Comparison of the efficacy of fluoroscopic guided caudal epidural injection of methylprednisolone versus triamcinolone in patients with degenerative lumbar canal stenosis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the analgesic efficacy of fluoroscopically guided caudal epidural injection of
研究概览
简要总结
Lumbar canal stenosis (LCS) causes neurogenic claudication, radicular pain and functional disability, especially in the elderly. Initial conservative management includes medications, physical therapy and epidural steroid injections (ESI). ESIs provide short-term relief by reducing inflammation around nerve roots. Caudal ESIs allow access to lower lumbar levels and provide significant relief to the symptoms. Previous studies compared particulate vs non-particulate steroids with conflicting efficacy results. Hyaluronidase may enhance steroid spread and duration when used as an adjuvant through reducing fibrosis and facilitating spread. However, there is a lack of studies directly comparing triamcinolone and methylprednisolone combined with hyaluronidase for fluoroscopic-guided caudal ESIs in LCS. This prospective randomized study aims to compare the analgesic efficacy and functional outcomes of fluoroscopic caudal epidural injections of triamcinolone vs methylprednisolone, using hyaluronidase as an adjuvant, in symptomatic degenerative LCS patients. Outcomes will be assessed using scales like VAS, Likert, and Swiss Spinal Stenosis questionnaire.
Aim
To compare efficacy of fluoroscopic guided caudal epidural injection of methylprednisolone
versus triamcinolone in degenerative lumbar canal stenosis patients.
Objectives
1 To compare the analgesic efficacy of fluoroscopically guided caudal epidural injection of
methylprednisolone versus triamcinolone with hyaluronidase as adjuvant, using ‘visual
analogue scale’ in patients with lumbar canal stenosis.
- To compare the functional outcomes achieved by administering fluoroscopically guided
caudal epidural injection of methylprednisolone versus triamcinolone with hyaluronidase
as adjuvant, using ‘Swiss Spinal Stenosis’ score.
- To compare the patient satisfaction outcomes achieved by administering fluoroscopically
guided caudal epidural injection of methylprednisolone versus triamcinolone with
hyaluronidase as adjuvant, using five-point ‘Likert scale’.
Methodolgy
This section outlines the initial preparation, randomization, allocation, and blinding process for the study comparing caudal epidural triamcinolone versus methylprednisolone with hyaluronidase in lumbar canal stenosis patients.
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Patients meeting inclusion criteria will undergo pre-procedure investigations, mri classification, and baseline assessments (VAS, SSS scores).
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60 patients will be randomly allocated to Group 1 (methylprednisolone 80mg, ropivacaine 0.2%, hyaluronidase 1500IU) or Group 2 (triamcinolone 80mg, ropivacaine 0.2%, hyaluronidase 1500IU) using sealed opaque envelopes.
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The study will be double-blinded with patients and interventionists unaware of group allocation.
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On the procedure day, patients will be positioned prone, prepped with all aseptic precautions, and the caudal epidural space identified under fluoroscopy.
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After negative aspiration, the 20ml study drug solution will be injected as per allocated group.
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Patients will be monitored post-procedure for any complications like hypotension, dural puncture, allergic reactions which will be managed accordingly.
Following observations will be recorded in all patients:
- Pain assessment of patient by VAS score at pre-intervention, 1, 2, and 3-month post-
intervention.
- Functional status of patient by SSS score at pre-intervention, 1, 2, and 3-month post-
intervention.
- Patient satisfaction level by Likert 5 -point scale at pre-intervention, 1, 2, and 3-month
post-intervention.
- Any immediate or delayed complications due to caudal ESI will be recorded during or
post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed signs and symptoms suggestive of neurogenic claudication pain refractory to conservative treatment for more than 3 months.
- •Age range between 40 and 80 years.
- •Magnetic Resonance Imaging (MRI) based Lee’s Grading 1 to 3 for lumbar central canal or foraminal stenosis.
排除标准
- •Previous history of lumbar surgery
- •Back or leg pain due to other etiologies (e.g. spinal fracture, metastasis, neuropathy, vascular claudication etc.)
- •Pregnancy and lactating women
- •Severe bleeding diathesis or on anticoagulation therapy
- •Patient with severe heart, lung, hepatic, renal, psychiatric, connective tissue disorder, neurological, uncontrolled diabetes mellites or hypertension
- •Presence of systemic infection or local infection at the injection site
- •Significant allergic reaction or hypersensitivity to contrast, anaesthetic, or corticosteroids
- •Patient diagnosed with malignancy
- •Patient on uncontrollable or unstable opioid use
- •Patient having severe motor weakness, rapidly progressing neurological deficit, or cauda equina syndrome.
结局指标
主要结局
To compare the analgesic efficacy of fluoroscopically guided caudal epidural injection of
时间窗: Pain assessment of patient by VAS score at pre-intervention, 1, 2, and 3-month post- | intervention.
methylprednisolone versus triamcinolone with hyaluronidase as adjuvant, using ‘visual
时间窗: Pain assessment of patient by VAS score at pre-intervention, 1, 2, and 3-month post- | intervention.
analogue scale’ in patients with lumbar canal stenosis.
时间窗: Pain assessment of patient by VAS score at pre-intervention, 1, 2, and 3-month post- | intervention.
次要结局
- 1. To compare the functional outcomes achieved by administering fluoroscopically guided(caudal epidural injection of methylprednisolone versus triamcinolone with hyaluronidase)
- 2. To compare the patient satisfaction outcomes achieved by administering fluoroscopically(guided caudal epidural injection of methylprednisolone versus triamcinolone with)
研究者
Dr M Priyadarshini
Government Medical College and Hospital,Chandigarh Sector 32