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

NCT06638008 | Not Yet Recruiting DMC

• 1 other identifier: Sara thesis
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• diagnosis and follow up of patients by nerve conduction study and neuromuscular US

  one year

Study Arms (3)

group will receive placental growth factor injection

EXPERIMENTAL

Drug: perineural injection

group will receive platelet rich plasma injection

EXPERIMENTAL

Drug: perineural injection

group with only follow up

NO INTERVENTION

Interventions

perineural injection DRUG

perineural intervention of placental growth factor in one group and PRP in other group

group will receive placental growth factor injection; group will receive platelet rich plasma injection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Essam Ahmed Abda, professor

  professor of Rheumatology, Rehabilitation and physical medicine

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Sara Taher Amin, assistant lecturer

CONTACT

+201111337547; Sarataher.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Main investigator

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: January 15, 2025
• Primary Completion: January 15, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 15, 2024

Record last verified: 2024-10