Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study

Study Overview
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Brief Summary
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Comparison between ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis; a Randomized Double Blinded Controlled Study

Detailed Description
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The sacroiliac joints (SIJ) are the largest axial joints in the human body. By aging, osteoarthritic degeneration occurs to SIJ. SIJ dysfunction typically results from abnormal motion and malalignment of the joint (1). SIJ pain is one of the differential diagnoses of low back pain. Approximately, 10-25% of these patients will have SIJ dysfunction which should be considered clinically (1, 2). This pain affects physical, psychological and social aspects of the person reducing the work performance. It imposes a huge burden on nations globally (3, 4). SIJ pain can be a difficult condition to treat and a multidisciplinary approach to treatment including multimodal medical, psychological, physical, and interventional approach is recommended (5). Corticosteroids are a very magic therapy since their first use and they offer anti-inflammatory mechanisms to reduce low back pain and joint pain. SIJ steroid injections are typically performed for SIJ pain related to osteoarthritis, ligamentous sprain and sacroiliitis associated with inflammatory spondyloarthropathies (5, 6). Intra-articular steroid injections have intermediate-term benefits, in which more than half of the patients had positive responses to treatment in a 6-month follow-up (7, 8). Another treatment modality is Platelet-rich plasma (PRP) which is autologous blood that contains platelet concentrations above normal physiological levels (9). PRP is believed to stimulate regeneration through the release of growth factors and proteins that may be involved in repairing the degeneration (10, 11). While corticostroid injection has rapid onset of pain releif with short duration, the PRP injection has delayed onset and long term of pain releif in recent studies (12-14). Ozone therapy has been used in the treatment of many musculoskeletal diseases including low back pain (LBP), lumbar disk herniation, cervical pain, cervical disk herniation, failed back surgery syndrome, degenerative spinal disease, knee osteoarthritis, meniscal injuries, sacroiliitis, plantar fasciitis and carpal tunnel syndrome (8, 15). However, ozone therapy is not tested well in SIJ. Ozone has multiple mechanisms of action:, antioxidant, analgesic and antiinflammatory effects (16, 17). Ultrasound has gained increasing popularity in pain management (18). Furthermore, it is a valuable tool for pain physicians in confirming the diagnosis of many musculoskeletal pain conditions (19). It has many advantages when compared to fluoroscopy techniques (20). It has no radiation exposure, procedures can be done outside operating room which will decrease the costs (21).

Official Title
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Comparison Between Ultrasound Guided Ozone, Platelet-Rich Plasma or Steroid Injection in the Treatment of Sacroiliitis; a Randomized Double Blinded Controlled Study

Conditions
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the Efficacy of Ultrasound Guided Sacroiliac Injection of Ozone, Platelet Rich Plasma (PRP) or Steroid for Treatment of Sacroiliitis

Intervention / Treatment
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* Procedure: ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis
* Drug: methylprednisolone acetate and lidocaine
* Drug: PRP and lidocaine
* Drug: medical ozone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>40 mg methylprednisolone acetate and 1 mL lidocaine will be injected in sacroiliac joint in first week by ultrasound. While the second and third injections in the second and third weeks will be done by sham injection | Procedure: ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis<br>* ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis<br>Drug: methylprednisolone acetate and lidocaine<br>* 40 mg methylprednisolone acetate and 1 mL lidocaine<br>|
| Experimental: Group 2<br>3 mL PRP and 1 mL lidocaine will be injected in sacroiliac joint by ultrasound once/week for 3 weeks | Procedure: ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis<br>* ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis<br>Drug: PRP and lidocaine<br>* 3 mL PRP and 1 mL lidocaine<br>|
| Experimental: Group 3<br>10 ml of medical ozone of 20 μg/ml will be injected in sacroiliac joint by ultrasound once/week for 3 weeks | Procedure: ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis<br>* ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis<br>Drug: medical ozone<br>* 10 ml of medical ozone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain intensity using visual analog scale (VAS) | Primary outcome | 2 years |