Comparison Between Ultrasound Guided Subacromial and Systemic Injection of Steroid for Frozen Shoulder: a Double Blind Multicenter Pilot Study for Randomized Control Trial

Status: Completed
Location: See all (13) locations...
Intervention Type: Other, Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this multicenter pilot study is to validate the effectiveness of extending the injection interval between betamethasone doses from one to two weeks for treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 75. This study also aims to screen potential study centers and gather data to refine the sample size calculation for a larger, future trial. The main questions it aims to answer are: * Does extending the interval between injections maintain effectiveness in improving shoulder function and reducing pain for frozen shoulder? * Which centers in this pilot study are qualified for a larger, future trial? * What is the appropriate sample size for conducting a multicenter RCT study with the same research design at the selected centers? Participants will: * Receive 3 injections over 4 weeks and will be followed up for another 8 weeks * Complete shoulder function assessments * Perform home rehabilitation exercises

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• History of ≤9 months, clinically diagnosed with primary frozen shoulder (including frozen shoulder associated with diabetes).

• Aged between 18 and 75 years old

• Pain NRS score ≥4

• Measured passive range of motion of the affected shoulder in at least two of the three directions (forward flexion, external rotation with arm at the side, and internal rotation with arm at the side) is reduced by 25% or more compared to the contralateral normal shoulder.

• Exclusion of osteoarthritis, dislocation, and other shoulder abnormalities through X-ray and MRI of the affected shoulder.

Locations
Other Locations
China
Army Specialty Medical Center of the People's Liberation Army of China
Chongqing
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
The First People's Hospital of Linping District, Hangzhou
Hangzhou
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou
Huzhou Central Hospital
Huzhou
Pujiang People's Hospital
Jinhua
First Affiliated Hospital of Ningbo University
Ningbo
Ningbo Ninth Hospital
Ningbo
Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group
Ningbo
The Second Affiliated Hospital, Fujian Medical University
Quanzhou
Yangpu District Central Hospital of Shanghai
Shanghai
Shengzhou People's Hospital
Shanhu
Guangde County People's Hospital
Xuancheng
Time Frame
Start Date: 2024-10-15
Completion Date: 2025-09-02
Participants
Target number of participants: 40
Treatments
Experimental: gluteal injection
gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4, ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.~The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
Active_comparator: subacromial injection
gluteal injection of 5 ml normal saline at week 0,2,4, ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.~The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov