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Clinical Trials/NCT03834480
NCT03834480
Completed
Not Applicable

Ultra Sound Guided Injection of Platelet Rich Plasma Versus Steroid for Sacroiliac Joint Pain

Mansoura University1 site in 1 country2 target enrollmentDecember 1, 2017
ConditionsSacroiliitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sacroiliitis
Sponsor
Mansoura University
Enrollment
2
Locations
1
Primary Endpoint
visual analog score
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Comparison between the effect of steroids and platelet-rich plasma on low back pain after ultrasound-guided sacroiliac injection to determine any is more effective and of long duration

Detailed Description

A prospective randomized controlled study was conducted at the department of anesthesiology Mansoura University Hospital during the period from December 2017 to January 2019 on fifty ASA I-III adult patients, of both sex after approval of IRB (Institutional Review Board) ID number MS17.10.03 \& IRB date 12-11-2017. The patients were randomly allocated into two groups each of 25 patients according to computer-generated random number codes that were placed in sealed envelopes, double blinded, with parallel-group comparison. Steroid Group (S) (n. 25):- Patients were injected by 4 ml of sterile water containing the methylprednisolone Acetate (Depo-Medrol) per-kg calculated dose (0.5mg/kg up to a lean muscle body weight of 80kg in the painful sacroiliac joint). Platelet rich plasma Group (P) (n. 25):-Patients received fixed volume of 4 ml platelet-rich plasma in the inflamed painful sacroiliac joint.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
January 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients of either sex.
  • ASA I\&III.
  • Age between 18 - 70 years.
  • Chronic lower back pain of sacroiliac origin.
  • Anatomy of the joint can identified by the ultrasonography. Exclusion criteria
  • Patients with contraindications to sacroiliac injection.
  • Patients known to be allergic to platelet rich plasma or local anesthetics.
  • History of immune suppression or immune compromised diseases
  • Patient below age of 18 as the joint will undergo normal physiological changes.
  • Patient over 70 years.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

visual analog score

Time Frame: Basal and after 6 months

To evaluate the changes in visual analogue score over a 6-month follow-up period after intra-articular injection and compare these changes among the studied groups.

Study Sites (1)

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