Clinical trial NCT05919446: The Feasibility, Potential Efficacy, and Experiences of Using a Group-based Acceptance and Commitment Therapy Among Older People With Chronic Low Back Pain
Official title: The Feasibility, Potential Efficacy, and Experiences of Using a Group-based Acceptance and Commitment Therapy Among Older People With Chronic Low Back Pain: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic Low-back Pain (CLBP)
Acceptance and commitment therapy (ACT)
psychological flexibility
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: No study has investigated the effects of ACT on community-dwelling Chinese older adults. Given that clinical practice guidelines have recommended exercise therapy for treating people with CLBP, a combination of ACT and exercise therapy may yield better clinical outcomes than exercise alone among community-dwelling older adults with CLBP. A double-blinded (participants and statistician) pilot randomized controlled trial (RCT) will be conducted to evaluate the feasibility and the relative effects of ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical wellbeing, and quality of life of community-dwelling older people with CLBP. Further, a qualitative research study will be conducted to understand the experiences of participating in ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).

Detailed description: Participants will be recruited from rehabilitation clinics, or community centres by posters posted in these locations. A total of 30 older people with LBP will be recruited and randomized into either a 4-week ACT plus back exercise group, or a back exercise control group. Immediately after the 4-week treatment, participants will be invited to complete another set of questionnaires that are identical to their baseline questionnaires to evaluate the effects of interventions on their pain, physical function, psychological wellbeing, and quality of life. At 3-month post-treatment, participants will be invited to complete the identical questionnaires again.

Eligibility criteria: Inclusion Criteria:

1. have 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
2. have sought some medical or healthcare professional treatments for CLBP
3. able to read and write at an adequate level of proficiency in Chinese
4. Mini-Mental Status Examination (MMSE) scores 23 or above

Exclusion Criteria:

1. people with malignant pain or lumbar spinal stenosis
2. confirmed dementia
3. severe cognitive impairment
4. serious psychiatric or psychological disorders
5. Mini-Mental Status Examination (MMSE) scores below 23

Primary outcomes:
measure: Change from baseline of psychological flexibility at immediately after the 4-week treatments
timeFrame: Baseline and at immediately after the 4-week treatments
Secondary outcomes:
measure: Change of LBP intensity
timeFrame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
measure: Change of LBP-related disability
timeFrame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
measure: Change of health-related quality of life
timeFrame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
measure: Change of depression, anxiety, and stress
timeFrame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
measure: Overall perceived changes in symptom severity, treatment response and the efficacy of treatment
timeFrame: Baseline, immediately after the 4-week treatments, and at 3-month post-treatment
measure: Change from baseline of psychological flexibility at 3-month post-treatment
timeFrame: Baseline and at 3-month post-treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arnold Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: