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Completed

NCT Number: NCT03834480

Intraartecular Platelet Rich Plasma for Sacroiliitis

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

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Key information

Conditions

Sacroiliitis Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura faculty of Medicine

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.
  • Sacroiliac pain of multiple sources.
  • Preoperative shivering or fever (>38oc).
  • Hepatic, renal and heart failure patients.
  • Patients on; anticoagulants, antiplatelet, and with INR≥1.5.
  • Exclude corticosteroid injection in the sacroiliac joint at the last three months.
  • Patient refusal.

Treatment and study plan

Ultrasound guided Sacroiliac intra-articular injection

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 8, 2019
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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