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

June 21, 2023 updated by: Ahmed Abdelnaby Ibrahim, Tanta University
Comparison between ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis; a Randomized Double Blinded Controlled Study

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt, 31527
        • Recruiting
        • Tanta University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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
ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis
Drug: methylprednisolone acetate and lidocaine
40 mg methylprednisolone acetate and 1 mL lidocaine
Experimental: Group 2
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
ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis
Drug: PRP and lidocaine
3 mL PRP and 1 mL lidocaine
Experimental: Group 3
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
ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis
Drug: medical ozone
10 ml of medical ozone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 23, 2023

Primary Completion (Estimated)

March 23, 2025

Study Completion (Estimated)

March 23, 2025

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264MD46/3/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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