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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05748028
• Other study ID #: SBLAB1/19
• Status: Recruiting
• Start date: June 15, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Maria Nolano, MD, PhD
• Phone: +390824909257
• Email: maria.nolano[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple System Atrophy
• Parkinson Disease
• Parkinsonian Disorders
• Shy-Drager Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	ICS Maugeri - Castelgoffredo	Castel Goffredo	Mantova
Italy	ICS Maugeri - Lumezzane	Lumezzane	Brescia
Italy	ICS Maugeri - Milano	Milano
Italy	ICS Maugeri - Mistretta	Mistretta	Messina
Italy	ICS Maugeri - Montescano	Montescano	Pavia
Italy	ICS Maugeri - Pavia	Pavia
Italy	ICS Maugeri - Pavia Boezio	Pavia
Italy	ICS Maugeri - IRCCS of Telese Terme	Telese Terme	Benevento
Italy	ICS Maugeri - Veruno	Veruno	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Autonomic symptoms	Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire	At the recruitment
Secondary	Autonomic symptoms	Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire	At the end of the rehabilitation program, an average of 30 days