Intraartecular Platelet Rich Plasma for Sacroiliitis

NCT03834480 | Completed

• 1 other identifier: MS17.10.03
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Sacroiliitis

Keywords

Platelet reach plasma; sacroiliac; Ultrasound; Steroid; Chronic low back Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

• Steroid Group (S)

EXPERIMENTAL

Other: Ultrasound guided Sacroiliac intra-articular injection

• Platelet rich plasma Group (PRP)

EXPERIMENTAL

Other: Ultrasound guided Sacroiliac intra-articular injection

Interventions

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.

• Platelet rich plasma Group (PRP); • Steroid Group (S)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura faculty of Medicine

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Sacroiliitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

EG (1)