Telemedicine Intervention in Patients With Chronic Pain in PD

December 22, 2023 updated by: VA Office of Research and Development
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130-4817
        • Recruiting
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
        • Principal Investigator:
          • David William Sparrow, DSc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combined physical and cognitive exercise intervention
Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months.
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.
Experimental: Physical exercise intervention
Participants will receive the physical exercise intervention for 3 months.
Behavioral: Physical exercise intervention
Home-based physical exercise with the use of a stationary recumbent style bike.
Experimental: Cognitive exercise intervention
Participants will receive the cognitive exercise intervention for 3 months.
Behavioral: Cognitive exercise intervention
Home-based cognitive exercise with the use of smartphone to complete cognitive activities.
Active Comparator: Control group
Participants will receive health education for 3 months.
Behavioral: Health education
Provision of general information about a variety of topics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity
Time Frame: 3 months
Change in pain severity score from baseline to 3-month follow-up is the outcome
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: David William Sparrow, DSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N3769-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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