Epidural Contrast Patterns as Predictors of Radicular Pain Relief: A Three-Arm Randomized Trial Comparing High-Volume Interlaminar, Low-Volume Interlaminar, and Transforaminal Injections
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Clinically Meaningful Pain Response
研究概览
简要总结
This study will compare three fluoroscopy-guided epidural steroid injection approaches for adults with unilateral lumbosacral radicular pain caused by lumbar disc herniation. The study will evaluate whether the pattern of contrast spread in the epidural space predicts meaningful pain relief.
Ninety-nine participants will be randomly assigned in equal numbers to receive one of three treatments: high-volume parasagittal interlaminar injection, low-volume parasagittal interlaminar injection, or transforaminal epidural steroid injection. Participants will not be told which injection approach they receive. Pain and disability will be assessed before treatment and at 2 weeks, 1 month, 3 months, and 6 months after injection. The main outcome is the proportion of participants with clinically meaningful improvement in pain at 3 months.
详细描述
Lumbar disc herniation may cause lumbosacral radicular pain through nerve-root compression and inflammation. Fluoroscopy-guided epidural steroid injections are commonly used when symptoms persist despite conservative treatment. Parasagittal interlaminar (PIL) and transforaminal epidural steroid injection (TFESI) approaches may produce different patterns of contrast distribution within the epidural space. It remains unclear whether contrast spread pattern independently predicts clinical response, apart from injection approach and injectate volume.
This prospective, three-arm randomized clinical trial will enroll adults with unilateral lumbosacral radicular pain and magnetic resonance imaging-confirmed lumbar disc herniation. Participants will be allocated in a 1:1:1 ratio to high-volume PIL injection (10 mL), low-volume PIL injection (7 mL), or TFESI (3 mL). Before administration of the therapeutic injectate, 2 mL of non-ionic iodinated contrast medium will be injected under real-time fluoroscopy to confirm epidural placement, exclude intravascular or intrathecal injection, and document contrast distribution.
Blinded assessors will classify contrast spread according to ventral epidural spread, laterality, foraminal or nerve-root spread, epidural distribution pattern, and cephalocaudal extent. Dynamic fluoroscopic assessment will measure time to first ventral opacification. Participants, radiographic assessors, and outcome assessors will be blinded to treatment allocation where feasible; the procedural physician cannot be blinded because of the procedural differences.
The study will assess whether contrast spread variables independently predict responder status at 3 months, defined as a reduction of at least 2 points or 30% from baseline in Numerical Rating Scale pain score. Additional outcomes include changes in pain intensity and Oswestry Disability Index scores, procedural efficiency, duration of pain relief, and responder status during follow-up through 6 months.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to the assigned injection approach and injectate volume. Outcome assessors collecting pain and disability scores and radiographic assessors evaluating contrast-spread images will be blinded to treatment allocation. The procedural physician cannot be blinded because of inherent differences between injection techniques. Statistical analysis will be conducted with the analyst blinded to arm assignment where feasible.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years.
- •Unilateral lumbosacral radicular pain consistent with a dermatomal distribution.
- •Magnetic resonance imaging-confirmed lumbar disc herniation (bulge, protrusion, or extrusion) at the corresponding clinical level.
- •Persistent symptoms despite at least 6 weeks of conservative management, including analgesics and physiotherapy.
- •Baseline Numerical Rating Scale pain score of 4 or greater.
- •American Society of Anesthesiologists physical status I to III.
- •Ability to understand and complete outcome assessments.
- •Written informed consent provided.
排除标准
- •Previous lumbar spine surgery or failed back surgery syndrome.
- •Red-flag signs, including foot drop, urinary incontinence, or cauda equina syndrome.
- •Bilateral radicular symptoms or central canal stenosis requiring surgical intervention.
- •Coagulopathy or ongoing anticoagulant therapy.
- •Local or systemic infection or hepatic dysfunction.
- •Known allergy to contrast medium, local anesthetics, or corticosteroids.
- •Pregnancy.
- •Severe renal impairment contraindicating contrast use.
- •Chronic opioid use, defined as daily opioid use for more than 3 months before enrollment.
- •Uncontrolled systemic disease, including unstable diabetes or severe cardiopulmonary disease.
- •Inability to comply with follow-up.
研究组 & 干预措施
High-Volume PIL
Participants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 10 mL therapeutic injectate: betamethasone 24 mg and bupivacaine 0.5% 20 mg.
干预措施: Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Drug)
TFESI
participants receive a fluoroscopy-guided transforaminal epidural steroid injection with 3 mL therapeutic injectate: betamethasone 7.2 mg and bupivacaine 0.5% 6 mg.
干预措施: Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Drug)
Low-Volume PIL
PILParticipants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 7 mL therapeutic injectate: betamethasone 16.8 mg and bupivacaine 0.5% 14 mg.
干预措施: Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Drug)
Low-Volume PIL
PILParticipants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 7 mL therapeutic injectate: betamethasone 16.8 mg and bupivacaine 0.5% 14 mg.
干预措施: Bupivacaine (Drug)
High-Volume PIL
Participants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 10 mL therapeutic injectate: betamethasone 24 mg and bupivacaine 0.5% 20 mg.
干预措施: High-Volume Parasagittal Interlaminar Epidural Steroid Injection (Procedure)
Low-Volume PIL
PILParticipants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 7 mL therapeutic injectate: betamethasone 16.8 mg and bupivacaine 0.5% 14 mg.
干预措施: Low-Volume Parasagittal Interlaminar Epidural Steroid Injection (Procedure)
TFESI
participants receive a fluoroscopy-guided transforaminal epidural steroid injection with 3 mL therapeutic injectate: betamethasone 7.2 mg and bupivacaine 0.5% 6 mg.
干预措施: Transforaminal epidural steroid injection (Procedure)
TFESI
participants receive a fluoroscopy-guided transforaminal epidural steroid injection with 3 mL therapeutic injectate: betamethasone 7.2 mg and bupivacaine 0.5% 6 mg.
干预措施: Bupivacaine (Drug)
High-Volume PIL
Participants receive a fluoroscopy-guided parasagittal interlaminar epidural steroid injection with 10 mL therapeutic injectate: betamethasone 24 mg and bupivacaine 0.5% 20 mg.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Proportion of Participants With Clinically Meaningful Pain Response
时间窗: 3 months after injection
Responder status is defined as a reduction from baseline of at least 2 points or at least 30% in Numerical Rating Scale (NRS) pain score. The association between contrast-spread variables and responder status will be assessed.
次要结局
- Change in Numerical Rating Scale Pain Score(Baseline, 2 weeks, 1 month, 3 months, and 6 months after injection.)
- Change in Oswestry Disability Index Score(Baseline; 2 weeks, 1 month, 3 months, and 6 months after injection)
- Total fluoroscopy time(During the index injection procedure)
- number of fluoroscopic images(During the index injection procedure)
- procedure duration(During the index injection procedure)
- Duration of Pain Relief(From injection through 6 months after injection)
研究者
Samar Rafik Mohamed Amin
assistant professor of anesthesia and intensive care
Benha University