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Набор скоро начнётся NCT07474714

Hyaluronic Acid Injection in Idiopathic Carpal Tunnel Syndrome; is it Effective as Local Corticosteroids

Фаза III С лечением Carpal Tunnel Syndrome (CTS)

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: Low Molecular Weight Hyaluronic Acid, corticosteroid.
Кому может быть актуально
Состояния в реестре: Carpal Tunnel Syndrome (CTS). 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Hyaluronic Acid Injection in Idiopathic Carpal Tunnel Syndrome; is it Effective as Local Corticosteroids? A Comparative Follow up Study

Обзор

This study compares the effectiveness of two types of local injections-Hyaluronic Acid (HA) and corticosteroids-for treating mild to moderate idiopathic Carpal Tunnel Syndrome (CTS). Sixty adult patients will be assigned to receive one of the two injections under ultrasound guidance. The goal is to see if HA is as effective as the standard corticosteroid treatment in improving symptoms and nerve function over a 3-month follow-up period.

Подробное описание

This is a prospective comparative 3-month follow-up study. Sixty adult patients diagnosed with mild or moderate idiopathic CTS by electro-diagnostic studies will be recruited from the Rheumatology and rehabilitation clinic at Minia University Hospitals, Egypt. Participants will be divided into two groups of 30: one receiving low molecular weight hyaluronic acid and the other receiving corticosteroids, both administered via ultrasound-guided perineural injection. Baseline and follow-up assessments at 1- and 3-months post-injection will include the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) scores, electro-diagnostic parameters (sensory and motor latencies, CMAP, etc.), and neuromuscular ultrasound examination (median nerve cross-sectional area, flattening ratio, etc.).

Вмешательства

  • Препарат Low Molecular Weight Hyaluronic Acid
    Ultrasound-guided perineural injection of low molecular weight Hyaluronic Acid.
  • Препарат corticosteroid
    Ultrasound-guided perineural injection of corticosteroids

Первичные конечные точки

  • Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Scores [Срок оценки: Baseline, 1 month, and 3 months post-injection]
  • Change in Electro-diagnostic Parameters [Срок оценки: Time Frame Baseline, 1 month, and 3 months post-injection]
  • Change in Neuromuscular Ultrasound Examination Parameters [Срок оценки: Baseline, 1 month, and 3 months post-injection]

Критерии участия

Критерии включения

  • Numbness or pain in the Median Nerve (MN) distribution.
  • Nerve conduction studies (NCS) consistent with CTS as per the AANEM guidelines.
  • An MN cross-sectional area (CSA) at the wrist >12 mm²

Критерии исключения

  • Patients with severe symptoms (indication for surgery).
  • Patients who show improvement on medical treatment.
  • Patients with previous surgical or injectional CTS treatment.
  • Coexistence of brachial plexopathy, or thoracic outlet syndrome.
  • Patients with infection at the site of injection.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Minia University Hosopital — Minya

Публикации

  • Senna MK, Shaat RM, Ali AAA. Platelet-rich plasma in treatment of patients with idiopathic carpal tunnel syndrome. Clin Rheumatol. 2019 Dec;38(12):3643-3654. doi: 10.1007/s10067-019-04719-7. Epub 2019 Aug 16. PMID 31420812
  • Jiang J, Xing F, Luo R, Liu M. Effectiveness of Platelet-Rich Plasma for Patients With Carpal Tunnel Syndrome: A Systematic Review and meta-Analysis of Current Evidence in Randomized Controlled Trials. Front Pharmacol. 2022 Apr 27;13:834213. doi: 10.3389/fphar.2022.834213. eCollection 2022. PMID 35571114
  • Malahias MA, Nikolaou VS, Johnson EO, Kaseta MK, Kazas ST, Babis GC. Platelet-rich plasma ultrasound-guided injection in the treatment of carpal tunnel syndrome: A placebo-controlled clinical study. J Tissue Eng Regen Med. 2018 Mar;12(3):e1480-e1488. doi: 10.1002/term.2566. Epub 2017 Dec 17. PMID 28873284
  • Cansever U, Koldas Dogan S, Erdem Toslak I, Bilgilisoy Filiz M, Toraman NF. Comparison of the effectiveness of platelet-rich plasma (PRP) injection and steroid injection in patients with bilateral moderate carpal tunnel syndrome: a prospective randomized controlled trial. Injury. 2026 Mar;57(3):113018. doi: 10.1016/j.injury.2026.113018. Epub 2026 Jan 9. PMID 41548406
  • Hong P, Zheng Y, Rai S, Ding Y, Zhou Y, Liu R, Li J. Efficacy and safety of platelet-rich plasma in the treatment of carpal tunnel syndrome: A network meta-analysis of different injection treatments. Front Pharmacol. 2022 Nov 10;13:906075. doi: 10.3389/fphar.2022.906075. eCollection 2022. PMID 36438824
  • Buntragulpoontawee M, Chang KV, Vitoonpong T, Pornjaksawan S, Kitisak K, Saokaew S, Kanchanasurakit S. The Effectiveness and Safety of Commonly Used Injectates for Ultrasound-Guided Hydrodissection Treatment of Peripheral Nerve Entrapment Syndromes: A Systematic Review. Front Pharmacol. 2021 Mar 5;11:621150. doi: 10.3389/fphar.2020.621150. eCollection 2020. PMID 33746745
  • Senlikci HB, Afsar SI, Cosar SN, Kurtcebe AN, Ozen S, Yemisci OU. The effectiveness of single-dose blinded platelet-rich plasma (PRP) vs. corticosteroid injection in mild-to-moderate carpal tunnel syndrome: A prospective, randomized, double blind study. J Bodyw Mov Ther. 2025 Jun;42:995-1001. doi: 10.1016/j.jbmt.2025.01.057. Epub 2025 Jan 31. PMID 40325784
  • Lin CP, Chang KV, Huang YK, Wu WT, Ozcakar L. Regenerative Injections Including 5% Dextrose and Platelet-Rich Plasma for the Treatment of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-Analysis. Pharmaceuticals (Basel). 2020 Mar 18;13(3):49. doi: 10.3390/ph13030049. PMID 32197544

Идентификаторы

NCT: NCT07474714 · 1875/02/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗