Life-Style Medicine for Chronic Musculoskeletal Pain in Older People
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
patient with cancer-related pain
inflammatory rheumatic disease
a recent history of stroke or major surgery in the past 6 months
terminal illness
Trial design
Design model
Parallel
Treatments tested in this trial
Lifestyle medicine Health coaching
BehavioralParticipants 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.
Treatment groups
268 Participants
are divided into 2 treatment groupsGroup A: Waitlist controlNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Brief Pain Inventory - Severity score
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.
Time frame
Week 0, 12, 24Secondary outcomes
1
BPI-Interference
The Brief Pain Inventory (BPI) is a self-report questionnaire that assesses the intensity of pain and its effects on daily functioning. BPI- Interference measures the level of interference as a result of pain. Participants are asked to rate the level of interference experienced over the past 24 hours on a 0-10 Numeric Rating Scale for seven interference items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Higher scores indicate greater pain interference.
Time frame
week 0, 12, 242
Pain-Self Efficacy questionnaire
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item self-report questionnaire that measures an individual's confidence in performing daily activities and managing life despite experiencing persistent pain. Each item is measured on a 7-point Likert scale (ranging from 0 to 6). The items assess confidence in performing tasks such as household chores, socializing, working, and coping without medication. A higher total score indicates a stronger belief in managing pain effectively.
Time frame
Week 0 12, 243
Chinese International Physical Activity Questionnaire (Short form)
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is an 8-item self-report questionnaire designed to assess the overall physical activity over the past 7 days. Questionnaire items measure the frequency (days) and duration (time) of activities, including walking, moderate-intensity, vigorous-intensity activities, and sedentary behavior.
Time frame
Week 0, 12, 244
Chinese Short Food Frequency Questionnaire
The Food Frequency Questionnaire (FFQ) consists of 50 food items reflecting the typical dietary intake of Chinese older adults in Hong Kong. The FFQ captures habitual food consumption by combining frequency and portion data to quantify nutrient and food group intake. Participants report the frequency of consumption and portion size for each item, allowing estimation of average daily intake.
Time frame
Week 0, 12, 24Sponsors and contacts
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Source ClinicalTrials.gov