Image-Guided Intra-Articular Versus Periarticular Injection in Sacroiliac Joint Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAssiut University
About this trial
Sacroiliac joint (SIJ) pain is a common cause of chronic low back pain that can arise from within the joint itself or from the surrounding ligaments and supporting soft tissues. Image-guided injections using corticosteroids and local anesthetics are widely used to treat SIJ pain when physical therapy or medications fail. However, it remains uncertain whether administering the injection directly inside the joint space (intra-articular) or into the surrounding posterior ligaments (periarticular) provides greater early pain relief and functional recovery.
The primary purpose of this clinical trial is to compare the efficacy, safety, and functional outcomes of fluoroscopy-guided intra-articular versus periarticular injections in adult patients with chronic sacroiliac joint pain.
Participants are randomly assigned in a 1:1 ratio to receive one of two fluoroscopy-guided procedures:
* Intra-Articular Injection Group: Participants receive an injection of methylprednisolone acetate and bupivacaine delivered directly into the synovial space of the sacroiliac joint under fluoroscopic guidance, confirmed with radiographic contrast. * Periarticular Injection Group: Participants receive an injection of methylprednisolone acetate and bupivacaine deposited along the posterior sacroiliac ligament complex and outer capsule under fluoroscopic guidance.
All participants are followed for 8 weeks after the procedure. Changes in pain intensity are tracked using the Numeric Rating Scale (NRS) at baseline, 2 weeks, 4 weeks, and 8 weeks. Physical function and daily activity impairment are measured using the Oswestry Disability Index (ODI) at baseline, 4 weeks, and 8 weeks. Patient global improvement, side effects, and rescue pain medication consumption will also be monitored throughout the study period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 to 70 years
Clinical diagnosis of sacroiliac joint (SIJ) pain confirmed by at least 3 positive provocation tests out of 5 (FABER, Gaenslen's, thigh thrust, compression, or distraction tests)
Chronic SIJ pain with a symptom duration of at least 3 months
Pain intensity score of at least 4 out of 10 on the Numeric Rating Scale (NRS ≥ 4/10) at enrollment
Disqualifiers
Known coagulopathy or current anticoagulant therapy that cannot be safely bridged
Active local infection at the injection site or systemic infection
Known hypersensitivity or allergy to corticosteroids, local anesthetics, or contrast media
History of prior SIJ surgery or joint fusion
Trial design
Design model
Parallel
Treatments tested in this trial
Fluoroscopy-Guided Intra-Articular SIJ Injection
Procedure/SurgeryUnder continuous C-arm fluoroscopic guidance (15-25° ipsilateral oblique view), a 22-gauge spinal needle is advanced into the synovial cavity of the lower third of the sacroiliac joint using a posteroanterior approach. Proper intra-articular needle position is verified by injecting 0.5-1 mL iohexol contrast medium to confirm an arthrogram pattern. A 3 mL injectate consisting of methylprednisolone acetate 40 mg (1 mL) and bupivacaine 0.25% (2 mL) is then administered.
Fluoroscopy-Guided Periarticular SIJ Injection
Procedure/SurgeryUnder fluoroscopic guidance, a 22-gauge spinal needle is directed toward the posterior capsular region and posterior sacroiliac ligament complex overlying the middle and upper thirds of the joint. Correct placement is confirmed via contrast injection showing spread along the posterior capsular surface without intra-articular entry. An injectate of up to 5 mL containing methylprednisolone acetate 40 mg (1 mL) and bupivacaine 0.25% is deposited in a fan-like distribution.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Intra-Articular Sacroiliac Joint InjectionActive comparator 1 intervention
Group B: Periarticular Sacroiliac Joint InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Pain Intensity on the Numeric Rating Scale (NRS) at 4 Weeks
Pain intensity is assessed using an 11-point Numeric Rating Scale (NRS), where scores range from 0 to 10 (0 = "no pain", 10 = "worst imaginable pain"). This measure evaluates the change in pain score from baseline to 4 weeks post-procedure. A greater reduction or lower score indicates greater pain relief.
Time frame
Baseline and 4 weeks post-injectionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: