A Phase 2 interventional study of Corticosteroid and Placebo Injection in Pelvic Girdle Pain, sponsored by Loyola University. Terminated at 1 site in United States. Open to female participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Loyola University · Phase 2, Interventional, and Treatment
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.
55 studies on the registry are indexed under Pelvic Girdle Pain; 12 are open to participants now.
This study's enrollment of 2 is below the median of 57 across 39 interventional studies indexed under Pelvic Girdle Pain.
Browse Pelvic Girdle Pain studies →Loyola University is the lead sponsor of 132 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participant's randomized to this condition will receive a placebo injection once weekly
Drug: Placebo Injection
40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine
Also known as: Medrol
A placebo injection
Also known as: Saline
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
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
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
| Milestone | Treatment | Placebo |
|---|---|---|
| Started | 2 | 0 |
| Completed | 2 | 0 |
| Not completed | 0 | 0 |
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.
| change score on the NRS pain scale | Treatment | Placebo |
|---|---|---|
| Change in Pain | -3 (-5 to -1) | — |
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.
| change score on the PGQ scale | Treatment | Placebo |
|---|---|---|
| Pelvic Functioning | -35.5 (-75 to 4) | — |
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.
| change score on the ODI scale | Treatment | Placebo |
|---|---|---|
| Disability | -15.25 (-44.5 to 14) | — |
Collected over Adverse event data were collected for 1 year, 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Placebo | — | — | — |
| Event | Treatment | Placebo |
|---|---|---|
| Premature birthPregnancy, puerperium and perinatal conditions | 1/2 | — |
| Event | Treatment | Placebo |
|---|---|---|
| BronchitisRespiratory, thoracic and mediastinal disorders | 1/2 | — |
| Premature contractionsPregnancy, puerperium and perinatal conditions | 1/2 | — |
The baseline analysis population comprises all participants who signed an informed consent document to participate in the trial.
| Age, Categorical(Participants) | Treatment | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 0 | 2 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Treatment | Placebo | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 0 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — There is no plan to share individual participant data
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Loyola University