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Идёт набор NCT07633730

Efficacy of the Erector Spinae Plane Block for Persistent Back Pain in Patients With Ankylosing Spondylitis

Без фазы С лечением Ankylosing Spondylitis (AS) Back Pain ESPB Regional Anesthesia

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: Erector spinae plane block(ESBP).
Кому может быть актуально
Состояния в реестре: Ankylosing Spondylitis (AS), Back Pain, ESPB, Regional Anesthesia. 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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Обзор

Despite adequate control of disease activity with standard medical therapies, there remains an ongoing need for complementary and interventional approaches for the management of persistent back pain in patients with ankylosing spondylitis. Although the erector spinae plane block has been described in the literature as a safe and effective analgesic intervention for chronic back pain in various patient populations, to the best of our knowledge, no clinical study has specifically evaluated its use for persistent back pain in patients with ankylosing spondylitis receiving medical treatment. Therefore, the present study aims to evaluate the effects of erector spinae plane block on pain severity and clinical outcomes in patients with ankylosing spondylitis whose disease activity is controlled under treatment but who continue to experience persistent back pain.

Подробное описание

Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease primarily affecting the axial skeleton, including the spine and sacroiliac joints. The most prominent clinical manifestations of AS are chronic back pain and progressive spinal stiffness; however, the disease may also involve peripheral joints and entheses.

The primary goals in the management of AS are to reduce pain and stiffness, preserve functional capacity, and decrease overall disease burden. Nonsteroidal anti-inflammatory drugs (NSAIDs) constitute the first-line treatment, while biologic agents and disease-modifying antirheumatic drugs (DMARDs) are used in appropriate patients.

Back pain in AS represents one of the hallmark symptoms of the disease and mainly arises from inflammation involving the spine and sacroiliac joints. This symptom is frequently associated with functional impairment and reduced quality of life.

Although contemporary treatment strategies can effectively suppress disease activity in many patients, a subset of individuals continue to experience persistent symptoms and disease burden despite treatment, a condition commonly referred to as "residual disease." Residual symptoms are frequently reported even in patients achieving clinical remission or low disease activity, and a considerable proportion of these patients continue to suffer from ongoing pain. Therefore, persistent back pain despite controlled disease activity has emerged as an important unmet clinical need, potentially associated not only with inflammatory mechanisms but also with accompanying mechanical factors and comorbid conditions.

The erector spinae plane (ESP) block is a regional analgesic technique performed under ultrasound guidance by advancing the needle tip into the fascial plane deep to the erector spinae muscle at the level of the transverse process, followed by injection of local anesthetic and steroid agents. Owing to the cranio-caudal spread of the injectate, the ESP block can provide analgesia across multiple dermatomes. In patients with persistent back pain, ESP block has been described as a complementary interventional option administered at thoracic or lumbar levels, either as a single or repeated procedure depending on the clinical scenario, with the aims of reducing pain severity, improving functional status, and decreasing analgesic requirements. However, the current evidence remains limited for many chronic pain indications, consisting predominantly of case reports, case series, and a limited number of clinical studies.

The present study aims to evaluate the effects of erector spinae plane block on pain severity and clinical outcomes in patients with ankylosing spondylitis whose disease activity is adequately controlled under medical treatment but who continue to experience persistent back pain.

Вмешательства

  • Процедура Erector spinae plane block(ESBP)
    The procedure will be performed in the prone position under sterile conditions and ultrasound guidance. Using a 22-gauge needle at the T5-T7 vertebral levels, the fascial plane between the deep fascia of the erector spinae muscle group and the transverse process of the vertebra will be accessed. A combination consisting of 5 cc of 0.5% bupivacaine, 4 cc of 0.9% normal saline, and 1 cc dexamethasone (8 mg/2 mL) will then be injected into the targeted plane. The procedure will be performed by exp

Первичные конечные точки

  • Numeric Rating Scale (NRS) [Срок оценки: Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).]
Вторичные конечные точки (5)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) [Срок оценки: Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).]
  • Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) [Срок оценки: Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Срок оценки: Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).]
  • Bath Ankylosing Spondylitis Functional Index (BASFI) [Срок оценки: Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).]
  • Istanbul Low Back Pain Functional Scale (ILBPFS) [Срок оценки: Assessments will be performed at baseline (T0), 2 weeks after the erector spinae plane block procedure (T1), and 2 months after the procedure (T2).]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Diagnosis of ankylosing spondylitis according to the Modified New York Criteria
  • Patients receiving ongoing treatment with controlled disease activity but persistent back pain
  • Willingness to participate in the study

Критерии исключения

  • Body mass index (BMI) greater than 35 kg/m²
  • History of thoracic surgery
  • Intellectual disability or mental retardation
  • Presence of major psychiatric comorbidity
  • Congenital spinal anomaly
  • Pregnancy
  • History of bleeding diathesis
  • Presence of active local and/or systemic infection
  • Known allergy to the medications to be injected
  • Hemodynamic instability
  • Active phase of the disease (elevated acute phase reactants, active arthritis findings, etc.)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Marmara University Faculty of Medicine Pendik Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07633730 · 09.2026.607

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗