A comparison on the efficacy of low volume versus high volume injection of epidural steroids in the management of back pain and radiculopathy associated with lumbar degenerative disc disease - A Randomised superiority clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- To compare the efficacy of low volume
研究概览
简要总结
1.Kumar VP, Karuppal R. Comparison between clinical, magnetic resonance imaging, and arthroscopic findings in meniscal and cruciate ligament injuries: A cross-sectional study. Apollo Medicine. 2022 Jul 1;19(3):137.
2.Fazil VM, Surendran S, Karuppal R, Gopinathan P, Marthya A. Mini-open transverse flexor crease incision versus limited longitudinal palmar incision carpal tunnel release: A short term outcome study. Journal of Orthopaedics. 2022 Jan 1;29:15-21.
3.Vishnu M, Mathew J, Karuppal R, Prasad A. Relapse Pattern in Club Foot Treated with Ponseti Technique-A Prospective Observational Study from Kerala, India.
4.OP Jamshad, Jacob Mathew, Raju Karuppal Functional and Radiological Outcome of Unstable Intertrochanteric Fracture in Old Age Treated with Proximal Femoral Nail Antirotation-2. Journal of Clinical and Diagnostic Research. 2021 Apr, Vol-15(4): RC05-RC07
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Surendran S, Patinharayil G, Karuppal R, Marthya A, Fazil M, Ali SM. Arthroscopic capsular release and continuous upper arm brachial block in frozen shoulder–A midterm outcome analysis. Journal of Orthopaedics. 2020 Sep 1;21:459-64.
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Mathew J, Karuppal R, Somasundaran S, Sinildas PD. Single Event Multilevel Surgery for Crouch Gait in Cerebral Palsy-An Evaluation Using Functional Mobility Score-A Retrospective Analysis.
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Sibin Surendran D, Karuppal R, Marthya A. Parenteral tranexamic acid reduces postoperative blood loss and transfusion rates after total knee arthroplasty: A prospective randomized controlled trial.
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Sajeev S, Karuppal R. A prospective study to evaluate the efficacies of low volume and high volume caudal epidural steroid injections in the treatment of lumbar degenerative disc disease. International Journal of Research in Medical Sciences. 2017 Aug;5(8):3493.
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Sibin Surendran D, Karuppal R, Valoor HT. The management of proximal pole scaphoid nonunion with avascular necrosis using 1, 2 intercompartmental supraretinacular arterial bone graft and radial styloidectomy: A midterm outcome study. International Journal of
Orthopaedics. 2018;4(4):138-43.
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Karuppal R, Somasundaran S. Functional outcomes of the stable elastic intramedullary nailing for the fractures of femur in children. Indian Journal of Orthopaedics Surgery. 2018 Jan 15;3(4):330-4.
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Karuppal R, Somasundaran S. Functional outcome of Ilizarov ring fixation in infected non-union tibia: A prospective study. International Journal of Orthopaedics. 2017;3(2):191-4.
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Madhu LN, Raman RV, Karuppal R, Thottath J, Hareendranath S, Juvaina P, Mothampally S, Menon II. MAGNETIC RESONANCE IMAGING ARTHROGRAM FINDINGS IN RECURRENT DISLOCATION OF SHOULDER. JOURNAL OF EVOLUTION OF MEDICAL
AND DENTAL SCIENCES-JEMDS. 2017 Jun 1;6(44):3452-8.
- Karuppal R, Surendran S. Scaphoid non-union and results of the Match stick strut graft technique. IJSR. APRIL - 2017; VOLUME-6 (4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Day(s) 至 50.00 Day(s)（—）
- 性别
- All
入选标准
- •Adult patients (aged 25-50 Years), capable of providing consent and complying with the outcome instruments
- •Single-level lumbar disc herniation diagnosed by MRI
- •Lower lumbar disc herniation diagnosed by MRI (L4/L5 or L5S1).
- •Signs and symptoms consistent with the nerve root irritation
- •Patients with lumbar radicular pain, irrespective of neurological signs.
- •Patients have refractory pain, even after treatment with NSAIDs, opioids, and/or physical therapies for more than two weeks duration.
- •Failure after a minimum of 6 weeks of conservative treatment.
排除标准
- •Patient’s reluctance and lack of compliance, does not provide informed consent for the study
- •Patients with previous back surgery at the affected segmental level and radiologically proven facet syndrome
- •Multiple level lumbar disc herniation diagnosed by MRI
- •Patients with a severe motor deficit, segmental instability, spinal deformities.
- •Any systemic infection or local infection at the injection site
- •Patients presenting with cauda equina syndrome
- •Patients on anticoagulation therapy or having any bleeding disorder
- •Pregnant females or ongoing breastfeeding females
- •Patients with underlying malignancy
- •Patients are not excluded based on the duration of pain alone.
- •Patients who are allergic to any component of the medicine?
结局指标
主要结局
To compare the efficacy of low volume
时间窗: 1. Pre injection | 2. Post injection | At 3 weeks, 6 weeks, and 3 months
corticosteroid injections in the treatment of low
时间窗: 1. Pre injection | 2. Post injection | At 3 weeks, 6 weeks, and 3 months
back pain and radiculopathy associated with
时间窗: 1. Pre injection | 2. Post injection | At 3 weeks, 6 weeks, and 3 months
lumbar degenerative diseases with that of
时间窗: 1. Pre injection | 2. Post injection | At 3 weeks, 6 weeks, and 3 months
conventional high-volume injection.
时间窗: 1. Pre injection | 2. Post injection | At 3 weeks, 6 weeks, and 3 months
次要结局
- To compare the side effects, if any, of low-volume versus high-volume corticosteroid injections(in the treatment of low back pain.)