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临床试验/CTRI/2023/02/049467
CTRI/2023/02/049467尚未招募2 期

Comparison of Suprascapular Nerve Block and Capsular Hydrodilatation in Adhesive Capsulitis of Shoulder: A Randomized Controlled Trial

Asem Rangita Chanu1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月3日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Change in function (SPADI score) of the shoulder

研究概览

简要总结

Adhesive capsulitis (AC) of the shoulder is characterized by painful, restricted shoulder ROM in patients with normal radiographs and has long been considered self-limiting with spontaneous resolution (over a period of 18–24 months) that renders invasive treatment modalities superfluous. However, even after a fair trial of conservative measures (e.g., physical modalities, anti-inflammatory medications, exercises, corticosteroid injections), it has been reported that around 30% of patients do not improve clinically, thereby prolonging their functional limitations, emotional and economic hardships. In patients who do not improve with conservative treatment, further invasive treatments (such as manipulation under anesthesia and arthroscopic lysis of adhesions) have been tried. However, there has been no universally accepted method regarding invasive treatment options for refractory cases. Suprascapular Nerve Block (SSNB) has been tried in refractory AC but suboptimal response and complications can occur especially with the surface landmark technique and in the hands of those with limited expertise. Some studies have shown capsular hydrodilatation as a potential non-surgical option in the management of AC. However, its role compared with more established treatments for AC remains undefined. The present study aims to compare the effect of Suprascapular Nerve Block (SSNB) and capsular hydrodilatation in refractory cases of AC of the shoulder. We hypothesize that capsular hydrodilatation is as efficacious as SSNB in refractory cases of AC of the shoulder.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •a) Patients of either sex aged between 18 and 75 years attending the outpatient clinic of the Department of Physical Medicine & Rehabilitation with complaints of shoulder pain and stiffness for at least 3 months will be screened for eligibility b) Clinical diagnosis of AC made by a thorough history and clinical examination of each shoulder c) Normal plain radiographic appearance and presence of no secondary causes for the patient’s complaints d) Patients who receive conservative management (hot fomentation of affected shoulder, Codman’s exercise, Range of Motion exercises and activities of affected shoulder, acetaminophen 650mg when required for pain up to a maximum of 5 tablets a day) for at least 2 weeks with no meaningful relief (less than 50% improvement in the passive range of movement in the affected shoulder for at least two of the three movements: forward flexion, abduction or external rotation).

排除标准

  • 未提供

结局指标

主要结局

Change in function (SPADI score) of the shoulder

时间窗: 1, 4 and 6 weeks

次要结局

  • Change in passive ROM of the shoulder(1, 4 and 6 weeks)
  • Change in triple-phase bone scan findings of the shoulder(6 weeks)
  • Relationship between ultrasound findings and change in function and passive ROM of the shoulder(NA)

研究者

发起方
Asem Rangita Chanu
申办方类型
Other [self]

研究点 (1)

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