Image-Guided Intra-Articular Versus Periarticular Injection in Sacroiliac Joint Pain: A Comparative Study of Early Pain Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Change from Baseline in Pain Intensity on the Numeric Rating Scale (NRS) at 4 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Failure of conservative management (physiotherapy and/or NSAIDs for at least 6 weeks)
- •Willingness and ability to provide written informed consent
排除标准
- •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
- •Previous sacroiliac joint injection within the last 3 months
- •Pregnancy or breastfeeding
- •Severe spinal or pelvic deformity preventing safe and accurate needle placement
- •Significant cognitive impairment precluding informed consent or reliable outcome reporting
- •Active malignancy involving the pelvis or sacrum
研究组 & 干预措施
Periarticular Sacroiliac Joint Injection
Participants receive a fluoroscopy-guided periarticular injection targeting the posterior sacroiliac ligament complex and posterior capsular tissues overlying the middle and upper thirds of the joint. Needle position is confirmed with contrast showing spread along the posterior capsule without intra-articular filling. Patients receive up to 5 mL total injectate containing 40 mg (1 mL) methylprednisolone acetate and bupivacaine 0.25% in a fan-like distribution.
干预措施: Fluoroscopy-Guided Periarticular SIJ Injection (Procedure)
Intra-Articular Sacroiliac Joint Injection
Participants receive a fluoroscopy-guided intra-articular injection into the lower third of the sacroiliac joint. A 22-gauge spinal needle is advanced under C-arm fluoroscopy (15-25° ipsilateral oblique view). Needle placement is confirmed with 0.5-1 mL iohexol contrast medium demonstrating an intra-articular arthrogram. Patients receive 3 mL total injectate containing 40 mg (1 mL) methylprednisolone acetate and 2 mL bupivacaine 0.25%.
干预措施: Fluoroscopy-Guided Intra-Articular SIJ Injection (Procedure)
结局指标
主要结局
Change from Baseline in Pain Intensity on the Numeric Rating Scale (NRS) at 4 Weeks
时间窗: Baseline and 4 weeks post-injection
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.
次要结局
未报告次要终点
研究者
Mariam Bassem Shokry Saad
Resident of Diagnostic Radiology
Assiut University