Combining group exercise with therapy for elderly with chronic low back pain
Effects of Combining Physiotherapy Group Exercise With Acceptance and Commitment Therapy in Elderly With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
This study is testing if combining group exercise with therapy can help older adults with chronic low back pain feel better compared to just doing group exercise alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Kowloon) |
| Trial ID | NCT06148896 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the effectiveness of a combined intervention of Group Exercise and Acceptance and Commitment Therapy (GrExPACT) compared to Group Exercise alone (GrEx) for elderly individuals suffering from chronic low back pain. Participants will be stratified based on their risk level using the STarT Back Screening Tool and will undergo a 5-week program. The primary outcome will be measured using the Roland Morris Disability Questionnaire, alongside various secondary outcomes assessing pain acceptance, self-efficacy, and functional performance. The study aims to recruit 86 subjects from local community centers in Hong Kong.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 65 and older with chronic nonspecific low back pain for more than three months, classified as medium or high-risk.
Not a fit: Patients with specific causes of low back pain, serious uncontrolled comorbidities, or those unable to participate in exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve functional recovery and quality of life for elderly patients with chronic low back pain.
How similar studies have performed: Previous studies have shown promise in combining physical therapy with psychological approaches for chronic pain management, suggesting potential success for this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Ages ≥ 65; 2. Nonspecific LBP for \> 3 month; 3. Stratified as medium-risk category (i.e., total score ≥ 4 and sub score ≤ to 3) and high-risk category (i.e., total score ≥ 4 and sub score ≥ 4) using the STarT Back Screening Tool; 4. Roland Morris Disability Questionnaire (RMDQ) score ≥ 5 (with reference to the minimal level of detectable change)(30, 31); 5. Able to walk with or without assistive aid and with Modified Functional Ambulatory Category ≥ 6 (32); 6. Able to read Chinese characters; 7. Able to speak and understand Cantonese; and 8. Abbreviated mental test (AMT) ≥ 6 (33). Exclusion Criteria 1. Specific cause of LBP such as tumor, infection, or apparent neurological deficit; 2. Serious uncontrolled co-morbidities or systematic diseases which is contraindicated to exercise; 3. Orthopedic condition like recent fracture require immobilization and not fitting for exercise; 4. Unstable cardiac, pulmonary, metabolic, and psychological disease requiring acute care; 5. Severe cognitive, language or hearing deficits; 6. Spinal surgery in the past 12 months as not to confound with effect of surgery; 7. People who had prior treatment with ACT at any time; or 8. People who had received physiotherapy treatment in the previous 6 months.
Where this trial is running
Kowloon
- Hong Kong Polytechnic University — Kowloon, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Man Ha Sharon Tsang, Doctor — Hong Kong Polytechnic University
- Study coordinator: Kit Chi Yeung
- Email: angelinayeungykc@gmail.com
- Phone: 852 35053239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.