This project aims to assess the feasibility and preliminary efficacy of a supervised group-based art intervention for adults with chronic low back pain (CLBP).
Chronic low back pain (CLBP) is a widespread and debilitating condition that affects millions globally, profoundly impacting individuals' physical, psychological, and social well-being. This pilot randomized controlled trial (RCT) aims to explore the feasibility and potential efficacy of a novel intervention that combines supervised group art therapy with exercise for adults suffering from CLBP. The primary objective of this study is to assess participant recruitment, retention, and adherence while identifying any logistical challenges encountered during the implementation of the intervention. The investigators will gather preliminary data on its effectiveness by measuring changes in pain intensity, functional disability, psychological flexibility, and health-related quality of life (HRQoL). In addition to quantitative measures, the investigators will conduct qualitative interviews and focus groups to explore participants' lived experiences, identifying facilitators and barriers to engagement. By integrating art therapy-an approach that promotes emotional expression and coping strategies-this study seeks to provide a holistic method for pain management, ultimately enhancing the HRQoL of individuals affected by CLBP. The successful implementation of this pilot RCT may yield critical insights that can inform a larger-scale definitive RCT, paving the way for innovative, interdisciplinary strategies in chronic pain management and improving community health outcomes. This research not only aims to validate a new therapeutic approach but also aspires to create a supportive environment for individuals grappling with the challenges of CLBP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
one hour of expressive art intervention followed by one hour of exercise training. The art therapy will be conducted in small groups of eight participants, facilitated by a part-time registered expressive art therapist. Each session begins with a 5-minute introduction and check-in, welcoming participants and inviting them to share their current status. This is followed by a 10-minute brief mindfulness exercise to help center participants and promote relaxation, setting the stage for the creative activities that follow. The core of each session consists of a 20-minute art-making process centered around specific themes that guide participants in exploring their pain and personal narratives.
each one-hour session in the exercise control group will involve progressive back and general reconditioning exercises, along with back care education to support self-management of LBP.
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Hong Kong, Hong Kong, Hong Kong
RECRUITINGThe Hong Kong Polytechnic University
Hong Kong, Kowloon, Hong Kong
NOT_YET_RECRUITINGRecruitment rate
The proportion of eligible participants who agree to enrol in the study.
Time frame: Baseline
Retention Rate
The proportion of participants who complete the full study protocol.
Time frame: Immediately post intervention at 8-week
Proportion of participants adhering to intervention
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.
Time frame: Weekly from week 1 through 8
Acceptability of the Intervention-satisfaction
Participants will rate their satisfaction with the program on a scale from 0 (not satisfied) to 10 (very satisfied).
Time frame: Weekly from week 1 through 8
Acceptability of the Intervention-perceived burden
Participants will rate the perceived burden of the intervention on a scale from 0 (not demanding) to 10 (very demanding).
Time frame: Weekly from week 1 through 8
Acceptability of the Intervention-willingness to continue
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).
Time frame: Weekly from week 1 through 8
Feasibility of Data Collection Procedures
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.
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Time frame: At 3-month post intervention
Safety and Adverse Events
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
Time frame: Weekly from week 1 through 8
Global Impression of Change scale
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.
Time frame: Immediately (at the 8-week timepoint) and at the 3-month follow-up post-intervention
Numeric Pain Rating Scale (NPRS)
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.
Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention
Acceptance and Action Questionnaire II (AAQ-II)
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
Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention
EQ-5D-5L
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.
Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention
Roland Morris Disability Index
The 24-item Chinese version assesses LBP-related disability in CLBP, with scores indicating functional limitations.
Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention
Depression, Anxiety, and Stress Scales (DASS)
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.
Time frame: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention