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

Sponsor
Loyola University (Other)
Overall Status
Terminated
CT.gov ID
NCT02044991
Collaborator
American Academy of Physical Medicine and Rehabilitation (Other)
2
Enrollment
1
Location
2
Arms
40
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain: A Randomized Controlled Trial
Actual Study Start Date :
Oct 24, 2013
Actual Primary Completion Date :
Feb 22, 2017
Actual Study Completion Date :
Feb 22, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Pain [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.

    Secondary Outcome Measures

    1. Pelvic Functioning [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.

    2. Disability [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loyola University Health System Maywood Illinois United States 60153

    Sponsors and Collaborators

    • Loyola University
    • American Academy of Physical Medicine and Rehabilitation

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Colleen Fitzgerald, M.D., Associate Professor, Loyola University
    ClinicalTrials.gov Identifier:
    NCT02044991
    Other Study ID Numbers:
    • 205418
    First Posted:
    Jan 24, 2014
    Last Update Posted:
    Aug 8, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Colleen Fitzgerald, M.D., Associate Professor, Loyola University
    Sciatica
    Pelvic girdle pain
    Additional relevant MeSH terms:
    Pelvic Girdle Pain

    Study Results

    Participant Flow

    Recruitment Details Recruitment for this trial began in May 2015 and ended in May 2016 (12 months). The trial was terminated in February 2017 due to poor recruitment
    Pre-assignment Detail
    Arm/Group Title Treatment Placebo
    Arm/Group Description Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine Participant's randomized to this condition receive a saline injection with lidocaine.
    Period Title: Overall Study
    STARTED 2 0
    COMPLETED 2 0
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Treatment Placebo Total
    Arm/Group Description Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine Participant's randomized to this condition receive a saline injection with lidocaine. Total of all reporting groups
    Overall Participants 2 0 2
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    NaN
    0
    0%
    Between 18 and 65 years
    2
    100%
    0
    NaN
    2
    100%
    >=65 years
    0
    0%
    0
    NaN
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    2
    100%
    0
    NaN
    2
    100%
    Male
    0
    0%
    0
    NaN
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    NaN
    0
    0%
    Asian
    0
    0%
    0
    NaN
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    NaN
    0
    0%
    Black or African American
    0
    0%
    0
    NaN
    0
    0%
    White
    2
    100%
    0
    NaN
    2
    100%
    More than one race
    0
    0%
    0
    NaN
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    NaN
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Change in Pain
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.
    Arm/Group Title Treatment Placebo
    Arm/Group Description Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine Participant's randomized to this condition receive a saline injection with lidocaine.
    Measure Participants 2 0
    Median (Full Range) [change score on the NRS pain scale]
    -3
    2. Secondary Outcome
    Title Pelvic Functioning
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.
    Arm/Group Title Treatment Placebo
    Arm/Group Description Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine Participant's randomized to this condition receive a saline injection with lidocaine.
    Measure Participants 2 0
    Median (Full Range) [change score on the PGQ scale]
    -35.5
    3. Secondary Outcome
    Title Disability
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.
    Arm/Group Title Treatment Placebo
    Arm/Group Description Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine Participant's randomized to this condition receive a saline injection with lidocaine.
    Measure Participants 2 0
    Median (Full Range) [change score on the ODI scale]
    -15.25

    Adverse Events

    Time Frame Adverse event data were collected for 1 year, 7 months
    Adverse Event Reporting Description For the placebo arm, the number of participants at risk for an adverse event, serious adverse event, and all-cause mortality is zero. This is because no participants were assigned to placebo. In this study, only two individuals were assigned to an intervention and both received the injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine.
    Arm/Group Title Treatment Placebo
    Arm/Group Description Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine Participant's randomized to this condition receive a saline injection with lidocaine.
    All Cause Mortality
    Treatment Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/2 (0%) 0/0 (NaN)
    Serious Adverse Events
    Treatment Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/2 (50%) 0/0 (NaN)
    Pregnancy, puerperium and perinatal conditions
    Premature birth 1/2 (50%) 1 0/0 (NaN) 0
    Other (Not Including Serious) Adverse Events
    Treatment Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/2 (100%) 0/0 (NaN)
    Pregnancy, puerperium and perinatal conditions
    Premature contractions 1/2 (50%) 1 0/0 (NaN) 0
    Respiratory, thoracic and mediastinal disorders
    Bronchitis 1/2 (50%) 1 0/0 (NaN) 0

    Limitations/Caveats

    The trial was terminated in February 2017 due to poor recruitment

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Colleen Fitzgerald, M.D., M.S.
    Organization Loyola University
    Phone 708-216-2180
    Email cfitzgerald@lumc.edu
    Responsible Party:
    Colleen Fitzgerald, M.D., Associate Professor, Loyola University
    ClinicalTrials.gov Identifier:
    NCT02044991
    Other Study ID Numbers:
    • 205418
    First Posted:
    Jan 24, 2014
    Last Update Posted:
    Aug 8, 2018
    Last Verified:
    Jul 1, 2018