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

December 12, 2019 updated by: Ahmed Abdalla, Cairo University
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

Study Overview

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11451
        • Ahmed Abdalla Mohamed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intraarticular 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

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.

Other Names:
  • Intra articular injection of hyaluronic acid and platelet rich plasma
ACTIVE_COMPARATOR: 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.
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.
Other Names:
  • Thermal radiation of Genicular nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Measurment via Visual analogue score
Time Frame: 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
Measured throuout 6 months follow up session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic requirements Comparison
Time Frame: Throuout 6 months follow up session
Compairing between analgesia requirements in Rf group and IAI group
Throuout 6 months follow up session
Improvement of daily activities between 2 groups
Time Frame: Throuout 6 months follow up session
Compairing between analgesia requirements in Rf group and IAI group
Throuout 6 months follow up session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 5, 2018

Primary Completion (ACTUAL)

January 15, 2019

Study Completion (ACTUAL)

January 18, 2019

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (ACTUAL)

December 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Till Publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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