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Intra Articular Injection of Ozone With Corticosteroids vs PRGF in Knee Osteoarthritis

Primary Purpose

Intra Articular Injection, Corticosteroids, Plasma Rich in Growth Factors

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intra-articular Ozone and corticosteroids
intra-articular PRGF Method
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intra Articular Injection

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 21-65 years both genders who will be diagnosed with stage 2-3 knee osteoarthritis according to the Kellgren-Lawrence Classification System (K-L) [10], with WOMAC Score > 2 for pain stiffness and physical disabilities having symptoms of Knee OA at least 3 months after getting usual conservative treatment like oral analgesics and Therapeutic Exercises. Exclusion Criteria: Patient refusal. Patients who will be diagnosed with Stage 1or 4 OA according to K-L Classification History of knee trauma within the past month History of malignancies Any surgical intervention of the knee Local or systemic infection Any patient with sever renal Impairment Bleeding disorders

Sites / Locations

  • Ahmed Hamdy saied Ayad
  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group ozone

Group PRGF(plasma rich in growth factors)

Arm Description

Outcomes

Primary Outcome Measures

knee osteoarthritis pain
according to Visual Analogue Scale (VAS) which is a subjective scale used to quantitatively assess pain (0-10, 0 = No pain, 10 = Severe pain).
Decrease of Analgesic requirement for pain control after injection
One week before injections all patients will be given etoricoxib 60 mg orally once daily and if pain is not controlled on this dose etoricoxib dose will be increased to 90 mg per day orally, if pain is still patient will add paracetamol 665 mg once daily orally up to 3 times per day till patient reach satisfactory level of pain control, analgesic type and dose will be recorded , patients will continue on these analgesia till the end of injection sessions , after injections the dose of analgesia will reduced gradually on opposite way till the patient reach the same satisfactory level of pain control before injection then the doses of analgesics will be recorded.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2023
Last Updated
June 25, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05837494
Brief Title
Intra Articular Injection of Ozone With Corticosteroids vs PRGF in Knee Osteoarthritis
Official Title
Comparative Study Between Intra Articular Injection of Ozone With Corticosteroids Versus Plasma Rich in Growth Factors in Limitation of Pain in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the effectiveness of intra-articular injection of ozone with corticosteroids versus plasma rich in growth factors (PRGF) in improvement of pain in knee osteoarthritis patients.
Detailed Description
Knee osteoarthritis (OA) is a prevalent degenerative condition in which functional impairment is caused by mechanical and chemical stress against the joint, resulting in pain and decreased range of motion (ROM) . A multiplicity of treatments has been suggested for this disease : some of which include patient education, medication, exercise prescription, conventional and physical agent modalities such as pulsed radio-frequency, and surgical management , The current therapeutic options available for knee osteoarthritis are not effective and satisfactory for patients, and pain has been complained of by at least 40% of those cases who underwent surgical arthroplasty , Also old age prevalence of knee osteoarthritismake treatment with analgesics has several side effects over stomach, liver and kidney and also surgical one has high morbidities and mortalities for old ages. Therefore, in the last two decades, a large body of work has been performed to develop non-operative or minimally invasive interventions to decrease Knee osteoarthritis symptoms or slow down its progression. Among These modalities of intra-articular injections the autologous PRP has gained more attention in the treatment of patients with knee osteoarthritis in recent years. Several studies is supporting the use of PRP injection as an effective method for Knee osteoarthritis, as latelet-rich plasma (PRP) could serve as anti-nociceptive and induce cell proliferation. also intra-articular injection of latelet-rich plasma modulates joint environment, promote chondrogenesis and inhibits the destruction of knee joint probably by reducing the production of pro-inflammatory mediators by the supra-physiologic concentrations of biological molecules and growth factors exist in in the granules of the platelets which could potentially reverse the catabolic environment in osteoarthritis, balancing the homeostasis of the joint, and subsequently stimulate the repair of damaged cartilage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra Articular Injection, Corticosteroids, Plasma Rich in Growth Factors, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group ozone
Arm Type
Active Comparator
Arm Title
Group PRGF(plasma rich in growth factors)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Intra-articular Ozone and corticosteroids
Intervention Description
patients will undergo one session a week for a total of four sessions of intra-articular knee injection with combination of 5ml (25 μg/ml) ozone injection + 2 ml lignocaine 2% + 2 ml Betamethasone sodium phosphate 4 mg. Under aseptic precautions. A22-gauge needle was positioned inferior-laterally into the infera-patellar pouch, injection of 2 ml of 4 mg Betamethasone sodium phosphate, and 2 ml injection lignocaine 2% was injected slowly (over 1-2 minutes). The needle was left in space for the 5 ml (25 μg/ml) ozone injection. Patients were advised to avoid strenuous activity for 2-3 days following the intra-articular injection.
Intervention Type
Drug
Intervention Name(s)
intra-articular PRGF Method
Intervention Description
Patients will undergoes two doses with 2 weeks interval by injection of already synthetic plasma rich in growth factors [PRGF] vial intra-articularly. This vial is formed of lyophilized cake of platelet growth factors in a tightly sealed container stored at 2-8◦C which synthesized under complete aseptic technique by activation of platelets to release its growth factors and cytokines which help in knee cartilage regeneration and act as potent anti-inflammatory to reduce the pain. Prior to usage, reconstitution of the product was done using 1 ml saline and 1 ml lignocaine 2% followed by gentle vial rubbing for 3 min then, the mixture was kept at ambient temperature for 5 min to ensure complete protein re-hydration.
Primary Outcome Measure Information:
Title
knee osteoarthritis pain
Description
according to Visual Analogue Scale (VAS) which is a subjective scale used to quantitatively assess pain (0-10, 0 = No pain, 10 = Severe pain).
Time Frame
six months following injection
Title
Decrease of Analgesic requirement for pain control after injection
Description
One week before injections all patients will be given etoricoxib 60 mg orally once daily and if pain is not controlled on this dose etoricoxib dose will be increased to 90 mg per day orally, if pain is still patient will add paracetamol 665 mg once daily orally up to 3 times per day till patient reach satisfactory level of pain control, analgesic type and dose will be recorded , patients will continue on these analgesia till the end of injection sessions , after injections the dose of analgesia will reduced gradually on opposite way till the patient reach the same satisfactory level of pain control before injection then the doses of analgesics will be recorded.
Time Frame
six months following injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 21-65 years both genders who will be diagnosed with stage 2-3 knee osteoarthritis according to the Kellgren-Lawrence Classification System (K-L) [10], with WOMAC Score > 2 for pain stiffness and physical disabilities having symptoms of Knee OA at least 3 months after getting usual conservative treatment like oral analgesics and Therapeutic Exercises. Exclusion Criteria: Patient refusal. Patients who will be diagnosed with Stage 1or 4 OA according to K-L Classification History of knee trauma within the past month History of malignancies Any surgical intervention of the knee Local or systemic infection Any patient with sever renal Impairment Bleeding disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed H Ayad, master
Phone
01009598637
Ext
139
Email
ahmed162098_pg@med.tanta.edu.eg
Facility Information:
Facility Name
Ahmed Hamdy saied Ayad
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed H Ayad, master
Phone
01009598637
Ext
139
Email
ahmed162098_pg@med.tanta.edu.eg
Facility Name
Tanta University
City
Tanta
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed H Ayad, MBBCh
Phone
00201559995155
Email
ahmed162098_pg@med.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon reasonable request from the principal investigator
IPD Sharing Time Frame
one year

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Intra Articular Injection of Ozone With Corticosteroids vs PRGF in Knee Osteoarthritis

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