Virtual Walking to Reduce Chronic Neuropathic Pain in Subjects With SCI
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Virtual Walking, Sham Virtual Walking.
- Кому может быть актуально
- Состояния в реестре: Spinal Cord Injuries (SCI), Neuropathic Pain Due to Spinal Cord Injury. Базовые параметры: 18 лет — 75 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
- Швейцария
- Следующий шаг
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Официальное название
Virtual Walking With Habitual Feedback to Reduce Chronic Neuropathic Pain in Individuals With Spinal Cord Injury
Обзор
About 70% of people with a spinal cord injury in Switzerland have chronic pain that lasts more than 3 to 6 months. This pain can be caused by muscle or joint problems, or by nerve damage (neuropathic pain). Neuropathic pain is often hard to treat, and current treatments may cause side effects or not work well. This study will test whether virtual walking from different visual perspectives can reduce chronic neuropathic pain and improve quality of life after spinal cord injury. We will also compare which perspective works best. To better understand how the training works, we will use two tests-quantitative sensory testing (QST) and contact heat-evoked potentials (CHEPs)-to measure changes in the pain and nerve systems.
Подробное описание
Chronic pain conditions are highly prevalent in the Swiss spinal cord injury (SCI) population with a prevalence of 73% (Müller et al., 2017). Most of those individuals show multiple pain modalities (neuropathic, nociceptive and unknown pain type) (Mahnig et al., 2016; Siddall et al., 2003). For example, Mahnig et al. (2016) reported prevalences of 79% neuropathic and 61% nociceptive pain in individuals with SCI seen in a pain clinic. The current practice of pharmacological first- and second-line treatments comes along with many side effects and unsatisfactory results (Finnerup et al., 2015). This is because the underlying biology of chronic neuropathic pain (NeP) and the mechanisms that lead to chronification of pain are highly complex and not fully understood. Latest research suggests that chronification of pain is associated with anatomical and functional reorganization of the brain (Reckziegel et al., 2019; Wrigley et al., 2009). More specifically, cortical grey matter density changes and neuroanatomical reorganization of the primary somatosensory cortex are discussed as factors associated with pain chronification. Additional mechanisms proposed to explain NeP after SCI include spinal cord plasticity, supraspinal reorganization, and increased neuronal excitability of dorsal horn neurons (Finnerup, 2013).
MRI data show, that there is a correlation between the grade of cortical reorganisation and pain intensity in people with complete SCI (Gustin et al., 2023). However, it is unclear whether there is a systematic influence of the severity of the SCI lesion, graded by the American Spinal Injury Association (ASIA) Impairment Scale (complete or incomplete SCI), on pain intensity.
Alongside with studies about pain mechanisms and improved pharmaceutical treatment, non-invasive and non-pharmacological alternative treatments with minimal side effects have been investigated, such as, for example virtual reality (VR). Changes of pain perception due to VR interventions in individuals with neuropathic spinal cord injury pain (SCIP) are described in the literature (Eick \& Richardson, 2015; Kumru et al., 2013; Moseley, 2007; Özkul et al., 2015; Soler et al., 2010; Trost et al., 2022). Recent reviews have shown good short-term effects of VR in the treatment of SCIP (Chi et al., 2019; de Araújo et al., 2019). However, there is lack of evidence from randomized controlled trials.
Chronic pain in SCI is often modulated by psycho-social factors such as depression, anxiety, extent of social support and pain catastrophising (Braunwalder et al., 2022; Braunwalder et al., 2021; Müller et al., 2017; Wollaars et al., 2007). Data about the influence of psycho-social factors on VR therapy are only reported for VR therapy in first person perspective (Trost et al., 2022). Data about the influence of psycho-social factors third person perspective are not available.
Recently, a virtual walking (VW) treatment protocol in third person perspective inclusive an additional haptic feedback modality (controlled movement of the wheelchair seat to improve the walking immersion) has been set up and evaluated within a feasibility study with individuals with SCIP, reporting a high level of satisfaction and acceptance of the VW procedure at the Centre for Pain Medicine, Swiss Paraplegic Centre (SPC), Nottwil. In this uncontrolled explorative trial, there was a tendency towards reduced pain intensity and spread of reported pain after VW (Aerni, 2020).
To better understand individual responses to VR and explore underlying pain mechanisms, neurophysiological assessments such as quantitative sensory testing (QST) and contact heat-evoked potentials (CHEPs) are used as biomarkers to identify sensory phenotypes.
To address the challenges of assessing and treating pain following SCI, the systematic evaluation of all somatosensory submodalities is strongly recommended for both pathophysiological research and treatment trials in individuals with SCI-related pain (Finnerup, 2013).
Landmann et al. (2024) demonstrated that QST can identify distinct sensory phenotypes in individuals with neuropathic spinal cord injury pain (SCIP). Furthermore, the combination of QST and CHEPs enables objective and standardized measurement of sensory system alterations, thereby contributing to a better understanding of underlying mechanisms (Opsommer et al., 2021).
The aim of the present study is to evaluate (1) the efficiency of the standardised VW-setting with regard to pain reduction in subjects with complete and incomplete SCI, (2) bio-psycho-social prognostic factors which may influence the efficacy of VR, and (3) the influence of VR on psycho-social characteristics of subjects with SCI and (4) to identify pain and sensory phenotypes in individuals with SCIP and examine whether these phenotypes are associated with differential effects of VR on pain reduction..
Вмешательства
- Поведенческое Virtual Walking
This virtual walking therapy uses a life-sized video avatar of the participant walking through a forest environment. A green screen setup combines a live video of the participant's upper body with pre-recorded walking legs, creating a full-body walking illusion. The participant is seated in a modified wheelchair that tilts 2° to each side to mimic pelvic movement during walking. This approach differs from the sham condition (Group 2), which displays only the moving forest without an avatar or wh - Поведенческое Sham Virtual Walking
Participants view a moving forest environment on a large projection screen for 10 sessions over 2 weeks (each up to 20 minutes). No avatar of the participant is displayed, and the wheelchair tilt function is disabled. This differs from the experimental intervention (Group 1), which includes a life-sized walking avatar and wheelchair tilt to mimic pelvic movement, and from the standard care group (Group 3), which receives no virtual walking therapy.
Первичные конечные точки
- Proportion of participants with a clinically meaningful reduction in average pain intensity [Срок оценки: 15 weeks]
Вторичные конечные точки (12)
- Change in pain distribution [Срок оценки: Baseline (1 week before intervention) to 2, 3, 4, 7, and 15 weeks after start of intervention]
- Change in pain distribution [Срок оценки: Baseline (1 week before intervention) to 2, 3, 4, 7, and 15 weeks after start of intervention]
- Pain interference, diagnosis, type, and duration [Срок оценки: Baseline, 4 and 12 weeks post-treatment]
- Neuropathic pain quality [Срок оценки: Baseline, 4 and 12 weeks post-treatment]
- Severity of chronic pain [Срок оценки: Baseline, 4 and 12 weeks post-treatment]
- Pain chronicity [Срок оценки: Baseline, 4 and 12 weeks post-treatment]
- General health-related quality of life [Срок оценки: Baseline, 4 and 12 weeks post-treatment]
- General well-being [Срок оценки: Baseline, 4 and 12 weeks post-treatment]
- Pain catastrophizing [Срок оценки: Baseline, 4 and 12 weeks post-treatment]
- Depression, anxiety, and stress [Срок оценки: Baseline, 4 and 12 weeks post-treatment]
- Subjective impression of change [Срок оценки: 4 and 12 weeks post-treatment]
- Experienced emotions [Срок оценки: Baseline, 4 and 12 weeks post-treatment]
Критерии участия
Критерии включения
- Sufficient knowledge of German language to understand the instructions, assessments and to fill in questionnaires.
- Age ≥ 18y, ≤ 75y
- Chronic traumatic or non-traumatic SCI (>6 month after SCI) with an SCI severity grade AIS A, B, C or D
- At or below level spinal cord injury neuropathic pain on trunk or lower extremities diagnosed by a neurologist following the ISCIP classification (Bryce et al., 2012) of at least 4/10 intensity on a NRS (Langford et al., 2023)
- Ability to draw with a pen
Критерии исключения
- \- Serious psychiatric disorders, which are accompanied by imminent or current acute harm to oneself or others, or which require inpatient psychiatric treatment for other reasons, or other indications of a foreseeable, seriously harmful effect of participation in the study based on the clinical impression from the psychological screening interview
- Participants with a walking ability more than 5 minutes without walking aids
- Pregnancy (anamnestic) in women of child-bearing age (18-49 years)
- Known epilepsy
- neurological disorders (multiple sclerosis, ALS, Guillan-Barré Syndrome, congenital disorders, polyneuropathy)
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Швейцария · 1 центр
- Schweizer Paraplegiker Zentrum Nottwil — Nottwil
Публикации
- Mahnig S, Landmann G, Stockinger L, Opsommer E. Pain assessment according to the International Spinal Cord Injury Pain classification in patients with spinal cord injury referred to a multidisciplinary pain center. Spinal Cord. 2016 Oct;54(10):809-815. doi: 10.1038/sc.2015.219. Epub 2016 Jan 12. PMID 26754471
- Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7. PMID 25575710
- Finnerup NB. Pain in patients with spinal cord injury. Pain. 2013 Dec;154 Suppl 1:S71-S76. doi: 10.1016/j.pain.2012.12.007. Epub 2012 Dec 22. PMID 23375163
- Wydenkeller S, Maurizio S, Dietz V, Halder P. Neuropathic pain in spinal cord injury: significance of clinical and electrophysiological measures. Eur J Neurosci. 2009 Jul;30(1):91-9. doi: 10.1111/j.1460-9568.2009.06801.x. Epub 2009 Jun 25. PMID 19558605
- Wrigley PJ, Press SR, Gustin SM, Macefield VG, Gandevia SC, Cousins MJ, Middleton JW, Henderson LA, Siddall PJ. Neuropathic pain and primary somatosensory cortex reorganization following spinal cord injury. Pain. 2009 Jan;141(1-2):52-9. doi: 10.1016/j.pain.2008.10.007. Epub 2008 Nov 21. PMID 19027233
- Widerstrom-Noga E, Biering-Sorensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Rosner J, Taylor J. The international spinal cord injury pain basic data set (version 3.0). Spinal Cord. 2023 Oct;61(10):536-540. doi: 10.1038/s41393-023-00919-w. Epub 2023 Jul 25. PMID 37491608
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Идентификаторы
NCT: NCT07165353 · 2023-17