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Completed

NCT Number: NCT04264000

Platelet-rich Plasma Injection for Ulnar Neuropathy at Elbow

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.

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Key information

Conditions

Ulnar Neuropathy at Elbow

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yung-Tsan Wu

Taipei, Neihu District, 886, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

platelet-rich plasma

Drug

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

5% Dextrose

Drug

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

Primary outcomes

  1. Visual analog scale (VAS)

    Time frame: Change from baseline at 6 month after injection

    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 outcomes

  1. Disabilities of the Arm, Shoulder and Hand (DASH)

    Time frame: Change from baseline at 6 month after injection

    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.

  2. Electrophysiological study

    Time frame: Change from baseline at 6 month after injection

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

  3. Cross-sectional area of ulnar nerve

    Time frame: Change from baseline at 6 month after injection

    Using the musculoskeletal sonogram to measure the cross-sectional area of the ulnar nerve before treatment and multiple time frame after treatment.

Sponsors and collaborators

Lead sponsor

Yung-Tsan Wu

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2020
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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