Lumbar Fusion or Non-operative Care for Treatment of Presumed Discogenic Pain: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 主要终点
- Low back pain assessed with Visual Analog Scale
研究概览
简要总结
Title and abstract
1 a. Title: Lumbar fusion or non-operative care for treatment of presumed discogenic pain.
A randomized study.
1 b. Structured summary:
Authors: B. Nyström, B. Schillberg, E. Svensson, T. Stiles.
Corresponding author: Bo Nyström, Clinic of Spinal Surgery, Strängnäs, Sweden. e-mail address: pgbo.nystrom@gmail.com
Background: At present there is no clear evidence that surgical treatment by fusion operation is more advisable than non-surgical treatment in patients suffering from unspecific chronic low back pain (CLBP). By personal experience a subgroup among the CLBP patients is selected, possibly representing patients with pain from a motion segment/disc, thus making patient selection more specified. Furthermore, selection of level to fuse based on radiological findings has not been found reliable. Therefore a mechanical provocation test has been developed at the clinic. The aim of this randomized study was to compare the outcomes in pain and pain related functions perceived by this specific subgroup of CLBP patients following fusion surgery with those following non-surgical treatment.
Methods: Patients with a specified symptomatology and specified clinical signs at examination were recruited and randomized to either type of treatment, non-surgical (NS) including cognitive-behavioral therapy and physiotherapy (37 pat.) or surgical (S), including the same cognitive-behavioral therapy and physiotherapy as in the NS group plus fusion surgery (37 pat.). All patients were thoroughly investigated before start of the study and at follow-up one year after treatment. The outcomes perceived by the patients were assessed on the validated questionnaires Oswestry Disability Index (ODI), Roland-Morris, Balanced Inventory for Spinal Disorders (BIS), Short-Form-36 (SF-36) and Euro-Quol (EQ-5D).
详细描述
- a. Title: Lumbar fusion or non-operative care for treatment of presumed discogenic pain.
A randomized study.
Introduction
Background and objectives: 2. a. Only two out of five existing randomized studies comparing results from fusion surgery for chronic low back pain (CLBP) with results from conservative treatment have reported the results from surgery to be better. Systematic review of these trials also found methodological concerns. At present, therefore, there is no clear evidence that surgical treatment is more advisable than non-surgical treatment in patients suffering from unspecific CLBP.
2 b. The investigators hypothesis is that a/ there exists a specific identifiable subgroup of patients within the CLBP group in whom the pain emanates from the disc, and that b/ patients in this subgroup may be selected based on thorough symptom analysis, and c/ that the actual disc may be localized, not by radiological methods or discography, but by mechanical testing procedures, making pain reduction possible by a fusion operation at that level.
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
- None
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
- •Low back pain
- •Clinical diagnosis
- •No radiological correlates
排除标准
- •No previous fusion operation.
结局指标
主要结局
Low back pain assessed with Visual Analog Scale
时间窗: One year
Visual Analog Scale for Pain
Low back pain assessed with Balanced Inventory for Spinal Disorders (BIS)
时间窗: One year
Balanced Inventory for Spinal Disorders (BIS)
Low back pain assessed with Oswestry Disability Index (ODI)
时间窗: One year
Oswestry Disability Index (ODI)
Low back pain assessed with Short-Form-36 (SF-36)
时间窗: One year
Short-Form-36 (SF-36)
次要结局
- Pain related functions assessed with Roland-Morris questionnaire(One year)
- Pain related functions assessed with European Quality-of-Life Scale (EQ-5D)(One year)
- Pain related functions assessed with Balanced Inventory for Spinal Disorders questionnaire (BIS)(One year)
- Pain related functions assessed with Short-Form-36 questionnaire (SF-36)(One year)
研究者
Bo Nyström
MD, PhD
Spinal Surgery Clinic, Strängnäs