Clinical trial NCT06638008: Ultrasound Guided Placental Growth Factor Vs Platelet Rich Plasma Injection in Peripheral Nerve Injury: an Interventional Study
Official title: Ultrasound Guided Placental Growth Factor Vs Platelet Rich Plasma Injection in Peripheral Nerve Injury: an Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Nerve Injury Upper Limb
Keywords: peripheral nerve injury
median and ulnar nerves
nerve conduction study
neuromuscular ultrasound
placental growth factor
perineural injection
platelet rich plasma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 75
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: efficacy of placental growth factor injection guided by ultrasound and nerve conduction
timeFrame: one year
measure: efficacy of platelet rich plasma injection guided by ultrasound and nerve conduction
timeFrame: one year
Secondary outcomes:
measure: diagnosis and follow up of patients by nerve conduction study and neuromuscular US
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: professor of Rheumatology, Rehabilitation and physical medicine
name: Essam Ahmed Abda, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor of Rheumatology, Rehabilitation and physical medicine
name: Mohammed Raouf Abd El-razik, Assistant professor
role: STUDY_DIRECTOR
affiliation: lecturer of Rheumatology, Rehabilitation and physical medicine
name: Amira Mostafa El-sonbaty, lecturer
role: STUDY_DIRECTOR
References: