Potential of Virtual Reality in Primary 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: Pain science education and virtual reality.
- Кому может быть актуально
- Состояния в реестре: Low Back Pain. Базовые параметры: от 18 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
- Португалия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is a single-case experimental design study enrolling individuals with chronic low back pain who will be receiving pain science education and virtual reality over 3 weeks.
Подробное описание
The main objective of this study is to evaluate the potential of virtual reality in reducing pain intensity in individuals with primary chronic low back pain. Secondary objectives include analysing the impact of virtual reality on pain catastrophizing and fear of movement, as well as exploring participants' perspectives on the integration of virtual reality into the intervention plan.
The study will be divided into three phases: baseline assessment, intervention, and post-intervention assessment. The baseline assessment phase will have a different duration for each participant.
At baseline, participants will complete several paper-based questionnaires (sociodemographic and anthropometric data; pain location, intensity and characteristics; pain catastrophizing; fear of movement; pain during movement; and pain-related disability). After completing all questionnaires, participants will receive a paper diary to complete daily at home. This diary will record information such as pain intensity, fear of movement, and pain catastrophizing.
Participants will return to the office only on the first day of the intervention phase, which will coincide with the first session. Sessions will be individual, will last between 30 and 45 minutes, and will take place with an interval of one to two days. The intervention phase will end on the 29th day of the study for all participants and consists of pain science education and virtual reality.
On the final day of the study (i.e., the 35th day), participants will complete the same questionnaires administered at baseline, with the addition of the Global Perceived Effect scale. At that time, the diary provided at the beginning of the study will be collected.
Вмешательства
- Другое Pain science education and virtual reality
The intervention period will take place between the 5th and the 29th day of the study (i.e., 3 weeks), noting that each participant will have a specific day to start the intervention. Three sessions will be conducted per week, with a total of 6 to 10 sessions per participant. The first 6 sessions will last 45 minutes, and the remaining 4 sessions will last 30 minutes. The sessions will combine Pain Neuroscience Education (PNE) and Virtual Reality (VR) using the Meta Quest 3S.
Первичные конечные точки
- Pain intensity [Срок оценки: Baseline (Day 1)]
- Pain intensity [Срок оценки: Daily (from day 1 to day 35)]
- Pain intensity [Срок оценки: End of the intervention (day 35)]
Вторичные конечные точки (12)
- pain mechanism [Срок оценки: Baseline (day 1)]
- pain mechanism [Срок оценки: End of the intervention (day 35)]
- Pain intensity during movement [Срок оценки: Baseline (day 1)]
- Pain intensity during movement [Срок оценки: End of the intervention (day 35)]
- Perceived disability [Срок оценки: Baseline (day 1)]
- Perceived disability [Срок оценки: End of the intervention (day 35)]
- Catastrophizing [Срок оценки: Baseline (day 1)]
- Catastrophizing [Срок оценки: End of the intervention (day 35)]
- Fear of movement [Срок оценки: Baseline (day 1)]
- Fear of movement [Срок оценки: End of the intervention (day 35)]
- Knowledge on pain neurophysiology [Срок оценки: Baseline (day 1)]
- Knowledge on pain neurophysiology [Срок оценки: End of the intervention (day 35)]
Критерии участия
Критерии включения
- Individuals with primary chronic low back pain aged ≥18 years, who present a moderate pain intensity (≥4 on the Numeric Pain Rating Scale) and a mild level of fear of movement.
Критерии исключения
- have a diagnosis of spondylolisthesis or lumbar spinal stenosis;
- are experiencing an exacerbation of low back pain symptoms at the time of screening;
- present with constant and widespread nonspecific pain;
- are in an active phase of rheumatoid arthritis;
- have a progressive neurological disease;
- are currently pregnant or within 6 months postpartum;
- have a diagnosed psychiatric disorder;
- have a malignant disease;
- have serious cardiac conditions;
- have contraindications to physical exercise in general;
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Португалия · 1 центр
- General Community — Amarante
Идентификаторы
NCT: NCT07742111 · 25-CEIC-UA/2025-M