Telemedicine Intervention in Patients With Chronic Pain in PD

VA Office of Research and Development

Status: Enrolling

Conditions: Parkinson's Disease

Treatments: Behavioral: Cognitive exercise intervention; Behavioral: Physical exercise intervention; Behavioral: Health education

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05410392

N3769-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 estimated patients

Sex: All

Ages: 40 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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166 participants in 4 patient groups

Combined physical and cognitive exercise intervention

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive exercise intervention

Behavioral: Physical exercise intervention

Physical exercise intervention

Experimental group

Description:

Participants will receive the physical exercise intervention for 3 months.

Treatment:

Behavioral: Physical exercise intervention

Cognitive exercise intervention

Experimental group

Description:

Participants will receive the cognitive exercise intervention for 3 months.

Treatment:

Behavioral: Cognitive exercise intervention

Control group

Active Comparator group

Description:

Participants will receive health education for 3 months.

Treatment:

Behavioral: Health education