Telemedicine Intervention in Patients With Chronic Pain in PD
Primary Purpose
Parkinson's Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical exercise intervention
Cognitive exercise intervention
Health education
Sponsored by
About this trial
This is an interventional other trial for Parkinson's Disease focused on measuring Parkinson's disease, Pain
Eligibility Criteria
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
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MARecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Combined physical and cognitive exercise intervention
Physical exercise intervention
Cognitive exercise intervention
Control group
Arm Description
Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months.
Participants will receive the physical exercise intervention for 3 months.
Participants will receive the cognitive exercise intervention for 3 months.
Participants will receive health education for 3 months.
Outcomes
Primary Outcome Measures
Pain Severity
Change in pain severity score from baseline to 3-month follow-up is the outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT05410392
First Posted
June 2, 2022
Last Updated
January 13, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05410392
Brief Title
Telemedicine Intervention in Patients With Chronic Pain in PD
Official Title
Telemedicine Intervention in Patients With Chronic Pain in PD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined physical and cognitive exercise intervention
Arm Type
Experimental
Arm Description
Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months.
Arm Title
Physical exercise intervention
Arm Type
Experimental
Arm Description
Participants will receive the physical exercise intervention for 3 months.
Arm Title
Cognitive exercise intervention
Arm Type
Experimental
Arm Description
Participants will receive the cognitive exercise intervention for 3 months.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants will receive health education for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise intervention
Intervention Description
Home-based physical exercise with the use of a stationary recumbent style bike.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive exercise intervention
Intervention Description
Home-based cognitive exercise with the use of smartphone to complete cognitive activities.
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
Provision of general information about a variety of topics
Primary Outcome Measure Information:
Title
Pain Severity
Description
Change in pain severity score from baseline to 3-month follow-up is the outcome
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David W Sparrow, DSc
Phone
(857) 364-6400
Ext
46400
Email
David.Sparrow@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David William Sparrow, DSc
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David W Sparrow, DSc
Phone
(857) 364-6400
Ext
46400
Email
David.Sparrow@va.gov
First Name & Middle Initial & Last Name & Degree
David William Sparrow, DSc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telemedicine Intervention in Patients With Chronic Pain in PD
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