Chronic Low Back PainNCT07141082
Expressive Art Therapy for Elder Adults With Chronic Low Back Pain
A study testing Art therapy combined with Exercise and Exercise in people with Chronic Low Back Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Art therapy combined with Exercise and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Aug 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- malignant pain
- lumbar spinal stenosis
- confirmed dementia
- severe cognitive impairment
- serious major medical or psychiatric disorders
- currently receiving physiotherapy, cognitive therapy, or psychological treatments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Hong Kong
Fadi MQ Al Zoubi, PhD, 852 2766 6705, fadi.alzoubi@polyu.edu.hk
Fadi MQ Al Zoubi, PhD
About this study
Official title: A Pilot Randomized Controlled Trial Exploring the Use of Supervised Group Art Therapy Among Older Adults With Chronic Low Back Pain: Feasibility, Potential Efficacy, and Participant Experiences
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Art therapy combined with Exercise, Exercise
- Keywords
- art therapy, expressive art, chronic low back pain, Musculoskeletal Diseases, physiotherapy practice, Physical therapists, Physiotherapists
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapy combined with ExerciseOther
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.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Expressive art therapy | Experimental | One hour of expressive art therapy followed by exercise session. Receives: Other: Exercise |
| 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. Receives: Other: Art therapy combined with Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The proportion of eligible participants who agree to enrol in the study.
Measured: Baseline
Retention Rate of participants
The proportion of participants who complete the full study protocol.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: Weekly from week 1 through 8
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately post-intervention, and 3 month follow up post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start2 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Fadi AL ZOUBI, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141082
- Sponsor's protocol ID
- HSEARS20250416004-01
- Other IDs
- 1-WZBS
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Exploring the Use of Supervised Group Art Therapy Among Older Adults With Chronic Low Back Pain: Feasibility, Potential Efficacy, and Participant Experiences
- ClinicalTrials.gov ID
- NCT07141082
- Acronym / sponsor ID
- HSEARS20250416004-01
- Conditions
- Chronic Low Back Pain
- Keywords
- art therapy, expressive art, chronic low back pain, Musculoskeletal Diseases, physiotherapy practice, Physical therapists, Physiotherapists
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Expressive art therapy | Experimental | Other: ExerciseOne hour of expressive art therapy followed by exercise session. |
| Control Group: Exercise | Active comparator | Other: Art therapy combined with ExerciseThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- malignant pain
- lumbar spinal stenosis
- confirmed dementia
- severe cognitive impairment
- serious major medical or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art therapy combined with ExerciseThe 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. | Other | Control Group: Exercise |
| Exerciseeach 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. | Other | Experimental: Expressive art therapy |
Primary outcome
Recruitment rate
Time frame: Baseline
The proportion of eligible participants who agree to enrol in the study.
Retention Rate of participants
Time frame: Through study completion, an average of 8 weeks
The proportion of participants who complete the full study protocol.
Proportion of Participants Adhering to Intervention
Time frame: 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.
Acceptability of the Intervention-satisfaction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Safety and Adverse Events of participants
Time frame: 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
6 secondary outcomes
Global Impression of Change scale
Time frame: Immediately post-intervention and at the 3-month follow-up post-intervention
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, immediately post-intervention, and 3 month follow up post-intervention
Acceptance and Action Questionnaire II (AAQ-II)
Time frame: Baseline, immediately post-intervention, and 3 month follow up post-intervention
EQ-5D-5L
Time frame: Baseline, immediately post-intervention, and 3 month follow up post-intervention
Roland Morris Disability Index (RMDQ)
Time frame: Baseline, immediately post-intervention, and 3 month follow up post-intervention
Depression, Anxiety, and Stress Scales (DASS)
Time frame: Baseline, immediately post-intervention, and 3 month follow up post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy combined with Exercise and Exercise in people with Chronic Low Back Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fadi Al Zoubi, PhD (852-2766-6705, fadi.alzoubi@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.