Clinical Trial: Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Loyola University

Current Primary Outcome: Change in Pain [ Time Frame: 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.


Original Primary Outcome: Change from Baseline in Pain, as measured by Pain Numeric Rating Scale (NRS) (0-10) [ Time Frame: 4 weeks ]

Does ultrasound guided posterior sacroiliac ligament corticosteroid injection combined with standard physical therapy provide superior pain relief in pregnant women with PGP in the second trimester compared with placebo injection plus physical therapy as measured by the pain Numeric Rating Scale (NRS) (0-10)?


Current Secondary Outcome:

  • Pelvic Functioning [ Time Frame: 52 weeks ]
    Pelvic functioning is measured at baseline (0 weeks) and week 52 using the Pelvic Girdle Questionnaire (PGQ), which ranges from 0 to 75 points with higher scores revealing greater pelvic girdle pain. The change in pelvic functioning between these two time points (i.e., the difference score) is compared between the two groups.
  • Disability [ Time Frame: 52 weeks ]
    Disability is measured at baseline (0 weeks) and week 52 using the Oswestry Disability Index (ODI), which is a measure of low back pain that ranges from 0 points to 100 with higher scores indicating greater disability. The change in disability between these two time points (i.e., the difference score) is compared between the two groups.


Original Secondary Outcome: Oswestry Disability Index (ODI), Pelvic Girdle Questionnaire and physical examination testing [ Time Frame: 1 year ]

Does posterior sacroiliac ligament corticosteroid injection combined with standard physical therapy in pregnant women with PGP in the second trimester result in less disability and improved physical examination as compared with placebo injection plus physical therapy?


Information By: Loyola University

Dates:
Date Received: January 17, 2014
Date Started: October 24, 2013
Date Completion:
Last Updated: April 3, 2017
Last Verified: April 2017