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RecruitingNCT05748028Updated Apr 17, 2026

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

An observational study in Parkinson Disease and Multiple System Atrophy, sponsored by Istituti Clinici Scientifici Maugeri SpA. Recruiting at 9 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Istituti Clinici Scientifici Maugeri SpA · Observational

From the registry’s dates

  • Started Jun 2019; still recruiting 7 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
280
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease
  • Multiple System Atrophy

Keywords

  • pain
  • autonomic symptoms
  • rehabilitation
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 280 is above the median of 96 across 1,085 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 126 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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).
  • score at least 10

Exclusion criteria

Exclusion Criteria:

  • vascular or pharmacological parkinsonism
  • diabetes mellitus
  • hepatic or renal dysmetabolism,
  • hypothyroidism or hyperthyroidism
  • assumption of potentially neurotoxic drugs
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
280 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherRehabilitation

    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.

  • OtherAdministration 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.

06

What researchers measure

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 recruitment

  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

    Time frame: At the end of the rehabilitation program, an average of 30 days

Secondary 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 recruitment

  2. 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 days

07

Study locations

9 of 9 sites recruiting
08

References and documents

Publications

  • 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. PubMed 23716362 ↗
  • 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. PubMed 15036166 ↗
  • 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. PubMed 26309254 ↗
  • 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. PubMed 18515869 ↗
  • 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. PubMed 22942216 ↗
  • 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. PubMed 20108376 ↗
  • 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. PubMed 26096067 ↗
  • 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. PubMed 30363423 ↗
  • 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. PubMed 26474316 ↗
  • 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. PubMed 18725592 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2019 (actual). Primary completion is estimated for Sep 2026, 87 months after the start.

Of 378 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's planned 87 months is above that.

Counting every sponsor, half of 438 studies reached it within 47 months; a quarter within 22 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2023
First posted
Feb 28, 2023
StartActual
Jun 15, 2019
Primary completionEst.
Sep 30, 2026
CompletionEst.
Dec 30, 2026
Last update
Apr 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05748028
Responsible party
Sponsor
First posted
Feb 28, 2023
Start date
Jun 15, 2019
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Apr 17, 2026

Study contacts

Maria Nolano, MD, PhD
Contact
maria.nolano@icsmaugeri.it
+390824909257
Giuseppe Caporaso
Contact
giuseppe.caporaso@icsmaugeri.it
+390824909645
Maria Nolano, MD, PhD
principal investigator · Isituti Clinici Scientifici Maugeri SpA SB - IRCCS of Telese Terme

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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