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临床试验/NCT04305509
NCT04305509已完成不适用

Outcomes After Chiropractic Spinal Manipulative Therapy for Patients With Lumbar Disc Herniation and Radiculopathy

Balgrist University Hospital1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2020年3月9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
98
试验地点
1
主要终点
intensity of low back pain

研究概览

简要总结

In a study that was approved nine years ago (EK-22/2009) we could show (i) that spinal manipulative therapy (SMT) is a very effective and safe treatment for acute and chronic lumbar disc herniation (LDH); (ii) that SMT is as effective and less expensive than lumbar nerve root injections and (iii) that the recurrence rate up to one year was very low in acute and in chronic LDH patients. However, the long-term outcome of this conservatively treated LDH patients is unknown. Thus, the objective of this amendment is to investigate the proportion of long-term recurrences in these patients who were treated with SMT for their LDH and to compare these results with already existing data from other treatments, e.g. surgery. This is important information to know whether this conservative method is a sustainable approach for treating LDH.

详细描述

All 148 patients with magnetic resonance imaging-confirmed disc herniation who were recruited for the study EK 22-2009 will be re-contacted to assess the course of their back problem during the past approx. nine years using a questionnaire.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •The same patients who were recruited for the study EK-22/2009

排除标准

  • •The same as for study EK-22/2009:
  • •Patients with specific pathologies of the lumbar spine that are contraindications to chiropractic manipulative treatment, such as tumors, infections, inflammatory spondylarthropathies, acute fractures, Paget's disease and severe osteoporosis, will be excluded. Also excluded will be patients with previous spinal surgery, signs of cauda equina syndrome (CES), sequestration of disc material, body mass index >30, spondylolisthesis, neurogenic claudication and pregnancy.

结局指标

主要结局

intensity of low back pain

时间窗: 1 month

intensity of low back pain in the last month (numeric rating scale)

次要结局

未报告次要终点

研究者

发起方
Balgrist University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brigitte Wirth

Senior scientist Chiropractic Medicine

Balgrist University Hospital

研究点 (1)

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