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

NCT05837494 | Completed

• 1 other identifier: 35293/2/22
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Intra Articular Injection; Corticosteroids; Plasma Rich in Growth Factors; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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).

  six months following injection

• 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.

  six months following injection

Study Arms (2)

Group ozone

ACTIVE COMPARATOR

Drug: Intra-articular Ozone and corticosteroids

Group PRGF(plasma rich in growth factors)

ACTIVE COMPARATOR

Drug: intra-articular PRGF Method

Interventions

Intra-articular Ozone and corticosteroids DRUG

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.

Group ozone

intra-articular PRGF Method DRUG

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.

Group PRGF(plasma rich in growth factors)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Ahmed Hamdy saied Ayad

Tanta, El-Gharbia, 31527, Egypt

Location

Tanta University

Tanta, 31527, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ozone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty Of Medicine Tanta University

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: May 1, 2023
• Study Start: June 1, 2022
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year

Locations

EG (2)