Bone Marrow EdemaNCT04895228
Impact of Sacroiliac Joint Injection on Bone Marrow Edema
A study testing injection in people with Bone Marrow Edema, run by Sohag University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bone Marrow Edema
- What is being tested?
- injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2021to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patient < 18 years old.
- Malignancy, DM, Hepatitis and active infectious disorders
- Spine surgery.
- Ankylosed sacroiliac joint
- Recent SIJ injection
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohair Maher Mahrous
Sohag, 82749
Sohair Maher, 01143619857, sohier.ahmed@med.sohag.edu.eg
sohair maher
About this study
Official title: Impact of Sacroiliac Joint Injection on Bone Marrow Edema and Disease Outcome Measures in Spondyloarthritis (SpA) Patients
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 .
Read the 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
- Being tested
- injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectionProcedure or surgery
triamcinilone 40 mg injection (Kenacort) + 4 ml of .5 % lidocaine hydrochloride (Xylocaine) under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: injection |
| placebo group | Placebo comparator | Group 2 will receive similar amount of saline injecteed subcutaneously Receives: Procedure: injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of bone marrow edema
after steroid injection of sacroiliac joint improvement of bone marrow edema in MRI
Measured: with in 3 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start15 May 2021
- Primary completion20 Sep 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow EdemaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohair Maher mahrous, Sohag University
- Investigators
- sohair maher, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895228
- Sponsor's protocol ID
- Soh-Med-21-05-10
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sacroiliac Joint Injection on Bone Marrow Edema and Disease Outcome Measures in Spondyloarthritis (SpA) Patients
- ClinicalTrials.gov ID
- NCT04895228
- Acronym / sponsor ID
- Soh-Med-21-05-10
- Conditions
- Bone Marrow Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 20 Sep 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SpA patients recieving local steroid injection | Active comparator | Procedure: injectionthe active group will receive triamcinilone 40 mg injection (Kenacort) + 4 ml of .5 % lidocaine hydrochloride (Xylocaine) under ultrasound guidance. |
| placebo group | Placebo comparator | Procedure: injectionGroup 2 will receive similar amount of saline injecteed subcutaneously |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Patient < 18 years old.
- Malignancy, DM, Hepatitis and active infectious disorders
- Spine surgery.
- Ankylosed sacroiliac joint
- Recent SIJ injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injectiontriamcinilone 40 mg injection (Kenacort) + 4 ml of .5 % lidocaine hydrochloride (Xylocaine) under ultrasound guidance | Procedure or surgery | SpA patients recieving local steroid injection, placebo group |
Primary outcome
change of bone marrow edema
Time frame: with in 3 moths
after steroid injection of sacroiliac joint improvement of bone marrow edema in MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sohair maher principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection in people with Bone Marrow Edema, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact maher (01143619857, sohier.ahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of bone marrow edema (time frame: with in 3 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.