Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis

Not Applicable

Recruiting

• Conditions: Postoperation Pain

• Registration Number: NCT06553716
• Lead Sponsor: General Hospital of Ningxia Medical University

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.

Study Timeline

• Study Start: 2024-02-05
• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-11
• Last Update Submitted: 2024-08-11
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 1. Age ≥18 years old, clinical diagnosis of periarthritis of shoulder; 2) (i) symptom duration > 1 month, (ii) 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index	At baseline, one week, three weeks, six weeks, 12 weeks after treatment.	The SPADI was used to assess the severity ofpain and disability. A previous study has shown that the Chinese version of the SPADI has high internal consistency and test-retest reliability (Yao et al., 2017). It consists of 13 items that are divided into 2 subscales: pain scale (5 items) and disability scale (8 items) (Roach et al., 1991). Each item is rated from 0 (no pain/no difficulty) to 10 (worst pain experienced/ very difficult). The score is then transformed to a 100-point scale, with the highest score indicating the most severe pain and disability. In the literature, the minimal and clinically relevant difference for SPADI has been reported to be 10 points

Secondary Outcome Measures

Name	Time	Method
Active shoulder range of motion	Baseline data, six weeks,12 weeks after treatment	In terms of ROM, the degrees of shoulder flexion, abduction, external and internal rotation were measured by a goniometer in the supine position in a random sequence
adverse reaction	one week after treatment	Pain after hydrodilation , reduced sensation and motor control of the affected arm, skin flushing, nausea, dizziness, and fainting
visual analogue scale	At baseline, one week, three weeks, six weeks, 12 weeks after treatment.	Regarding VAS, patients were asked to indicate the intensity of their average level ofpain in the affected shoulder within the past 1 week using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).

Trial Locations

Locations (1)

General hospital of Ningxia medical university; 🇨🇳 Yinchuan, Ningxia, China