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Набор скоро начнётся NCT07326982

Ultrasound-Guided Interfascial Hydrodissection for Gluteal Myofascial Pain in Piriformis Syndrome: A Prospective Study

Без фазы С лечением Piriformis Syndrome Gluteus Maximus Myofascial 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: Ultrasound-Guided Interfascial Hydrodissection, Ultrasound-Guided Gluteus Maximus Dry Needling.
Кому может быть актуально
Состояния в реестре: Piriformis Syndrome, Gluteus Maximus Myofascial Pain. Базовые параметры: 18 лет — 75 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Efficacy of Ultrasound-Guided Interfascial Hydrodissection for Myofascial Pain Syndrome of the Gluteus Maximus in Patients With Piriformis Syndrome: A Double-Blind Randomized Controlled Trial.

Обзор

This randomized, double-blind prospective trial investigates whether ultrasound-guided interfascial hydrodissection using 10% dextrose is more effective than dry needling in treating gluteal myofascial pain coexisting with piriformis syndrome. Following diagnostic piriformis injection response, eligible patients will be randomized into two treatment arms and followed at 1 hour, 1 week, 1 month, and 3 months. The primary hypothesis is that interfascial hydrodissection will provide superior long-term analgesic outcomes due to fascial separation, neuromodulation, and nociceptor suppression.

Подробное описание

Piriformis syndrome (PS) is a neuromuscular condition characterized by compression or irritation of the sciatic nerve at the piriformis muscle level. Patients frequently present with unilateral gluteal pain that worsens with prolonged sitting, hip movement, or palpation over the piriformis locus. Although the neuropathic component of PS is attributed to sciatic nerve irritation, the somatic pain component is believed to arise from myofascial dysfunction within gluteal structures, particularly the piriformis muscle.

Recent clinical observations indicate that many patients diagnosed with PS also exhibit features of gluteus maximus myofascial pain syndrome (GM-MPS). The gluteus maximus muscle has a large fascial interface with the piriformis muscle, and nociceptive stimulation originating from this interface may contribute to persistent gluteal pain in PS. Despite this, the fascial contribution to symptom persistence remains poorly investigated, and therapeutic interventions are largely directed toward the piriformis alone.

Interfascial hydrodissection is an emerging ultrasound-guided technique in which liquid is injected between tissue planes to mechanically separate fascial layers, improve gliding, and modulate sensory nociceptive fibers. Dextrose solutions have been increasingly used in ultrasound-guided interfascial injections based on their proposed neuromodulatory and regenerative effects. However, evidence regarding its long-term efficacy in gluteal myofascial pain, particularly when coexisting with PS, is limited.

This prospective, randomized, double-blind clinical trial aims to evaluate the therapeutic effectiveness of interfascial hydrodissection using 10% dextrose solution between the gluteus maximus and piriformis muscles in patients with PS diagnosed through positive diagnostic injection response. Patients with ≥50% pain reduction one hour after diagnostic piriformis injection will be randomized into two treatment groups. Randomization will be performed by an independent co-investigator using a pre-prepared 1:1 allocation list. Outcome assessment will be conducted by an investigator blinded to treatment allocation. Patients will then be assigned to one of the following treatment groups: (1) ultrasound-guided interfascial hydrodissection and (2) dry needling of the gluteus maximus muscle.Both interventions will be performed under ultrasound guidance to ensure accuracy and standardization.

Outcome assessment will include numerical pain scoring, percentage pain reduction, and clinical improvement at one hour, one week, one month, and three months post-intervention. The first assessor will be blinded to treatment allocation, ensuring independent measurement of outcomes. It is hypothesized that interfascial hydrodissection will provide superior long-term pain relief compared with dry needling by separating adhered fascial planes, improving local mobility, and reducing nociceptive drive through dextrose-mediated neuromodulation.

If successful, this trial will provide the first structured evidence evaluating the role of gluteus maximus-piriformis fascial interface treatment in PS and may identify an overlooked pain generator in this common syndrome. Results could expand therapeutic options for PS, support broader application of interfascial hydrodissection, and contribute to clinical understanding of fascial pain mechanisms.

Вмешательства

  • Процедура Ultrasound-Guided Interfascial Hydrodissection
    Ultrasound-guided interfascial hydrodissection is performed in the interfascial plane between the gluteus maximus and piriformis muscles.
  • Процедура Ultrasound-Guided Gluteus Maximus Dry Needling
    Ultrasound-guided dry needling is performed on the gluteus maximus muscle without fluid administration.

Первичные конечные точки

  • Pain Intensity Assessed by Numeric Rating Scale [Срок оценки: 3 months after the intervention]
Вторичные конечные точки (2)
  • Pain Intensity Assessed by Numeric Rating Scale [Срок оценки: 1 week after the intervention]
  • Pain Intensity Assessed by Numeric Rating Scale [Срок оценки: 1 month after the intervention]

Критерии участия

Критерии включения

  • Adults aged 18 to 75 years
  • Buttock pain with or without radiation to the lower extremity
  • Ability to understand and provide written informed consent

Критерии исключения

  • Active lumbar radiculopathy
  • History of hip joint pathology or prior hip surgery
  • Previous injection or dry needling treatment to the gluteal region within the last 3 months
  • Coagulation disorders or use of anticoagulant therapy
  • Pregnancy
  • Local infection at the injection site
  • Inability to complete the study protocol or attend follow-up visits.

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
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine — Istanbul

Публикации

  • Tantanatip A, Patisumpitawong W, Lee S. Comparison of the Effects of Physiologic Saline Interfascial and Lidocaine Trigger Point Injections in Treatment of Myofascial Pain Syndrome: A Double-Blind Randomized Controlled Trial. Arch Rehabil Res Clin Transl. 2021 Mar 9;3(2):100119. doi: 10.1016/j.arrct.2021.100119. eCollection 2021 Jun. PMID 34179755
  • Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71. PMID 25794202
  • Kaga M, Ueda T. Effectiveness of Hydro-Dissection of the Piriformis Muscle Plus Low-Dose Local Anesthetic Injection for Piriformis Syndrome: A Report of 2 Cases. Am J Case Rep. 2022 Feb 6;23:e935346. doi: 10.12659/AJCR.935346. PMID 35124689

Идентификаторы

NCT: NCT07326982 · CTFPIRHD2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗