Chronic Low-back PainNCT06576414
Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises for Older People With Chronic Low Back Pain
A study testing Acceptance and Commitment Therapy (ACT), back exercise and back care education 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 online ACT on community-dwelling 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), 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
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2024to 15 May 2026
- 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
- Montreal Cognitive Assessment (MoCA) scores 22 or above
Who cannot join
- people with malignant pain or lumbar spinal stenosis
- confirmed dementia
- severe cognitive impairment
- serious psychiatric or psychological disorders
- Montreal Cognitive Assessment (MoCA) scores below 22
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises Versus Online Education Plus Exercises for Older People With Chronic Low Back Pain: A Pilot Randomized Controlled Trial
No study has investigated the effects of online ACT on community-dwelling 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 online ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical well-being, and quality of life of community-dwelling older people with CLBP at different time points. The clinical outcomes will be measured at baseline, immediately after the 4-week treatment, and at the 3- and 6-month post-treatment follow-ups. Further, a qualitative research study will be conducted to understand the experiences of participating in online ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).
Read the detailed description
Recruitment posters will be displayed in five Hong Kong community centers. A total of 40 older people with LBP will be recruited and randomized to either a 4-week online ACT-plus-back-exercise group or a 4-week online spine care education-back-exercise control group. All participants will be screened for eligibility.
After providing the informed consent, participants will undergo baseline assessments. Then they will be randomized into either group. Immediately after the 4-week treatment and at 3- and 6-month post-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 well-being, and quality of life.
Semi-structured interviews will be conducted to collect the user experience of participants in both groups by purposive sampling. The interviews will be conducted immediately post-treatment and at the 6-month post-treatment follow-up to evaluate the perspectives at different time points.
- Conditions
- Chronic Low-back Pain
- 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, Online intervention
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
the first hour of ACT intervention followed by 30 minutes of back exercise class, which led by a trained ACT counsellor and a trained exercise trainer
back exerciseBehavioural
30 minutes of back exercise class led by a trained exercise trainer
back care educationBehavioural
1 hour long interactive lesson to participants about LBP-related pathology, disability, psychology, and pain management skills.
| Study group | Role | What they receive |
|---|---|---|
| Older people with online 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 | Active comparator | 4-week back exercise control 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 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. AAQII has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.
Measured: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment (All these time points are consistent with the description)
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 last 7 days.
Measured: Baseline, immediately after the 4-week treatment, and at 3- and 6-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. 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 treatment, and at 3- and 6-month post-treatment
Change of health-related quality of life
The Chinese version of EuroQol-5 Dimensions-levels (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 treatment, and at 3- and 6-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). Double the sum of the subscale raw scores to acquire each subscale's total score. The total score for each subscale ranges from 0 to 42. 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 treatment, and at 3- and 6-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. The score ranges from 1 (Very much better) to 7 (Very much worse).
Measured: Immediately after the 4-week treatment, and at 3- and 6-month post-treatment
Change of psychological flexibility
The Open and Engaged State Questionnaire will be used to rate participants' experiences over the previous seven days on an 11-point Likert scale (from "not at all" to "very much"). After reverse-scoring Item 3, a total score is calculated by summing all four items. The total score ranges from 0 to 40, with higher scores indicating greater psychological inflexibility.
Measured: Baseline, immediately after the 4-week treatment, and at 3- and 6-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 posted28 Aug 2024
- Study start1 Jul 2024
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
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
- NCT06576414
- Sponsor's protocol ID
- HSEARS20240503001
- Status last verified
- Jun 2026
- First submitted
- 13 May 2024
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises Versus Online Education Plus Exercises for Older People With Chronic Low Back Pain: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06576414
- Acronym / sponsor ID
- HSEARS20240503001
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic Low-back Pain (CLBP), Acceptance and commitment therapy (ACT), Psychological flexibility, Online intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 28 Aug 2024 (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 online ACT on community-dwelling 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 online ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical well-being, and quality of life of community-dwelling older people with CLBP at different time points. The clinical outcomes will be measured at baseline, immediately after the 4-week treatment, and at the 3- and 6-month post-treatment follow-ups. Further, a qualitative research study will be conducted to understand the experiences of participating in online ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).
Detailed description
Recruitment posters will be displayed in five Hong Kong community centers. A total of 40 older people with LBP will be recruited and randomized to either a 4-week online ACT-plus-back-exercise group or a 4-week online spine care education-back-exercise control group. All participants will be screened for eligibility.
After providing the informed consent, participants will undergo baseline assessments. Then they will be randomized into either group. Immediately after the 4-week treatment and at 3- and 6-month post-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 well-being, and quality of life.
Semi-structured interviews will be conducted to collect the user experience of participants in both groups by purposive sampling. The interviews will be conducted immediately post-treatment and at the 6-month post-treatment follow-up to evaluate the perspectives at different time points.
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 online ACT intervention | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Behavioral: back exercise4 week ACT plus back exercise group |
| Older people without ACT intervention | Active comparator | Behavioral: back exercise, Behavioral: back care education4-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
- Montreal Cognitive Assessment (MoCA) scores 22 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
- Montreal Cognitive Assessment (MoCA) scores below 22
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)the first hour of ACT intervention followed by 30 minutes of back exercise class, which led by a trained ACT counsellor and a trained exercise trainer | Behavioural | Older people with online ACT intervention |
| back exercise30 minutes of back exercise class led by a trained exercise trainer | Behavioural | Older people with online ACT intervention, Older people without ACT intervention |
| back care education1 hour long interactive lesson to participants about LBP-related pathology, disability, psychology, and pain management skills. | Behavioural | Older people without ACT intervention |
Primary outcome
Change from baseline of psychological flexibility at immediately after the 4-week treatments
Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment (All these time points are consistent with the description)
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. AAQII 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 treatment, and at 3- and 6-month post-treatment
Change of LBP-related disability
Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
Change of health-related quality of life
Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
Change of depression, anxiety, and stress
Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
Overall perceived changes in symptom severity, treatment response and the efficacy of treatment
Time frame: Immediately after the 4-week treatment, and at 3- and 6-month post-treatment
Change of psychological flexibility
Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, 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: finished, as of the sponsor's last update on 4 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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, immediately after the 4-week treatment, and at 3- and 6-month post-treatment (All these time points are consistent with the description)). 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 4 Jun 2026.