Life-Style Medicine for Chronic Musculoskeletal Pain in Older People

NCT ID: NCT07194239

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-10-31

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.

Conditions

Musculoskeletal; Pain Management; Chronic Pain; Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Lifestyle medicine Health coaching

Intervention Type: BEHAVIORAL

Participants assigned to this group will have 4 face-to-face sessions with the health coach. Lifestyle modifications with the aim of pain reduction will be determined in a shared decision-making approach. Lifestyle modifications will be based on the 6 pillars of lifestyle medicine: Physical activity, Healthy eating, Stress reduction, Sleep restoration, Social Support, and Avoiding risky substances. The health coach will make use of motivational techniques such as motivational interviewing to guide and assist participants in realizing the lifestyle modifications.

Interventions

Lifestyle medicine Health coaching

Participants assigned to this group will have 4 face-to-face sessions with the health coach. Lifestyle modifications with the aim of pain reduction will be determined in a shared decision-making approach. Lifestyle modifications will be based on the 6 pillars of lifestyle medicine: Physical activity, Healthy eating, Stress reduction, Sleep restoration, Social Support, and Avoiding risky substances. The health coach will make use of motivational techniques such as motivational interviewing to guide and assist participants in realizing the lifestyle modifications.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Regina Wing Shan Sit

Associate Professor (Clinical)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025.553

Identifier Type: OTHER

Identifier Source: secondary_id

2025.553

Identifier Type: -

Identifier Source: org_study_id