Comparison of Ultrasound-Guided Subacromial vs. Systemic Steroid Injections for Frozen Shoulder: a Multicenter Pilot Study

NCT06626568 | Completed Phase 2

• 1 other identifier: 2024-0405
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

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

Conditions

Frozen Shoulder

Keywords

frozen shoulder; intramuscular injection; subacromial injection; compound betamethasone; ultrasound guidance

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Disability Index (SPADI)

  The SPADI score ranges from 0 to 100. A score of 0 indicates no pain or disability, while a score of 100 reflects the worst possible pain and maximum functional disability in the shoulder. Data entry will be performed by blinded research staff. They will present the paper CRF sample form to the participants and ask questions one by one, directly entering the responses of participants into the corresponding electronic CRF form in the EDC system using handheld electronic devices (such as smartphones, tablets, or laptops).

  Baseline and 12 weeks

Secondary Outcomes (21)

• progression rate of rotator cuff tears

  From enrollment to the end of follow-up at 12 weeks

• short version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH）

  Baseline and 12 weeks

• Numerical Rating Scale (NRS)

  Baseline and 12 weeks

• five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)

  Baseline and 12 weeks

• passive range of motion of shoulder

  Baseline and 12 weeks

Other Outcomes (2)

• incidence of serious adverse events (SAE)

  From enrollment to the end of follow-up at 12 weeks

• incidence of adverse events (AE)

  From enrollment to the end of follow-up at 12 weeks

Study Arms (2)

gluteal injection

EXPERIMENTAL

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.

Drug: Compound betamethasone Injection(Gluteal muscle injection); Other: Normal Saline as Placebo (ultrasound-guided subacromial injection); Behavioral: home exercise

subacromial injection

ACTIVE COMPARATOR

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.

Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection); Other: Normal Saline as Placebo (gluteal muscle inection); Behavioral: home exercise

Interventions

Compound betamethasone Injection(Gluteal muscle injection) DRUG

gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4

gluteal injection

Compound betamethasone Injection(Subacromial Ultrasound Guided injection) DRUG

ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.

subacromial injection

Normal Saline as Placebo (ultrasound-guided subacromial injection) OTHER

ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.

gluteal injection

Normal Saline as Placebo (gluteal muscle inection) OTHER

gluteal injection of 5 ml normal saline at week 0,2,4.

subacromial injection

home exercise BEHAVIORAL

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.

gluteal injection; subacromial injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).
• Patients unable to undergo MRI due to financial reasons, claustrophobia, pacemaker, or other metallic implants in the body.
• Local infection in the affected shoulder or other contraindications to shoulder injections.
• Patients with contraindications to steroid therapy (e.g., poorly controlled blood sugar in diabetes).
• Patients with frozen shoulder who have already undergone shoulder injections, manipulation under anesthesia, arthroscopic capsular release, or open surgery for capsular release.
• Received any form of steroid treatment within the past 3 months.
• History of glucocorticoid use for more than 3 months.
• Bilateral frozen shoulder or a history of frozen shoulder in the contralateral shoulder.
• Pregnant or breastfeeding women.
• Patients lacking the cognitive ability to comply with the study protocol.
• Patients not residing in the area where the study is being conducted.
• Patients with compensation claims or legal disputes related to workplace injury or car accidents.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (9)

Guangde County People's Hospital

Xuancheng, Anhui, 242299, China

Location

Yangpu District Central Hospital of Shanghai

Shanghai, Shanghai Municipality, 200082, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

The First People's Hospital of Linping District, Hangzhou

Hangzhou, Zhejiang, 311199, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, 313000, China

Location

Pujiang People's Hospital

Jinhua, Zhejiang, 322200, China

Location

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315020, China

Location

Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group

Ningbo, Zhejiang, 315799, China

Location

Shengzhou People's Hospital

Shanhu, Zhejiang, 312400, China

Location

MeSH Terms

Conditions

Bursitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bin Han, Medical Doctor

  The 2nd Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 4, 2024
• Study Start: October 15, 2024
• Primary Completion: August 21, 2025
• Study Completion: September 2, 2025
• Last Updated: January 30, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: We will consider sharing the data after the completion of the subsequent full trial.
• Access Criteria: Researchers who have published at least one peer-reviewed clinical study on frozen shoulder, as well as journal editors and corresponding peer reviewers involved in reviewing our subsequent formal study (CUSIS-FS, a multicenter RCT on frozen shoulder), will be able to access the IPD and supporting information.

Locations

CN (9)