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Since the COVID-19 pendemic, the regular follow-up of participant became very hard. The participant were not willing to go back to the hospital for repeat measurement. So we stop the study and plan to redesign the protocol.
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This study aim to compare the efficacy of guteal muscle injection and subacromial ultrasound guided injection to treat frozen shoulder. Firstly, in order to calculate the sample size correctly, we start the preliminary study. Besides, in order to propose clinical new technology which combines the advantages of the two therapies, improve the efficacy ratio of frozen shoulder therapy, and provide a frozen shoulder treatment plan according to health economics.
In recent years, there have been studies suggesting that small doses of corticosteroid systemic medication and joint local injection to treat shoulder sleeve disease is equivalent, frozen shoulder is clinically in addition to shoulder sleeve disease another common cause of shoulder pain disease, local injection of small dose of corticosteroid is a clinically commonly used treatment of frozen shoulder mature therapy, however, because of the risk of joint infection and other serious complications, and it's personnel experience depended and high qualification requirements, resulting in higher treatment costs. However, it has not been widely used in clinical applications and is generally used as a second-line therapy for the treatment of frozen shoulders. There are studies suggesting that joint cavity hormone injection may be mainly effective through its systemic effect, however, there is currently no random blind control study comparing small doses of hormone systemic injection with local injection of shoulder joints to freeze shoulder, if the equivalence of the two can be confirmed through such studies will greatly change the clinical treatment of frozen shoulders, with hip injection and other systemic medication will provide great health economic advantages, and can avoid the inherent risk of joint cavity injection, reduce the social cost of frozen shoulder treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gluteal muscle injection plus physical therapy group | Experimental | Gluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy |
|
| Subacromial Ultrasound Guided injection plus physical therapy group | Experimental | Gluteal muscle injection(sodium chloride 5ml)) + Subacromial Ultrasound Guided injection(corticosteroid 1ml+normal saline 4ml) + Physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound betamethasone Injection(Gluteal muscle injection) | Drug | Gluteal muscle injection(Compound betamethasone 1ml + Sodium Chloride Injection 4ml) + Subacromial Ultrasound Guided injection(Sodium Chloride Injection 5ml) |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Shoulder Pain and Disability Index (SPADI) | The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. | 0,1,2,4,8,12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Numeric Rating Scale for Pain (NRS) (Score: 0-10) | The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line. Similar to the pain VAS, the NRS is anchored by terms describing pain severity extremes | 0,1,2,4,8,12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pintong Huang | Department of Ultrasound in Medicine, The Second Affiliated AHospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hanzhou | Zhejiang | 310000 | China |
I'd like to share the IPD with the other researchers after the paper is published.
I'd like to share the IPD with the other researchers after the paper is published.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2021 | Jun 17, 2021 |
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|
| Compound betamethasone Injection(Subacromial Ultrasound Guided injection) | Drug | Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml) |
|
|
| Physical therapy | Behavioral | paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home |
|
| Anterior flexion of shoulder joint (0-180°) | Passive activity of the shoulder joint | 0,1,2,4,8,12 weeks |
| shoulder joint abduction (0-180°) | Passive activity of the shoulder joint | 0,1,2,4,8,12 weeks |
| shoulder internal rotator (1-18 score) | The thumb tip reaches the highest point of the back cone:Score1-12: T1-T12; Score13-17:L1-L5;18: below the sacrum; | 0,1,2,4,8,12 weeks |
| shoulder external rotator (0-180°) | Passive activity of the shoulder joint | 0,1,2,4,8,12 weeks |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D002062 | Bursitis |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D018771 | Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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