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NCT Number: NCT07416916

Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder

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

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Key information

Conditions

Frozen Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yangpu District Central Hospital of Shanghai, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all must be met):

  • 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.

Exclusion criteria

(any of the following):

  • 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).
  • 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.

Treatment and study plan

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 program

Other

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.

Primary outcomes

  1. Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 8

    Time frame: Baseline (Week 0) 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.

Secondary outcomes

  1. Change in QuickDASH Score from Baseline to Week 8

    Time frame: Baseline (Week 0) 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.

  2. Change in EQ-5D-5L Index Score from Baseline to Week 8

    Time frame: Baseline (Week 0) 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.

  3. Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 8

    Time frame: Baseline (Week 0) 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.

  4. Change in Passive Shoulder Range of Motion (ROM) from Baseline to Week 8

    Time frame: Week 0 (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).

  5. Change in SPADI Total Score from Baseline to Week 12

    Time frame: Baseline (Week 0) 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.

  6. Change in QuickDASH Score from Baseline to Week 12

    Time frame: Baseline (Week 0) 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.

  7. Change in EQ-5D-5L Index Score from Baseline to Week 12

    Time frame: Baseline (Week 0) 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.

  8. Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 12

    Time frame: Baseline (Week 0) 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.

  9. Change in Passive Shoulder ROM from Baseline to Week 12

    Time frame: Baseline (Week 0) 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).

  10. Change in SPADI Total Score over 12 Weeks (Longitudinal)

    Time frame: SPADI total score assessed at Weeks 0/2/4/8/12; longitudinal change over 12 weeks will be evaluated.

    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.

  11. Change in QuickDASH Score over 12 Weeks (Longitudinal)

    Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and 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. Longitudinal change in QuickDASH score over 12 weeks will be evaluated; decreasing scores over time indicate improvement.

  12. Change in EQ-5D-5L Index Score over 12 Weeks (Longitudinal)

    Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and 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. Longitudinal change in EQ-5D-5L index over 12 weeks will be evaluated; increasing scores over time indicate improvement.

  13. Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) over 12 Weeks (Longitudinal)

    Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and 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. Longitudinal change in NRS over 12 weeks will be evaluated; decreasing scores over time indicate improvement.

  14. Change in Passive Shoulder Range of Motion (ROM) over 12 Weeks (Longitudinal)

    Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12

    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.

Other outcomes

  1. Incidence of at Least One Serious Adverse Event (SAE)

    Time frame: Up to 12 weeks

    Counts and proportion of participants experiencing ≥1 SAE during the 12-week follow-up

  2. Incidence of at Least One Adverse Event (AE)

    Time frame: Up to 12 weeks

    Counts and proportion of participants experiencing ≥1 AE during the 12-week follow-up.

  3. Incidence of Injection-related Local Adverse Events

    Time frame: Up to 12 weeks

    Incidence of injection-related local adverse events during follow-up, including pre-defined, systematically assessed local AEs (AESI; solicited at scheduled visits) (e.g., marked post-injection shoulder pain flare, local infection, skin/subcutaneous changes) and investigator-attributed injection-related local AEs identified non-systematically (unsolicited reports/clinical assessment/medical record review), including injection-related events not pre-specified as AESI.

  4. Incidence of Injection-related Systemic Adverse Events

    Time frame: Up to 12 weeks

    Incidence of injection-related systemic adverse events during follow-up, including pre-defined, systematically assessed systemic AEs (AESI; solicited at scheduled visits) (e.g., facial flushing, mood/sleep changes, gastrointestinal discomfort, transient hyperglycemia/hypertension, suspected adrenal suppression) and investigator-attributed injection-related systemic AEs identified non-systematically (unsolicited reports/clinical assessment/medical record review), including injection-related events not pre-specified as AESI.

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Han, Medical Doctor

CONTACT

[email protected]

+86-13735402700

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Ultrasound-Guided Intra-Articular Versus Systemic Corticosteroid Injection for Frozen Shoulder: A Multicenter, Blinded, Randomized Controlled Trial

Acronym: CUSIS-FS

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Feb 18, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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