Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

NCT ID: NCT04264000

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2024-03-31

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.

Conditions

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Ulnar Neuropathy at Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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platelet-rich plasma

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

Group Type EXPERIMENTAL

platelet-rich plasma

Intervention Type DRUG

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

5% dextrose

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

Group Type ACTIVE_COMPARATOR

5% dextrose

Intervention Type DRUG

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

Interventions

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platelet-rich plasma

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

Intervention Type DRUG

5% dextrose

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yung-Tsan Wu

OTHER

Sponsor Role lead

Responsible Party

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Yung-Tsan Wu

Attending Physician and associated professor of Department of Physical Medicine and Rehabilitation

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yung-Tsan Wu

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Locations

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Yung-Tsan Wu

Taipei, Neihu District, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 31368191 (View on PubMed)

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.

Reference Type RESULT
PMID: 30187524 (View on PubMed)

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.

Reference Type RESULT
PMID: 28273894 (View on PubMed)

Other Identifiers

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PRP for ulnar neuropathy

Identifier Type: -

Identifier Source: org_study_id

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