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

NCT03518840 | Completed Results FDA Device

• 1 other identifier: 210146
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Girdle Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 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 Outcomes (1)

• Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks

  Baseline and 4 weeks

Study Arms (1)

Sacroiliac Joint Belt

OTHER

All patients will receive and be fitted by the PI with an SIJ belt.

Device: SIJ Belt

Interventions

SIJ Belt DEVICE

Support Belts

Sacroiliac Joint Belt

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Health System

Maywood, Illinois, 60153, United States

Location

Related Publications (9)

• Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.

  PMID: 18259783 BACKGROUND

• Wu WH, Meijer OG, Uegaki K, Mens JM, van Dieen JH, Wuisman PI, Ostgaard HC. Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence. Eur Spine J. 2004 Nov;13(7):575-89. doi: 10.1007/s00586-003-0615-y. Epub 2004 Aug 27.

  PMID: 15338362 BACKGROUND

• Ekman EF, Koman LA. Acute pain following musculoskeletal injuries and orthopaedic surgery: mechanisms and management. Instr Course Lect. 2005;54:21-33.

  PMID: 15948432 BACKGROUND

• Kristiansson P, Svardsudd K, von Schoultz B. Serum relaxin, symphyseal pain, and back pain during pregnancy. Am J Obstet Gynecol. 1996 Nov;175(5):1342-7. doi: 10.1016/s0002-9378(96)70052-2.

  PMID: 8942512 BACKGROUND

• Flack NA, Hay-Smith EJ, Stringer MD, Gray AR, Woodley SJ. Adherence, tolerance and effectiveness of two different pelvic support belts as a treatment for pregnancy-related symphyseal pain - a pilot randomized trial. BMC Pregnancy Childbirth. 2015 Feb 15;15:36. doi: 10.1186/s12884-015-0468-5.

  PMID: 25885585 BACKGROUND

• Kordi R, Abolhasani M, Rostami M, Hantoushzadeh S, Mansournia MA, Vasheghani-Farahani F. Comparison between the effect of lumbopelvic belt and home based pelvic stabilizing exercise on pregnant women with pelvic girdle pain; a randomized controlled trial. J Back Musculoskelet Rehabil. 2013;26(2):133-9. doi: 10.3233/BMR-2012-00357.

  PMID: 23640314 BACKGROUND

• Mens JM. Does a pelvic belt reduce hip adduction weakness in pregnancy-related posterior pelvic girdle pain? A case-control study. Eur J Phys Rehabil Med. 2017 Aug;53(4):575-581. doi: 10.23736/S1973-9087.17.04442-2. Epub 2017 Mar 1.

  PMID: 28251846 BACKGROUND

• Soisson O, Lube J, Germano A, Hammer KH, Josten C, Sichting F, Winkler D, Milani TL, Hammer N. Pelvic belt effects on pelvic morphometry, muscle activity and body balance in patients with sacroiliac joint dysfunction. PLoS One. 2015 Mar 17;10(3):e0116739. doi: 10.1371/journal.pone.0116739. eCollection 2015.

  PMID: 25781325 BACKGROUND

• Fitzgerald CM, Bennis S, Marcotte ML, Shannon MB, Iqbal S, Adams WH. The impact of a sacroiliac joint belt on function and pain using the active straight leg raise in pregnancy-related pelvic girdle pain. PM R. 2022 Jan;14(1):19-29. doi: 10.1002/pmrj.12591. Epub 2021 May 20.

  PMID: 33745213 DERIVED

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Limitations and Caveats

There are no limitations or caveats to report.

Results Point of Contact

• Title: Colleen Fitzgerald, M.D., M.S.
• Organization: Loyola University Chicago

CFITZGERALD@lumc.edu

708-216-3380

Study Officials

• Colleen Fitzgerald, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Associate Professor

Model Details: All patients receive an SIJ belt.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 8, 2018
• Study Start: November 7, 2017
• Primary Completion: March 21, 2019
• Study Completion: March 21, 2019
• Last Updated: November 24, 2020
• Results First Posted: October 28, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)