Clinical trial NCT06576414: Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises for Older People With Chronic Low Back Pain
Official title: Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises Versus Online Education Plus Exercises for 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
Online intervention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 40
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 online ACT on community-dwelling 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 online ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical well-being, and quality of life of community-dwelling older people with CLBP at different time points. The clinical outcomes will be measured at baseline, immediately after the 4-week treatment, and at the 3- and 6-month post-treatment follow-ups. Further, a qualitative research study will be conducted to understand the experiences of participating in online ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).

Detailed description: Recruitment posters will be displayed in five Hong Kong community centers. A total of 40 older people with LBP will be recruited and randomized to either a 4-week online ACT-plus-back-exercise group or a 4-week online spine care education-back-exercise control group. All participants will be screened for eligibility.

After providing the informed consent, participants will undergo baseline assessments. Then they will be randomized into either group. Immediately after the 4-week treatment and at 3- and 6-month post-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 well-being, and quality of life.

Semi-structured interviews will be conducted to collect the user experience of participants in both groups by purposive sampling. The interviews will be conducted immediately post-treatment and at the 6-month post-treatment follow-up to evaluate the perspectives at different time points.

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, immediately after the 4-week treatment, and at 3- and 6-month post-treatment (All these time points are consistent with the description)
Secondary outcomes:
measure: Change of LBP intensity
timeFrame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
measure: Change of LBP-related disability
timeFrame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
measure: Change of health-related quality of life
timeFrame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
measure: Change of depression, anxiety, and stress
timeFrame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
measure: Overall perceived changes in symptom severity, treatment response and the efficacy of treatment
timeFrame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Arnold YL Wong
state: None Selected
Study officials:
References: