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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: Completed NA study, sponsored by Loyola University.
NCT03518840 is a NA study that has completed, run by Loyola University. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ASLR scale is an assessment of the functioning level of a patient's affected leg. It ranges from 0 to 5 with higher values indicating greater impairment.
Interventions
- DEVICE SIJ Belt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2017-11-07 |
| Est. Completion | 2019-03-21 |
| Phase | NA |
What the finished NCT03518840 record still lists
NCT03518840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which SIJ Belt is the first listed.
NCT03518840 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03518840's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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