Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03518840
Other study ID # 210146
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2017
Est. completion date March 21, 2019

Study information

Verified date November 2020
Source Loyola University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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:


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date March 21, 2019
Est. primary completion date March 21, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
SIJ Belt
Support Belts

Locations

Country Name City State
United States Loyola University Health System Maywood Illinois

Sponsors (1)

Lead Sponsor Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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

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. — View Citation

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. — View Citation

Kristiansson P, Svärdsudd K, von Schoultz B. Serum relaxin, symphyseal pain, and back pain during pregnancy. Am J Obstet Gynecol. 1996 Nov;175(5):1342-7. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Wu WH, Meijer OG, Uegaki K, Mens JM, van Dieën 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. Epub 2004 Aug 27. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03541343 - GreenBRIC Clinical Trial N/A
Completed NCT04873778 - Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain N/A
Completed NCT04981418 - Evaluating the Management of Chronic Pelvic Girdle Pain N/A
Terminated NCT02044991 - Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain Phase 2
Recruiting NCT06284278 - Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain N/A
Completed NCT05181384 - Pelvic Floor Muscles and Stabilization Integrated Training Improved Pregnancy-related Pelvic Girdle Pain N/A
Withdrawn NCT04377516 - Effects of Specific Pelvic Stabilization Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain Women N/A
Not yet recruiting NCT05507853 - Exploring Central Sensitization in Pregnant Women
Recruiting NCT05879575 - Effects and Pathophysiology of Weight Training on Pregnancy-related Pelvic Girdle Pain (PPGP) N/A
Completed NCT03261687 - The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain N/A
Active, not recruiting NCT05382845 - Screening for Pregnancy Related Pelvic Girdle Pain N/A
Active, not recruiting NCT03606720 - Effect of Low Level Laser Therapy and Pelvic Stabilisation Exercises on Postpartum Pelvic Girdle Pain N/A
Recruiting NCT02789735 - Low Level Laser Therapy in Persistent Pelvic Girdle Pain N/A
Completed NCT02543515 - Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy N/A
Completed NCT01098136 - Pelvic Girdle Pain in a Pregnant Population in Western Norway. N/A
Completed NCT03436888 - Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language
Recruiting NCT04266184 - Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain N/A
Not yet recruiting NCT05403437 - Pelvic Girdle Pain Symptom Severity in Pregnant Women With Gestational Diabetes Mellitus
Not yet recruiting NCT05403424 - Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnancy Pelvic Girdle Pain
Recruiting NCT04226716 - The Role of Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study N/A