Clinical trial

Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow: A Randomized Double-blind Trial

Name
PRP for ulnar neuropathy
Description
Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy after carpal tunnel syndrome (CTS). Although many conservative managements of UNE were found, their effectiveness were often unsatisfied without existed guideline. Recently, the perineural injection of 5% dextrose wate (D5W) is a novel management for CTS but its effect for UNE is not obviously as CTS. Hence, it is very important to find another novel injectate for UNE.
Trial arms
Trial start
2020-08-01
Estimated PCD
2024-03-31
Trial end
2024-03-31
Status
Completed
Treatment
platelet-rich plasma
Ultrasound-guided 3cc PRP injection between medial epicondyle and ulnar nerve
Arms:
platelet-rich plasma
5% dextrose
Ultrasound-guided 3cc 5% dextrose injection between medial epicondyle and ulnar nerve
Arms:
5% dextrose
Size
30
Primary endpoint
Visual analog scale (VAS)
Change from baseline at 6 month after injection
Eligibility criteria
Inclusion Criteria: 1. Age between 20-80 year-old. 2. Diagnosis as ulnar neuropathy at elbow at least one month Exclusion Criteria: 1. Cancer 2. Coagulopathy 3. Pregnancy 3. Any active infection status 4. Polyneuropathy of upper extremity 5. Brachial plexopathy 6. Thrombocytopenia Previously undergone wrist surgery or steroid injection for ulnar neuropathy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-04-10

1 organization

2 products

1 indication

Organization
Yung-Tsan Wu