Impact of Sacroiliac Joint Injection on Bone Marrow Edema

NCT04895228 | Unknown DMC

• 1 other identifier: Soh-Med-21-05-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

Bone Marrow Edema

Outcome Measures

Primary Outcomes (1)

• change of bone marrow edema

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

  with in 3 moths

Study Arms (2)

SpA patients recieving local steroid injection

ACTIVE COMPARATOR

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

Procedure: injection

placebo group

PLACEBO COMPARATOR

Group 2 will receive similar amount of saline injecteed subcutaneously

Procedure: injection

Interventions

injection PROCEDURE

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

SpA patients recieving local steroid injection; placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohair Maher Mahrous

Sohag, 82749, Egypt

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• sohair maher

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

maher

CONTACT

01143619857; sohier.ahmed@med.sohag.edu.eg

sohair maher

CONTACT

01143619857; sohier.ahmed@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sohair Maher Mahrous

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: May 15, 2021
• Primary Completion: September 20, 2021
• Study Completion: December 20, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)