Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis

Official title

Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis:The Effect of the Rotator Cuff Interval With Posterior Glenohumeral Recess Approaches on the Improvement of Joint Motion and Pain

Overview

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.

Interventions

• Procedure 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.
• 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.

Primary outcome measures

• Shoulder Pain and Disability Index [Time frame: At baseline, one week, three weeks, six weeks, 12 weeks after treatment.]

Secondary outcome measures (3)

• visual analogue scale [Time frame: At baseline, one week, three weeks, six weeks, 12 weeks after treatment.]
• Active shoulder range of motion [Time frame: Baseline data, six weeks,12 weeks after treatment]
• adverse reaction [Time frame: one week after treatment]

Eligibility criteria

Inclusion criteria

• Age ≥18 years old, clinical diagnosis of periarthritis of shoulder;
• symptom duration > 1 month, shoulder ROM limitation in at least two directions, defined as abduction < 80°, flexion < 130°, and rotation < 30°;
• Before enrollment, the patients received plain radiographs, ultrasound images, and magnetic resonance imaging to rule out the cause of secondary shoulder capsitis.

Exclusion criteria

• Secondary frozen shoulder, such as rotator cuff tear, calcifying tendinitis, osteoarthritis, infection, tuberculosis infection, rheumatic disease, shoulder impingement syndrome;
• Previous history of shoulder joint surgery;
• Involved cervical nervous system symptoms or abnormal nervous system;
• corticosteroid injection in the affected shoulder within 3 months;
• Mental illness;
• Patients with contraindications to cortisol-hormone use.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• General hospital of Ningxia medical university — Yinchuan

Identifiers

NCT: NCT06553716 · Peng Ma-2024-0201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗