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临床试验/NCT00900601
NCT00900601已完成不适用

Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma - A Study to Measure Effect of Surgery, Analysis of Clinical Tests and Detection of Sacroiliac Instability Using RSA.

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9
试验地点
2
主要终点
Oswestry Disability Index (ODI)

研究概览

简要总结

Pelvic girdle pain (PGP) related to pregnancy is a common reason to sick leave during pregnancy. Low back pain and PGP affects about 50% of women during pregnancy. Most of the women recover, however about 10% of the women still have complaints after birth. Most patients have positive effect from conservative treatment, but unfortunately some do still have much pain despite intensive conservative rehabilitation. Surgery has been tried on these women with various results. Surgical treatment is controversial and there is a lack of documentation. The investigators will operate 20 patients with arthrodesis to the sacroiliac joint and symphysis. Radiostereometric analysis (RSA) will be used to evaluate the joint movement in different part of the process.

Hypothesis: Severe pelvic girdle pain is caused by pelvic joint instability in some cases and surgically fixation of the affected joints can help these women to get back to a normal life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Pain in one or more pelvic joints.
  • Minimum 2 positive clinical tests.
  • High pain and disability score
  • Tried adequate physiotherapy without effect.

排除标准

  • Known psychiatric diagnosis
  • Other spine pathology
  • CT verified ankylosis

研究组 & 干预措施

Sacroilliac fusion

Experimental

Pastient are treated with sacroiliac joint arthrodesis to the sacroiliac joint and symphysis

干预措施: Arthrodesis to the sacroiliac joint and symphysis (Procedure)

结局指标

主要结局

Oswestry Disability Index (ODI)

时间窗: 12 months

Oswestry Disability Index is a 10 item questionnaire comprises 10 questions about physical function. Each item has a 0-5 scale and the raw score is multiplied by 2 and the sum is the total score. Zero represents excellent physical function and 100 is more or less bedridden. This is the most used outcome measure in low back pain studies.

Visual Analogue Scale (VAS) 0 to 10

时间窗: 12 months

Visual Analogue Scale is a 0 -10 scale. Zero is no pain and 10 is the worst pain you can imagine. In this study the patients were asked to report the morgning and evening pain by this scale.

次要结局

  • Healing Measured by CT(12 months)

研究者

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

Thomas Johan Kibsgård

Consultant

Oslo University Hospital

研究点 (2)

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