Musculoskeletallifestyle medNCT07194239
Life-Style Medicine for Chronic Musculoskeletal Pain in Older People
A study testing Lifestyle medicine Health coaching in people with Musculoskeletal and Pain Management, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Musculoskeletal, Pain Management, Chronic Pain
- What is being tested?
- Lifestyle medicine Health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Feb 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
4/F, Lek Yuen Health Center, Shatin, New Territories, Hong Kong
Hong Kong
About this study
Official title: Life-Style Medicine for Chronic Musculoskeletal Pain in Older People: A Pragmatic, Randomized Controlled Clinical 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.
- Conditions
- Musculoskeletal, Pain Management, Chronic Pain, Musculoskeletal Pain
- Being tested
- Lifestyle medicine Health coaching
- Keywords
- Musculoskeletal pain, lifestyle medicine, older people, health coaching, Chronic Musculoskeletal Pain, Behavior change
- Medical subject headings
- Agnosia, Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle medicine Health coachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control | No intervention | 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 | Experimental | 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. Receives: Behavioral: Lifestyle medicine Health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, 12, 24
Secondary outcomes (10)
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.
Measured: week 0, 12, 24
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.
Measured: Week 0 12, 24
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.
Measured: Week 0, 12, 24
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.
Measured: Week 0, 12, 24
10-item Perceived Stress Scale (PSS-10)
The 10-item Perceived Stress Scale (PSS-10) is a self-reported questionnaire that measures the degree to which individuals perceive their lives as unpredictable, uncontrollable, and overloaded over the past month. The items are rated on a 5-point Likert scale from "never" to "very often". Items include six negatively phrased items assessing perceived helplessness and four positively phrased items measuring perceived self-efficacy or coping. Scores for the positively worded items are reverse-coded, and the total score ranges from 10 to 50, with higher scores indicating greater perceived stress.
Measured: Week 0, 12, 24
7-item Insomnia Severity Index (ISI)
The 7-item Insomnia Severity Index (ISI) is a self-report questionnaire that assesses the severity and impact of insomnia symptoms. It evaluates difficulties with sleep onset, sleep maintenance, early morning awakening, satisfaction with current sleep patterns, interference with daily functioning, the degree to which the sleep problem is noticeable to others, and the level of distress caused by the sleep problem. Each item is rated on a 5-point scale, ranging from 0 (no problem) to 4 (very severe problem), with total scores ranging from 0 to 28. Higher scores indicate more severe insomnia.
Measured: Week 0, 12, 24
Lubben Social Network Scale-6 (LSNS-6)
The Lubben Social Network Scale-6 (LSNS-6) is a brief, 6-item self-report questionnaire designed to assess social engagement and the size of social networks among older adults by measuring perceived social support from family and friends. Items include questions on relatives and friends seen or heard from at least once a month, and those the respondent feels comfortable talking to or can call on for help. Scores range from 0 to 30, with higher scores indicating stronger social networks and lower risk of social isolation.
Measured: Week 0, 12, 24
EuroQuol-5D-5L (EQ-5D-5L)
The EuroQuol-5D-5L (EQ-5D-5L) assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, ranging from "no problems" to "extreme problems". The questionnaire also includes a visual analogue scale (VAS) for rating overall health on a scale from 0 (worst) to 100 (best).
Measured: Week 0, 12, 24
Quantity of smoking and alcohol consumption
The participant's past or current history of smoking and the level of alcohol consumption over the past year will be recorded.
Measured: Week 0, 12, 24
Quality-adjusted life years (QALYs) on EQ-5D-5L
Quality-Adjusted Life Years (QALYs) based on the EQ-5D-5L are calculated by multiplying a health utility value, which ranges from 0 (equivalent to death) to 1 (perfect health), by the time spent in that health state. These utility values are derived from the EQ-5D-5L questionnaire responses using country-specific value sets that reflect societal preferences for different health conditions. This calculation provides a combined measure of both the quality and length of life, commonly used to evaluate the effectiveness and cost-efficiency of healthcare interventions.
Measured: Week 0, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start9 Feb 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MusculoskeletalStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Wing Shan Sit, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194239
- Sponsor's protocol ID
- 2025.553
- Other IDs
- 2025.553
- Acronym
- lifestyle med
- Status last verified
- May 2026
- First submitted
- 17 Sep 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life-Style Medicine for Chronic Musculoskeletal Pain in Older People: A Pragmatic, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07194239
- Acronym / sponsor ID
- lifestyle med / 2025.553
- Conditions
- Musculoskeletal, Pain Management, Chronic Pain, Musculoskeletal Pain
- Keywords
- Musculoskeletal pain, lifestyle medicine, older people, health coaching, Chronic Musculoskeletal Pain, Behavior change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 9 Feb 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist control | No intervention | –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 | Experimental | Behavioral: Lifestyle medicine Health coachingA 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle medicine Health coachingParticipants 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. | Behavioural | Intervention group |
Primary outcome
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.
10 secondary outcomes
BPI-Interference
Time frame: week 0, 12, 24
Pain-Self Efficacy questionnaire
Time frame: Week 0 12, 24
Chinese International Physical Activity Questionnaire (Short form)
Time frame: Week 0, 12, 24
Chinese Short Food Frequency Questionnaire
Time frame: Week 0, 12, 24
10-item Perceived Stress Scale (PSS-10)
Time frame: Week 0, 12, 24
7-item Insomnia Severity Index (ISI)
Time frame: Week 0, 12, 24
Lubben Social Network Scale-6 (LSNS-6)
Time frame: Week 0, 12, 24
EuroQuol-5D-5L (EQ-5D-5L)
Time frame: Week 0, 12, 24
Quantity of smoking and alcohol consumption
Time frame: Week 0, 12, 24
Quality-adjusted life years (QALYs) on EQ-5D-5L
Time frame: Week 0, 12, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle medicine Health coaching in people with Musculoskeletal and Pain Management, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheryl Fung, Bachelor (+852 2609 5050, cheryllcfung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory - Severity score (time frame: Week 0, 12, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.