Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study

Conditions
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Frozen Shoulder, Shoulder Pain, Bursitis

Intervention / Treatment
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* Drug: Compound betamethasone Injection(Gluteal muscle injection)
* Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection)
* Behavioral: Physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Primary frozen shoulder 2. Older than 18 years of age and less than 75 years of age 3. The SHOULDER PAIN VAS SCORE IS GREATER THAN 3 POINTS AND LASTS AT LEAST 1 MONTH AND LESS THAN 9 MONTHS 4. The passive activity of the side shoulder joint in at least 2 directions in the three directions of front, internal and outer rotation decreased by more than 30 degrees compared to the side shoulder joint or the normal reference value 5. corticosteroid injections were not given within 3 months of visit Exclusion Criteria: 1. A history of trauma, osteoarthritis, tumors, etc. 2. Combined shoulder sleeve injury with magnetic resonance or B-mode ultrasound confirmed 3. There is a history of corticosteroid injections within 3 months of visit 4. Suffer from a partial infection of the side shoulder or other cases where there is a contraindication of shoulder injection 5. Both side shoulder joints become ill at the same time 6. The patient has not signed an informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gluteal muscle injection plus physical therapy group<br>Gluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy | Drug: Compound betamethasone Injection(Gluteal muscle injection)<br>* Gluteal muscle injection(Compound betamethasone 1ml + Sodium Chloride Injection 4ml) + Subacromial Ultrasound Guided injection(Sodium Chloride Injection 5ml)<br>* Other names: corticosteroid;Behavioral: Physical therapy<br>* paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home<br>|
| Experimental: Subacromial Ultrasound Guided injection plus physical therapy group<br>Gluteal muscle injection(sodium chloride 5ml)) + Subacromial Ultrasound Guided injection(corticosteroid 1ml+normal saline 4ml) + Physical therapy | Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection)<br>* Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml)<br>* Other names: corticosteroid;Behavioral: Physical therapy<br>* paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |