Shoulder Pain Clinical Trial
Official title:
Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study
Verified date | December 2023 |
Source | Second Affiliated Hospital, School of Medicine, Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hanzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Anterior flexion of shoulder joint (0-180°) | Passive activity of the shoulder joint | 0,1,2,4,8,12 weeks | |
Secondary | shoulder joint abduction (0-180°) | Passive activity of the shoulder joint | 0,1,2,4,8,12 weeks | |
Secondary | 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 | |
Secondary | shoulder external rotator (0-180°) | Passive activity of the shoulder joint | 0,1,2,4,8,12 weeks |
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