Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis

NCT ID: NCT06553716

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2024-11-30

Brief Summary

The purpose of this study was to compare the efficacy of ultrasus-guided hydrodilation of Rotator Cuff Interval combined with Posterior Glenohumeral recess approach and hydrodilation of the Rotator cuff Interval alone in Adhesive Capsulitis.

Detailed Description

For patients with perihumeral arthritis, shoulder capsule hydrodilation is usually performed using ultrasound-guided water dilation through the posterior glenohumeral recess. Recently, a new transrotator cuff space approach has been described, and this study was designed to compare the efficacy of triamcinolone olonide transrotator cuff space combined with posterior glenohumeral recess and rotator cuff space dilation in the treatment of adhesive joint capsitis.

Conditions

Postoperation Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rotator cuff space approach (GroupA)

In the Rotator cuff interval recess group,we injected 20 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into into the Rotator cuff interval/anterior capsule.

Group Type: ACTIVE_COMPARATOR

Ultrasound-Guided Hydrodilatation by the Rotator cuff interval recess

Intervention Type: PROCEDURE

The injection contained 5ml of triamcinolone acetonide (40 mg)mixed with 5ml of 2% lidocaine hydrochloride and 15ml of normal saline in both groups,In the Rotator cuff interval recess group,we injected 20 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into into the Rotator cuff interval/anterior capsule.

Rotator cuff space approach combined with posterior glenohumeral recess approach (GroupB)

In the Rotator cuff interval and posterior glenohumeral recess group,we injected 10 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the Rotator cuff interval/anterior capsule and 10 mL mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the posterior glenohumeral.

Group Type: EXPERIMENTAL

Ultrasound-Guided Hydrodilatation by the Rotator cuff interval and posterior glenohumeral recess

Intervention Type: PROCEDURE

The injection contained 5ml of triamcinolone acetonide (40 mg)mixed with 5ml of 2% lidocaine hydrochloride and 15ml of normal saline in both groups,In the Rotator cuff interval and posterior glenohumeral recess group,we injected 10 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the Rotator cuff interval/anterior capsule and 10 mL mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the posterior glenohumeral.

Interventions

Ultrasound-Guided Hydrodilatation by the Rotator cuff interval recess

The injection contained 5ml of triamcinolone acetonide (40 mg)mixed with 5ml of 2% lidocaine hydrochloride and 15ml of normal saline in both groups,In the Rotator cuff interval recess group,we injected 20 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into into the Rotator cuff interval/anterior capsule.

Intervention Type: PROCEDURE

Ultrasound-Guided Hydrodilatation by the Rotator cuff interval and posterior glenohumeral recess

The injection contained 5ml of triamcinolone acetonide (40 mg)mixed with 5ml of 2% lidocaine hydrochloride and 15ml of normal saline in both groups,In the Rotator cuff interval and posterior glenohumeral recess group,we injected 10 mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the Rotator cuff interval/anterior capsule and 10 mL mL lidocaine with 2 mg/mL triamcinolone acetonide (Shincort) into the posterior glenohumeral.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old, clinical diagnosis of periarthritis of shoulder;

2. symptom duration > 1 month, shoulder ROM limitation in at least two directions, defined as abduction < 80°, flexion < 130°, and rotation < 30°;

3. Before enrollment, the patients received plain radiographs, ultrasound images, and magnetic resonance imaging to rule out the cause of secondary shoulder capsitis.

Exclusion Criteria

1. Secondary frozen shoulder, such as rotator cuff tear, calcifying tendinitis, osteoarthritis, infection, tuberculosis infection, rheumatic disease, shoulder impingement syndrome;

2. Previous history of shoulder joint surgery;

3. Involved cervical nervous system symptoms or abnormal nervous system;

4. corticosteroid injection in the affected shoulder within 3 months;

5. Mental illness;

6. Patients with contraindications to cortisol-hormone use.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General hospital of Ningxia medical university

Yinchuan, Ningxia, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinli Ni, MD

Role: CONTACT

xinlini6@nyfy.com.cn

13909586966

Peng Ma

Role: CONTACT

2234073178@qq.com

18209631464

Facility Contacts

Xinli Ni, MD

Role: primary

xinlini6@nyfy.com.cn

13909586966

Peng Ma

Role: backup

2234073178@qq.com

18209631464

Other Identifiers

Peng Ma-2024-0201

Identifier Type: -

Identifier Source: org_study_id