Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-04-05 @ 1:17 AM
Study NCT ID:
NCT07141069
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Art Therapy for Adults With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible participants will be randomized using computer-generated numbers placed in sealed, opaque envelopes, allocating them into two groups: the expressive art therapy plus exercises group or the exercise-only group on a 1:1 basis. 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'Baseline', 'description': 'The proportion of eligible participants who agree to enrol in the study.'}, {'measure': 'Retention Rate', 'timeFrame': 'Immediately post intervention at 8-week', 'description': 'The proportion of participants who complete the full study protocol.'}, {'measure': 'Proportion of participants adhering to intervention', 'timeFrame': 'Weekly from week 1 through 8', 'description': '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.'}, {'measure': 'Acceptability of the Intervention-satisfaction', 'timeFrame': 'Weekly from week 1 through 8', 'description': 'Participants will rate their satisfaction with the program on a scale from 0 (not satisfied) to 10 (very satisfied).'}, {'measure': 'Acceptability of the Intervention-perceived burden', 'timeFrame': 'Weekly from week 1 through 8', 'description': 'Participants will rate the perceived burden of the intervention on a scale from 0 (not demanding) to 10 (very demanding).'}, {'measure': 'Acceptability of the Intervention-willingness to continue', 'timeFrame': 'Weekly from week 1 through 8', 'description': '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).'}, {'measure': 'Feasibility of Data Collection Procedures', 'timeFrame': 'At 3-month post intervention', 'description': 'This outcome measure will evaluate the feasibility and acceptability of the data collection methods used in the study, including completion rates for outcome assessments.\n\nFeasibility Metrics:\n\nCompletion Rates for Outcome Assessments: The number of completed assessments will be divided by the total number of scheduled assessments to calculate the completion rate.'}, {'measure': 'Safety and Adverse Events', 'timeFrame': 'Weekly from week 1 through 8', 'description': 'This outcome measure will document any adverse events or safety concerns that arise during the study, including:\n\nUndesirable 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.\n\nThese adverse events will be categorized into:\n\nSerious Related Adverse Events Non-Serious Adverse Events\n\nSafety Metrics:\n\nNumber and type of adverse events Proportion of participants who report serious related adverse events Proportion of participants who report non-serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Global Impression of Change scale', 'timeFrame': 'Immediately (at the 8-week timepoint) and at the 3-month follow-up post-intervention', 'description': "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."}, {'measure': 'Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention', 'description': '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.'}, {'measure': 'Acceptance and Action Questionnaire II (AAQ-II)', 'timeFrame': 'Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention', 'description': "This 7-item Chinese version measures participants' psychological flexibility, rated on a 7-point scale, where higher scores indicate less flexibility.\n\nAAQ-II has been cross-culturally adapted and validated among local adolescents and has demonstrated satisfactory internal consistency and test-retest reliability"}, {'measure': 'EQ-5D-5L', 'timeFrame': 'Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention', 'description': "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').\n\nIt has been found to useful in monitoring treatments' effects on HRQoL."}, {'measure': 'Roland Morris Disability Index', 'timeFrame': 'Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention', 'description': 'The 24-item Chinese version assesses LBP-related disability in CLBP, with scores indicating functional limitations.'}, {'measure': 'Depression, Anxiety, and Stress Scales (DASS)', 'timeFrame': 'Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['art therapy', 'expressive art', 'chronic low back pain', 'musculoskeletal diseases', 'physiotherapy practice', 'physical therapists', 'physiotherapists'], 'conditions': ['Chronic Low Back Pain (CLBP)']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nThe 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).\n\nIn 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years to 59 years old\n* currently experiencing non-specific low back pain for at least three months\n* who have sought medical treatment for CLBP\n* can read and write in Traditional Chinese\n\nExclusion Criteria:\n\n* lumbar spinal stenosis\n* confirmed dementia\n* severe cognitive impairment\n* serious major medical or psychiatric disorders\n* currently receiving physiotherapy, cognitive therapy, or psychological treatments'}, 'identificationModule': {'nctId': 'NCT07141069', 'briefTitle': 'Art Therapy for Adults With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'A Pilot Randomized Controlled Trial Exploring the Use of Supervised Group Art Therapy Among Individuals With Chronic Low Back Pain: Feasibility, Potential Efficacy, and Participant Experiences', 'orgStudyIdInfo': {'id': 'HSEARS20250416004'}, 'secondaryIdInfos': [{'id': '1-WZBS', 'type': 'OTHER_GRANT', 'domain': 'Faculty Collaborative Research Scheme between Social Sciences and Health Sciences, The Hong Kong Polytechnic University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expressive art therapy group', 'description': 'One hour of expressive art intervention, followed by exercise training.', 'interventionNames': ['Other: Art therapy combined with Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise group', 'description': 'The control group will participate in one hour of exercises focused on progressive back strengthening and general reconditioning, supplemented with education on back care to promote self-management of low back pain', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Art therapy combined with Exercise', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Expressive art therapy group']}, {'name': 'Exercise', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Fadi MQ Al Zoubi, PhD', 'role': 'CONTACT', 'email': 'fadi.alzoubi@polyu.edu.hk', 'phone': '852 2766 6705'}], 'facility': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'state': 'Kowloon', 'status': 'NOT_YET_RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Fadi Al Zoubi, PhD', 'role': 'CONTACT', 'email': 'fadi.alzoubi@polyu.edu.hk', 'phone': '852-2766-6705'}], 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Fadi MQ Al Zoubi, PhD', 'role': 'CONTACT', 'email': 'fadi.alzoubi@polyu.edu.hk', 'phone': '852-2766-6705'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All personal data will be anonymized. We will minimize our 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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Prof. Fadi AL ZOUBI', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}