Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises for Older People With Chronic Low Back Pain

The Hong Kong Polytechnic University50 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Interventions

Acceptance and Commitment Therapy (ACT)BEHAVIORAL

the first hour of ACT intervention followed by 30 minutes of back exercise class, which led by a trained ACT counsellor and a trained exercise trainer

back exerciseBEHAVIORAL

30 minutes of back exercise class led by a trained exercise trainer

back care educationBEHAVIORAL

1 hour long interactive lesson to participants about LBP-related pathology, disability, psychology, and pain management skills.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. Montreal Cognitive Assessment (MoCA) scores 22 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. Montreal Cognitive Assessment (MoCA) scores below 22

Outcomes

Primary Outcomes

Change from baseline of psychological flexibility at immediately after the 4-week treatments

The 7-item Chinese version of the Acceptance and Action Questionnaire II (AAQ-II) will be used to measure participants' psychological flexibility. It comprises 7 statements, which are rated on a 7-point scale, where 1 means "never true" and 7 means "always true." The maximum total score is 49. Higher total scores mean less flexibility. AAQII has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability.

Time frame: 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

Change of LBP intensity

An 11-point numeric pain rating scale will be used to measure LBP intensity, where 0 means no pain and 10 means the worst imaginable pain. Participants need to report their back pain in the last 7 days.