ISRCTN54386944已完成不适用
Segmental epidural steroid injections for lumbosacral radicular syndrome: a randomised controlled trial comparing cost-effectiveness of a segmental epidural injection with usual care for patients with lumbosacral radicular syndrome (LRS) in general practice
niversity Medical Centre Groningen (UMCG) (The Netherlands)0 个研究点目标入组 80 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Answering to the definition of lumbosacral radicular syndrome as described by the Guidelines of the Dutch College of General Practitioners (see introduction). The GP diagnoses the patient on grounds of history and physical examination.
- •2. Underwent usual medical care for lumbosacral radicular syndrome with insufficient response in one to two weeks of treatment. Inadequate response is, in accordance with the guideline of the Dutch college of general practitioners, left to the agreement of patients and GPs together.
- •3. Aged between 18 and 60 years old
排除标准
- •1. Pain that has lasted for more than one month before the patient presents to the GP (we want to include acute patients)
- •2. Having experienced a previous episode of lumbosacral radicular syndrome in the twelve months before the study
- •3. Previously having undergone spinal surgery. Previous spinal surgery will have caused adhesions in the patients' vertebrae, making the approach and the application of the epidural injection much more difficult. Chances of complications are a lot higher and the risk of needle misplacing increases.
- •4. Complaints arising after trauma. Patients who developed lumbosacral radicular syndrome as a result of trauma may have pathology that needs additional diagnostic imaging and treatment other than injections.
- •5. Maintenance therapy of oral corticosteroids. Apart from possible interference with the study results, patients on maintenance therapy of oral corticosteroids have a higher risk that their symptoms may be caused by osteoporosis which may need additional diagnostic imaging.
- •6. Oral anticoagulant therapy or bleeding disorders. Treatment with acenocoumarol and/or other anticoagulants increases the risk of bleeding. Since this risk is not as high with platelet aggregation inhibitors, we will not exclude patients on acetylsalicyclic acid or non-steroidal anti-inflammatory drug (NSAID) maintenance therapy.
- •7. Paresis or cauda equina syndrome. Lower extremity paresis and especially cauda equina syndrome are indications for immediate referral to a neurosurgeon.
- •8. Morbid obesity: body mass index (BMI) (weight/square length) greater than 35 In these patients, back pain complaints are much more likely to have other causes than lumbosacral radicular syndrome. Besides, administration of SESI is much more difficult in obese patients since the epidural space is harder to find and the needle may be to short. This increases the risk of false-negative results, needle misplacement and complications
- •9. Inadequate mastering of Dutch language. When patients are unable to communicate with the primary researcher or fill in the questionnaires, it is not possible to assess their progress or receive informed consent.
- •10. Allergy to corticosteroids
- •11. Women who are pregnant, have an active pregnancy wish or are lactating
- •12. Incapacity of will
研究者
相似试验
尚未招募
不适用
SLURP: Steroidinjections in LUmbosacral Radicular Syndrome.NL-OMON23550MTA (doelmatigheidsbureau) UMCG.Department of General Practice, University of Groningen.80
已完成
不适用
Epidural steroid injection in chronic lumbar back pain: a cross-over, single-blinded study of methyl-prednisolone 80mg versus methyl-prednisolone 40mgISRCTN43299460Record Provided by the NHSTCT Register - 2007 Update - Department of Health60
进行中（未招募）
1 期
Epidural steroid injection in chronic, lumbar back pain; a cross-over, single-blinded study of Methyl-prednisolone 80mg versus Methyl-prednisolone 40mg. - Effect of epidural steroid dose on low back disability scores. v4Chronic, lumbar back pain.EUCTR2005-006196-12-GBottingham City Hospital NHS Trust60
已完成
3 期
Comparison of pain relief in backache caused due to nerve compression by giving Epidural steroid injections in different approaches.CTRI/2023/05/052795Jency Arockiasamy88
已完成
不适用
A study to determine whether caudal epidural steroid injection is better than undergoing physical therapy program in patients suffering from degenerative lumbar spinal stenosisCTRI/2017/07/009036Dr Mohit Kishore Srivastava64