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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-12-16

No results posted yet for this study

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

Interventions

DRUG

Intra articular injection Group

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.

DEVICE

Radiofrequency Group

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.

Sponsors & Collaborators

  • Tanta University

    collaborator OTHER

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2019-01-15
Completion
2019-01-18

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188561 on ClinicalTrials.gov