Intraartecular Platelet Rich Plasma for Sacroiliitis

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

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

Study Overview

• Status: Completed
• Conditions: Sacroiliitis
• Intervention / Treatment: Other: Ultrasound guided Sacroiliac intra-articular injection

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt
      • Mansoura faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

  1. Patients with contraindications to sacroiliac injection.
  2. Patients known to be allergic to platelet rich plasma or local anesthetics.
  3. History of immune suppression or immune compromised diseases
  4. Patient below age of 18 as the joint will undergo normal physiological changes.
  5. Patient over 70 years.
  6. Sacroiliac pain of multiple sources.
  7. Preoperative shivering or fever (>38oc).
  8. Hepatic, renal and heart failure patients.
  9. Patients on; anticoagulants, antiplatelet, and with INR≥1.5.
  10. Exclude corticosteroid injection in the sacroiliac joint at the last three months.
  11. Patient refusal.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: • Steroid Group (S)	Other: Ultrasound guided Sacroiliac intra-articular injection; At the level of the sacral hiatus, the sacral cornuae were identified. posterior aspect of the sacroiliac joint, at 4.5 cm depth the SIJ was found. localal anesthetic was injected at the medial edge of the transducer, the spinal needle was advanced in a medial to lateral direction, under direct vision, until the needle was positioned in the SIJ. Local steroid solution or PRP 4ml volume was injected according to the study group and patient enrollment. If the injection is extra-articular, injectate (hyperechoic solution as it contains particulate steroid) can be seen spreading medially over the sacrum. The visual analog score, Oswestry Disability Index (ODI) score and the overall success rate basal, after one week,after one month,after three and six month's follow-up period after the initial block.
Experimental: • Platelet rich plasma Group (PRP)	Other: Ultrasound guided Sacroiliac intra-articular injection; At the level of the sacral hiatus, the sacral cornuae were identified. posterior aspect of the sacroiliac joint, at 4.5 cm depth the SIJ was found. localal anesthetic was injected at the medial edge of the transducer, the spinal needle was advanced in a medial to lateral direction, under direct vision, until the needle was positioned in the SIJ. Local steroid solution or PRP 4ml volume was injected according to the study group and patient enrollment. If the injection is extra-articular, injectate (hyperechoic solution as it contains particulate steroid) can be seen spreading medially over the sacrum. The visual analog score, Oswestry Disability Index (ODI) score and the overall success rate basal, after one week,after one month,after three and six month's follow-up period after the initial block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog score	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.	Basal and after 6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; Steroid; Platelet reach plasma; sacroiliac; Chronic low back Pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Sacroiliitis
• Other Study ID Numbers: MS17.10.03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No