Art Therapy for Adults With Chronic Low Back Pain
- Conditions
- Chronic Low Back Pain (CLBP)
- Registration Number
- NCT07141069
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- aged 18 years to 59 years old
- 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
- 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.
Retention Rate Immediately post intervention at 8-week The proportion of participants who complete the full study protocol.
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).
Safety and Adverse Events 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 eventsProportion 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.
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-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).
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).
- Secondary Outcome Measures
Name Time Method Numeric Pain Rating Scale (NPRS) Baseline, immediately post intervention (at 8th week), 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.
Acceptance and Action Questionnaire II (AAQ-II) Baseline, immediately post intervention (at 8th week), 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 reliabilityEQ-5D-5L Baseline, immediately post intervention (at 8th week), 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 Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention The 24-item Chinese version assesses LBP-related disability in CLBP, with scores indicating functional limitations.
Global Impression of Change scale Immediately (at the 8-week timepoint) 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.
Depression, Anxiety, and Stress Scales (DASS) Baseline, immediately post intervention (at 8th week), 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 (2)
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
🇭🇰Hong Kong, Hong Kong, Hong Kong
The Hong Kong Polytechnic University
🇭🇰Hong Kong, Kowloon, Hong Kong
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University🇭🇰Hong Kong, Hong Kong, Hong KongFadi MQ Al Zoubi, PhDContact852 2766 6705fadi.alzoubi@polyu.edu.hk