Intraartecular Platelet Rich Plasma for Sacroiliitis

Not Applicable

Completed

• Conditions: Sacroiliitis
• Interventions: Other: Ultrasound guided Sacroiliac intra-articular injection

• Registration Number: NCT03834480
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-06
• Last Update Submitted: 2019-02-06
• Study First Posted: 2019-02-08
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• 1. Patients of either sex. 2. ASA I&III. 3. Age between 18 - 70 years. 4. Chronic lower back pain of sacroiliac origin. 5. Anatomy of the joint can identified by the ultrasonography. Exclusion criteria

  2. Patients with contraindications to sacroiliac injection.

  3. Patients known to be allergic to platelet rich plasma or local anesthetics.

  4. History of immune suppression or immune compromised diseases

  5. Patient below age of 18 as the joint will undergo normal physiological changes.

  6. Patient over 70 years.

  7. Sacroiliac pain of multiple sources.

  8. Preoperative shivering or fever (>38oc).

  9. Hepatic, renal and heart failure patients.

  10. Patients on; anticoagulants, antiplatelet, and with INR≥1.5.

  11. Exclude corticosteroid injection in the sacroiliac joint at the last three months.

  12. Patient refusal.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
• Steroid Group (S)	Ultrasound guided Sacroiliac intra-articular injection	-
• Platelet rich plasma Group (PRP)	Ultrasound guided Sacroiliac intra-articular injection	-

Primary Outcome Measures

Name	Time	Method
visual analog score	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.

Trial Locations

Locations (1)

Mansoura faculty of Medicine; 🇪🇬 Mansourah, Dakahlia, Egypt