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Intraartecular Platelet Rich Plasma for Sacroiliitis

Primary Purpose

Sacroiliitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound guided Sacroiliac intra-articular injection
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sacroiliitis focused on measuring Platelet reach plasma, sacroiliac, Ultrasound, Steroid, Chronic low back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

• Steroid Group (S)

• Platelet rich plasma Group (PRP)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2019
Last Updated
February 6, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03834480
Brief Title
Intraartecular Platelet Rich Plasma for Sacroiliitis
Official Title
Ultra Sound Guided Injection of Platelet Rich Plasma Versus Steroid for Sacroiliac Joint Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliitis
Keywords
Platelet reach plasma, sacroiliac, Ultrasound, Steroid, Chronic low back Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
• Steroid Group (S)
Arm Type
Experimental
Arm Title
• Platelet rich plasma Group (PRP)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Ultrasound guided Sacroiliac intra-articular injection
Intervention Description
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 Outcome Measure Information:
Title
visual analog score
Description
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.
Time Frame
Basal and after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mansoura faculty of Medicine
City
Mansourah
State/Province
Dakahlia
Country
Egypt

12. IPD Sharing Statement

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Intraartecular Platelet Rich Plasma for Sacroiliitis

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