Chronic Low-back PainNCT05919446
The Feasibility, Potential Efficacy, and Experiences of Using a Group-based Acceptance and Commitment Therapy Among Older People With Chronic Low Back Pain
A study testing Acceptance and commitment therapy (ACT) and back exercise in people with Chronic Low-back Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
No study has investigated the effects of ACT on community-dwelling Chinese older adults. Given that clinical practice guidelines have recommended exercise therapy for treating people with CLBP, a combination of ACT and exercise therapy may yield better clinical outcomes than exercise alone among community-dwelling… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Acceptance and commitment therapy (ACT) and back exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2023to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have 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
- have sought some medical or healthcare professional treatments for CLBP
- able to read and write at 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
- serious psychiatric or psychological disorders
- Mini-Mental Status Examination (MMSE) scores below 23
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Arnold Wong, PhD, 2766 6741, arnold.wong@polyu.edu.hk
Arnold Wong, PhD
About this study
Official title: The Feasibility, Potential Efficacy, and Experiences of Using a Group-based Acceptance and Commitment Therapy Among Older People With Chronic Low Back Pain: a Pilot Randomized Controlled Trial
No study has investigated the effects of ACT on community-dwelling Chinese older adults. Given that clinical practice guidelines have recommended exercise therapy for treating people with CLBP, a combination of ACT and exercise therapy may yield better clinical outcomes than exercise alone among community-dwelling older adults with CLBP. A double-blinded (participants and statistician) pilot randomized controlled trial (RCT) will be conducted to evaluate the feasibility and the relative effects of ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical wellbeing, and quality of life of community-dwelling older people with CLBP. Further, a qualitative research study will be conducted to understand the experiences of participating in ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).
Read the detailed description
Participants will be recruited from rehabilitation clinics, or community centres by posters posted in these locations. A total of 30 older people with LBP will be recruited and randomized into either a 4-week ACT plus back exercise group, or a back exercise control group. Immediately after the 4-week treatment, participants will be invited to complete another set of questionnaires that are identical to their baseline questionnaires to evaluate the effects of interventions on their pain, physical function, psychological wellbeing, and quality of life. At 3-month post-treatment, participants will be invited to complete the identical questionnaires again.
- Conditions
- Chronic Low-back Pain
- Being tested
- Acceptance and commitment therapy (ACT), back exercise
- Keywords
- Chronic Low-back Pain (CLBP), Acceptance and commitment therapy (ACT), psychological flexibility
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 session in the ACT group will include the first hour of ACT intervention followed by 1 hour of back exercise class. The ACT group will be led by a trained ACT counsellor and a trained exercise trainer.
back exerciseBehavioural
The control group will undergo 1 hour of back exercise class, while the control group will be led by a trained exercise trainer.
| Study group | Role | What they receive |
|---|---|---|
| Older people with ACT intervention | Experimental | 4 week ACT plus back exercise group Receives: Behavioral: Acceptance and commitment therapy (ACT); Behavioral: back exercise |
| Older people without ACT intervention | Other | 4-week back exercise control group Receives: Behavioral: back exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of psychological flexibility at immediately after the 4-week treatments
The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure participants' psychological flexibility. It comprises 7 statements, which are rated on a 7-point scale, where 1 means "never true" and 7 means "always true." The maximum total score is 49. Higher total scores mean less flexibility. AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
Measured: Baseline and at immediately after the 4-week treatments
Secondary outcomes (6)
Change of LBP intensity
An 11-point numeric pain rating scale will be used to measure LBP intensity, where 0 means no pain and 10 means the worst imaginable pain. Participants need to report their back pain in the current moment, in the last 24 hours and the last 3 months.
Measured: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change of LBP-related disability
The Chinese version of 24-item Roland Morris Disability Index will be used to evaluate the LBP-related disability in older adults.30 It consists of 24 yes/no items related to LBP-related functional limitations. The summation of the scores of items with "yes" answer indicates the severity of LBP-related disability. The maximum score is 24.
Measured: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change of health-related quality of life
The Chinese version of EQ-5D-5L will be used to measure health-related quality of life (HRQOL) in our participants. It comprises 5 items related to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each item has 5 options (no problem, slight problems, moderate problems, severe problems, extreme problems/unable to). It has been found to useful in monitoring HRQOL responses to treatment.
Measured: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change of depression, anxiety, and stress
The Chinese version of 21-item Depression, Anxiety Stress Scales (DASS) 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 mental health issues. It has been cross-culturally adapted to Hong Kong settings.
DASS has demonstrated excellent internal consistency for depression, anxiety, and stress subscales.
Measured: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Overall perceived changes in symptom severity, treatment response and the efficacy of treatment
Global impression of change scale will be used to evaluate the overall perceived changes in symptom severity, treatment response and the efficacy of treatment immediately after the 4 week interventions.
Measured: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change from baseline of psychological flexibility at 3-month post-treatment
The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure participants' psychological flexibility. It comprises 7 statements, which are rated on a 7-point scale, where 1 means "never true" and 7 means "always true." The maximum total score is 49. Higher total scores mean less flexibility. AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
Measured: Baseline and at 3-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Aug 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies 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
- 30 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
- Investigators
- Arnold Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919446
- Sponsor's protocol ID
- HSEARS20230104002
- Status last verified
- Feb 2024
- First submitted
- 30 May 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu JQJ, Mak YW, Tang ALY, Kwan C, Al Zoubi F, Wong TKT, Tsang GSH, Kwong HCW, Lai SWT, Sze SPS, Hui KTK, Cheung CKC, Samartzis D, Chow KKS, Wong AYL. Effects of acceptance and commitment therapy plus exercise for older adults with chronic low back pain: A preliminary cluster randomized controlled trial with qualitative interviews. J Pain. 2025 May;30:105350. doi: 10.1016/j.jpain.2025.105350. Epub 2025 Feb 26.
PubMed 40020954
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility, Potential Efficacy, and Experiences of Using a Group-based Acceptance and Commitment Therapy Among Older People With Chronic Low Back Pain: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05919446
- Acronym / sponsor ID
- HSEARS20230104002
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic Low-back Pain (CLBP), Acceptance and commitment therapy (ACT), psychological flexibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 26 Jun 2023 (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.
No study has investigated the effects of ACT on community-dwelling Chinese older adults. Given that clinical practice guidelines have recommended exercise therapy for treating people with CLBP, a combination of ACT and exercise therapy may yield better clinical outcomes than exercise alone among community-dwelling older adults with CLBP. A double-blinded (participants and statistician) pilot randomized controlled trial (RCT) will be conducted to evaluate the feasibility and the relative effects of ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical wellbeing, and quality of life of community-dwelling older people with CLBP. Further, a qualitative research study will be conducted to understand the experiences of participating in ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).
Detailed description
Participants will be recruited from rehabilitation clinics, or community centres by posters posted in these locations. A total of 30 older people with LBP will be recruited and randomized into either a 4-week ACT plus back exercise group, or a back exercise control group. Immediately after the 4-week treatment, participants will be invited to complete another set of questionnaires that are identical to their baseline questionnaires to evaluate the effects of interventions on their pain, physical function, psychological wellbeing, and quality of life. At 3-month post-treatment, participants will be invited to complete the identical questionnaires again.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older people with ACT intervention | Experimental | Behavioral: Acceptance and commitment therapy (ACT), Behavioral: back exercise4 week ACT plus back exercise group |
| Older people without ACT intervention | Other | Behavioral: back exercise4-week back exercise control group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- have 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
- have sought some medical or healthcare professional treatments for CLBP
- able to read and write at an adequate level of proficiency in Chinese
- Mini-Mental Status Examination (MMSE) scores 23 or above
Key exclusion criteria (5 listed)
- people with malignant pain or lumbar spinal stenosis
- confirmed dementia
- severe cognitive impairment
- serious psychiatric or psychological disorders
- 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 session in the ACT group will include the first hour of ACT intervention followed by 1 hour of back exercise class. The ACT group will be led by a trained ACT counsellor and a trained exercise trainer. | Behavioural | Older people with ACT intervention |
| back exerciseThe control group will undergo 1 hour of back exercise class, while the control group will be led by a trained exercise trainer. | Behavioural | Older people with ACT intervention, Older people without ACT intervention |
Primary outcome
Change from baseline of psychological flexibility at immediately after the 4-week treatments
Time frame: Baseline and at immediately after the 4-week treatments
The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure participants' psychological flexibility. It comprises 7 statements, which are rated on a 7-point scale, where 1 means "never true" and 7 means "always true." The maximum total score is 49. Higher total scores mean less flexibility. AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
6 secondary outcomes
Change of LBP intensity
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change of LBP-related disability
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change of health-related quality of life
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change of depression, anxiety, and stress
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Overall perceived changes in symptom severity, treatment response and the efficacy of treatment
Time frame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
Change from baseline of psychological flexibility at 3-month post-treatment
Time frame: Baseline and at 3-month post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 40020954Liu JQJ, Mak YW, Tang ALY, Kwan C, Al Zoubi F, Wong TKT, Tsang GSH, Kwong HCW, Lai SWT, Sze SPS, Hui KTK, Cheung CKC, Samartzis D, Chow KKS, Wong AYL. Effects of acceptance and commitment therapy plus exercise for older adults with chronic low back pain: A preliminary cluster randomized controlled trial with qualitative interviews. J Pain. 2025 May;30:105350. doi: 10.1016/j.jpain.2025.105350. Epub 2025 Feb 26.
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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. This study is not recruiting at the moment.
Arnold Wong, PhD principal investigator
The Hong Kong Polytechnic University
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) and back exercise in people with Chronic Low-back Pain, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnold Wong, PhD (27666741, 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 from baseline of psychological flexibility at immediately after the 4-week treatments (time frame: Baseline and at immediately after the 4-week treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05919446, which also lists 1 linked publication.
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 28 Feb 2024.