Frozen ShoulderPhase 4CUSIS-FSNCT07416916
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
A Phase 4 study testing Compound betamethasone injection (dorsogluteal intramuscular), Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral) and Standardized home-based shoulder rehabilitation exercise program in people with Frozen Shoulder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 10 sites in China.
Trial summary
The goal of this clinical trial is to determine if a gluteal muscle injection of compound betamethasone is as effective as an ultrasound-guided intra-articular injection in treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 65. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Compound betamethasone injection (dorsogluteal intramuscular), Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral) and Standardized home-based shoulder rehabilitation exercise program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 528 participants
- Where
- 10 sitesChina
- Study dates
- 23 Feb 2026to Jan 2031
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptom duration ≤9 months; clinically diagnosed unilateral primary (idiopathic) frozen shoulder (including diabetes-associated frozen shoulder).
- Age 18 to 65 years.
- Worst shoulder pain in the past 24 hours (NRS-WP, 0-10) ≥4.
- Passive range of motion (ROM) limitation of the affected shoulder: compared with the contralateral normal shoulder, a decrease of ≥30° in at least two of the following three directions: forward flexion, abduction, and external rotation with the arm at the side.
- Radiographic exclusion of other shoulder pathology: Affected-shoulder anteroposterior (AP) radiograph excludes glenohumeral osteoarthritis, calcific tendinopathy, and other structural abnormalities; and axillary view and/or scapular Y (outlet) or transthoracic view excludes glenohumeral dislocation.
Who cannot join
- Secondary frozen shoulder due to thyroid disease, cardiovascular disease, stroke, radiotherapy, prior neurosurgical or breast surgery, etc. (diabetes excluded from this item); or frozen shoulder secondary to major shoulder trauma requiring medical care (e.g., fracture, dislocation, rotator cuff tear).
- Confirmed or highly suspected full-thickness or massive rotator cuff tear causing functional pseudoparalysis (e.g., positive Jobe test with marked strength loss).
- Local infection of the affected shoulder or any contraindication to shoulder injection (e.g., uncorrected bleeding risk/coagulopathy).
- Contraindication to corticosteroid therapy (e.g., poorly controlled diabetes, systemic infection).
- Prior manipulation under anesthesia, arthroscopic capsular release, or open surgical release for frozen shoulder on the affected shoulder.
- Any corticosteroid treatment via any route within the past 3 months (including shoulder injection).
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- Requires long-term or intermittent corticosteroid use for other conditions (e.g., autoimmune disease such as rheumatoid arthritis, acute asthma exacerbations).
- Bilateral frozen shoulder, or contralateral history of frozen shoulder not yet fully recovered.
- Conditions significantly affecting upper-limb function assessment or ability to perform rehabilitation (e.g., marked limb disability).
- Pregnant or breastfeeding.
- Lacks the cognitive ability to comply with study procedures.
- Does not reside in the region served by the participating hospital(s) (anticipated inability to complete follow-up).
- Compensation claims (e.g., work-related injury, traffic accident) or ongoing legal disputes/litigation.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Yuepeng Xie, Medical Master, 86-15988115953, 421522908@qq.com
Yuepeng Xie, Medical Master
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Bin Han, Medical Doctor, +86-13735402700, icydoctor@zju.edu.cn
Bin Han, Medical Doctor
- Not yet recruiting
The First People's Hospital of Linping District, Hangzhou
Hangzhou, Zhejiang, 311199
Shenghua Wu, Medical Bachelor, +86-13372503239, shenghuawu022@gmail.com
Shenghua Wu, Medical Bachelor
- Recruiting
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Jianyou Li, Medical Doctor, +86-13857255511, ljywn1977@126.com
Fengfeng Wu, Medical Doctor, +86-13567289166, wufengfeng@zju.edu.cn
- Recruiting
Pujiang People's Hospital
Jinhua, Zhejiang, 322200
Hongpeng Jian, Medical Bachelor, +86-18757991192, 630166613@qq.com
Hongpeng Jian, Medical Bachelor
- Recruiting
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020
Yunfeng Mi, Medical Doctor, +86-15968412281, bee-cloud@163.com
Yunfeng Mi, Medical Doctor
- Not yet recruiting
Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group
Ningbo, Zhejiang, 315799
Lei Zhang, Medical Master, +86-18858222839, 675244086@qq.com
Lei Zhang, Medical Master
- Recruiting
Yangpu District Central Hospital of Shanghai
Shanghai, Shanghai Municipality, 200082
Huaming Xue, Medical Doctor, +86-18964859835, x11h22m33@126.com
Huaming Xue, Medical Doctor
- Recruiting
Shengzhou People's Hospital
Shanhu, Zhejiang, 312400
Haidong Zhou, Medical Master, +86-13858567997, haidongzhou@qq.com
Haidong Zhou, Medical Master
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Bo Zhu MD，PhD, +86-15972229727, jubal_cn@hotmail.com
About this study
Official title: Ultrasound-Guided Intra-Articular Versus Systemic Corticosteroid Injection for Frozen Shoulder: A Multicenter, Blinded, Randomized Controlled Trial
The goal of this clinical trial is to determine if a gluteal muscle injection of compound betamethasone is as effective as an ultrasound-guided intra-articular injection in treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 65. The main questions it aims to answer are:
- Is gluteal injection as effective as ultrasound-guided intra-articular injection for improving shoulder function and reducing pain?
- What are the side effects of each treatment method? Researchers will compare these two injection methods.
Participants will:
- Receive one injection at baseline and will be followed up for 12 weeks
- Complete shoulder function assessments
- Perform home rehabilitation exercises
- Conditions
- Frozen Shoulder
- Being tested
- Compound betamethasone injection (dorsogluteal intramuscular), Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral), 0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo), 0.9% sodium chloride injection (dorsogluteal intramuscular placebo), Standardized home-based shoulder rehabilitation exercise program
- Keywords
- frozen shoulder, intramuscular injection, compound betamethasone, ultrasound guidance, intra-articular injection
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound betamethasone injection (dorsogluteal intramuscular)Drug
A single dorsogluteal intramuscular injection at Week 0 (baseline): compound betamethasone 1 mL mixed with 0.9% sodium chloride 4 mL (total volume 5 mL), as part of a double-dummy design.
Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral)Drug
A single ultrasound-guided intra-articular glenohumeral injection at Week 0 (baseline): compound betamethasone 1 mL mixed with 0.9% sodium chloride 4 mL (total volume 5 mL), as part of a double-dummy design.
0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo)Drug
A single ultrasound-guided intra-articular glenohumeral placebo injection at Week 0 (baseline): 0.9% sodium chloride 5 mL, to mimic the local (intra-articular) injection in the double-dummy design.
0.9% sodium chloride injection (dorsogluteal intramuscular placebo)Drug
A single dorsogluteal intramuscular placebo injection at Week 0 (baseline): 0.9% sodium chloride 5 mL, to mimic the systemic (intramuscular) injection in the double-dummy design.
Standardized home-based shoulder rehabilitation exercise programOther
All participants perform a standardized home-based rehabilitation exercise program for 12 weeks after outpatient instruction, approximately 40 minutes per day (twice daily, 20 minutes per session), following the study-provided instructional video.
| Study group | Role | What they receive |
|---|---|---|
| Systemic steroid / Gluteal injection | Experimental | At Week 0 (baseline), participants receive a single dorsogluteal intramuscular injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single ultrasound-guided intra-articular glenohumeral injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session). Receives: Drug: Compound betamethasone injection (dorsogluteal intramuscular); Drug: 0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo); Other: Standardized home-based shoulder rehabilitation exercise program |
| Local steroid / Intra-articular injection | Active comparator | At Week 0 (baseline), participants receive a single ultrasound-guided intra-articular glenohumeral injection of compound betamethasone injection 1 mL diluted with 0.9% sodium chloride 4 mL (total volume 5 mL), plus a single dorsogluteal intramuscular injection of 0.9% sodium chloride 5 mL (placebo) as part of a double-dummy design. All participants follow a standardized home-based shoulder rehabilitation program for 12 weeks (approximately 40 minutes/day; twice daily, 20 minutes/session). Receives: Drug: Compound betamethasone injection (ultrasound-guided intra-articular glenohumeral); Drug: 0.9% sodium chloride injection (dorsogluteal intramuscular placebo); Other: Standardized home-based shoulder rehabilitation exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 8
Shoulder Pain and Disability Index (SPADI) total score (validated Simplified Chinese version; range 0-100, where 0 = no pain/disability and 100 = worst pain/disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Primary endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); negative change indicates improvement.
Measured: Baseline (Week 0) to Week 8
Secondary outcomes (14)
Change in QuickDASH Score from Baseline to Week 8
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (official Simplified Chinese version; range 0-100, where 0 = no disability and 100 = most severe disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); negative change indicates improvement.
Measured: Baseline (Week 0) to Week 8
Change in EQ-5D-5L Index Score from Baseline to Week 8
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) health utility index (Simplified Chinese version; index derived using the Chinese value set; range -0.391 to 1.000, where 1.000 = full health and higher scores indicate better health-related quality of life). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); positive change indicates improvement.
Measured: Baseline (Week 0) to Week 8
Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 8
Worst shoulder pain in the past 24 hours measured by a Numeric Rating Scale (NRS) item from the Brief Pain Inventory-Chinese version (BPI-C) (range 0-10, where 0 = no pain and 10 = worst imaginable pain; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0); negative change indicates improvement.
Measured: Baseline (Week 0) to Week 8
Change in Passive Shoulder Range of Motion (ROM) from Baseline to Week 8
Passive shoulder range of motion (ROM) of the affected shoulder assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Passive flexion measured by goniometer (0-180 degrees; higher degrees indicate better ROM), passive abduction by goniometer (0-180 degrees; higher degrees indicate better ROM), and passive external rotation at side by goniometer (-20 to 90 degrees; higher degrees indicate better ROM). Passive internal rotation is recorded as a 1-18 score based on the highest spinal level reached by the thumb tip behind the back (1-12 = T1-T12, 13-17 = L1-L5, 18 = sacral region or below; lower score indicates better ROM). Endpoint is the change from baseline to Week 8 (Week 8 minus Week 0).
Measured: Week 0 (baseline) to Week 8
Change in SPADI Total Score from Baseline to Week 12
Shoulder Pain and Disability Index (SPADI) total score (range 0-100, where 0 = no pain/disability and 100 = worst pain/disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0); negative change indicates improvement.
Measured: Baseline (Week 0) to Week 12
Change in QuickDASH Score from Baseline to Week 12
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (range 0-100, where 0 = no disability and 100 = most severe disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0); negative change indicates improvement.
Measured: Baseline (Week 0) to Week 12
Change in EQ-5D-5L Index Score from Baseline to Week 12
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) health utility index (index derived using the Chinese value set; range -0.391 to 1.000; higher scores indicate better health-related quality of life). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0); positive change indicates improvement.
Measured: Baseline (Week 0) to Week 12
Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 12
Worst shoulder pain in the past 24 hours measured by Numeric Rating Scale (NRS) (range 0-10, where 0 = no pain and 10 = worst imaginable pain; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0); negative change indicates improvement.
Measured: Baseline (Week 0) to Week 12
Change in Passive Shoulder ROM from Baseline to Week 12
Passive shoulder range of motion (ROM) of the affected shoulder assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Passive flexion measured by goniometer (0-180 degrees; higher degrees indicate better ROM), passive abduction by goniometer (0-180 degrees; higher degrees indicate better ROM), and passive external rotation at side by goniometer (-20 to 90 degrees; higher degrees indicate better ROM). Passive internal rotation is recorded as a 1-18 score based on the highest spinal level reached by the thumb tip behind the back (1-12 = T1-T12, 13-17 = L1-L5, 18 = sacral region or below; lower score indicates better ROM). Endpoint is the change from baseline to Week 12 (Week 12 minus Week 0).
Measured: Baseline (Week 0) to Week 12
Change in SPADI Total Score over 12 Weeks (Longitudinal)
Shoulder Pain and Disability Index (SPADI) total score (range 0-100, where 0 = no pain/disability and 100 = worst pain/disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Longitudinal change in SPADI total score over 12 weeks will be evaluated; decreasing scores over time indicate improvement.
Measured: SPADI total score assessed at Weeks 0/2/4/8/12; longitudinal change over 12 weeks will be evaluated.
Change in QuickDASH Score over 12 Weeks (Longitudinal)
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score (range 0-100, where 0 = no disability and 100 = most severe disability; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Longitudinal change in QuickDASH score over 12 weeks will be evaluated; decreasing scores over time indicate improvement.
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12
Change in EQ-5D-5L Index Score over 12 Weeks (Longitudinal)
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) health utility index (index derived using the Chinese value set; range -0.391 to 1.000; higher scores indicate better health-related quality of life). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Longitudinal change in EQ-5D-5L index over 12 weeks will be evaluated; increasing scores over time indicate improvement.
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12
Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) over 12 Weeks (Longitudinal)
Worst shoulder pain in the past 24 hours measured by Numeric Rating Scale (NRS) (range 0-10, where 0 = no pain and 10 = worst imaginable pain; higher scores indicate worse outcome). Assessed at Weeks 0 (baseline), 2, 4, 8, and 12. Longitudinal change in NRS over 12 weeks will be evaluated; decreasing scores over time indicate improvement.
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12
Change in Passive Shoulder Range of Motion (ROM) over 12 Weeks (Longitudinal)
Passive shoulder range of motion (ROM) of the affected shoulder assessed longitudinally at Weeks 0 (baseline), 2, 4, 8, and 12. Passive flexion measured by goniometer (0-180 degrees; higher degrees indicate better ROM), passive abduction by goniometer (0-180 degrees; higher degrees indicate better ROM), and passive external rotation at side by goniometer (-20 to 90 degrees; higher degrees indicate better ROM). Passive internal rotation is recorded as a 1-18 score based on the highest spinal level reached by the thumb tip behind the back (1-12 = T1-T12, 13-17 = L1-L5, 18 = sacral region or below; lower score indicates better ROM). Longitudinal change over 12 weeks will be evaluated.
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start23 Feb 2026
- Primary completionOct 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Han, Medical Doctor, Principal investigator, The 2nd Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416916
- Sponsor's protocol ID
- 2024-0434
- Acronym
- CUSIS-FS
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Analytic dataset sufficient to reproduce the primary publication results (deidentified IPD with data dictionary and derivation specifications) and scripts for main tables/figures; 2. Full analyzable dataset sufficient to support protocol-specified primary/secondary outcomes and prespecified subgroup/sensitivity analyses (deidentified IPD with data dictionary and derivation specifications).