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Active, Not Recruiting

NCT Number: NCT05410392

Telemedicine Intervention in Patients With Chronic Pain in PD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Exercise Intervention

Behavioral

Home-based physical exercise with the use of a stationary recumbent style bike.

Cognitive exercise intervention

Behavioral

Home-based cognitive exercise with the use of smartphone to complete cognitive activities.

Health Education

Behavioral

Provision of general information about a variety of topics

Primary outcomes

  1. Pain Severity

    Time frame: 3 months

    Change in pain severity score from baseline to 3-month follow-up is the outcome

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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