Acceptance and Commitment Therapy Plus Exercise for Older People With Chronic Low-back Pain: A Pragmatic Cluster Randomised Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acceptance and commitment therapy (ACT), back exercise, back care education.
- Who it may be relevant to
- Registry conditions: Chronic Low-back Pain (cLBP). Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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. - Behavioral back exercise
30-minute exercise class - Behavioral back care education
1-hour interactive lesson on back care
Primary outcome measures
- Change in Pain intensity [Time frame: Baseline, immediately after treatment, at the 3- and 6-month follow-ups]
Secondary outcome measures (5)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT07211464 · HSEARS20241101005