Acceptance and Commitment Therapy Plus Exercise for Older People With Chronic Low-back Pain: A Pragmatic Cluster Randomised Controlled Trial

NCT ID: NCT07211464

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-08-31

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.

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ACT-plus-exercise group

8-week ACT plus back exercise group

Group Type: EXPERIMENTAL

Acceptance and commitment therapy (ACT)

Intervention Type: BEHAVIORAL

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 exercise

Intervention Type: BEHAVIORAL

30-minute exercise class

Exercise control group

8-week back care education plus exercise group

Group Type: ACTIVE_COMPARATOR

back exercise

Intervention Type: BEHAVIORAL

30-minute exercise class

back care education

Intervention Type: BEHAVIORAL

1-hour interactive lesson on back care

Interventions

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.

Intervention Type: BEHAVIORAL

back exercise

30-minute exercise class

Intervention Type: BEHAVIORAL

back care education

1-hour interactive lesson on back care

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Arnold Wong Yu Lok

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Dr Arnold Wong Yu Lok

Role: CONTACT

arnold.wong@polyu.edu.hk

(852) 2766 6741

Facility Contacts

Dr Arnold Wong Yu Lok

Role: primary

arnold.wong@polyu.edu.hk

(852) 2766 6741

Other Identifiers

HSEARS20241101005

Identifier Type: -

Identifier Source: org_study_id