Life-Style Medicine for Chronic Musculoskeletal Pain in Older People: A Pragmatic, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory - Severity score
研究概览
简要总结
The goal of this clinical trial is to determine the clinical effectiveness of lifestyle medicine in reducing chronic musculoskeletal pain in older adults, as measured by pain intensity, pain interference, self-management efficacy, stress level, sleep quality, healthier diet, better quality of life, and cost-effectiveness, compared to a waitlist control group.
Participants will be randomly assigned to either the intervention or the waitlist group. The intervention group will meet the health coach face-to-face for four sessions to negotiate and set personalized health goals. The waitlist control group will continue to receive usual care without any additional intervention for 24 weeks. Both groups will complete three assessments: at the start of the study, one month after the intervention, and three months after the intervention. The waitlist control group will be offered the same intervention after completing the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic musculoskeletal pain, defined as pain that lasted for more than 3 months persistently or intermittently, including regional pain (joints, limbs, back, and/or neck)
- •a degenerative joint condition, such as osteoarthritis, and/or musculoskeletal complaints that fall under the classification of the International Classification of Disease-11 as "chronic primary musculoskeletal pain" or "chronic secondary musculoskeletal pain"
- •Pain intensity score ≥ 4 on a numerical rating scale of 10
- •stable baseline physical activity
- •ability to understand written and verbal Chinese
排除标准
- •patient with cancer-related pain
- •inflammatory rheumatic disease
- •a recent history of stroke or major surgery in the past 6 months
- •terminal illness
- •serious mental illness
- •severe or uncontrolled heart disease
- •comorbid conditions that might impede active participation in the study
研究组 & 干预措施
Waitlist control
Patients allocated to the Waitlist arm will continue receiving their "usual care" without any additional intervention until they have completed the outcome assessment at 24 weeks.
Intervention group
A coaching context to enhance the well-being of individuals and to facilitate the achievement of their health-related goals. The coach will negotiate and set personalized health goals with participants, ensuring the goals are realistic, achievable, and aligned with their needs.
干预措施: Lifestyle medicine Health coaching (Behavioral)
结局指标
主要结局
Brief Pain Inventory - Severity score
时间窗: Week 0, 12, 24
The Brief Pain Inventory (BPI) is a self-report questionnaire that assesses the intensity of pain and its effects on daily functioning. BPI- Severity measures the intensity of pain. Participants are asked to rate their pain on a 0-10 Numeric Rating Scale for their pain experienced at its "worst," "least," "average," and "now" over the past 24 hours. Higher scores indicate greater pain severity.
次要结局
- BPI-Interference(week 0, 12, 24)
- Pain-Self Efficacy questionnaire(Week 0 12, 24)
- Chinese International Physical Activity Questionnaire (Short form)(Week 0, 12, 24)
- Chinese Short Food Frequency Questionnaire(Week 0, 12, 24)
- 10-item Perceived Stress Scale (PSS-10)(Week 0, 12, 24)
- 7-item Insomnia Severity Index (ISI)(Week 0, 12, 24)
- Lubben Social Network Scale-6 (LSNS-6)(Week 0, 12, 24)
- EuroQuol-5D-5L (EQ-5D-5L)(Week 0, 12, 24)
- Quantity of smoking and alcohol consumption(Week 0, 12, 24)
- Quality-adjusted life years (QALYs) on EQ-5D-5L(Week 0, 12, 24)
研究者
Regina Wing Shan Sit
Associate Professor (Clinical)
Chinese University of Hong Kong