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Идёт набор NCT06761300

Psychological Assessment in Patients Treated with Spinal Cord Stimulation

— Наблюдательное Spinal Cord Stimulation (SCS) Chronic 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: Psychological assessment.
Кому может быть актуально
Состояния в реестре: Spinal Cord Stimulation (SCS), Chronic 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
Италия
Следующий шаг
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Официальное название

Psychological Assessment in Patients Suffering from Chronic Pain Treated with Spinal Cord Stimulation

Обзор

This is a prospective observational study to investigate the impact of spinal cord stimulation (SCS) procedure in chronic pain perception and management. Patients' psychological status at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention will be also evaluated. The primary aim is to study the associations between psychological variables and intervention outcomes (pain reduction, satisfaction, removal of SCS). Our hypothesis is that people with higher scores in anxiety and depression symptoms would report lower satisfaction with SCS procedure and higher levels of perceived pain after the implantation of the device

Подробное описание

More than 30% of people worldwide suffer from chronic pain (CP), defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage".

Patients suffering from CP in charge of the Palliative Care and Pain Therapy Division at the European Institute of Oncology IRCCS (Milan, Italy) will be proposed to undergo SCS surgical implantation to mitigate pain symptoms.

The SCS surgical implantation is a two-step procedure; after the hospital admission, a temporary SCS device will be firstly implanted. In this way patients have the possibility to experiment the device impact on their CP conditions, to familiarize with the external device and adjust to its presence, and to eventually grow their motivation toward the implantation of the permanent device. Only after one month, if the patients are convinced of the intervention utility, the temporary device will be changed with a permanent one.

After the medical consultation, patients accepting the surgical procedure and meeting the inclusion criteria will be invited to participate to the study.

Patients signing the Informed Consent will receive a link to complete a set of questionnaires investigating psychological well-being, the impact of chronic pain in daily activities and the decision-making process to undergo to a surgical procedure. Participants who will not be able to complete the online form, will fill it on paper. Patients will complete different questionnaires at different time-points before and after the two-step SCS implantation.

Вмешательства

  • Другое Psychological assessment
    Psychological assessment evaluation at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention.

Первичные конечные точки

  • Evaluation of pain reduction [Срок оценки: 8 months]
  • Evaluation of removal of SCS [Срок оценки: 8 months]
  • Evaluation of satisfaction. [Срок оценки: 8 months]
Вторичные конечные точки (1)
  • The perceived benefits of psychological counseling throughout the care pathway. [Срок оценки: 8 months]

Критерии участия

Критерии включения

  • Patients suffering from chronic pain (VAS>4) from at least 6 months
  • Patient eligible for SCS implantation
  • Age >18 years old
  • Willingness and ability to comply with scheduled visits and other trial procedures
  • Understanding and speaking Italian language
  • Written informed consent

Критерии исключения

  • Psychiatric disorders or conditions that might impair the ability to give informed consent
  • Comorbidity that may impact on compliance to study procedures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Италия · 1 центр
  • European Institute of Oncology — Milan

Публикации

  • Marzorati C, Pezzolato M, Didier F, Borgogni F, Fodor CI, Meneghin S, Guardamagna VA, Pravettoni G. Psychological assessment in patients suffering from chronic pain treated with Spinal Cord Stimulation: A prospective observational study protocol. PLoS One. 2026 Jul 14;21(7):e0352398. doi: 10.1371/journal.pone.0352398. eCollection 2026. PMID 42447077

Идентификаторы

NCT: NCT06761300 · IEO 2028

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗