Life-Style Medicine for Chronic Musculoskeletal Pain in Older People: A Pragmatic, Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 268
- Locations
- 1
- Primary Endpoint
- Brief Pain Inventory - Severity score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Lifestyle medicine Health coaching (Behavioral)
Outcomes
Primary Outcomes
Brief Pain Inventory - Severity score
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Regina Wing Shan Sit
Associate Professor (Clinical)
Chinese University of Hong Kong