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

August 27, 2024 updated by: Dr Arnold Wong Yu Lok, The Hong Kong Polytechnic University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • None Selected
      • Hong Kong, None Selected, Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Older people with online ACT intervention
4 week ACT plus back exercise group
Behavioral: Acceptance and Commitment Therapy (ACT)
the first hour of ACT intervention followed by 1 hour of back exercise class, which led by a trained ACT counsellor and a trained exercise trainer
Behavioral: back exercise
1 hour of back exercise class led by a trained exercise trainer
Active Comparator: Older people without ACT intervention
4-week back exercise control group
Behavioral: back exercise
1 hour of back exercise class led by a trained exercise trainer
Behavioral: back care education
1 hour long interactive lesson to participants about LBP-related pathology, disability, psychology, and pain management skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 current moment, in the last 24 hours and the last 3 months.
Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
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.30 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.
Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
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.
Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
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). 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.
Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment
Overall perceived changes in symptom severity, treatment response and the efficacy of treatment
Time Frame: Baseline, 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.
Baseline, immediately after the 4-week treatment, and at 3- and 6-month post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20240503001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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