Clinical trial NCT06626568: Comparison of Ultrasound-Guided Subacromial Vs. Systemic Steroid Injections for Frozen Shoulder: a Multicenter Pilot Study
Official title: Comparison Between Ultrasound Guided Subacromial and Systemic Injection of Steroid for Frozen Shoulder: a Double Blind Multicenter Pilot Study for Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Frozen Shoulder
Keywords: frozen shoulder
intramuscular injection
subacromial injection
compound betamethasone
ultrasound guidance
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. History of ≤9 months, clinically diagnosed with primary frozen shoulder (including frozen shoulder associated with diabetes).
2. Aged between 18 and 75 years old
3. Pain NRS score ≥4
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.
5. Exclusion of osteoarthritis, dislocation, and other shoulder abnormalities through X-ray and MRI of the affected shoulder.

Exclusion Criteria:

1. Secondary frozen shoulder caused by thyroid disease, cardiovascular disease, cancer, stroke, radiotherapy, neurosurgery, or breast surgery (excluding diabetes); secondary frozen shoulder caused by major shoulder trauma requiring medical care (e.g., fractures, dislocations, rotator cuff tears).
2. Full-thickness rotator cuff tear in the affected shoulder confirmed by MRI (excluding rotator cuff tendinopathy and partial-thickness rotator cuff tear in patients with frozen shoulder without a history of major shoulder trauma).
3. Patients unable to undergo MRI due to financial reasons, claustrophobia, pacemaker, or other metallic implants in the body.
4. Local infection in the affected shoulder or other contraindications to shoulder injections.
5. Patients with contraindications to steroid therapy (e.g., poorly controlled blood sugar in diabetes).
6. Patients with frozen shoulder who have already undergone shoulder injections, manipulation under anesthesia, arthroscopic capsular release, or open surgery for capsular release.
7. Received any form of steroid treatment within the past 3 months.
8. History of glucocorticoid use for more than 3 months.
9. Bilateral frozen shoulder or a history of frozen shoulder in the contralateral shoulder.
10. Pregnant or breastfeeding women.
11. Patients lacking the cognitive ability to comply with the study protocol.
12. Patients not residing in the area where the study is being conducted.
13. Patients with compensation claims or legal disputes related to workplace injury or car accidents.

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: progression rate of rotator cuff tears
timeFrame: From enrollment to the end of follow-up at 12 weeks
measure: short version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH）
timeFrame: Baseline and 12 weeks
measure: Numerical Rating Scale (NRS)
timeFrame: Baseline and 12 weeks
measure: five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
timeFrame: Baseline and 12 weeks
measure: passive range of motion of shoulder
timeFrame: Baseline and 12 weeks
measure: Direct Medical Cost
timeFrame: Baseline
measure: Direct Medical Cost
timeFrame: Baseline and week2
measure: Direct Medical Cost
timeFrame: Week2 and week4
measure: Direct Medical Cost
timeFrame: Week4 and week8
measure: Direct Medical Cost
timeFrame: Week8 and week12
measure: work absenteeism
timeFrame: Week 0
measure: work absenteeism
timeFrame: Week 0 and Week 2
measure: work absenteeism
timeFrame: Week 2 and Week 4
measure: work absenteeism
timeFrame: Week 4 and Week 8
measure: work absenteeism
timeFrame: Week 8 and Week 12
measure: Unplanned concomitant use of analgesics
timeFrame: Week 2
measure: Unplanned concomitant use of analgesics
timeFrame: Week 4
measure: Unplanned concomitant use of analgesics
timeFrame: Week 8
measure: Unplanned concomitant use of analgesics
timeFrame: Week 12
measure: Glycated Hemoglobin (HbA1c)
timeFrame: week 0 and week 12
measure: glycated albumin
timeFrame: week 0 and week 4
Other outcomes:
measure: incidence of serious adverse events (SAE)
timeFrame: From enrollment to the end of follow-up at 12 weeks
measure: incidence of adverse events (AE)
timeFrame: From enrollment to the end of follow-up at 12 weeks
Locations:
city: Xuancheng
country: China
facility: Guangde County People&#39;s Hospital
state: Anhui
city: Chongqing
country: China
facility: Army Specialty Medical Center of the People&#39;s Liberation Army of China
state: Chongqing
city: Shanghai
country: China
facility: Yangpu District Central Hospital of Shanghai
state: Shanghai
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The First People&#39;s Hospital of Linping District, Hangzhou
state: Zhejiang
city: Ningbo
country: China
facility: First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Ningbo
country: China
facility: Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group
state: Zhejiang
city: Pujiang
country: China
facility: Pujiang People's Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shengzhou People&amp;amp;#39;s Hospital
state: Zhejiang
Study officials:
References: