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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Cheryl Fung, Bachelor contact

+852 2609 5050

cheryllcfung@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • 4/F, Lek Yuen Health Center, Shatin, New Territories, Hong Kong

    Hong Kong

    Recruiting

Other trials in 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.

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 groups in NCT07194239
Study groupRoleWhat they receive
Waitlist controlNo interventionPatients 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 groupExperimentalA 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.

  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.

    Measured: Week 0, 12, 24

Secondary outcomes (10)
  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.

    Measured: week 0, 12, 24

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted26 Sep 2025
  2. Study start9 Feb 2025
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

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)
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

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.

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