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NCT Number: NCT05748028

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ICS Maugeri - IRCCS of Telese Terme, Telese Terme, Benevento, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rehabilitation

Other

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.

Administration of Clinical scales

Other

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.

Primary outcomes

  1. Prevalence and Characterization of Pain

    Time frame: At the recruitment

    Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms through KING'S PAIN score

  2. Prevalence and Characterization of Pain

    Time frame: 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 outcomes

  1. Autonomic symptoms

    Time frame: At the recruitment

    Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire

  2. Autonomic symptoms

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Caporaso

CONTACT

[email protected]

+390824909645

Maria Nolano, MD, PhD

CONTACT

[email protected]

+390824909257

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2023
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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