US-guided Hydro Dissection vs Fluoroscopy-guided Hydro Dissection for Adhesive Capsulitis

Официальное название

Is Hydro Dissection Treatment More Successful With Ultrasonography or Fluoroscopy in the Management of Adhesive Capsulitis?

Обзор

This study aims to evaluate the differences in joint range of motion, Visual Analog Scale (VAS) scores, and the Shoulder Pain and Disability Index (SPADI) outcomes in patients with adhesive capsulitis (frozen shoulder) who undergo hydrodilatation therapy with either ultrasound (USG) or fluoroscopy guidance, in addition to a suprascapular nerve block.

Подробное описание

Adhesive capsulitis is a common condition characterized by painful restriction of both active and passive glenohumeral movement, especially when joint degeneration alone is insufficient to explain the limitation. The condition is more prevalent in women and has a strong correlation with diabetes mellitus and thyroid dysfunction. The prevalence in the general population is approximately 3-5%, but it can reach up to 20% in diabetic patients.

The primary goals of treatment are to alleviate pain, improve mobility, shorten symptom duration, and facilitate a return to normal activities. The suprascapular nerve is a major sensory nerve for the posterior and superior aspects of the shoulder and is an accessible target for blockade. Conditions in which suprascapular nerve block is used include chronic shoulder pain syndromes such as rheumatoid arthritis, glenohumeral osteoarthritis, post-stroke shoulder pain, motor neuron disease-related shoulder pain, and various rotator cuff disorders.

Hydrodilatation therapy works by releasing the contracted joint capsule and reducing fibrosis, while corticosteroids exert strong anti-inflammatory effects throughout the shoulder joint. The high-pressure transmission mechanism used in hydrodilatation enhances the distribution of corticosteroids throughout the glenohumeral joint capsule. The procedure involves injecting fluid into the joint cavity under radiological guidance using either ultrasound or fluoroscopy.

This study aims to determine whether performing hydrodilatation under ultrasound versus fluoroscopy guidance in addition to suprascapular nerve block leads to differences in joint range of motion, VAS scores, and SPADI disability index outcomes in patients diagnosed with adhesive capsulitis. Assessments will be performed before the procedure, on the day of the procedure, and at the 3rd month

Вмешательства

• Процедура US-guided Hydro Dissection
  All procedures are performed under sterile conditions. The patient is seated in a sitting position with the physician behind the patient, the shoulder joint and the surrounding area is cleaned extensively with 10% povidone iodine. The probe is placed in the posterior lateral region of the shoulder, below the level of the scapular spine. The posterior labrum is observed as a triangular hyperechoic structure extending from the glenoid to the humeral head. A 22 G spinal needle is inserted approxima
• Процедура Fluoroscopy-guided Hydro Dissection
  The patient is placed on the scope table in supine position and the shoulder joint is cleaned with 10% povidone iodine. The acromioclavicular joint and the glenohumeral joint are visualized using C-arm fluoroscopy with anteroposterior view. The acromioclavicular joint is marked as the entry point to the shoulder joint. After the skin and subcutaneous tissue is anesthetized with 1 cc 2% lidocaine with a 27 G needle, a 22 G spinal needle is inserted through the acromioclavicular joint and the need

Первичные конечные точки

• Visual analog scale (VAS) [Срок оценки: Change from baseline to 1st and 3rd month after treatment]

Вторичные конечные точки (1)

• Shoulder Pain and Disability Index (SPADI) [Срок оценки: Change from baseline to 1st and 3rd month after treatment]

Критерии участия

Критерии включения

• Diagnosis of frozen shoulder disease
• VAS>5

Критерии исключения

• Other shoulder diseases that may cause shoulder pain (Rotator cuff tear, clavicle fracture, etc.)
• Allergy to local anesthetics
• History of shoulder surgery in the last 12 months
• Pregnancy
• Coagulopathy or antiplatelet use
• The patient has a mental illness that prevents decision-making

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

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Diskapi Training and Research Hospital — Ankara

Идентификаторы

NCT: NCT06888791 · US-guided vs fluoro-guided HD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗