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

NCT07211464 | Recruiting

• 1 other identifier: HSEARS20241101005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain (cLBP)

Keywords

Chronic Low-back Pain (CLBP); Acceptance and commitment therapy (ACT); psychological flexibility; exercise; back care education

Outcome Measures

Primary Outcomes (1)

• Change in Pain intensity

  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.

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

Secondary Outcomes (5)

• Change in Pain-related disability

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

• Change in Psychological flexibility

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

• Change in HRQOL

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

• Change in Psychological factors

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

• Change in falling risk

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

Study Arms (2)

ACT-plus-exercise group

EXPERIMENTAL

8-week ACT plus back exercise group

Behavioral: Acceptance and commitment therapy (ACT); Behavioral: back exercise

Exercise control group

ACTIVE COMPARATOR

8-week back care education plus exercise group

Behavioral: back exercise; Behavioral: back care education

Interventions

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.

ACT-plus-exercise group

back exercise BEHAVIORAL

30-minute exercise class

ACT-plus-exercise group; Exercise control group

back care education BEHAVIORAL

1-hour interactive lesson on back care

Exercise control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Dr Arnold Wong Yu Lok

CONTACT

(852) 2766 6741; arnold.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded (participants and statistician)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: at baseline, immediately after treatment, and at the 3- and 6-month follow-ups
• Access Criteria: Upon reasonable request to the principal investigator

Locations

HK (1)