Pain ManagementNCT07137806
Enhanced Pain Relief With Ultrasound Guided Combined Submaltifidus and Sacroiliac Joint Injection
A study testing sacroiliac joint injection and combined sacroiliac joint injection and sub maltifidous plane block in people with Pain Management, run by Tanta University at 1 site in Egypt.
Trial summary
Sacroiliitis is not the same as SI joint dysfunction. Sacroiliitis is specific to an inflammatory processes present in the SI joint and the pain sensed is a direct result of those inflammatory processes, whereas sacroiliac joint dysfunction is a condition caused by abnormal motion or slight mispositioning of the SI… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- sacroiliac joint injection and combined sacroiliac joint injection and sub maltifidous plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged above 21 years, both genders diagnosed with chronic sacroiliac joint pain with a rating on the numeric pain rating scale (NPRS) of at least 5, without radiculopathy lasting 3 months or longer, and lack of medical treatment satisfactory response
Who cannot join
- Patient refusal. Patients who have any allergies to local anesthetics or have had a reaction to contrast dyes in the past.
- Patients who are unable to describe their pain (e.g., language barrier or neuropsychiatric disorder).
- Patients with history of bleeding diathesis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Beyond the Joint: Enhanced Pain Relief With Ultrasound Guided Combined Submaltifidus and Sacroiliac Joint Injection - a Randomized Controlled Trial
Sacroiliitis is not the same as SI joint dysfunction. Sacroiliitis is specific to an inflammatory processes present in the SI joint and the pain sensed is a direct result of those inflammatory processes, whereas sacroiliac joint dysfunction is a condition caused by abnormal motion or slight mispositioning of the SI joint.
Sacroiliac joint syndrome is a condition that is difficult to diagnose and is often overlooked by physicians and physiotherapist
Read the detailed description
Treatment of SI joint pain usually involves a multi-pronged approach, utilizing both, multi-modal medical pain control and interventional pain/surgical techniques such as local anesthetic and steroid injections, radiofrequency nerve ablation, and minimally invasive sacroiliac arthrodesis.[7] Sacroiliac (SI) joint injection is a minimally invasive procedure that involves injecting a mixture of local anesthetic and/or corticosteroid medication directly into the SI joint[8] Depending on the mixture of medications used, the duration of pain relief varies but can last anywhere from several days to months[9] Local anesthetic and corticosteroid medications are used to reduce inflammation and provide symptom relief to patients with arthritis, inflammatory conditions, and/or acute injuries[10]
The goal of SI joint injections is to provide enough pain relief to allow the patient to improve their functional status. Participation in physical therapy or exercise is encouraged, which can lead to longer-term improvements in pain and function. The number of SI joint injections required for effective pain relief can vary depending on the patient. [11, 12] Some patients may only require one injection, while others may require several injections. As a general guideline, injections may be administered once every 2 weeks, and no more than 3 injections may be given per year[11, 12] In general, if the first injection provides significant relief, additional injections may be recommended. However, the exact timing can vary based on the doctor's guidance, the patient's response to the treatment, and the type of injection[13] The long-term outcomes of SI joint injections can vary depending on a number of factors, including the underlying cause of the pain, the patient's overall health, the patient's response to the injection, and the type of injection used. Steroid injections may work well for some patients, while others may respond more positively to prolotherapy or PRP therapy[14]
Sacral Multifidus Plane Block(SMPB), a variant of paraspinal plane blocks, has been used for various surgeries in the perineal and buttock region[15]
- Conditions
- Pain Management
- Being tested
- sacroiliac joint injection, combined sacroiliac joint injection and sub maltifidous plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacroiliac joint injectionProcedure or surgery
Ultrasound-guided injection of the SI joints The patient is placed in a prone position to receive this injection treatment. The Curvilinear transducer is placed in a transverse orientation to identify the sacral hiatus first. After identifying the sacral cornu, the transducer is moved in a lateral direction until the lateral edge of the sacrum is observed. With the transducer maintained in the transverse orientation, it is then moved in a cephalad or upward direction until the bony contour of the ileum is identified. The cleft between the bony contours of the sacrum and ileum represents the posterior aspect of the SI joint. By tilting the transducer in a caudal direction, the lower one third of the SI joint is identified. Because of its synovial component, the lower one third of the SI joint is the portion of the entire SI joint in which the injection should be performed. The medial to lateral approach and intraarticular deposition is preferred for the ultrasound-guided SI joint
combined sacroiliac joint injection and sub maltifidous plane blockProcedure or surgery
patients will be positioned prone. A 6-13 MHz linear array ultrasound transducer was placed in the parasagittal orientation with the second sacral foramen (SF-2) in the field. A 21G short bevel needle is inserted in-plane approach from the cephalad to the caudad direction. After hitting the underlying bone, twenty millilitres of local anaesthetic solution (1:1 mixture of lidocaine 2% and bupivacaine 0.25%) will be injected. An anechoic LA spread in the plane between the multifidus muscle (MFM) and the hyperechoic bony area (between the median and intermediate sacral crests) will be confirmed. The Curvilinear transducer is placed in a transverse orientation to identify the sacral hiatus first. After identifying the sacral cornu, the transducer is moved in a lateral direction until the lateral edge of the sacrum is observed. With the transducer maintained in the transverse orientation, it is then moved in a cephalad or upward direction until the bony contour of the ileum is identified.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided sacroiliac joint injection group | Active comparator | patients included in this group will receive SIJ injection alone.The injectate includes 40 mg of methylprednisolone acetate diluted in 2 mL of bupivacaine 0.25% with epinephrine 1:200,000 (total 3 mL injectate). Receives: Procedure: sacroiliac joint injection |
| combined ultrasound guide sacroiliac joint injection and submaltifidous plan (combined block group): | Experimental | patients included in this group will receive combined SMPB and SIJ injection twenty millilitres of local anaesthetic solution (1:1 mixture of lidocaine 2% and bupivacaine 0.25%) will be injected in the plane between the multifidus muscle (MFM) and the hyperechoic bony area (between the median and intermediate sacral crests) Receives: Procedure: combined sacroiliac joint injection and sub maltifidous plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sacroiliac joint pain assessment according to Numerical rating Scale at 1month after injection.
Measured: at one month from intervention
Secondary outcomes (2)
Analgesics consumption during 6month follow-up period
Measured: over 6 month from intection
Level of disability was measured by Oswestry Disability Index (ODI) scores
Measured: 6 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohamed Shebl Abdelghany
- Responsible party
- Principal investigator, Aliaa Muhammad Belal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137806
- Sponsor's protocol ID
- Faculty of Medicine, Tanta Uni
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual issues
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Joint: Enhanced Pain Relief With Ultrasound Guided Combined Submaltifidus and Sacroiliac Joint Injection - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07137806
- Acronym / sponsor ID
- Faculty of Medicine, Tanta Uni
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Mohamed Shebl Abdelghany
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 22 Aug 2025 (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.
Sacroiliitis is not the same as SI joint dysfunction. Sacroiliitis is specific to an inflammatory processes present in the SI joint and the pain sensed is a direct result of those inflammatory processes, whereas sacroiliac joint dysfunction is a condition caused by abnormal motion or slight mispositioning of the SI joint.
Sacroiliac joint syndrome is a condition that is difficult to diagnose and is often overlooked by physicians and physiotherapist
Detailed description
Treatment of SI joint pain usually involves a multi-pronged approach, utilizing both, multi-modal medical pain control and interventional pain/surgical techniques such as local anesthetic and steroid injections, radiofrequency nerve ablation, and minimally invasive sacroiliac arthrodesis.[7] Sacroiliac (SI) joint injection is a minimally invasive procedure that involves injecting a mixture of local anesthetic and/or corticosteroid medication directly into the SI joint[8] Depending on the mixture of medications used, the duration of pain relief varies but can last anywhere from several days to months[9] Local anesthetic and corticosteroid medications are used to reduce inflammation and provide symptom relief to patients with arthritis, inflammatory conditions, and/or acute injuries[10]
The goal of SI joint injections is to provide enough pain relief to allow the patient to improve their functional status. Participation in physical therapy or exercise is encouraged, which can lead to longer-term improvements in pain and function. The number of SI joint injections required for effective pain relief can vary depending on the patient. [11, 12] Some patients may only require one injection, while others may require several injections. As a general guideline, injections may be administered once every 2 weeks, and no more than 3 injections may be given per year[11, 12] In general, if the first injection provides significant relief, additional injections may be recommended. However, the exact timing can vary based on the doctor's guidance, the patient's response to the treatment, and the type of injection[13] The long-term outcomes of SI joint injections can vary depending on a number of factors, including the underlying cause of the pain, the patient's overall health, the patient's response to the injection, and the type of injection used. Steroid injections may work well for some patients, while others may respond more positively to prolotherapy or PRP therapy[14]
Sacral Multifidus Plane Block(SMPB), a variant of paraspinal plane blocks, has been used for various surgeries in the perineal and buttock region[15]
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided sacroiliac joint injection group | Active comparator | Procedure: sacroiliac joint injectionpatients included in this group will receive SIJ injection alone.The injectate includes 40 mg of methylprednisolone acetate diluted in 2 mL of bupivacaine 0.25% with epinephrine 1:200,000 (total 3 mL injectate). |
| combined ultrasound guide sacroiliac joint injection and submaltifidous plan (combined block group): | Experimental | Procedure: combined sacroiliac joint injection and sub maltifidous plane blockpatients included in this group will receive combined SMPB and SIJ injection twenty millilitres of local anaesthetic solution (1:1 mixture of lidocaine 2% and bupivacaine 0.25%) will be injected in the plane between the multifidus muscle (MFM) and the hyperechoic bony area (between the median and intermediate sacral crests) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged above 21 years, both genders diagnosed with chronic sacroiliac joint pain with a rating on the numeric pain rating scale (NPRS) of at least 5, without radiculopathy lasting 3 months or longer, and lack of medical treatment satisfactory response
Key exclusion criteria (3 listed)
- Patient refusal. Patients who have any allergies to local anesthetics or have had a reaction to contrast dyes in the past.
- Patients who are unable to describe their pain (e.g., language barrier or neuropsychiatric disorder).
- Patients with history of bleeding diathesis
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 |
|---|---|---|
| sacroiliac joint injectionUltrasound-guided injection of the SI joints The patient is placed in a prone position to receive this injection treatment. The Curvilinear transducer is placed in a transverse orientation to identify the sacral hiatus first. After identifying the sacral cornu, the transducer is moved in a lateral direction until the lateral edge of the sacrum is observed. With the transducer maintained in the transverse orientation, it is then moved in a cephalad or upward direction until the bony contour of the ileum is identified. The cleft between the bony contours of the sacrum and ileum represents the posterior aspect of the SI joint. By tilting the transducer in a caudal direction, the lower one third of the SI joint is identified. Because of its synovial component, the lower one third of the SI joint is the portion of the entire SI joint in which the injection should be performed. The medial to lateral approach and intraarticular deposition is preferred for the ultrasound-guided SI joint | Procedure or surgery | ultrasound guided sacroiliac joint injection group |
| combined sacroiliac joint injection and sub maltifidous plane blockpatients will be positioned prone. A 6-13 MHz linear array ultrasound transducer was placed in the parasagittal orientation with the second sacral foramen (SF-2) in the field. A 21G short bevel needle is inserted in-plane approach from the cephalad to the caudad direction. After hitting the underlying bone, twenty millilitres of local anaesthetic solution (1:1 mixture of lidocaine 2% and bupivacaine 0.25%) will be injected. An anechoic LA spread in the plane between the multifidus muscle (MFM) and the hyperechoic bony area (between the median and intermediate sacral crests) will be confirmed. The Curvilinear transducer is placed in a transverse orientation to identify the sacral hiatus first. After identifying the sacral cornu, the transducer is moved in a lateral direction until the lateral edge of the sacrum is observed. With the transducer maintained in the transverse orientation, it is then moved in a cephalad or upward direction until the bony contour of the ileum is identified. | Procedure or surgery | combined ultrasound guide sacroiliac joint injection and submaltifidous plan (combined block group): |
Primary outcome
Sacroiliac joint pain assessment according to Numerical rating Scale at 1month after injection.
Time frame: at one month from intervention
2 secondary outcomes
Analgesics consumption during 6month follow-up period
Time frame: over 6 month from intection
Level of disability was measured by Oswestry Disability Index (ODI) scores
Time frame: 6 month after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No. individual issues
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sacroiliac joint injection and combined sacroiliac joint injection and sub maltifidous plane block in people with Pain Management, run by Tanta 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Aug 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliaa M Belal, Assistant Professor (0201068936038, loloohamody@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sacroiliac joint pain assessment according to Numerical rating Scale at 1month after injection. (time frame: at one month from intervention). 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 22 Aug 2025.