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Набор скоро начнётся NCT07484100

Efficacy of Proximal Median Nerve Release

Без фазы С лечением Carpal Tunnel Surgery Median Nerve Compression Median Nerve Entrapment

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: Proximal median nerve release, Physiotherapy.
Кому может быть актуально
Состояния в реестре: Carpal Tunnel Surgery, Median Nerve Compression, Median Nerve Entrapment. 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
Финляндия
Следующий шаг
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Официальное название

Efficacy of Operative Versus Conservative Treatment in Proximal Median Nerve Compression

Обзор

A multi-center randomized controlled clinical trial which determines the efficacy of proximal median nerve release in patients with persistent proximal median nerve compression. The primary outcome is patient reported improvement of symptoms on a 7-point Likert scale at 6 months after the randomization to treatment group.

Подробное описание

Carpal tunnel surgery is one of the most common surgeries in upper extremity. Most patients benefit from carpal tunnel surgery, but some patients complain weakness and pain symptoms after surgery. According to a case series by Özdemir et al. (2020), after carpal tunnel surgery up to 13% of patients were diagnosed with proximal median nerve compression. Proximal median nerve compression is a poorly known and recognized condition that is likely to be underdiagnosed. Surgical treatment has become more common in recent years even though the effect of surgical treatment is unclear at the moment.

The planned multi-center randomized controlled clinical trial determines the efficacy of proximal median nerve release in patients with persistent proximal median nerve compression. The primary outcome is patient reported improvement of symptoms on a 7-point Likert scale at 6 months after the randomization to treatment group.

Вмешательства

  • Процедура Proximal median nerve release
    Participants randomized to operative treatment will be scheduled for surgery. During surgery, the proximal median nerve compression will be released in a manner deemed best by the treating surgeon. Patients randomized to surgery will also receive conservative management following surgery.
  • Другое Physiotherapy
    Participants randomized to conservative treatment will receive information about median nerve compression and written instructions for self-directed nerve stretching exercises. There will be one supervision visit with a physiotherapist at the beginning of the treatment period.

Первичные конечные точки

  • Global improvement [Срок оценки: 6 months]
Вторичные конечные точки (12)
  • Global improvement [Срок оценки: 3 months, and 1, 2, 5 years]
  • Global improvement [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • Global improvement [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • Questions on proximal nerve symptoms [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • The use of painkillers [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • EUROQOL EQ-5D-5L [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • Patient reported wrist and hand evaluation (PRWHE) [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • Patient accepted symptom state (PASS) [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • Return to work [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]
  • Adverse effects [Срок оценки: 3 and 6 months, and 1, 2, and 5 years]

Критерии участия

Критерии включения

  • Clinically diagnosed PMNC
  • If the patient has clinically and electrodiagnostically confirmed carpal tunnel syndrome, at least 6 months must have passed since surgical treatment
  • Age 18 or over
  • Ability to understand Finnish
  • Ability to complete electronic questionnaires independently
  • Willingness to participate in research and follow research instructions
  • Provision of informed consent from the participant

Критерии исключения

  • Nerve root disorder findings in ENMG
  • Thoracic outlet syndrome, TOS
  • Other neurological condition that causes upper limb symptoms such as MS, previous nerve injury
  • Active rheumatoid arthritis or any other active inflammatory joint disease that affects hand function
  • Significant compression symptoms of another peripheral nerve in association with PMNC
  • Other upper extremity operation performed less than 6 months ago
  • Another disease or condition that accounts for most of the patient's symptoms
  • Other known reasons that may prevent participation or implementation of treatment during the study

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
Открытое
Основная цель
Лечение

Центры проведения

Финляндия · 2 центра
  • Seinäjoki Central Hospital — Seinäjoki
  • Tampere University Hospital — Tampere

Идентификаторы

NCT: NCT07484100 · R23045

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗