NCT04264000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

3.7 years

First QC Date

February 4, 2020

Last Update Submit

April 9, 2024

Conditions

Ulnar Neuropathy at Elbow

Keywords

Ulnar Neuropathy at Elbowplatelet-rich plasmaPerineural injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

platelet-rich plasma

EXPERIMENTAL

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

Drug: platelet-rich plasma

5% dextrose

ACTIVE COMPARATOR

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

Drug: 5% dextrose

Interventions

platelet-rich plasmaDRUG

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

platelet-rich plasma
5% dextroseDRUG

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

5% dextrose

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20-80 year-old.
  • Diagnosis as ulnar neuropathy at elbow at least one month

You may not qualify if:

  • Cancer
  • Coagulopathy
  • Pregnancy
  • \. Any active infection status 4. Polyneuropathy of upper extremity 5. Brachial plexopathy 6. Thrombocytopenia Previously undergone wrist surgery or steroid injection for ulnar neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yung-Tsan Wu

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 31368191RESULT

  • 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.

    PMID: 30187524RESULT

  • 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.

    PMID: 28273894RESULT

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Yung-Tsan Wu

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physician and associated professor of Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 11, 2020

Study Start

August 1, 2020

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

TW(1)