Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

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

Sponsors

Lead Sponsor: Yung-Tsan Wu

Source Tri-Service General Hospital
Brief Summary

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

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.

Overall Status Recruiting
Start Date 2020-08-01
Completion Date 2022-08-31
Primary Completion Date 2022-08-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual analog scale (VAS) Change from baseline at 6 month after injection
Secondary Outcome
Measure Time Frame
Disabilities of the Arm, Shoulder and Hand (DASH) Change from baseline at 6 month after injection
Electrophysiological study Change from baseline at 6 month after injection
Cross-sectional area of ulnar nerve Change from baseline at 6 month after injection
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: platelet-rich plasma

Description: Ultrasound-guided 3cc PRP injection between medial epicondyle and ulnar nerve

Arm Group Label: platelet-rich plasma

Intervention Type: Drug

Intervention Name: 5% dextrose

Description: Ultrasound-guided 3cc 5% dextrose injection between medial epicondyle and ulnar nerve

Arm Group Label: 5% dextrose

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

Gender:

All

Minimum Age:

20 Years

Maximum Age:

80 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Yung-Tsan Wu Principal Investigator Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Overall Contact

Last Name: Yung-Tsan Wu

Phone: +886287923311

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Yung-Tsan Wu Yung-Tsan Wu 0287923311 [email protected] Yung-Tsan Wu Principal Investigator
Location Countries

Taiwan

Verification Date

2021-02-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Tri-Service General Hospital

Investigator Full Name: Yung-Tsan Wu

Investigator Title: Attending Physician and associated professor of Department of Physical Medicine and Rehabilitation

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: platelet-rich plasma

Type: Experimental

Description: The perineural injection with PRP is a potential treatment for peripheral entrapment neuropathy

Label: 5% dextrose

Type: Active Comparator

Description: The perineural injection of 5% dextrose is a novel management for peripheral entrapment neuropathy

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

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