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

NCT04188561 | Completed Phase 4 DMC

• 1 other identifier: 32094/01/18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain Measurment via Visual analogue score

  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

  Measured throuout 6 months follow up session

Secondary Outcomes (2)

• Analgesic requirements Comparison

  Throuout 6 months follow up session

• Improvement of daily activities between 2 groups

  Throuout 6 months follow up session

Study Arms (2)

Intraarticular injection Group

ACTIVE COMPARATOR

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

Drug: Intra articular injection Group

Radiofrequency Group

ACTIVE COMPARATOR

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.

Device: Radiofrequency Group

Interventions

Intra articular injection Group DRUG

Patients included in the study had been received 2 ml high molecular weight (1.476 x 106 average Daltons) hyaluronic acid with concentration of 22mg/ml (OPTIVISC UK hyaluronic acid for intra articular injection). 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. 3 distinct layers are produced by the end of the centrifugation: plasma, buffy coat (platelet) and RBCs, about 3 - 3.5 ml of PRP is produced at the end with platelet concentration of 1.4 - 1.6 million/μl on average.

Also known as: Intra articular injection of hyaluronic acid and platelet rich plasma

Intraarticular injection Group

Radiofrequency Group DEVICE

Thermal radiation is done by Neurotherm 2000 (Neurotherm NT 2000 Radiofrequency (RF) Generator is a four electrode pain management (RF) generator for interventional pain management procedures. Neurotherm's newest system offers accurate independent controls of each electrode through the touch screen interface and output control knobs.), Patients from the radiofrequency (RF) group 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.

Also known as: Thermal radiation of Genicular nerve

Radiofrequency Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Tanta University: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Closed Opauqe Envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Model Details: This Prospective randomized study was conducted on (100) knees with mild to moderate osteoarthritis and scheduled for Intra articular injection or Genicular nerve radiofrequency at Tanta University Hospital (Intra articular injection was done in pain clinic and Radiofrequency was done in operating room

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: December 6, 2019
• Study Start: April 5, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 18, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

EG (1)