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Telemedicine Intervention in Patients With Chronic Pain in PD

Telemedicine Intervention in Patients With Chronic Pain in PD

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05410392
Enrollment
166
Registered
2022-06-08
Start date
2023-01-01
Completion date
2026-10-31
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, Pain

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.

Interventions

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

BEHAVIORALCognitive exercise intervention

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

BEHAVIORALHealth education

Provision of general information about a variety of topics

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Severity3 monthsChange in pain severity score from baseline to 3-month follow-up is the outcome

Countries

United States

Contacts

Primary ContactDavid W Sparrow, DSc
David.Sparrow@va.gov(857) 364-6400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026