Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
vascular or pharmacological parkinsonism
diabetes mellitus
hepatic or renal dysmetabolism,
hypothyroidism or hyperthyroidism
Trial population
Patients will be enrolled from the population of inpatient and outpatient admitted for rehabilitation to ICS Maugeri SpA institutes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Rehabilitation
Other interventionAll 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 interventionAll 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.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Parkinson Disease2 interventions
Group B: Multiple System Atrophy2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
At the recruitment2
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
Time frame
At the end of the rehabilitation program, an average of 30 daysSecondary outcomes
1
Autonomic symptoms
Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire
Time frame
At the recruitment2
Autonomic symptoms
Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire
Time frame
At the end of the rehabilitation program, an average of 30 daysSponsors and contacts
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Source ClinicalTrials.gov