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

Phase 2TerminatedNCT02044991

Loyola University2 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pelvic Girdle Pain

Interventions

CorticosteroidDRUG

40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine

Placebo InjectionDRUG

A placebo injection

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Loyola University Health System

Maywood, Illinois, United States

Outcomes

Primary Outcomes

Change in Pain

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.

Time frame: 8 weeks

Secondary Outcomes

Pelvic Functioning

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.

Time frame: 8 weeks

Disability

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.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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