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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| progression rate of rotator cuff tears | Third-party experts will conduct blinded readings of shoulder MRI scans, classifying rotator cuff status into three grades: Grade I (intact), Grade II (partial tear), and Grade III (complete tear). Patients classified as Grade III at week 0 will be excluded from the study, as baseline grading (determined by each research center) assesses eligibility per exclusion criterion 2. The lead center provided MRI reading training to all centers, using T2-weighted images with a pure white fluid signal occupying full or partial thickness of the rotator cuff across at least two consecutive MRI slices as the diagnostic criterion for full- or partial-thickness tears. Patients with Grade I or II tears at week 0 will receive study treatment and be followed up at week 12. Tear progression is defined as an increase of at least one grade between weeks 0 and 12, assessed by blinded experts. The progression rate is the number of subjects with progression divided by the total number in each group. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of serious adverse events (SAE) | The incidence of serious adverse events (SAE) at 12 weeks | From enrollment to the end of follow-up at 12 weeks |
| incidence of adverse events (AE) | The incidence of adverse events (AE) at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bin Han, Medical Doctor | The 2nd Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangde County People's Hospital | Xuancheng | Anhui | 242299 | China | ||
| Yangpu District Central Hospital of Shanghai |
The current registration is for a pilot study for a later larger trial. We will consider sharing the data after the completion of the subsequent full trial.
We will consider sharing the data after the completion of the subsequent full trial.
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.
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| 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. |
|
| Normal Saline as Placebo (ultrasound-guided subacromial injection) | Other | ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4. |
|
| Normal Saline as Placebo (gluteal muscle inection) | Other | gluteal injection of 5 ml normal saline at week 0,2,4. |
|
| 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. |
|
| From enrollment to the end of follow-up at 12 weeks |
| short version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH） | The QuickDASH score ranges from 0 to 100. A score of 0 means no disability, and a score of 100 signifies the highest level of disability related to arm, shoulder, and hand function. 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 |
| Numerical Rating Scale (NRS) | The NRS score ranges from 0 to 10. A score of 0 indicates no pain, while a score of 10 reflects the worst possible pain. 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 |
| five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) | The EQ-5D-5L provides an overall health utility score ranging from -0.281 to 1, where 1 represents perfect health, zero represents a state equivalent to death, and negative values indicate health states worse than death. It also reports on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels from no problems to extreme problems. 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 |
| passive range of motion of shoulder | The passive range of motion for shoulder flexion, abduction, internal rotation (at the side), and external rotation (at the side) on the affected side will be measured using a goniometer by trained researchers following a pre-established standard operating procedure. | Baseline and 12 weeks |
| Direct Medical Cost | The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the onset of frozen shoulder. | Baseline |
| Direct Medical Cost | The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the last outpatient research follow-up. | Baseline and week2 |
| Direct Medical Cost | The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the last outpatient research follow-up. | Week2 and week4 |
| Direct Medical Cost | The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the last outpatient research follow-up. | Week4 and week8 |
| Direct Medical Cost | The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the last outpatient research follow-up. | Week8 and week12 |
| work absenteeism | The questionnaire surveys the number of workdays missed since the onset of frozen shoulder is collected at baseline. | Week 0 |
| work absenteeism | The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up. | Week 0 and Week 2 |
| work absenteeism | The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up. | Week 2 and Week 4 |
| work absenteeism | The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up. | Week 4 and Week 8 |
| work absenteeism | The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up. | Week 8 and Week 12 |
| Unplanned concomitant use of analgesics | This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up. | Week 2 |
| Unplanned concomitant use of analgesics | This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up. | Week 4 |
| Unplanned concomitant use of analgesics | This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up. | Week 8 |
| Unplanned concomitant use of analgesics | This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up. | Week 12 |
| Glycated Hemoglobin (HbA1c) | Depending on the specific assay methods used by the laboratory departments of different study centers, HbA1c will be measured by high-Performance Liquid Chromatography (HPLC), Immunoturbidimetric Method, Enzymatic Method, Affinity Chromatography, Electrophoresis, Capillary Electrophoresis or Ion-Exchange Chromatography. | week 0 and week 12 |
| glycated albumin | Depending on the specific assay methods used by the laboratory departments of different study centers, glycated albumin will be measured by Enzymatic Method, Immunoturbidimetric Method, High-Performance Liquid Chromatography (HPLC), Affinity Chromatography, or Immunoelectrophoresis. | week 0 and week 4 |
| From enrollment to the end of follow-up at 12 weeks |
| Shanghai |
| Shanghai Municipality |
| 200082 |
| China |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| The First People's Hospital of Linping District, Hangzhou | Hangzhou | Zhejiang | 311199 | China |
| Huzhou Central Hospital | Huzhou | Zhejiang | 313000 | China |
| Pujiang People's Hospital | Jinhua | Zhejiang | 322200 | China |
| First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | 315020 | China |
| Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group | Ningbo | Zhejiang | 315799 | China |
| Shengzhou People's Hospital | Shanhu | Zhejiang | 312400 | China |
| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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