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

NCT05748028 | Recruiting

• 1 other identifier: SBLAB1/19
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 9

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.

Conditions

Parkinson Disease; Multiple System Atrophy

Keywords

pain; autonomic symptoms; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Autonomic symptoms

  At the recruitment

• Autonomic symptoms

  At the end of the rehabilitation program, an average of 30 days

Study Arms (2)

Parkinson Disease

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

Other: Rehabilitation; Other: Administration of Clinical scales

Multiple System Atrophy

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

Other: Rehabilitation; Other: Administration of Clinical scales

Interventions

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.

Multiple System Atrophy; Parkinson Disease

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.

Multiple System Atrophy; Parkinson Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be enrolled from the population of inpatient and outpatient admitted for rehabilitation to ICS Maugeri SpA institutes.

You may qualify if:

• 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

You may not qualify if:

• vascular or pharmacological parkinsonism
• diabetes mellitus
• hepatic or renal dysmetabolism,
• hypothyroidism or hyperthyroidism
• assumption of potentially neurotoxic drugs

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (9)

ICS Maugeri - IRCCS of Telese Terme

Telese Terme, Benevento, 82037, Italy

RECRUITING

ICS Maugeri - Lumezzane

Lumezzane, Brescia, 25065, Italy

RECRUITING

ICS Maugeri - Castelgoffredo

Castel Goffredo, Mantova, 46042, Italy

RECRUITING

ICS Maugeri - Mistretta

Mistretta, Messina, 98073, Italy

RECRUITING

ICS Maugeri - Veruno

Veruno, Novara, 28010, Italy

RECRUITING

ICS Maugeri - Montescano

Montescano, Pavia, 27040, Italy

RECRUITING

ICS Maugeri - Milano

Milan, 20138, Italy

RECRUITING

ICS Maugeri - Pavia Boezio

Pavia, 27100, Italy

RECRUITING

ICS Maugeri - Pavia

Pavia, 27100, Italy

RECRUITING

Related Publications (10)

• Bakkers M, Faber CG, Hoeijmakers JG, Lauria G, Merkies IS. Small fibers, large impact: quality of life in small-fiber neuropathy. Muscle Nerve. 2014 Mar;49(3):329-36. doi: 10.1002/mus.23910. Epub 2013 Jun 28.

  PMID: 23716362 BACKGROUND

• Quittenbaum BH, Grahn B. Quality of life and pain in Parkinson's disease: a controlled cross-sectional study. Parkinsonism Relat Disord. 2004 Mar;10(3):129-36. doi: 10.1016/j.parkreldis.2003.12.001.

  PMID: 15036166 BACKGROUND

• Valkovic P, Minar M, Singliarova H, Harsany J, Hanakova M, Martinkova J, Benetin J. Pain in Parkinson's Disease: A Cross-Sectional Study of Its Prevalence, Types, and Relationship to Depression and Quality of Life. PLoS One. 2015 Aug 26;10(8):e0136541. doi: 10.1371/journal.pone.0136541. eCollection 2015.

  PMID: 26309254 BACKGROUND

• Nolano M, Provitera V, Estraneo A, Selim MM, Caporaso G, Stancanelli A, Saltalamacchia AM, Lanzillo B, Santoro L. Sensory deficit in Parkinson's disease: evidence of a cutaneous denervation. Brain. 2008 Jul;131(Pt 7):1903-11. doi: 10.1093/brain/awn102. Epub 2008 May 31.

  PMID: 18515869 BACKGROUND

• Asahina M, Vichayanrat E, Low DA, Iodice V, Mathias CJ. Autonomic dysfunction in parkinsonian disorders: assessment and pathophysiology. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):674-80. doi: 10.1136/jnnp-2012-303135. Epub 2012 Sep 1.

  PMID: 22942216 BACKGROUND

• Linder J, Stenlund H, Forsgren L. Incidence of Parkinson's disease and parkinsonism in northern Sweden: a population-based study. Mov Disord. 2010 Feb 15;25(3):341-8. doi: 10.1002/mds.22987.

  PMID: 20108376 BACKGROUND

• Chaudhuri KR, Rizos A, Trenkwalder C, Rascol O, Pal S, Martino D, Carroll C, Paviour D, Falup-Pecurariu C, Kessel B, Silverdale M, Todorova A, Sauerbier A, Odin P, Antonini A, Martinez-Martin P; EUROPAR and the IPMDS Non Motor PD Study Group. King's Parkinson's disease pain scale, the first scale for pain in PD: An international validation. Mov Disord. 2015 Oct;30(12):1623-31. doi: 10.1002/mds.26270. Epub 2015 Jun 11.

  PMID: 26096067 BACKGROUND

• Rodriguez-Violante M, Alvarado-Bolanos A, Cervantes-Arriaga A, Martinez-Martin P, Rizos A, Chaudhuri KR. Clinical Determinants of Parkinson's Disease-associated Pain Using the King's Parkinson's Disease Pain Scale. Mov Disord Clin Pract. 2017 Feb 6;4(4):545-551. doi: 10.1002/mdc3.12469. eCollection 2017 Jul-Aug.

  PMID: 30363423 BACKGROUND

• Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.

  PMID: 26474316 BACKGROUND

• Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Durr A, Fowler CJ, Kaufmann H, Klockgether T, Lees A, Poewe W, Quinn N, Revesz T, Robertson D, Sandroni P, Seppi K, Vidailhet M. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008 Aug 26;71(9):670-6. doi: 10.1212/01.wnl.0000324625.00404.15.

  PMID: 18725592 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Pain

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Maria Nolano, MD, PhD

  Isituti Clinici Scientifici Maugeri SpA SB - IRCCS of Telese Terme

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Nolano, MD, PhD

CONTACT

+390824909257; maria.nolano@icsmaugeri.it

Giuseppe Caporaso

CONTACT

+390824909645; giuseppe.caporaso@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 28, 2023
• Study Start: June 15, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (9)