Impact of Sacroiliac Joint Injection on Bone Marrow Edema

NCT ID: NCT04895228

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2021-12-20

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

Conditions

Bone Marrow Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SpA patients recieving local steroid injection

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

Group Type: ACTIVE_COMPARATOR

injection

Intervention Type: PROCEDURE

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

placebo group

Group 2 will receive similar amount of saline injecteed subcutaneously

Group Type: PLACEBO_COMPARATOR

injection

Intervention Type: PROCEDURE

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

Interventions

injection

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Sohair Maher mahrous

Sohair Maher Mahrous

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sohair maher

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

Sohair Maher Mahrous

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

maher

Role: CONTACT

sohier.ahmed@med.sohag.edu.eg

01143619857

sohair maher

Role: CONTACT

sohier.ahmed@med.sohag.edu.eg

01143619857

Facility Contacts

Sohair Maher

Role: primary

sohier.ahmed@med.sohag.edu.eg

01143619857

Other Identifiers

Soh-Med-21-05-10

Identifier Type: -

Identifier Source: org_study_id