NCT07211464 Acceptance and Commitment Therapy Plus Exercise for Older People With Chronic Low-back Pain: A Pragmatic Cluster Randomised Controlled Trial
| NCT ID | NCT07211464 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Chronic Low-back Pain (cLBP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-09-01 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07211464 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Chronic Low-back Pain (cLBP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07211464 currently recruiting?
Yes, NCT07211464 is actively recruiting participants. Contact the research team at arnold.wong@polyu.edu.hk for enrollment information.
Where is the NCT07211464 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07211464 clinical trial?
NCT07211464 is sponsored by The Hong Kong Polytechnic University. The trial plans to enroll 100 participants.