Telemedicine Intervention in Patients With Chronic Pain in PD

Parkinson's Disease Clinical Trial

Official title:

Telemedicine Intervention in Patients With Chronic Pain in PD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410392
• Other study ID #: N3769-R
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: David W Sparrow, DSc
• Phone: (857) 364-6400
• Email: David.Sparrow[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain is a very common and disabling symptom in Parkinson's disease, yet it is often untreated. This study will assess the impact of home-based physical and cognitive exercise interventions to reduce pain in this disease. This approach would offer an easily implemented and affordable way to encourage and maintain use of these interventions by patients virtually indefinitely through remote access technology. The study findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and chronic pain.

Description:

Project Background/Rationale: Pain is one of the most disabling and common nonmotor symptoms in Parkinson's disease (PD), with a prevalence of 40-85%. Research indicates that undertreatment of pain is particularly high in the PD population. Only about one-half of patients with PD who report pain receive regular pain medications. There is increasing interest in nonpharmacological treatments for chronic pain in PD to supplement pharmacological approaches. While there is evidence to support the utility of physical exercise to improve chronic pain management, relatively less is known about the role of cognitive exercise.

Project Objective: The investigators propose to conduct a pilot randomized, controlled trial in patients with chronic pain in PD to assess the impact of physical and cognitive exercise interventions on pain outcomes.

Project Methods: A total of 166 community-dwelling Veterans, 40 years of age or older, with chronic pain in mild-to-moderate PD will be randomly assigned in a 2 x 2 factorial design to one of four groups (1 - combined cognitive and physical intervention, 2 - physical intervention only, 3 - cognitive intervention only, 4 - health education). The investigators will test the effects of the interventions at 3 months for the outcome of pain severity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: October 31, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

Inclusion Criteria:

• Physician diagnosis of idiopathic PD

• At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)

• Response to dopaminergic medication

Exclusion Criteria:

• Angina pectoris

• History of myocardial infarction (MI) within 6 months

• History of ventricular dysrhythmia requiring current therapy

Related Conditions & MeSH terms

• Chronic Pain
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Physical exercise intervention
Home-based physical exercise with the use of a stationary recumbent style bike.
• Cognitive exercise intervention
Home-based cognitive exercise with the use of smartphone to complete cognitive activities.
• Health education
Provision of general information about a variety of topics

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity	Change in pain severity score from baseline to 3-month follow-up is the outcome	3 months