Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperation Pain
• Intervention / Treatment: Procedure: Ultrasound-Guided Hydrodilatation by the Rotator cuff interval recess; Procedure: Ultrasound-Guided Hydrodilatation by the Rotator cuff interval and posterior glenohumeral recess

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinli Ni, MD; Phone Number: 13909586966; Email: xinlini6@nyfy.com.cn
• Study Contact Backup: Name: Peng Ma; Phone Number: 18209631464; Email: 2234073178@qq.com

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Xinli Ni, MD; Phone Number: 13909586966; Email: xinlini6@nyfy.com.cn
      • Contact: Peng Ma; Phone Number: 18209631464; Email: 2234073178@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability Index	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	At baseline, one week, three weeks, six weeks, 12 weeks after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale	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).	At baseline, one week, three weeks, six weeks, 12 weeks after treatment.
Active shoulder range of motion	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	Baseline data, six weeks,12 weeks after treatment
adverse reaction	Pain after hydrodilation , reduced sensation and motor control of the affected arm, skin flushing, nausea, dizziness, and fainting	one week after treatment

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: corticosteroid; Adhesive capsulitis; hydrodilatation; rotator cuff interval; Posterior Glenohumeral Recess
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: Peng Ma-2024-0201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No