NCT05410392

Telemedicine Intervention in Patients With Chronic Pain in PD

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 40 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Parkinson's Disease

Interventions

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

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-03-31
• Completion: 2026-11-30
• First posted: 2022-06-08
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States