Chronic Low-back Pain (cLBP)NCT07211464
Acceptance and Commitment Therapy Plus Exercise for Older People With Chronic Low-back Pain: A Pragmatic Cluster Randomised Controlled Trial
A study testing Acceptance and commitment therapy (ACT), back exercise and back care education in people with Chronic Low-back Pain (cLBP), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Low back pain (LBP) is the fifth-most common disorder among older adults 60 years or older. The prevalence of LBP increases with age, with the highest prevalence occurring at 85 years old. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Acceptance and commitment therapy (ACT), back exercise and back care education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2025to 31 Aug 2028
- 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
- aged 60 or above
- have had non-specific LBP in or near the lumbosacral spine, with or without leg pain, that lasts for at least 3 months in the last 12 months
- Average pain intensity (in the past week) ≥ 4 on a scale of 0 to 10
- must have sought some healthcare professional treatments for CLBP in the last 12 months
- have an adequate level of proficiency in Chinese
- Mini-Mental Status Examination (MMSE) scores: 23 or above
Who cannot join
- People with malignant pain or lumbar spinal stenosis, confirmed dementia, severe cognitive impairment, or serious psychiatric or psychological disorders that may hinder their study participation will be excluded
- Individuals with Mini-Mental Status Examination (MMSE) scores below 23
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
The Hong Kong Polytechnic University
Hong Kong
Dr Arnold Wong Yu Lok, (852) 2766 6741, arnold.wong@polyu.edu.hk
Dr Arnold Yu Lok Wong
About this study
Low back pain (LBP) is the fifth-most common disorder among older adults 60 years or older. The prevalence of LBP increases with age, with the highest prevalence occurring at 85 years old. Because many older individuals face various age-related life challenges (e.g., comorbidities, financial difficulties, and bereavement), the addition of chronic LBP (CLBP) to existing stressors may worsen their physical and psychological well-being. Unfortunately, CLBP is difficult to manage and is refractory to many existing treatments. Physiotherapy treatments alone show only modest improvements in LBP or LBP-related disability. Recent research has shown that proper pain self-management is crucial to reduce pain and disability in individuals with CLBP.
Acceptance and commitment therapy (ACT), a new mindfulness-based therapy, has been suggested for chronic pain management. ACT improves an individual's psychological flexibility, by improving their openness, awareness, and acceptance of the present moment (including pain). Combining ACT and exercise classes has the potential to improve the latter treatment's efficacy. Our recent pragmatic pilot, 2-arm cluster randomised controlled trial (RCT) on 40 older adults with CLBP revealed that eight weeks of ACT plus exercise and an 8-week back care education plus exercise program (control group) were safe, feasible, and well accepted by participants in elderly community centres. Moreover, compared to the control group, the ACT-plus-exercise group showed significantly greater improvements in pain intensity, LBP-related disability, health-related quality of life (HRQOL), and psychological flexibility immediately after treatment. These promising preliminary findings indicate that a fully powered clinical trial is warranted.
Read the detailed description
Building on our pilot study, we aim to conduct a pragmatic definitive cluster RCT in multiple elderly community centres to validate our findings immediately post-treatment and to explore its potential beneficial effects 3 and 6 months after treatment. Additionally, we will conduct a mediation analysis to explore potential mediation effects of psychological flexibility on the association between post-treatment changes in LBP-related disability and the corresponding changes in HRQOL in older adults with CLBP. Collectively, the project's results have the potential to help clinicians find a novel pragmatic approach to empower community-dwelling older adults to self-manage their CLBP.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Acceptance and commitment therapy (ACT), back exercise, back care education
- Keywords
- Chronic Low-back Pain (CLBP), Acceptance and commitment therapy (ACT), psychological flexibility, exercise, back care education
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapy (ACT)Behavioural
Each 1.5-hour session will consist of a 1-hour ACT intervention and 30 minutes of exercise training. The ACT group was led by a trained ACT counsellor and a trained exercise trainer.
back exerciseBehavioural
30-minute exercise class
back care educationBehavioural
1-hour interactive lesson on back care
| Study group | Role | What they receive |
|---|---|---|
| ACT-plus-exercise group | Experimental | 8-week ACT plus back exercise group Receives: Behavioral: Acceptance and commitment therapy (ACT); Behavioral: back exercise |
| Exercise control group | Active comparator | 8-week back care education plus exercise group Receives: Behavioral: back exercise; Behavioral: back care education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity
Current, worst, least, and average LBP intensities in the last 24 hours will be assessed in four days within a week before each assessment using separate 11-point NPRS. The NPRS ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable". The average LBP intensity over the four days will be calculated as a composite score for data analysis.
Measured: Baseline, immediately after treatment, at the 3- and 6-month follow-ups
Secondary outcomes (5)
Change in Pain-related disability
The Chinese version of the 24-item Roland-Morris Disability Questionnaire will be used to evaluate LBP-related disability in older adults.[21] It consists of 24 yes/no items concerning LBP-related functional limitations. The number of items with "yes" answers indicates the severity of the respondent's LBP-related disability. The maximum score is 24.
Measured: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Change in Psychological flexibility
Participants' psychological flexibility will be measured by The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II). It comprises 7 statements, which respondents rate on a 7-point scale, where 1 means "never true" and 7 means "always true". The maximum total score is 49. Higher total scores indicate less flexibility. The AAQ-II has been cross-culturally adapted and validated among Chinese adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
Measured: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Change in HRQOL
Participants' HRQOL will be measured by the Chinese version of the EQ-5D-5L. It comprises 5 items related to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each item has 5 response options ("no problem", "slight problems", "moderate problems", "severe problems", and "extreme problems/unable to"). It has been found to be useful in monitoring treatments' effects on HRQOL.
Measured: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Change in Psychological factors
The Hong Kong Chinese version of the 21-item Depression Anxiety Stress Scales will be used to evaluate depression (7 items), anxiety (7 items), and stress (7 items) in older adults. Each item is rated on a 4-point scale ranging from 0 ("not at all") to 3 ("most of the time"). Higher scores imply more severe mental health issues. This questionnaire and its subscales have demonstrated excellent internal consistency for assessing depression, anxiety, and stress.
Measured: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Change in falling risk
The Timed Up and Go test will be used to assess transfer skills and walking. It can identify community-dwelling older adults at risk of falling.
Measured: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Sep 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Arnold Wong Yu Lok, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211464
- Sponsor's protocol ID
- HSEARS20241101005
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy Plus Exercise for Older People With Chronic Low-back Pain: A Pragmatic Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07211464
- Acronym / sponsor ID
- HSEARS20241101005
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- Chronic Low-back Pain (CLBP), Acceptance and commitment therapy (ACT), psychological flexibility, exercise, back care education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 8 Oct 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.
Low back pain (LBP) is the fifth-most common disorder among older adults 60 years or older. The prevalence of LBP increases with age, with the highest prevalence occurring at 85 years old. Because many older individuals face various age-related life challenges (e.g., comorbidities, financial difficulties, and bereavement), the addition of chronic LBP (CLBP) to existing stressors may worsen their physical and psychological well-being. Unfortunately, CLBP is difficult to manage and is refractory to many existing treatments. Physiotherapy treatments alone show only modest improvements in LBP or LBP-related disability. Recent research has shown that proper pain self-management is crucial to reduce pain and disability in individuals with CLBP.
Acceptance and commitment therapy (ACT), a new mindfulness-based therapy, has been suggested for chronic pain management. ACT improves an individual's psychological flexibility, by improving their openness, awareness, and acceptance of the present moment (including pain). Combining ACT and exercise classes has the potential to improve the latter treatment's efficacy. Our recent pragmatic pilot, 2-arm cluster randomised controlled trial (RCT) on 40 older adults with CLBP revealed that eight weeks of ACT plus exercise and an 8-week back care education plus exercise program (control group) were safe, feasible, and well accepted by participants in elderly community centres. Moreover, compared to the control group, the ACT-plus-exercise group showed significantly greater improvements in pain intensity, LBP-related disability, health-related quality of life (HRQOL), and psychological flexibility immediately after treatment. These promising preliminary findings indicate that a fully powered clinical trial is warranted.
Detailed description
Building on our pilot study, we aim to conduct a pragmatic definitive cluster RCT in multiple elderly community centres to validate our findings immediately post-treatment and to explore its potential beneficial effects 3 and 6 months after treatment. Additionally, we will conduct a mediation analysis to explore potential mediation effects of psychological flexibility on the association between post-treatment changes in LBP-related disability and the corresponding changes in HRQOL in older adults with CLBP. Collectively, the project's results have the potential to help clinicians find a novel pragmatic approach to empower community-dwelling older adults to self-manage their CLBP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-plus-exercise group | Experimental | Behavioral: Acceptance and commitment therapy (ACT), Behavioral: back exercise8-week ACT plus back exercise group |
| Exercise control group | Active comparator | Behavioral: back exercise, Behavioral: back care education8-week back care education plus exercise group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 60 or above
- have had non-specific LBP in or near the lumbosacral spine, with or without leg pain, that lasts for at least 3 months in the last 12 months
- Average pain intensity (in the past week) ≥ 4 on a scale of 0 to 10
- must have sought some healthcare professional treatments for CLBP in the last 12 months
- have an adequate level of proficiency in Chinese
Key exclusion criteria (2 listed)
- People with malignant pain or lumbar spinal stenosis, confirmed dementia, severe cognitive impairment, or serious psychiatric or psychological disorders that may hinder their study participation will be excluded
- Individuals with Mini-Mental Status Examination (MMSE) scores below 23
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 |
|---|---|---|
| Acceptance and commitment therapy (ACT)Each 1.5-hour session will consist of a 1-hour ACT intervention and 30 minutes of exercise training. The ACT group was led by a trained ACT counsellor and a trained exercise trainer. | Behavioural | ACT-plus-exercise group |
| back exercise30-minute exercise class | Behavioural | ACT-plus-exercise group, Exercise control group |
| back care education1-hour interactive lesson on back care | Behavioural | Exercise control group |
Primary outcome
Change in Pain intensity
Time frame: Baseline, immediately after treatment, at the 3- and 6-month follow-ups
Current, worst, least, and average LBP intensities in the last 24 hours will be assessed in four days within a week before each assessment using separate 11-point NPRS. The NPRS ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable". The average LBP intensity over the four days will be calculated as a composite score for data analysis.
5 secondary outcomes
Change in Pain-related disability
Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Change in Psychological flexibility
Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Change in HRQOL
Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Change in Psychological factors
Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
Change in falling risk
Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups
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 8 Oct 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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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 Acceptance and commitment therapy (ACT), back exercise and back care education in people with Chronic Low-back Pain (cLBP), run by The Hong Kong Polytechnic University 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 6 inclusion and 2 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 8 Oct 2025. 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 Dr Arnold Wong Yu Lok ((852) 2766 6741, arnold.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity (time frame: Baseline, immediately after treatment, at the 3- and 6-month follow-ups). 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 8 Oct 2025.