Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

Study Overview
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Brief Summary
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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.

Detailed Description
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The platelet-rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Our previous research shown single injection with PRP was superior to D5W for CTS. However there is no study investigating the effect of PRP for UNE now. Hence, the purpose of this study was to assess the effect of perineural PRP injection for UNE.

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

Conditions
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Ulnar Neuropathy at Elbow

Intervention / Treatment
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* Drug: platelet-rich plasma
* Drug: 5% dextrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-80 year-old. Diagnosis as ulnar neuropathy at elbow at least one month Exclusion Criteria: Cancer Coagulopathy 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: platelet-rich plasma<br>The perineural injection with PRP is a potential treatment for peripheral entrapment neuropathy | Drug: platelet-rich plasma<br>* Ultrasound-guided 3cc PRP injection between medial epicondyle and ulnar nerve<br>|
| Active Comparator: 5% dextrose<br>The perineural injection of 5% dextrose is a novel management for peripheral entrapment neuropathy | Drug: 5% dextrose<br>* Ultrasound-guided 3cc 5% dextrose injection between medial epicondyle and ulnar nerve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) | Digital pain severity or paresthesia/dysthesia was evaluated using VAS. Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain. | Change from baseline at 6 month after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand (DASH) | Taiwan Disabilities of the Arm, Shoulder and Hand (DASH) contains 11-item disability/symptom scale and each item has five levels of response scoring from 1 to 5. The higher score means more disability or severer symptoms. | Change from baseline at 6 month after injection | 
| Electrophysiological study | Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment. | Change from baseline at 6 month after injection | 
| Cross-sectional area of ulnar nerve | Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment. | Change from baseline at 6 month after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perineural injection, Ulnar Neuropathy at Elbow, platelet-rich plasma