跳至主要内容
临床试验/NCT02044991
NCT02044991终止2 期

The Efficacy of Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain: A Randomized Controlled Trial

Loyola University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年10月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
2
试验地点
1
主要终点
Change in Pain

研究概览

简要总结

The purpose of this study is to see if pelvic girdle pain can be more effectively treated with the use of injectable anti-inflammatory medication plus physical therapy compared with physical therapy and a saline injection.

详细描述

Pelvic girdle pain (PGP) in pregnancy is common with prevalence estimates of 45%.1 It is defined as pain experienced between the posterior iliac crest and the gluteal fold, particularly in the region of the sacroiliac joint.2 Pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. In PGP, the endurance capacity for standing, walking and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes and must be reproducible by specific clinical tests. While various pain mechanisms including mechanical, hormonal, inflammatory, and neural have been proposed in the development of PGP, the etiology and pathogenesis is poorly understood. It is possible that musculoskeletal changes influenced by hormonal (Relaxin) elevation in pregnancy predispose pregnant women to acute musculoskeletal injury presenting clinically as PGP. An inflammatory response in other acute musculoskeletal injuries has been well described3 and may also occur in pregnancy related PGP particularly given the musculoskeletal vulnerability during this time. Though PGP is common in pregnancy, no study to date has investigated the efficacy of anti-inflammatory treatment in pregnancy related PGP in order to better establish the contribution of inflammation in the etiology of pregnancy related PGP.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who are not doing other therapies for pain (physical therapy, chiropractic management, pool)
  • Women between age 21 and 50 who plan to deliver at Loyola or Gottlieb
  • Pain Numeric Rating Scale (NRS) on average of greater than or equal to 5/10 at Visit 1
  • Pain must be between the upper level of the iliac crests and the gluteal folds in conjunction with or separately from pain in the pubic symphysis and influenced by position and locomotion
  • 2/4 positive physical examination tests on the symptomatic side including the P4 test, the LDL test, pubic symphysis palpation and the acute straight leg rise (ASLR)

排除标准

  • Women presenting with PGP in the first or third trimester (<13 weeks gestation or >28 weeks gestation)
  • Women with pubic symphysis (anterior) pain alone
  • Women who do not plan to deliver a baby at Loyola or Gottlieb
  • Pain above the upper level of the iliac crest
  • History of lumbar or pelvic fracture, neoplasm, inflammatory disease, active urogenital infection or active gastrointestinal illness, current physical therapy or other therapies for PGP, or previous surgery of the lumbar spine, pelvic girdle, hip joint or femur
  • History or signs of radiculopathy or other systemic neurologic disease
  • Women with diabetes or gestational diabetes

研究组 & 干预措施

Treatment

Active Comparator

Participants randomized to this arm will receive a corticosteroid. This is 40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine

干预措施: Corticosteroid (Drug)

Placebo

Placebo Comparator

Participant's randomized to this condition will receive a placebo injection once weekly

干预措施: Placebo Injection (Drug)

结局指标

主要结局

Change in Pain

时间窗: 8 weeks

Pain is measured using the Pain Numeric Rating Scale (NRS), which ranges from 0 to 10 with higher scores indicating greater pain. This measure is recorded at baseline (0 weeks) and 8 weeks. The change in pain between these two time points (i.e., the difference score) is compared between the two groups.

次要结局

  • Pelvic Functioning(8 weeks)
  • Disability(8 weeks)

研究者

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

Colleen Fitzgerald

M.D., Associate Professor

Loyola University

研究点 (1)

Loading locations...

相似试验