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Università politecnica di Hong KongArt Therapy for Adults With Chronic Low Back Pain
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La sperimentazione clinica NCT07141069 è uno studio interventistico per Chronic Low Back Pain (CLBP), attualmente in arruolamento. Avviato il 16 agosto 2025, prevede di arruolare 30 partecipanti. Sotto la guida di l'Università politecnica di Hong Kong, dovrebbe concludersi entro il 1 dicembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 26 agosto 2025.
Sommario breve
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).
Descrizione dettagliata
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.
Titolo ufficiale
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
Condizioni
Chronic Low Back Pain (CLBP)Altri ID dello studio
- HSEARS20250416004
- 1-WZBS (Altro numero di finanziamento) (Faculty Collaborative Research Scheme between Social Sciences and Health Sciences, The Hong Kong Polytechnic University)
Numero NCT
Data di inizio (effettiva)
2025-08-16
Ultimo aggiornamento pubblicato
2025-08-26
Data di completamento (stimata)
2027-12-01
Arruolamento (previsto)
30
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
art therapy
expressive art
chronic low back pain
musculoskeletal diseases
physiotherapy practice
physical therapists
physiotherapists
expressive art
chronic low back pain
musculoskeletal diseases
physiotherapy practice
physical therapists
physiotherapists
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleExpressive art therapy group One hour of expressive art intervention, followed by exercise training. | Art Therapy Combined with Exercise 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. |
Comparatore attivoExercise group 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 | Esercizio 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. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Recruitment rate | The proportion of eligible participants who agree to enrol in the study. | Baseline |
Retention Rate | The proportion of participants who complete the full study protocol. | 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. | 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 |
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 | 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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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. | 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. | 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 | 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. | 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. | 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. | Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention |
Criteri di eleggibilità
Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Tutti
- 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
Università politecnica di Hong Kong209 studi clinici attivi da esplorareParte responsabile dello studio
Prof. Fadi AL ZOUBI, Investigatore principale, Assistant Professor, The Hong Kong Polytechnic University
Contatti principali dello studio
Contatto: Fadi MQ Al Zoubi, PhD, 852-2766-6705, [email protected]
2 Centri dello studio in 1 paesi
Hong Kong
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, Hong Kong, 0000, Hong Kong
Fadi MQ Al Zoubi, PhD, Contatto, 852 2766 6705, [email protected]
In arruolamento
Kowloon
The Hong Kong Polytechnic University, Hong Kong, Kowloon, Hong Kong
Fadi Al Zoubi, PhD, Contatto, 852-2766-6705, [email protected]
Non ancora in arruolamento