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Completed

NCT Number: NCT06576414

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

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).

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Key information

Conditions

Chronic Low-back Pain

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arnold YL Wong

Hong Kong, None Selected

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • have sought some medical or healthcare professional treatments for CLBP
  • able to read and write at an adequate level of proficiency in Chinese
  • Montreal Cognitive Assessment (MoCA) scores 22 or above

Exclusion criteria

  • people with malignant pain or lumbar spinal stenosis
  • confirmed dementia
  • severe cognitive impairment
  • serious psychiatric or psychological disorders
  • Montreal Cognitive Assessment (MoCA) scores below 22

Treatment and study plan

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 exercise

Behavioral

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

back care education

Behavioral

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

Primary outcomes

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

    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)

    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.

Secondary outcomes

  1. Change of LBP intensity

    Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

    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.

  2. Change of LBP-related disability

    Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

    The Chinese version of 24-item Roland Morris Disability Index will be used to evaluate the LBP-related disability in older adults. It consists of 24 yes/no items related to LBP-related functional limitations. The summation of the scores of items with "yes" answer indicates the severity of LBP-related disability. The maximum score is 24.

  3. Change of health-related quality of life

    Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

    The Chinese version of EuroQol-5 Dimensions-levels (EQ-5D-5L) will be used to measure health-related quality of life (HRQOL) in our participants. It comprises 5 items related to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each item has 5 options (no problem, slight problems, moderate problems, severe problems, extreme problems/unable to). It has been found to useful in monitoring HRQOL responses to treatment.

  4. Change of depression, anxiety, and stress

    Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

    The Chinese version of 21-item Depression, Anxiety Stress Scales (DASS) will be used to evaluate depression (7 items), anxiety (7 items), and stress (7 items) in older adults. Each item is rated on a 4-point scale ranging from 0 (not at all) to 3 (most of the time). Double the sum of the subscale raw scores to acquire each subscale's total score. The total score for each subscale ranges from 0 to 42. Higher scores imply more mental health issues. It has been cross-culturally adapted to Hong Kong settings. DASS has demonstrated excellent internal consistency for depression, anxiety, and stress subscales.

  5. Overall perceived changes in symptom severity, treatment response and the efficacy of treatment

    Time frame: Immediately after the 4-week treatment, and at 3- and 6-month post-treatment

    Global impression of change scale will be used to evaluate the overall perceived changes in symptom severity, treatment response, and the efficacy of treatment immediately after the 4-week interventions. The score ranges from 1 (Very much better) to 7 (Very much worse).

  6. Change of psychological flexibility

    Time frame: Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

    The Open and Engaged State Questionnaire will be used to rate participants' experiences over the previous seven days on an 11-point Likert scale (from "not at all" to "very much"). After reverse-scoring Item 3, a total score is calculated by summing all four items. The total score ranges from 0 to 40, with higher scores indicating greater psychological inflexibility.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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