NCT05914350

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 23, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2025

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

May 31, 2023

Last Update Submit

June 21, 2023

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Assessment of pain intensity using visual analog scale (VAS)

    Primary outcome

    2 years

Study Arms (3)

Group 1

EXPERIMENTAL

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 sacroiliitisDrug: methylprednisolone acetate and lidocaine

Group 2

EXPERIMENTAL

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 sacroiliitisDrug: PRP and lidocaine

Group 3

EXPERIMENTAL

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 sacroiliitisDrug: medical ozone

Interventions

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitisPROCEDURE

ultrasound guided Ozone, platelet-rich plasma or steroid injection in the treatment of sacroiliitis

Group 1Group 2Group 3
methylprednisolone acetate and lidocaineDRUG

40 mg methylprednisolone acetate and 1 mL lidocaine

Group 1
PRP and lidocaineDRUG

3 mL PRP and 1 mL lidocaine

Group 2
medical ozoneDRUG

10 ml of medical ozone

Group 3

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- One hundred and five patients, ASA physical status I - III, age 21 - 65 years, diagnosed with sacroiliitis.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University hospitals

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

SteroidsMethylprednisolone AcetateLidocaine

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic CompoundsMethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Ahmed An Ibrahim

CONTACT

01092939382amer.soliman0@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ahmed elmaghrapy

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 22, 2023

Study Start

June 23, 2023

Primary Completion

March 23, 2025

Study Completion

March 23, 2025

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

EG(1)