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Идёт набор NCT06635213

Effectiveness of Desensitisation and Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain

Без фазы С лечением Carpal Tunnel Syndrome

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: Desensitisation, Pain neuroscience education.
Кому может быть актуально
Состояния в реестре: Carpal Tunnel Syndrome. Базовые параметры: 18 лет — 65 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Determination of the Effectiveness of Desensitisation and Pain Neuroscience Training in Patients With Carpal Tunnel Syndrome With Nosiplastic Pain Phenotype

Обзор

The aim of our study was to determine the effectiveness of desensitisation and pain neuroscience education in a group of patients with mixed phenotype pain (neuropathic and nosiplastic).

Подробное описание

People between the ages of 18-65, diagnosed with Carpal Tunnel Sedrome, who are suitable for the Nosiplastic pain phenotype and who volunteer to participate in the study will be included. The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain will be applied to patients with CTS. After determining the predominant pain phenotype in patients with CTS, patients with mixed type (neuropathic and nosiplastic pain phenotype) will be randomly divided into two groups. One group (Group 1) will receive desensitisation and the other group (Group 2) will receive desensitisation and pain neuroscience education. Numerical rating scale (NRS) will be used for pain assessment. Boston Carpal Tunnel Questionnaire - Symptom Severity Scale will be used for symptom severity assessment and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used for functional status assessment. Pressure pain threshold will be measured with an algometer to evaluate hypersensitivity. The Pain Catastrophising Scale and the Tampa Kinesiophobia Scale will be administered to the patients. Normality of the data distribution will be assessed using the Shapiro-Wilk test. Fischer's exact test and chi-square test will be used to verify the relationship between categorical variables. A mixed model ANOVA will be performed on 2 (group 1 and group 2) x 3 (time: baseline, post-intervention, 3 months post-intervention) different outcome measures (pain intensity, symptom severity, functional status, pain catastrophising and kinesiophobia) to detect between-group differences.

Вмешательства

  • Другое Desensitisation
    This technique is utilized to decrease, or normalize, the body's response to particular sensations.
  • Другое Pain neuroscience education
    PNE is an educational intervention aiming to alter a patient's beliefs and cognitions regarding their pain experience.

Первичные конечные точки

  • Pressure Paın Threshold Measurement [Срок оценки: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Boston Carpal Tunnel Questionnaire - Symptom Severity Scale [Срок оценки: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Boston Carpal Tunnel Questionnaire - Functional Status Scale [Срок оценки: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Pain Catastrophising Scale [Срок оценки: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Tampa Kinesiophobia Scale [Срок оценки: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
  • Numerical Rating Scale [Срок оценки: [at the beginning of the study] [At the end of 6 weeks] [3 months later]]
Вторичные конечные точки (5)
  • Cold Pain Threshold [Срок оценки: 2 minutes]
  • Hot Pain Threshold [Срок оценки: 2 minutes]
  • Pressure Pain Threshold [Срок оценки: 3 minutes]
  • Mechanical Pain Threshold [Срок оценки: 3 minutes]
  • Dynamic Mechanical Allodynia [Срок оценки: 3 minutes]

Критерии участия

Критерии включения

  • Being diagnosed with CTS
  • Being suitable for the nosiplastic pain phenotype
  • Being between the ages of 18-65
  • Volunteering to participate in the study

Критерии исключения

  • Having systemic inflammatory disease
  • Having a disease that may cause polyneuropathy such as diabetes mellitus
  • Having a pacemaker
  • Having a disease affecting the central nervous system
  • Having cervical radiculopathy
  • History of previous operation or local steroid injection due to CTS
  • Hypersensitivity to heat and cold

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
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Kutahya Health Science University — Kütahya

Идентификаторы

NCT: NCT06635213 · 2024-b

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗