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

November 6, 2020 updated by: Colleen M. Fitzgerald, MD, MS, Loyola University

The Predictive Value of the Active Straight Leg Raise on the Efficacy of a Sacroiliac Joint Belt in Posterior Pelvic Girdle Pain 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Clinically, pelvic belts are often used as a part of a multimodal approach to reduce PGP alongside other conservative treatments such as analgesics and physical therapy, or more alternative treatments such as acupuncture5. This makes it difficult to determine their individual effect on pain reduction. Further confounding this issue are variations in physician counseling, physical therapy regimens, and analgesic usage. Moreover, several support belts have been designed that vary in padding size, flexibility, and site of application5-7. Among these belts, it has not yet been identified which belt is most beneficial regarding pain reduction and patient tolerance5. Previous studies have found benefit in short term use (3-6 weeks) of maternity belts, providing women with improved pain and function compared to exercise or no intervention7. Pelvic belts are a cost-effective option to treating PGP, and more specifically SIJ pain, yet studies are limited regarding the effect they have on SIJ mobility and pain reduction8 and more specifically determining what clinically predicts those who will benefit most from an SIJ belt.

The active straight leg raise test originally described by Mens is an examination maneuver that measures functional mobility and has been correlated with pregnancy related PGP (cite). Anecdotally, our clinical team has observed that women who benefit from compression during the second part of the test, seem to benefit most from the use of an SIJ belt. Having a simple test for obstetric providers to perform in pregnant women with pain would be informative in determining who might benefit most from an SIJ belt. Hence our study seeks to investigate the following aims:

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 <18 or >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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sacroiliac Joint Belt
All patients will receive and be fitted by the PI with an SIJ belt.
Device: SIJ Belt
Support Belts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 4 Weeks.
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks
Time Frame: Baseline and 4 weeks
The NRS is a pain assessment scale ranging from 0 to 10, where 0 represents "No Pain", 5 represents "Moderate Pain", and a value of 10 represents the "Worst Possible Pain".
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

  • Principal Investigator: Colleen Fitzgerald, MD, Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2017

Primary Completion (Actual)

March 21, 2019

Study Completion (Actual)

March 21, 2019

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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