Clinical trial

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

Name
Study 2020-1064
Description
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.
Trial arms
Trial start
2021-06-01
Estimated PCD
2022-09-01
Trial end
2022-09-01
Status
Terminated
Phase
Early phase I
Treatment
Compound betamethasone Injection(Gluteal muscle injection)
Gluteal muscle injection(Compound betamethasone 1ml + Sodium Chloride Injection 4ml) + Subacromial Ultrasound Guided injection(Sodium Chloride Injection 5ml)
Arms:
Gluteal muscle injection plus physical therapy group
Other names:
corticosteroid
Compound betamethasone Injection(Subacromial Ultrasound Guided injection)
Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml)
Arms:
Subacromial Ultrasound Guided injection plus physical therapy group
Other names:
corticosteroid
Physical therapy
paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home
Arms:
Gluteal muscle injection plus physical therapy group, Subacromial Ultrasound Guided injection plus physical therapy group
Size
20
Primary endpoint
The Change of Shoulder Pain and Disability Index (SPADI)
0,1,2,4,8,12 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-12-29

1 organization

2 products

3 indications

Indication
Shoulder Pain
Indication
Bursitis