Frozen Shoulder
Conditions
Keywords
frozen shoulder, intramuscular injection, compound betamethasone, ultrasound guidance, intra-articular injection
Brief 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. 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
Interventions
DRUGCompound betamethasone injection (dorsogluteal intramuscular)
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.
DRUGCompound betamethasone injection (ultrasound-guided intra-articular glenohumeral)
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.
DRUG0.9% sodium chloride injection (ultrasound-guided intra-articular glenohumeral placebo)
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.
DRUG0.9% sodium chloride injection (dorsogluteal intramuscular placebo)
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.
OTHERStandardized home-based shoulder rehabilitation exercise program
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors are blinded to treatment allocation (double-dummy; participant-blinded and assessor-blinded). Designated unblinded injection administrators access the randomization result and prepare/perform the assigned injections; they are not involved in any follow-up assessments, outcome data collection, or outcome data entry, and have restricted, role-based access in the EDC/IWRS. Syringes and the injection field are shielded and standardized scripts are used to minimize unblinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
(all must be met): 1. Symptom duration ≤9 months; clinically diagnosed unilateral primary (idiopathic) frozen shoulder (including diabetes-associated frozen shoulder). 2. Age 18 to 65 years. 3. Worst shoulder pain in the past 24 hours (NRS-WP, 0-10) ≥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 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): 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 | Description |
|---|---|---|
| Change in Shoulder Pain and Disability Index (SPADI) Total Score from Baseline to Week 8 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in QuickDASH Score from Baseline to Week 8 | 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. |
| Change in EQ-5D-5L Index Score from Baseline to Week 8 | 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. |
| Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 8 | 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. |
| Change in Passive Shoulder Range of Motion (ROM) from Baseline to Week 8 | 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). |
| Change in SPADI Total Score from Baseline to Week 12 | 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. |
| Change in QuickDASH Score from Baseline to Week 12 | 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. |
| Change in EQ-5D-5L Index Score from Baseline to Week 12 | 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. |
| Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) from Baseline to Week 12 | 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. |
| Change in Passive Shoulder ROM from Baseline to Week 12 | 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). |
| Change in SPADI Total Score over 12 Weeks (Longitudinal) | 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. |
| Change in QuickDASH Score over 12 Weeks (Longitudinal) | 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. |
| Change in EQ-5D-5L Index Score over 12 Weeks (Longitudinal) | 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. |
| Change in Worst Shoulder Pain in the Past 24 Hours (NRS-WP) over 12 Weeks (Longitudinal) | 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. |
| Change in Passive Shoulder Range of Motion (ROM) over 12 Weeks (Longitudinal) | 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. |
Countries
China
Contacts
CONTACTBin Han, Medical Doctor
PRINCIPAL_INVESTIGATORBin Han, Medical Doctor
The 2nd Affiliated Hospital of Zhejiang University
Outcome results
None listed