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Набор скоро начнётся NCT06713005

The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency

Без фазы С лечением Suprascapular Nerve Shoulder Impingement Syndrome Pulsed Radiofrequency 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: suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve, suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve.
Кому может быть актуально
Состояния в реестре: Suprascapular Nerve, Shoulder Impingement Syndrome, Pulsed Radiofrequency, Chronic Pain. Базовые параметры: 18 лет — 80 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

The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency Treatment in Chronic Soulder Pain

Обзор

Chronic shoulder pain due to impingement syndrome and supraspinatus tendinosis is a debilitating condition. Suprascapular nerve innervates most part of shoulder joint. Supraspinatus nerve block can be used as a part of pain therapy. However, its efficacy is short-lasting. To prolong analgesia, short bursts of electrical stimulation to suprascapular nerve may be applied. To the date there is no consensus about duration of these type of stimulation. Investigators' aim is to investigate efficacy of two different duration of stimulation (pulsed radiofrequency) on chronic shoulder pain.

Подробное описание

Pulsed radiofrequency (pRF) treatment of suprascapular nerve can be used successfully to alleviate pain due to shoulder impingement syndrome and supraspinatus tendinosis. Radiofrequency waves produced by radiofrequency (RF) generator through pRF modality are applied to suprascapular nerve and create magnetic field. This field leads to pain modulation by changing neuronal activity and resulting in long term depression of pain transmitting nerve fibers. Temperature around nerve never exceeds 42 degree and by this way the nerve can be protected from coagulation necrosis and demiyelinisation. pRF can be used in the treatment of mixed type nerves such as suprascapular nerve. There are preclinical and clinical studies which report that with longer pRF duration, more favorable analgesia. Suprascapular pRF is performed with 22G, 10 cm, 5 mm active lead RF needle via USG guided posterior approach as institution procotol. Howeveri clinicians can choose any duration of pRF. Instution's pain medicine practitioners HAU and GEO choose 4 and 9 minutes of pRF duration, respectively. Investigators' aim is to investigate the efficacy of two different pRF duration, 4 and 9 minutes, on Shoulder Pain and Disability Index (SPADI) and Numeric Rating Scale-11(NRS-11) at 3 month follow-up.

Вмешательства

  • Процедура suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve
    suprascapular nerve pulsed rf
  • Процедура suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve
    suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve

Первичные конечные точки

  • Postprocedure 3th month pain severity [Срок оценки: From procedure to 3 months after prodecure]
Вторичные конечные точки (5)
  • Postprocedure pain severity at first week [Срок оценки: From procedure to 1 week after procedure]
  • Postprocedure first month pain severity [Срок оценки: From procedure to 1 month after procedure]
  • Postprocedure SPADI scores at first week [Срок оценки: From procedure to 1 week after procedure]
  • Postprocedure first month SPADI scores [Срок оценки: From procedure to 1 month after procedure]
  • Postprocedure 3th month SPADI scores [Срок оценки: From procedure to 3 month after procedure]

Критерии участия

Критерии включения

  • Patients aged 18-80 years
  • Shoulder pain caused by impingement syndrome
  • Shoulder pain due to supraspinatus tendinosis
  • Diagnosis of impingement syndrome and supraspinatus tendinosis confirmed through physical examination and radiological imaging (MRI)
  • Pain persisting for 3 months or longer
  • Numeric Pain Rating Scale (NRS) score of 4 or higher despite conservative treatment

Критерии исключения

  • Patients unwilling to participate in the study
  • Presence of chronic pain due to other conditions
  • Presence of cervical radiculopathy
  • History of opioid use
  • Uncontrolled diabetes (HbA1c > 8)
  • History of shoulder surgery on the affected side
  • Uncontrolled psychiatric disorders despite medical treatment
  • History of cancer
  • History of stroke

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara University — Ankara

Публикации

  • Gupta SK, Ghai B, Makkar JK, Dhiman D, Chouhan DK. Effectiveness of ultrasound-guided pulsed radiofrequency ablation of suprascapular nerve versus local anaesthetics with steroids in patients with chronic shoulder pain: A randomised controlled trial. Indian J Anaesth. 2024 Aug;68(8):731-734. doi: 10.4103/ija.ija_939_23. Epub 2024 Jul 2. No abstract available. PMID 39176114

Идентификаторы

NCT: NCT06713005 · 2024/765

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗