Intraartecular Platelet Rich Plasma for Sacroiliitis

NCT ID: NCT03834480

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-01-01

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.

Conditions

Sacroiliitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

• Steroid Group (S)

Group Type: EXPERIMENTAL

Ultrasound guided Sacroiliac intra-articular injection

Intervention Type: 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.

• Platelet rich plasma Group (PRP)

Group Type: EXPERIMENTAL

Ultrasound guided Sacroiliac intra-articular injection

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mansoura faculty of Medicine

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

MS17.10.03

Identifier Type: -

Identifier Source: org_study_id