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

NCT07211464 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-08

No results posted yet for this study

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)

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

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211464 on ClinicalTrials.gov