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Telemedicine Intervention in Patients With Chronic Pain in PD

NCT ID: NCT05410392

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-10-31

Brief Summary

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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

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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

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Parkinson's Disease

Keywords

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Parkinson's disease Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Combined physical and cognitive exercise intervention

Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months.

Group Type EXPERIMENTAL

Physical exercise intervention

Intervention Type BEHAVIORAL

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

Cognitive exercise intervention

Intervention Type BEHAVIORAL

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

Physical exercise intervention

Participants will receive the physical exercise intervention for 3 months.

Group Type EXPERIMENTAL

Physical exercise intervention

Intervention Type BEHAVIORAL

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

Cognitive exercise intervention

Participants will receive the cognitive exercise intervention for 3 months.

Group Type EXPERIMENTAL

Cognitive exercise intervention

Intervention Type BEHAVIORAL

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

Control group

Participants will receive health education for 3 months.

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type BEHAVIORAL

Provision of general information about a variety of topics

Interventions

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Physical exercise intervention

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

Intervention Type BEHAVIORAL

Cognitive exercise intervention

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

Intervention Type BEHAVIORAL

Health education

Provision of general information about a variety of topics

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David William Sparrow, DSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David W Sparrow, DSc

Role: CONTACT

Phone: (857) 364-6400

Email: [email protected]

Facility Contacts

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David W Sparrow, DSc

Role: primary

Other Identifiers

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N3769-R

Identifier Type: -

Identifier Source: org_study_id