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临床试验/NCT05410392
NCT05410392进行中(未招募)不适用

Telemedicine Intervention in Patients With Chronic Pain in PD

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
166
试验地点
2
主要终点
Pain Severity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Physician diagnosis of idiopathic PD
  • At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
  • Response to dopaminergic medication

排除标准

  • Angina pectoris
  • History of myocardial infarction (MI) within 6 months
  • History of ventricular dysrhythmia requiring current therapy

研究组 & 干预措施

Combined physical and cognitive exercise intervention

Experimental

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

干预措施: Physical exercise intervention (Behavioral)

Combined physical and cognitive exercise intervention

Experimental

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

干预措施: Cognitive exercise intervention (Behavioral)

Physical exercise intervention

Experimental

Participants will receive the physical exercise intervention for 3 months.

干预措施: Physical exercise intervention (Behavioral)

Cognitive exercise intervention

Experimental

Participants will receive the cognitive exercise intervention for 3 months.

干预措施: Cognitive exercise intervention (Behavioral)

Control group

Active Comparator

Participants will receive health education for 3 months.

干预措施: Health education (Behavioral)

结局指标

主要结局

Pain Severity

时间窗: 3 months

Change in pain severity score from baseline to 3-month follow-up is the outcome

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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