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| ID | Type | Description | Link |
|---|---|---|---|
| 1-WZBS | Other Grant/Funding Number | Faculty Collaborative Research Scheme between Social Sciences and Health Sciences, The Hong Kong Polytechnic University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Expressive art therapy | Experimental | One hour of expressive art therapy followed by exercise session. |
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| Control Group: Exercise | Active Comparator | The control group will be a one-hour session that includes progressive back strengthening and general reconditioning exercises, complemented by education on back care to support self-management of low back pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Art therapy combined with Exercise | Other | The intervention program consists of one hour of expressive art intervention followed by one hour of exercise training. Art therapy sessions 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 encouraging them to share their current status. This is followed by a 10-minute mindfulness exercise designed to center participants and promote relaxation, preparing them for the creative activities ahead. The core of each session features a 20-minute art-making process focused on specific themes that guide participants in exploring their pain and personal narratives. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The proportion of eligible participants who agree to enrol in the study. | Baseline |
| Retention Rate of participants | The proportion of participants who complete the full study protocol. | Through study completion, an average of 8 weeks |
| 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. | 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). | 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). | 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). | Weekly from week 1 through 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fadi Al Zoubi, PhD | Contact | 852-2766-6705 | fadi.alzoubi@polyu.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Sciences, The Hong Kong Polytechnic University | Recruiting | Hong Kong | Hong Kong |
All personal data will be anonymized. The investigators will minimize the use of personal data in the study as much as possible. The data will be kept for 5 years after project completion, with limited access by Dr. Fadi Al Zoubi.
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Eligible participants will be randomized using cluster randomization, allocating them into two groups: the expressive art therapy plus exercises group or the exercise-only group. A research assistant not involved in the study will manage allocation. Randomization will stratify participants based on sex and functional level to ensure balanced representation in both groups.
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| Exercise | Other | 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. |
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| 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. |
| At 3-month post intervention |
| Safety and Adverse Events of participants | 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 | Weekly from week 1 through 8 |
| Immediately post-intervention 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. | Baseline, immediately post-intervention, 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 | Baseline, immediately post-intervention, 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. | Baseline, immediately post-intervention, and 3 month follow up post-intervention |
| Roland Morris Disability Index (RMDQ) | 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. | Baseline, immediately post-intervention, 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. | Baseline, immediately post-intervention, and 3 month follow up post-intervention |