Comparing Ozone, Platelet-Rich Plasma, and Steroid Injections for Sacroiliitis Treatment
Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study
This study is testing whether ozone, platelet-rich plasma, or steroid injections can help relieve pain and improve function in people with sacroiliitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tanta) |
| Trial ID | NCT05914350 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy of ultrasound-guided injections of ozone, platelet-rich plasma (PRP), and steroids in treating sacroiliitis, a condition that causes pain in the sacroiliac joints. The study will involve 105 patients aged 21 to 65 who have been diagnosed with sacroiliitis, and will utilize a randomized, double-blinded controlled design to ensure unbiased results. Participants will receive one of the three treatment modalities, and their responses will be monitored to assess pain relief and functional improvement. The trial seeks to provide insights into the most effective treatment option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 65 diagnosed with sacroiliitis and classified as ASA physical status I-III.
Not a fit: Patients with psychological disturbances, severe cardiovascular diseases, or those who have had recent corticosteroid injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from sacroiliitis, potentially improving their quality of life.
How similar studies have performed: While there have been studies on the efficacy of steroid injections for sacroiliitis, the comparative approach of using ozone and PRP alongside steroids is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - One hundred and five patients, ASA physical status I - III, age 21 - 65 years, diagnosed with sacroiliitis. Exclusion Criteria: * • Patient refusal * Psychological disturbance. * Local skin infection at the site of injection. * Ozone allergy * Coagulation disorders. * Chronic opioid use. * Sacroiliitis associated with disk pathology. * Severe ankylosing spondylitis. * History of corticosteroid injection within last three months. * Uncontrolled concomitant medical condition. * Severe arrhythmia, hypertensive crisis and other cardiovascular diseases. * Pregnant women. * Bowel inflammatory disease. * Psoriasis
Where this trial is running
Tanta
- Tanta University hospitals — Tanta, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed An Ibrahim
- Email: amer.soliman0@gmail.com
- Phone: 01092939382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.