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

Primary Purpose

Pelvic Girdle Pain

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Corticosteroid

Placebo Injection

About this trial

This is an interventional treatment trial for Pelvic Girdle Pain focused on measuring Sciatica, Pelvic girdle pain

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Loyola University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02044991

First Posted

January 17, 2014

Last Updated

July 11, 2018

Sponsor

Loyola University

Collaborators

American Academy of Physical Medicine and Rehabilitation

1. Study Identification

Unique Protocol Identification Number

NCT02044991

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

The study was halted prematurely due to poor recruitment

Study Start Date

October 24, 2013 (Actual)

Primary Completion Date

February 22, 2017 (Actual)

Study Completion Date

February 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loyola University

Collaborators

American Academy of Physical Medicine and Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Girdle Pain

Keywords

Sciatica, Pelvic girdle pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Participants are assigned to receive either an injection of methylprednisolone acetate plus lidocaine or to receive an injection of saline with lidocaine using a randomized block design with a 1:1 allocation.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Corticosteroid

Other Intervention Name(s)

Medrol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo Injection

Other Intervention Name(s)

Saline

Intervention Description

A placebo injection

Primary Outcome Measure Information:

Title

Change in Pain

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Pelvic Functioning

Description

Time Frame

8 weeks

Title

Disability

Description

Time Frame

8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colleen Fitzgerald, MD

Organizational Affiliation

Loyola Univ Med Cntr-

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loyola University Health System

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share individual participant data

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

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