Intra-articular (Knee)injection of Ozone as a treatment for pain in patients with rheumatoid arthritis

Comparing The Efficacy Of Intra-Articular Ozone Injection Vs Intra-Articular Corticosteroid Injection In Knee Synovitis In Rheumatoid Arthritis. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085875

Enrollment

Registered

2025-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Interventions

Intervention1: Ozone: Patients in this group will be injected with 10 ml ozone oxygen(O3 O2) with 40 ug/ml concentration (made by generator) intraarticularly in the knee a total of three times, once w

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients age greater than 18 years, fulfilling the clinical criteria of rheumatoid arthritis defined by ACR EULAR diagnostic criteria greater or equal to 6/10 2. Increased knee pain and stiffness for at last 3 months. 3. Pain intensity on Visual Analog Scale greater than or equal to 4 out of 10 at knee joint. 4. RA diagnosed and patient has taken DMARDs for more than 6 months, with no alteration in dosage for the last 3 months.

Exclusion criteria

Exclusion criteria: 1. Diabetes mellitus 2. Pregnancy 3. Previous arthroplasty 4. Intra articular or peri articular injection in the past three months 5. Body mass index more than 40. 6. Any disease flare in the last 3 months 7. Any local lesion in the injection site. 8. Coagulation disorder, Allergic reaction to local anesthetic, ozone, and steroid in the past 9. Switch to any other treatment modality during the 12 weeks of follow up in the post injection period. 10. Any patient on systemic Biological DMARDs

Design outcomes

Primary

Measure	Time frame
To compare the improvement in pain in the intervened knee (measured by VAS 100mm scale) following intra-articular injection of ozone therapy against intra-articular injection of corticosteroid in rheumatoid arthritis patients with synovitis of kneeTimepoint: at 2, 6 and 12 weeks post intervention	—

Secondary

Measure	Time frame
Improvement in quality of life and functional improvementTimepoint: at 2, 6 and 12 weeks post intervention;measure decrease in synovial hypertrophy in injected kneeTimepoint: at 2, 6 and 12 weeks post intervention	—

Countries

India

Contacts

Public ContactDr Deshik Nekkalapudi

AIIMS Bhubaneswar

pmr_jagannath@aiimsbhubaneswar.edu.in9437081814

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026