇮🇹 Pavia, Italy

ICS Maugeri - Veruno; 🇮🇹 Veruno, Novara, Italy

ICS Maugeri - Milano; 🇮🇹 Milano, Italy

ICS Maugeri - Pavia; 🇮🇹 Pavia, Italy

ICS Maugeri - IRCCS of Telese Terme; 🇮🇹 Telese Terme, Benevento, Italy

ICS Maugeri - Lumezzane; 🇮🇹 Lumezzane, Brescia, Italy

ICS Maugeri - Montescano; 🇮🇹 Montescano, Pavia, Italy