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

NCT ID: NCT06576414

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-03-01

Brief Summary

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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

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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.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
double-blinded (participants and statistician)

Study Groups

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Older people with online ACT intervention

4 week ACT plus back exercise group

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Intervention Type BEHAVIORAL

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

back exercise

Intervention Type BEHAVIORAL

1 hour of back exercise class led by a trained exercise trainer

Older people without ACT intervention

4-week back exercise control group

Group Type ACTIVE_COMPARATOR

back exercise

Intervention Type BEHAVIORAL

1 hour of back exercise class led by a trained exercise trainer

back care education

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

back exercise

1 hour of back exercise class led by a trained exercise trainer

Intervention Type BEHAVIORAL

back care education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Arnold Wong Yu Lok

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Arnold YL Wong

Hong Kong, None Selected, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Arnold YL Wong

Role: CONTACT

Facility Contacts

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Arnold YL Wong, PhD

Role: primary

Other Identifiers

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HSEARS20240503001

Identifier Type: -

Identifier Source: org_study_id

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