NL-OMON23550尚未招募不适用
Segmental epidural steroid injections for lumbosacral radicular syndrome.A randomized controlled trial comparing cost-effectiveness of a segmental epidural injection with usual care for patients with lumbosacral radicular syndrome (LRS) in general practice.
MTA (doelmatigheidsbureau) UMCG.Department of General Practice, University of Groningen.0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
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 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: BMI (weight/square length) > 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
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