Telemedicine Intervention in Patients With Chronic Pain in PD
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
- 否
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
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
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
Participants will receive the physical exercise intervention for 3 months.
干预措施: Physical exercise intervention (Behavioral)
Cognitive exercise intervention
Participants will receive the cognitive exercise intervention for 3 months.
干预措施: Cognitive exercise intervention (Behavioral)
Control group
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
