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临床试验/CTRI/2022/01/039823
CTRI/2022/01/039823尚未招募不适用

Ultrasound-guided Suprascapular Nerve Block with Subacromial Injection versus Suprascapular Nerve Block alone in Adhesive Capsulitis of Shoulder: A Randomized Control Trial

AIIMS1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS
入组人数
50
试验地点
1
主要终点
Shoulder pain in terms of SPADI (Shoulder Pain and Disability Index) and NPRS (Numerical Pain Rating Scale) measurements

研究概览

简要总结

• **Introduction:**Adhesive capsulitis of Shoulder (ACS) is characterized by painful, gradual loss of motion due to capsular fibrosis and contracture. The prevalence is 2–5%  and managed with many

modalities like Supra-scapular nerve block (SSNB), Sub-acromial injection (SAI),Intra-articular injection (IAI) & Hydro-dissection (HD) etcPurpose: is adding SAI with SSNB is beneficial or not?

• Problem: There is a scanty evidence to support or refute the superiority of one modality of treatment over the other

• Null Hypothesis: In treatment of ACS, The SSNB with SAI is equally effective with SSNB alone

Aim

•To compare the outcome of ultrasound-guided SSNB with SAI and SSNB alone in ACS

Objectives

-Primary objectives:

• pain relief (Numeric Pain Rating Scale-NPRS)

• functional improvement (Shoulder Pain and Disability Index –SPADI)

-Secondary objective:

•Passive ROM ( Range of Motion) of affected shoulder

**Study population:**The recently diagnosed patients of ACS at AIIMS, Rishikesh

Inclusion Criteria

•Patients (male or female) between 35 to 75 years of age

•Conservative management of at least 2 weeks with no improvement

Exclusion Criteria

•Shoulder pain due to acute trauma fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology and rotator cuff disorder etc

•Having comorbid conditions like uncontrolled diabetes, chronic renal failure, thyroid diseases, coronary artery disease, stroke, connective tissue disorders etc

Study duration:   Two years

Study design: Randomized Control study

Sample Size: Using G power 3.1,an Apriori sample size calculation was done assuming 95% power of the study at 5% level of significance and the SPADI mean (standard deviation) percentage change in 6 weeks in SSNB 3.84(1.15) and in IASI 6.15 (2.69) with effect size of 1.116 and the required sample size for calculated effect sizeis22 participants in each group. Considering 10% dropout, the final sample size is 25 in each group. Total sample size is 50.

Data will be checked for normal distribution using Shapiro– Wilcoxon test. Effect of therapy on continuous variables will be analyzed between the two therapy arms using Mann– Whitney U�’test and within therapy arms using Friedman test followed by Bonferroni test for post hoc comparisons. Categorical variables will be analyzed using Chi�’squared test. The level of significance will be kept at 5%

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

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

入选标准

  • •Pain in the shoulder joint with stiffness more than 3 months duration
  • •Had taken at least 2 weeks of conservative management for pain with no relief from symptoms
  • •Patients who are willing to come for follow up.

排除标准

  • •Shoulder pain due to acute trauma fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology and rotator cuff disorder etc
  • •Bleeding disorder, acute and chronic infection, or any other contraindication for injection
  • •Patients who are sensitive to bupivacaine
  • •Having co-morbid conditions like uncontrolled diabetes, chronic renal failure, thyroid diseases, coronary artery disease, stroke, connective tissue disorders etc.

结局指标

主要结局

Shoulder pain in terms of SPADI (Shoulder Pain and Disability Index) and NPRS (Numerical Pain Rating Scale) measurements

时间窗: Baseline, 0, 1, 3 and, 6 weeks after intervention

次要结局

  • Passive range of motion of affected shoulder(Baseline, 0, 1, 3 and, 6 weeks after intervention)

研究者

发起方
AIIMS
申办方类型
Government medical college

研究点 (1)

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