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Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

Primary Purpose

Ulnar Neuropathy at Elbow

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
platelet-rich plasma
5% dextrose
Sponsored by
Yung-Tsan Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulnar Neuropathy at Elbow focused on measuring Ulnar Neuropathy at Elbow, platelet-rich plasma, Perineural injection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yung-Tsan WuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

platelet-rich plasma

5% dextrose

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Electrophysiological study
Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
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.

Full Information

First Posted
February 4, 2020
Last Updated
April 25, 2022
Sponsor
Yung-Tsan Wu
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1. Study Identification

Unique Protocol Identification Number
NCT04264000
Brief Title
Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow
Official Title
Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow: A Randomized Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yung-Tsan Wu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulnar Neuropathy at Elbow
Keywords
Ulnar Neuropathy at Elbow, platelet-rich plasma, Perineural injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
platelet-rich plasma
Arm Type
Experimental
Arm Description
The perineural injection with PRP is a potential treatment for peripheral entrapment neuropathy
Arm Title
5% dextrose
Arm Type
Active Comparator
Arm Description
The perineural injection of 5% dextrose is a novel management for peripheral entrapment neuropathy
Intervention Type
Drug
Intervention Name(s)
platelet-rich plasma
Intervention Description
Ultrasound-guided 3cc PRP injection between medial epicondyle and ulnar nerve
Intervention Type
Drug
Intervention Name(s)
5% dextrose
Intervention Description
Ultrasound-guided 3cc 5% dextrose injection between medial epicondyle and ulnar nerve
Primary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
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.
Time Frame
Change from baseline at 6 month after injection
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
Change from baseline at 6 month after injection
Title
Electrophysiological study
Description
Nerve motor conduction velocity of the ulnar nerve before treatment and multiple time frame after treatment.
Time Frame
Change from baseline at 6 month after injection
Title
Cross-sectional area of ulnar nerve
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.
Time Frame
Change from baseline at 6 month after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yung-Tsan Wu
Phone
+886287923311
Email
crwu98@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yung-Tsan Wu
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu
Phone
0287923311
Email
crwu98@gmail.com
Ext
Wu
Email
crwu98@gmail.com
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31368191
Citation
Shen YP, Li TY, Chou YC, Ho TY, Ke MJ, Chen LC, Wu YT. Comparison of perineural platelet-rich plasma and dextrose injections for moderate carpal tunnel syndrome: A prospective randomized, single-blind, head-to-head comparative trial. J Tissue Eng Regen Med. 2019 Nov;13(11):2009-2017. doi: 10.1002/term.2950. Epub 2019 Aug 20.
Results Reference
result
PubMed Identifier
30187524
Citation
Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.
Results Reference
result
PubMed Identifier
28273894
Citation
Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Huang GS, Chen LC. Six-month efficacy of platelet-rich plasma for carpal tunnel syndrome: A prospective randomized, single-blind controlled trial. Sci Rep. 2017 Dec;7(1):94. doi: 10.1038/s41598-017-00224-6. Epub 2017 Mar 7.
Results Reference
result

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Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

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