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

July 11, 2018 updated by: Colleen Fitzgerald, Loyola University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
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
Drug: Corticosteroid
40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine
Other Names:
  • Medrol
Placebo Comparator: Placebo
Participant's randomized to this condition will receive a placebo injection once weekly
Drug: Placebo Injection
A placebo injection
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Functioning
Time Frame: 8 weeks
Pelvic functioning is measured at baseline (0 weeks) and week 8 using the Pelvic Girdle Questionnaire (PGQ), which ranges from 0 to 100 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.
8 weeks
Disability
Time Frame: 8 weeks
Disability is measured at baseline (0 weeks) and week 8 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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Collaborators

American Academy of Physical Medicine and Rehabilitation

Investigators

  • Principal Investigator: Colleen Fitzgerald, MD, Loyola Univ Med Cntr-

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2013

Primary Completion (Actual)

February 22, 2017

Study Completion (Actual)

February 22, 2017

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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