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临床试验/NCT06888791
NCT06888791招募中不适用

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

Diskapi Teaching and Research Hospital2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年2月25日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
44
试验地点
2
主要终点
Visual analog scale (VAS)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of frozen shoulder disease

排除标准

  • 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

结局指标

主要结局

Visual analog scale (VAS)

时间窗: Change from baseline to 1st and 3rd month after treatment

VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Damla Yürük

Supervisor Investigator

Diskapi Teaching and Research Hospital

研究点 (2)

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