Clinical Trials Directory

Trials / Completed

CompletedNCT03834480

Intraartecular Platelet Rich Plasma for Sacroiliitis

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERUltrasound guided Sacroiliac intra-articular injectionAt 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.

Timeline

Start date
2017-12-01
Primary completion
2018-12-01
Completion
2019-01-01
First posted
2019-02-08
Last updated
2019-02-08

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03834480. Inclusion in this directory is not an endorsement.