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NCT03518840 · ClinicalTrials.gov registry record · NA

Predictive Value of the Active Straight Leg Raise on the Efficacy of a SJB in Posterior PGP During Pregnancy

A NA study, sponsored by Loyola University.

Completed
Registry status
NA
Development phase
63
Enrollment target

NCT03518840 is a NA study that has completed, run by Loyola University. The registered enrollment target is 63 participants.

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The verdict

NCT03518840, a NA study, has completed, sponsored by Loyola University.

COMPLETED
Registry status
NA
Development phase
63 participants
Enrollment target

Study Summary

During pregnancy, women often experience musculoskeletal pain, specifically in their low back and/or pelvic girdle. Pelvic girdle pain (PGP) is defined as pain between the posterior iliac crest and gluteal fold, particularly in the region of the sacroiliac joint (SIJ)1. Although it is often referred to as "sciatica". PGP in pregnancy is common with prevalence estimates of 45%2. Previous studies have found that one third of patients will rate their PGP intensity as severe, leading to functional impairments. Functional disabilities include sitting, walking, and standing; thus, significantly impacting the ability of patients to perform routine daily activities. This pain has been reported to develop as early as 17-19 weeks' gestation, lasting up to 3 months postpartum; with a peak incidence of 24-36 weeks. The etiology of PGP in pregnant women is still not fully understood, largely due to the complex interactions between bone, ligaments, fascia, and muscles in the pelvic joints3. Some studies suggest the increased mobility of the joints in the pelvic girdle during pregnancy due to relaxing cause a lack of stabilization in the sacroiliac region, which results in pain4. Thus, it is hypothesized that providing stabilization of the joints with an external force, such as a maternity or SIJ belt, will improve pain.

Interventions

  • DEVICE SIJ Belt

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2017-11-07
Est. Completion 2019-03-21
Phase NA

Sponsor

Loyola University

92 total trials

What the Registry Record Tells You About NCT03518840

The ClinicalTrials.gov registry entry for NCT03518840 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loyola University, which has 92 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which SIJ Belt is the first listed.

NCT03518840 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03518840 about?

NCT03518840 is a clinical study titled "Predictive Value of the Active Straight Leg Raise on the Efficacy of a SJB in Posterior PGP During Pregnancy". During pregnancy, women often experience musculoskeletal pain, specifically in their low back and/or pelvic girdle. Pelvic girdle pain (PGP) is defined as pain between the posterior iliac crest and gluteal fold, particularly in the region of the sacroiliac joint (SIJ)1. Although it is often referred...

What is the current status of trial NCT03518840?

This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2017-11-07. Estimated completion is 2019-03-21.

What interventions are being tested in trial NCT03518840?

The interventions under investigation include: SIJ Belt (DEVICE).

Who is sponsoring clinical trial NCT03518840?

This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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