Expressive Art Therapy for Elder Adults With Chronic Low Back Pain

Not Applicable

Recruiting

• Conditions: Chronic Low Back Pain

• Registration Number: NCT07141082
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

This research project aims to assess the feasibility of expressive art therapy for elderly adults with chronic low back pain and to evaluate the preliminary efficacy of combining art therapy with exercise intervention. Additionally, the study will investigate facilitators and barriers to participation.

A mixed-methods approach will be employed, including a quantitative questionnaire and qualitative semi-structured focus group discussions. The questionnaire will examine physical, functional, and psychological changes potentially influenced by art therapy, while the focus groups will provide in-depth insights into participants' experiences and perceptions of the combined intervention.

Detailed Description

Chronic low back pain (CLBP) is a common and debilitating condition that affects millions of older adults worldwide, significantly impacting their physical, emotional, and social well-being. This pilot randomized controlled trial (RCT) aims to explore the feasibility and potential effectiveness of a new approach that combines supervised group expressive art therapy with exercise for elderly individuals suffering from CLBP.

The primary goal is to assess participant recruitment, retention, and adherence to intervention. The investigators will also identify any logistical challenges that may arise during the process. To gather preliminary data on the intervention's effectiveness, the investigators will measure changes in pain intensity, functional ability, psychological flexibility, and health-related quality of life (HRQoL).

In addition to quantitative measures, the investigators will conduct qualitative interviews and focus groups to gain deeper insights into the participants' experiences. This will help to identify factors that facilitate or hinder their engagement with the program.

By incorporating expressive art therapy-an approach that encourages emotional expression and coping strategies-this study aims to provide a holistic method for managing pain. The ultimate goal is to enhance the quality of life for older adults affected by CLBP. If successful, this pilot RCT will offer valuable insights that could inform a larger, definitive RCT, paving the way for innovative, interdisciplinary strategies in chronic pain management and improving health outcomes in the community.

Study Timeline

• Study Start: 2025-08-02
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-18
• Study First Posted: 2025-08-26
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-08
• Primary Completion: 2026-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• aged 60 years and above
• currently experiencing non-specific low back pain for at least three months
• who have sought medical treatment for CLBP
• can read and write in Traditional Chinese
• MoCA-5 of 18 or above

Exclusion Criteria

• malignant pain
• lumbar spinal stenosis
• confirmed dementia
• severe cognitive impairment
• serious major medical or psychiatric disorders
• currently receiving physiotherapy, cognitive therapy, or psychological treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment rate	Baseline	The proportion of eligible participants who agree to enrol in the study.
Proportion of Participants Adhering to Intervention	Weekly from week 1 through 8	Intervention adherence will be assessed by the proportion of participants who attended at least 80% of the scheduled group sessions out of the total number randomized. Reasons for non-adherence will be explored through qualitative interviews with participants who did not meet the attendance threshold or discontinued the program prematurely.
Retention Rate of participants	Through study completion, an average of 8 weeks	The proportion of participants who complete the full study protocol.
Acceptability of the Intervention-willingness to continue	Weekly from week 1 through 8	Participants will rate their willingness to continue with the program on a scale from 0 (not willing to continue) to 10 (very willing to continue).
Feasibility of data collection procedures	At 3-month post intervention	This outcome measure will evaluate the feasibility and acceptability of the data collection methods used in the study, including completion rates for outcome assessments.; Feasibility Metrics: Completion Rates for Outcome Assessments: The number of completed assessments will be divided by the total number of scheduled assessments to calculate the completion rate.
Acceptability of the Intervention-satisfaction	Weekly from week 1 through 8	Participants will rate their satisfaction with the program on a scale from 0 (not satisfied) to 10 (very satisfied).
Acceptability of the Intervention-perceived burden	Weekly from week 1 through 8	Participants will rate the perceived burden of the intervention on a scale from 0 (not demanding) to 10 (very demanding).
Safety and Adverse Events of participants	Weekly from week 1 through 8	This outcome measure will document any adverse events or safety concerns that arise during the study, including: Undesirable medical occurrences or problems that a participant experiences during or after the intervention, lasting more than 2 days and/or causing the participant to seek additional treatment.; These adverse events will be categorized into: Serious Related Adverse Events Non-Serious Adverse Events; Safety Metrics: Number and type of adverse events Proportion of participants who report serious related adverse events Proportion of participants who report non-serious adverse events

Secondary Outcome Measures

Name	Time	Method
Acceptance and Action Questionnaire II (AAQ-II)	Baseline, immediately post-intervention, and 3 month follow up post-intervention	This 7-item Chinese version measures participants' psychological flexibility, rated on a 7-point scale, where higher scores indicate less flexibility.; AAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability
Global Impression of Change scale	Immediately post-intervention and at the 3-month follow-up post-intervention	This is a complementary measure allows patients to self-report their impression of the overall change in their condition from the beginning of a study or intervention to the current time point. This provides a global, subjective evaluation of the patient's perceived improvement or worsening of their symptoms or health status. This item has a 7-point rating, with the following response options: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse.
Numeric Pain Rating Scale (NPRS)	Baseline, immediately post-intervention, and 3 month follow up post-intervention	An 11-point scale measuring low back pain intensity, where 0 indicates no pain and 10 indicates 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.
EQ-5D-5L	Baseline, immediately post-intervention, and 3 month follow up post-intervention	The Chinese version of this instrument measures HRQoL across five domains, providing insight into participants' overall well-being.It comprises 5 items related to mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each item has 5 response options (no problem', 'slight problems', 'moderate problems', 'severe problems', and 'extreme problems/unable to').; It has been found to useful in monitoring treatments' effects on HRQoL.
Roland Morris Disability Index (RMDQ)	Baseline, immediately post-intervention, and 3 month follow up post-intervention	The 24-item Chinese version of the Roland-Morris Disability Questionnaire assesses disability related to low back pain (LBP) in individuals with chronic low back pain (CLBP). Scores range from 0 to 24, with higher scores indicating greater functional limitation and worse disability.
Depression, Anxiety, and Stress Scales (DASS)	Baseline, immediately post-intervention, and 3 month follow up post-intervention	The 21-item Chinese version evaluates mental health across three domains, with higher scores indicating greater issues. It has been cross-culturally adapted to Hong Kong settings,demonstrating excellent internal consistency for depression, anxiety, and stress subscales.

Trial Locations

Locations (1)

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong