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临床试验/NCT01539863
NCT01539863已完成不适用

Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain. A Randomized Controlled Trial With 1 Year Follow up

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
328
试验地点
2
主要终点
Number of Days With Bothersome Low Back Pain

研究概览

简要总结

As low back pain is often a recurrent and sometime persistent problem, research into prevention is important. Chiropractors have traditionally treated patients with maintenance care, which means that patients are seen on a regular basis to prevent recurrences or to stop a persistent problem getting worse. However, it is not known if this has the expected effect.

This study will test the effectiveness of the maintenance care approach. Patients with recurrent or persistent low back pain will be treated in accordance with two different models. The first model is the maintenance care model, meaning that chiropractors will see the patient on a regular basis, regardless symptoms. The other model means that patients should be treated patients only when they themselves experience symptoms bad enough to seek care. After one year, it will be possible to see if there has been any difference between the groups in terms of pain, disability, quality of life and total number of treatments over the study period and to investigate if there is any difference in the cost-effectiveness between the two treatment models.Thus, the study hypothesis is that there is no difference between the two models regarding the number of days with pain.

This study will be a multi-centre trial, and as part of the study, it will be necessary to formalize a network of research clinics all over Sweden in which participating chiropractors accept to perform complex data collection. This network will then have the expertise and potential to perform future clinical studies together with networks in other countries, allowing large clinical trials across countries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

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

入选标准

  • non-specific low back pain > 30 days previous year
  • non-specific low back pain with previous episodes
  • age 18-65
  • access to a mobile phone
  • knowledge of how to text message
  • proficiency in the Swedish language
  • must rate themselves as "definitely improved" by the 4th visit

排除标准

  • pregnancy
  • contraindication to spinal manipulative therapy
  • liability issues

结局指标

主要结局

Number of Days With Bothersome Low Back Pain

时间窗: 12 months

Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks.

次要结局

  • Cost-effectiveness(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iben Axen

Principal Investigator

Karolinska Institutet

研究点 (2)

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