跳至主要内容
临床试验/NCT05181579
NCT05181579已完成不适用

Efficacy of Manual Therapy and Sacroiliac Joint Injection in the Treatment of Patients With Sacroiliac Joint Dysfunction

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2021年9月29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
30
试验地点
2
主要终点
Numeric Rating Scale, NRS

研究概览

简要总结

The purpose of this study is to compare the efficacy of manual therapy and sacroiliac joint injections in patients with sacroiliac joint dysfunction

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
  • Pain score greater than 3 according to NRS
  • Unresponsiveness to conservative treatment (such as exercise, NSAID)
  • At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive

排除标准

  • Refusing to participate in the study
  • Pregnancy
  • History of inflammatory disease (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, etc.)
  • Infective sacroiliitis
  • Malignancy
  • Osteoporosis
  • Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
  • Neurological finding in the lower extremity
  • Pain spreading below the knee
  • History of spinal surgery
  • History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)

结局指标

主要结局

Numeric Rating Scale, NRS

时间窗: Change from baseline NRS at 3 months

NRS is an 11-grade scale that evaluates the severity of pain in adults .NRS is one of the most commonly used scales in the assessment of pain severity. Possible scores ranges from 0( no pain) to 10 ( worst pain)

次要结局

  • Oswestry Disability index(Baseline, Month 1, Month 3, Month 6)

研究者

发起方
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasin Demir

Associate professor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

研究点 (2)

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