Parkinson Disease
Conditions
Interventions
This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomized to receive either additional dopaminergic replacement therapy (DRT group) or placebo tablets (pla
Sponsors
Centro de Dor do Departamento de Neurologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Non-pregnant men and women aged between 18 and 85 years; idiopathic Parkinson’s disease; chronic nociceptive pain as defined by the Parkinson’s Disease Pain Classification System (PD-PCS); chronic pain of at least moderate intensity defined as a score equal to or greater than 4 on a 0–10 visual analog pain scale; capable of providing informed consent in accordance with current institutional policies
Exclusion criteria
Exclusion criteria: Patients with unstable psychiatric comorbidities; musculoskeletal pain intensity lower than 4 on a 0–10 visual analog scale; inability to provide free and informed consent; presence of uncontrolled active infection or severe decompensated clinical conditions; uncontrolled diabetes mellitus; uncontrolled systemic arterial hypertension; symptomatic pulmonary or cardiac diseases; concurrent participation in other clinical trials; and women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of individuals presenting with 50% or more reduction in the average pain intensity, assessed by the verbal numeric pain rating scale (Brief Pain Inventory item 5) at the end of two-week follow-up period, when compared to baseline values. | — |
Secondary
| Measure | Time frame |
|---|---|
| The total score of the Parkinson's Disease Pain Classification System (PD-PCS) at the end of the 2-week follow-up period.;The scores of the Brief Pain Inventory at the end of the two-week follow-up period.;The score of the PDQ-8 (8-item Parkinson's Disease Questionnaire) at the end of the 2-week follow-up period.;The total score of The Hospital Anxiety and Depression Scale (HADS), as well as of its anxiety and depression subscales, at the end of the 2-week follow-up period.;The score of the Clinical Global Impression of Change scale at the end of the 2-week follow-up period.;The scores of the Patient Global Impression of Change scale at the end of the 2-week follow-up period.;The score of the MDS-UPDRS (Movement Disorders Society - Unified Parkinson's Disease Rating Scale) Part III scale at the end of the end of the 2-week follow-up period. | — |
Countries
BR
Contacts
Public ContactGabriel Kubota
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed