Ultrasound Guided Placental Growth Factor Vs Platelet Rich Plasma Injection in Peripheral Nerve Injury: an Interventional Study

The goal of this clinical trial is to learn if placental growth factor injection and platelet rich plasma injection works to treat peripheral nerve injury in adults. and the role of nerve conduction study and neuromuscular ultrasound

The main questions it aims to answer are:

Does placental growth factor improve outcome after peripheral nerve injury? Does platelet rich plasma improve outcome after peripheral nerve injury? Researchers will compare drug both drugs to each other and will follow up the results via NCS and NMUS

Participants will be classified into 3 random groups:

one group will receive perineural injection of placental growth factor, the other group will receive peri neural PRP injection, third group will only be followed up without intervention Follow up of each patients will be done at 3 and 6 months

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Nerve Injury Upper Limb
• Intervention / Treatment: Drug: perineural injection

Detailed Description

Traumatic nerve injuries, particularly involving the median and ulnar nerves, pose significant clinical challenges and can lead to considerable morbidity Neuropathic pain, which can arise from nerve lesions, may persist for months or even years after the apparent healing of the affected tissues , Moreover, weakness or paralysis of specific muscles can impair grip strength and fine motor skills, making daily tasks challenging, and the chronic disability affects patient's quality of life.

Neuromuscular US is a non-invasive technique to diagnose peripheral nerve injuries, basic findings in nerve trauma may include focal enlargements suggesting a neuroma in continuity, disorganization of the internal fascicular structure, as well as partial or complete nerve transection.

Growth factors play a pivotal role in the process of nerve regeneration by promoting cellular growth, survival, and differentiation.

Placenta extract contains a variety of growth factors, such as: Vascular Endothelial Growth Factor (VEGF), Transforming Growth Factor-beta (TGF-β), Fibroblast Growth factor (FGF) and insulin-like growth factor (IGF), It also includes cytokines and proteins that support healing and modulate inflammatory responses(6)placental extract use showed a significant improvement in pain and range of motion in knee osteoarthritis, Fibromyalgia and Rheumatoid arthritis (RA).

Another rich source of growth factors is platelet-rich plasma (PRP) it allows gradual and sustained release of neurotrophic signaling molecules such as nerve growth factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), IGF-1, platelet-derived growth factor (PDGF), VEGF, and hepatocyte growth factor (HGF) and neurotropic factors (fibrin, fibronectin, and vitronectin) Studies on PRP and placental extract effect on nerve injuries are also still limited which needs further experimentation to understand its effect, and ability of regeneration of various neural components.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Taher Amin, assistant lecturer; Phone Number: +201111337547; Email: Sarataher.md@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients older than 16 yrs old.
2. Patients with traumatic median or ulnar nerve injury who are complaining of symptoms or functional disability.
3. Patients with these injuries for more than 3 months

Exclusion Criteria:

• 1- Presence of other causes of nerve affection (entrapment, Diabetes, etc).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group will receive placental growth factor injection	Drug: perineural injection; perineural intervention of placental growth factor in one group and PRP in other group
Experimental: group will receive platelet rich plasma injection	Drug: perineural injection; perineural intervention of placental growth factor in one group and PRP in other group
No Intervention: group with only follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of placental growth factor injection guided by ultrasound and nerve conduction	pre and post injection follow up will be done my measuring the nerve conduction velocity and amplitude , and by determining the cross sectional area of the nerve by ultrasound	one year
efficacy of platelet rich plasma injection guided by ultrasound and nerve conduction	pre and post injection parameters of nerve conduction as velocity and amplitude will be measured as will as parameters of ultrasound such as cross sectional area	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis and follow up of patients by nerve conduction study and neuromuscular US	patients will undergo baseline NCS and NMUS and then follow up the outcome of injection at 3 and 6 months the following parameters will be measured : nerve conduction velocity and amplitude as well as cross sectional area of the nerve	one year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Essam Ahmed Abda, professor, professor of Rheumatology, Rehabilitation and physical medicine; Study Director: Mohammed Raouf Abd El-razik, Assistant professor, Assistant professor of Rheumatology, Rehabilitation and physical medicine; Study Director: Amira Mostafa El-sonbaty, lecturer, lecturer of Rheumatology, Rehabilitation and physical medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: platelet rich plasma; peripheral nerve injury; perineural injection; nerve conduction study; placental growth factor; median and ulnar nerves; neuromuscular ultrasound
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nerve Injuries
• Other Study ID Numbers: Sara thesis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No