Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis

Not Applicable

Completed

• Conditions: Shoulder Capsulitis
• Interventions: Procedure: ultrasound-guided posterior hydrodilatation; Drug: corticosteroid, saline, and local anesthetic; Other: guided stretching and strengthening exercise program

• Registration Number: NCT05194852
• Lead Sponsor: Tanta University

Brief Summary

A prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior approach.

Detailed Description

patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach.

Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients.

A statistical power analysis was performed after sample size estimation, based on data from the current study (N = 60), comparing group I to group II.

Qualitative data was expressed as numbers and percentages, and Chi-squared test, Quantitative data were expressed as mean and standard deviation.

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-06-30
• Study Completion: 2018-09-28
• Study First Submitted: 2021-12-02
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients aged 35 to 60 years,
• patients who suffered pain and stiffness in only one shoulder, for 1 to 6 months
• patients who had restriction of passive motion.

Exclusion Criteria

• patients with previous trauma,
• patients with neurological
• patients with endocrinal diseases
• patients with shoulder tumor
• patients with arthritis
• people who had received intra-articular shoulder injection within the last 6 months.
• Patients with tendon tear

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	guided stretching and strengthening exercise program	Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach
group 2	ultrasound-guided posterior hydrodilatation	group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach
group 2	guided stretching and strengthening exercise program	group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach
group 1	corticosteroid, saline, and local anesthetic	Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach
group 1	ultrasound-guided posterior hydrodilatation	Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach

Primary Outcome Measures

Name	Time	Method
visual analoge state	3 months	minimum value: 0 maximum value: 10 higher scores mean a worse outcome.
shoulder pain and disability index	3 months	minimum value: 0 maximum value: 100 higher scores mean a worse outcome.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Tanta, Gharbia, Egypt