NCT02044991

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

Terminated Phase 2 Results posted Last updated 8 August 2018

What this trial tests

Phase 2 trial testing Corticosteroid in Pelvic Girdle Pain in 2 participants. Terminated before completion.

Timeline

24 October 2013

Primary endpoint
22 February 2017

22 February 2017

Quick facts

Lead sponsor	Loyola University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	2
Start date	24 October 2013
Primary completion	22 February 2017
Estimated completion	22 February 2017
Sites	1 location across United States

Drugs / interventions tested

• Corticosteroid — full drug profile →
• Placebo Injection

Conditions studied

• Pelvic Girdle Pain — all drugs for Pelvic Girdle Pain →

Sponsor

Loyola University

Who can join

Adults 21 to 50, female only, with Pelvic Girdle Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain Primary · 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.

Group	Value	95% CI
Treatment	-3	-5 – -1

Pelvic Functioning Secondary · 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.

Group	Value	95% CI
Treatment	-35.5	-75 – 4

Disability Secondary · 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.

Group	Value	95% CI
Treatment	-15.25	-44.5 – 14

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for 1 year, 7 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 1/2 (50%)

Deaths: 0/2

Placebo

Serious: 0

Deaths: 0

Serious adverse events (1 terms)

Reaction	System	Treatment	Placebo
Premature birth	Pregnancy, puerperium and perinatal conditions	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Treatment	Placebo
Bronchitis	Respiratory, thoracic and mediastinal disorders	—	—
Premature contractions	Pregnancy, puerperium and perinatal conditions	—	—

Most-reported serious reactions: Premature birth.

Data from ClinicalTrials.gov NCT02044991 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.