frozen shoulder
Conditions
Interventions
Gluteal injection group:Gluteal injection of 1 ml of compound betamethasone and 4 ml of normal saline at week 0
Intra-articular injection group:Ultrasound-guided intra-articular injection of 1 ml of compound betamethasone and 4 ml normal saline at week 0
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Symptom duration = 4; 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; 5.Radiographic exclusion of other shoulder pathology: Affected-shoulder 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
Exclusion criteria: 1.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); 2.Confirmed or highly suspected full-thickness or massive rotator cuff tear causing functional pseudoparalysis (e.g., positive Jobe test with marked strength loss); 3.Local infection of the affected shoulder or any contraindication to shoulder injection (e.g., uncorrected bleeding risk/coagulopathy); 4.Contraindication to corticosteroid therapy (e.g., poorly controlled diabetes, systemic infection); 5.Prior manipulation under anesthesia, arthroscopic capsular release, or open surgical release for frozen shoulder on the affected shoulder; 6.Any corticosteroid treatment via any route within the past 3 months (including shoulder injection); 7.Requires long-term or intermittent corticosteroid use for other conditions (e.g., autoimmune disease such as rheumatoid arthritis, acute asthma exacerbations); 8.Bilateral frozen shoulder, or contralateral history of frozen shoulder not yet fully recovered; 9.Conditions significantly affecting upper-limb function assessment or ability to perform rehabilitation (e.g., marked limb disability); 10.Pregnant or breastfeeding; 11.Lacks the cognitive ability to comply with study procedures; 12.Does not reside in the region served by the participating hospital(s) (anticipated inability to complete follow-up); 13.Compensation claims (e.g., work-related injury, traffic accident) or ongoing legal disputes/litigation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 8;Change in Passive Shoulder Range of Motion (ROM) from Baseline to Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in QuickDASH Score from Baseline to Week 12;Change in Passive Shoulder Range of Motion (ROM) over 12 Weeks (Longitudinal);Change in EQ-5D-5L Index Score from Baseline to Week 8;Incidence of Injection-related Systemic Adverse Events;Change in QuickDASH Score over 12 Weeks (Longitudinal);Change in SPADI Total Score over 12 Weeks (Longitudinal);Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 12;Incidence of at Least One Serious Adverse Event (SAE);Change in Passive Shoulder Range of Motion (ROM) from Baseline to Week 8;Change in EQ-5D-5L Index Score over 12 Weeks (Longitudinal);Incidence of at Least One Adverse Event (AE);Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 8;Incidence of Injection-related Local Adverse Events;Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) over 12 Weeks (Longitudinal);Change in QuickDASH Score from Baseline to Week 8;Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 12;Change in EQ-5D-5L Index Score from Baseline to Week 12; | — |
Countries
China
Contacts
Public ContactBin Han
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed