A Comparative Study on Nerve Blocks in Frozen Shoulder

Not yet recruiting

• Conditions: Stiffness of joint, not elsewhereclassified,

• Registration Number: CTRI/2022/01/039823
• Lead Sponsor: AIIMS

Brief Summary

• **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%

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-02
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Shoulder pain due to acute trauma fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology and rotator cuff disorder etc 2.
• Bleeding disorder, acute and chronic infection, or any other contraindication for injection 3.
• Patients who are sensitive to bupivacaine 4.
• Having co-morbid conditions like uncontrolled diabetes, chronic renal failure, thyroid diseases, coronary artery disease, stroke, connective tissue disorders etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shoulder pain in terms of SPADI (Shoulder Pain and Disability Index) and NPRS (Numerical Pain Rating Scale) measurements	Baseline, 0, 1, 3 and, 6 weeks after intervention

Secondary Outcome Measures

Name	Time	Method
Passive range of motion of affected shoulder	Baseline, 0, 1, 3 and, 6 weeks after intervention

Trial Locations

Locations (1)

AIIMS Rishikesh; 🇮🇳 Dehradun, UTTARANCHAL, India

AIIMS Rishikesh

🇮🇳Dehradun, UTTARANCHAL, India

Dr Shalini Mishra

Principal investigator

9871925596

drm.shalini@gmail.com