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NCT Number: NCT07211464

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

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.

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Key information

Conditions

Chronic Low-back Pain (cLBP) Behavior Motor Activity

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Location status: Recruiting

Location contact

Dr Arnold Wong Yu Lok

CONTACT

[email protected]

(852) 2766 6741

Dr Arnold Yu Lok Wong

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceptance and Commitment Therapy (ACT)

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

Behavioral

30-minute exercise class

back care education

Behavioral

1-hour interactive lesson on back care

Primary outcomes

  1. Change in Pain intensity

    Time frame: Baseline, immediately after treatment, at the 3- and 6-month follow-ups

    Current, worst, least, and average LBP intensities in the last 24 hours will be assessed in four days within a week before each assessment using separate 11-point NPRS. The NPRS ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable". The average LBP intensity over the four days will be calculated as a composite score for data analysis.

Secondary outcomes

  1. Change in Pain-related disability

    Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups

    The Chinese version of the 24-item Roland-Morris Disability Questionnaire will be used to evaluate LBP-related disability in older adults.[21] It consists of 24 yes/no items concerning LBP-related functional limitations. The number of items with "yes" answers indicates the severity of the respondent's LBP-related disability. The maximum score is 24.

  2. Change in Psychological flexibility

    Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups

    Participants' psychological flexibility will be measured by The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II). It comprises 7 statements, which respondents rate on a 7-point scale, where 1 means "never true" and 7 means "always true". The maximum total score is 49. Higher total scores indicate less flexibility. The AAQ-II has been cross-culturally adapted and validated among Chinese adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.

  3. Change in HRQOL

    Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups

    Participants' HRQOL will be measured by the Chinese version of the EQ-5D-5L. It comprises 5 items related to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each item has 5 response options ("no problem", "slight problems", "moderate problems", "severe problems", and "extreme problems/unable to"). It has been found to be useful in monitoring treatments' effects on HRQOL.

  4. Change in Psychological factors

    Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups

    The Hong Kong Chinese version of the 21-item Depression Anxiety Stress Scales 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 severe mental health issues. This questionnaire and its subscales have demonstrated excellent internal consistency for assessing depression, anxiety, and stress.

  5. Change in falling risk

    Time frame: Baseline, immediately after treatment, and at the 3- and 6-month follow-ups

    The Timed Up and Go test will be used to assess transfer skills and walking. It can identify community-dwelling older adults at risk of falling.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Arnold Wong Yu Lok

CONTACT

[email protected]

(852) 2766 6741

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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