Art Therapy for Adults With Chronic Low Back Pain
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Art therapy combined with Exercise, Exercise.
- Кому может быть актуально
- Состояния в реестре: Chronic Low Back Pain (CLBP). Базовые параметры: 18 лет — 59 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Гонконг
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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).
Подробное описание
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.
Вмешательства
- Другое 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 - Другое Exercise
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.
Первичные конечные точки
- Recruitment rate [Срок оценки: Baseline]
- Retention Rate [Срок оценки: Immediately post intervention at 8-week]
- Proportion of participants adhering to intervention [Срок оценки: Weekly from week 1 through 8]
- Acceptability of the Intervention-satisfaction [Срок оценки: Weekly from week 1 through 8]
- Acceptability of the Intervention-perceived burden [Срок оценки: Weekly from week 1 through 8]
- Acceptability of the Intervention-willingness to continue [Срок оценки: Weekly from week 1 through 8]
- Feasibility of Data Collection Procedures [Срок оценки: At 3-month post intervention]
- Safety and Adverse Events [Срок оценки: Weekly from week 1 through 8]
Вторичные конечные точки (6)
- Global Impression of Change scale [Срок оценки: Immediately (at the 8-week timepoint) and at the 3-month follow-up post-intervention]
- Numeric Pain Rating Scale (NPRS) [Срок оценки: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]
- Acceptance and Action Questionnaire II (AAQ-II) [Срок оценки: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]
- EQ-5D-5L [Срок оценки: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]
- Roland Morris Disability Index [Срок оценки: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]
- Depression, Anxiety, and Stress Scales (DASS) [Срок оценки: Baseline, immediately post intervention (at 8th week), and 3 month follow up post intervention]
Критерии участия
Критерии включения
- 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
Критерии исключения
- lumbar spinal stenosis
- confirmed dementia
- severe cognitive impairment
- serious major medical or psychiatric disorders
- currently receiving physiotherapy, cognitive therapy, or psychological treatments
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Гонконг · 2 центра
- Department of Rehabilitation Sciences, The Hong Kong Polytechnic University — Гонконг
- The Hong Kong Polytechnic University — Гонконг
Идентификаторы
NCT: NCT07141069 · HSEARS20250416004 · 1-WZBS