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Impact of Sacroiliac Joint Injection on Bone Marrow Edema

Primary Purpose

Bone Marrow Edema

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
injection
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Marrow Edema

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pateint >18 years old.
  • Patients fulfilling ASAS criteria for SpA with a diagnosis confirmed by a rheumatologist.
  • Patients having BME of the SIJ on MRI .
  • Able to be followed-up regularly

Exclusion Criteria:

  • Patient < 18 years old.
  • Malignancy, DM, Hepatitis and active infectious disorders
  • Spine surgery.
  • Ankylosed sacroiliac joint
  • Recent SIJ injection

Sites / Locations

  • Sohair Maher MahrousRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SpA patients recieving local steroid injection

placebo group

Arm Description

the active group will receive triamcinilone 40 mg injection (Kenacort) + 4 ml of .5 % lidocaine hydrochloride (Xylocaine) under ultrasound guidance.

Group 2 will receive similar amount of saline injecteed subcutaneously

Outcomes

Primary Outcome Measures

change of bone marrow edema
after steroid injection of sacroiliac joint improvement of bone marrow edema in MRI

Secondary Outcome Measures

Full Information

First Posted
May 17, 2021
Last Updated
May 19, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04895228
Brief Title
Impact of Sacroiliac Joint Injection on Bone Marrow Edema
Official Title
Impact of Sacroiliac Joint Injection on Bone Marrow Edema and Disease Outcome Measures in Spondyloarthritis (SpA) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Anticipated)
Study Completion Date
December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
SpA is a chronic, debilitating inflammatory rheumatic disease that affects axial and peripheral joints, internal organs, and other tissues. Sacroiliitis is a hallmark of axial SpA. Sacroliliitis has a great effect on spine pain, function and cephalic progression of the disease . The prevalence of SpA ranged from 9 to 30 per 10,000 persons in Caucasian populations, Europe or the United States . The management of axial SpA is really challenging. The traditional disease-modifying anti-rheumatic drugs (DMARDs) were ineffective in controlling the axial disease. Biological agents such as tumor necrosis factor alpha (TNFα) inhibitor and anti-interleukin 17 have shown promising results in achieving remission or low disease activity for axial SpA . Magnetic resonance imaging (MRI) is established as the imaging method of choice for the early diagnosis and follow-up of SpA patients. Although a positive imaging detection of the axial skeleton is no longer obligatory based on the new Assessment of Spondyloarthritis International Society (ASAS) classification criteria 2010, MRI imaging still plays a crucial role, especially in the early diagnosis arm. MRI has a high sensitivity in detection of acute inflammatory processes as well as the high-resolution visualization of anatomical alterations. The lack of radiation exposure makes MRI ideal for monitoring response to treatment .Bone marrow edema (BME) not only showed high sensitivity for detection of early sacroilitis, but also its reduction was a worthy indicator for disease remission. Intra Articular (IA) injections of SIJ with corticosteroids and anesthestics are often performed for pain relief. Although this technique is relatively old, it was not used on a lrage scale in axial SpA patients. Further, its effect on disease outcome measures were not well elucidated. To the best of our knowledge there is no single study have evaluated effect of steroid and local aneshestic injection on improvement of BME . Image guidance of the SIJ injection is fundamanetal, due to the complex anatomy of the joint causing a low accuracy when performed using blind technique .
Detailed Description
Study design: Randomized, double-blinded, prospective, placebo-controlled clinical trial. Aim of the work To evaluate the effectiveness of steroid and anestheisa injection on BME and disease outcome measures in SIJs of axial SpA patients . Patients and methods This study will be a prospective, single-center, randomized, blind clinical trial. It will be performed on patients following in the rheumatology and rehabilitation department in Sohag University Hospitals, Faculty of Medicine: N=60 fulfilling ASAS 2010 criteria for axial SpA, will be divided randomly into 2 groups. Group 1 the active group will receive triamcinilone 40 mg injection (Kenacort) + 4 ml of .5 % lidocaine hydrochloride (Xylocaine) under ultrasound guidance. Group 2 will receive similar amount of saline injecteed subcutaneously. Only the patient will be blinded. Particpants will be initially studied with no certain condition for medications wich will be kept unchanged during the study. MRI will be done at base line and BME will be considered as an entry criteria. SPArcc score will be berfoemed at baseline and in the follow-up at 24 weeks post-injection. Clinical out come measures including ASDAS BSADAI and BASMI will be performed at baseline and 12 and 24 weeks after SIJ injection. Inclusion criteria: Pateint >18 years old. Patients fulfilling ASAS criteria for SpA with a diagnosis confirmed by a rheumatologist. Patients having BME of the SIJ on MRI . Able to be followed-up regularly. Exclusion criteria: Patient < 18 years old. Malignancy, DM, Hepatitis and active infectious disorders Spine surgery. Ankylosed sacroiliac joint Recent SIJ injection

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a prospective, single-center, randomized, blind clinical trial. It will be performed on patients following in the rheumatology and rehabilitation department in Sohag University Hospitals, Faculty of Medicine: N=60 fulfilling ASAS 2010 criteria for axial SpA, will be divided randomly into 2 groups. Group 1 the active group will receive triamcinilone 40 mg injection (Kenacort) + 4 ml of .5 % lidocaine hydrochloride (Xylocaine) under ultrasound guidance. Group 2 will receive similar amount of saline injecteed subcutaneously. Only the patient will be blinded. Particpants will be initially studied with no certain condition for medications wich will be kept unchanged during the study. MRI will be done at base line and BME will be considered as an entry criteria. SPArcc score will be berfoemed at baseline and in the follow-up at 24 weeks post-injection.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SpA patients recieving local steroid injection
Arm Type
Active Comparator
Arm Description
the active group will receive triamcinilone 40 mg injection (Kenacort) + 4 ml of .5 % lidocaine hydrochloride (Xylocaine) under ultrasound guidance.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Group 2 will receive similar amount of saline injecteed subcutaneously
Intervention Type
Procedure
Intervention Name(s)
injection
Intervention Description
triamcinilone 40 mg injection (Kenacort) + 4 ml of .5 % lidocaine hydrochloride (Xylocaine) under ultrasound guidance
Primary Outcome Measure Information:
Title
change of bone marrow edema
Description
after steroid injection of sacroiliac joint improvement of bone marrow edema in MRI
Time Frame
with in 3 moths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pateint >18 years old. Patients fulfilling ASAS criteria for SpA with a diagnosis confirmed by a rheumatologist. Patients having BME of the SIJ on MRI . Able to be followed-up regularly Exclusion Criteria: Patient < 18 years old. Malignancy, DM, Hepatitis and active infectious disorders Spine surgery. Ankylosed sacroiliac joint Recent SIJ injection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
maher
Phone
01143619857
Email
sohier.ahmed@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
sohair maher
Phone
01143619857
Email
sohier.ahmed@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sohair maher
Organizational Affiliation
Sohag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sohair Maher Mahrous
City
Sohag
ZIP/Postal Code
82749
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohair Maher
Phone
01143619857
Email
sohier.ahmed@med.sohag.edu.eg
First Name & Middle Initial & Last Name & Degree
sohair maher

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Sacroiliac Joint Injection on Bone Marrow Edema

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