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N/A N=63 Treatment

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

Pelvic Girdle Pain

Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Change From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 4 Weeks. — 4.87; 2.92 score on a scale — p=<.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SIJ Belt (Device)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Loyola University
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 4 Weeks.
4.87; 2.92 <.001 sig
SECONDARY
Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks
6.10; 4.18 <.001 sig

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.

Eligibility Criteria

Inclusion Criteria

  • English speaking pregnant women presenting in their second or third trimester with posterior PGP. Trimester will be determined from date of last menses or ultrasound date.
  • 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
  • ASLR score between 2-10

Exclusion Criteria

  • Non-English speaking pregnant women 50 years old
  • Women presenting with PGP in the first trimester (<13 weeks gestation)
  • Women with pubic symphysis (anterior) pain alone
  • Pain above the upper level of the iliac crest
  • ASLR total score of <2
  • History of lumbar or pelvic fracture, neoplasm, inflammatory disease, active urogenital infection or active gastrointestinal illness, previous surgery of the lumbar spine, pelvic girdle, hip joint or femur
  • History or signs of radiculopathy or other systemic neurologic disease
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03518840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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