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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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Intra articular injection Group
Radiofrequency Group
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Ahmed Abdalla Mohamed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intraarticular injection Group

Radiofrequency Group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Analgesic requirements Comparison
Compairing between analgesia requirements in Rf group and IAI group
Improvement of daily activities between 2 groups
Compairing between analgesia requirements in Rf group and IAI group

Full Information

First Posted
November 17, 2019
Last Updated
December 12, 2019
Sponsor
Cairo University
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04188561
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Tanta University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare Provider
Masking Description
Closed Opauqe Envelopes
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraarticular injection Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Radiofrequency Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intra articular injection Group
Other Intervention Name(s)
Intra articular injection of hyaluronic acid and platelet rich plasma
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Radiofrequency Group
Other Intervention Name(s)
Thermal radiation of Genicular nerve
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Measurment via Visual analogue score
Description
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
Time Frame
Measured throuout 6 months follow up session
Secondary Outcome Measure Information:
Title
Analgesic requirements Comparison
Description
Compairing between analgesia requirements in Rf group and IAI group
Time Frame
Throuout 6 months follow up session
Title
Improvement of daily activities between 2 groups
Description
Compairing between analgesia requirements in Rf group and IAI group
Time Frame
Throuout 6 months follow up session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Ahmed Abdalla Mohamed
City
Cairo
ZIP/Postal Code
11451
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Till Publication

Learn more about this trial

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

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