Comparative Study Between Intra Articular Injection of Hyaluronic Acid (HA) With Platelet Rich Plasma (PRP) Versus Genicular Nerve Thermal Radiation in Management of Pain in Knee Osteoarthritis

Phase 4

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Intra articular injection Group; Device: Radiofrequency Group

• Registration Number: NCT04188561
• Lead Sponsor: Cairo University

Brief Summary

Intraarticular injection (IAI) of Platelet rich plasma (PRP) with Hyaluronic acid (HA) Versus Radiofrequency (RF) of genicular nerve for pain reduction of of knee osteoarthritis , Improving daily activity and reduction analgesia requirements

Detailed Description

In this study the investigators to comparing between the effect of Intra articular injection of hyaluronic acid (HA) with platelet rich plasma (PRP) versus genicular nerve thermal radiation in management of pain in knee osteoarthritis.

Knee assessment and pain score recorded according to Visual Analogue Scale (VAS) after one week, one month, three months, six months following intraarticular injection and radiation.

All analgesics stopped and only (Arcoxia "etoricoxib" 60 mg, 90 mg) was taken after the procedure, total day dose and frequency will be reported, other analgesics taken by the patient is reported also.

Improvement of daily activities and clinical examination for the studied knees is observed.

Study Timeline

• Study Start: 2018-04-05
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-18
• Study First Submitted: 2019-11-17
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-06
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Mild to moderate Knee osteoarthritis.
• Body mass index: 24 - 42 kg/m2

Exclusion Criteria

• Coagulopathy.
• Acute local or systemic infections with knee effusion Previous knee surgery (relative Contraindication).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraarticular injection Group	Intra articular injection Group	Patients included in the study had been received 2 ml hyaluronic acid with concentration of 22mg/ml . Platelet rich plasma is arranged by withdrawing 10 ml of patient's personal venous blood, anticoagulant is added, and centrifuged by duo-spin method, at the rate of 3500 rpm for five minutes then injected twice with 2 weeks interval
Radiofrequency Group	Radiofrequency Group	Radiofrequency Generator is a four electrode pain management for interventional pain management procedures. Patients had been placed in the supine position and their knee will be supported by a small pillow placed beneath the popliteal fossa. Fluoroscopic images of knee joint had been obtained. Possible locations of genicular nerves had been determined on the lateral, medial aspects of the lower end of the femoral bone and on the medial aspect of the tibia, under fluoroscopic guidance.

Primary Outcome Measures

Name	Time	Method
Pain Measurment via Visual analogue score	Measured throuout 6 months follow up session	Visual analogue score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity was measured throuout 6 months follow up session

Secondary Outcome Measures

Name	Time	Method
Improvement of daily activities between 2 groups	Throuout 6 months follow up session	Compairing between analgesia requirements in Rf group and IAI group
Analgesic requirements Comparison	Throuout 6 months follow up session	Compairing between analgesia requirements in Rf group and IAI group

Trial Locations

Locations (1)

Ahmed Abdalla Mohamed; 🇪🇬 Cairo, Egypt