Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04895228 |
| Other study ID # |
Soh-Med-21-05-10 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2021 |
| Est. completion date |
December 20, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Sohag University |
| Contact |
maher |
| Phone |
01143619857 |
| Email |
sohier.ahmed[@]med.sohag.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 .
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
