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

• Sponsor: Loyola University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03518840
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arm: 1
• Actual Duration (Months): 16.4
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Girdle Pain	Device: SIJ Belt	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All patients receive an SIJ belt.All patients receive an SIJ belt.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Predictive Value of the Active Straight Leg Raise on the Efficacy of a Sacroiliac Joint Belt in Posterior Pelvic Girdle Pain During Pregnancy
• Actual Study Start Date: Nov 7, 2017
• Actual Primary Completion Date: Mar 21, 2019
• Actual Study Completion Date: Mar 21, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 4 Weeks. [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.

Secondary Outcome Measures

1. Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks [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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loyola University Health System	Maywood	Illinois	United States	60153

Sponsors and Collaborators

• Loyola University

Investigators

• Principal Investigator: Colleen Fitzgerald, MD, Loyola University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 8, 2018
• Informed Consent Form - Jun 27, 2019

More Information

Publications

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

• Responsible Party: Colleen M. Fitzgerald, MD, MS, M.D. Associate Professor, Loyola University
• ClinicalTrials.gov Identifier: NCT03518840
• Other Study ID Numbers: 210146
• First Posted: May 8, 2018
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Pelvic Girdle Pain

Study Results

Participant Flow

Recruitment Details	Patients were recruited from November 2017 through June 2019 (20 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.

Arm/Group Title	Sacroiliac Joint Belt
Arm/Group Description	All patients receive an SIJ belt
Period Title: Overall Study
STARTED	63
COMPLETED	57
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Sacroiliac Joint Belt
Arm/Group Description	All patients receive an SIJ belt
Overall Participants	63
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.94 (4.93)
Sex: Female, Male (Count of Participants)
Female	63 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	28 44.4%
Not Hispanic or Latino	35 55.6%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Count of Participants)
Black or African American	13 20.6%
White	27 42.9%
Other	23 36.5%
Region of Enrollment (Count of Participants)
United States	63 100%
Employment (Count of Participants)
Employed	42 66.7%
Stay at home parent	16 25.4%
Unemployed	5 7.9%
Previous mode of delivery (Count of Participants)
Vaginal	34 54%
C-section	10 15.9%
Both	2 3.2%
Not reported	17 27%
Previous abdominal surgery (Count of Participants)
No	49 77.8%
Yes	13 20.6%
Not reported	1 1.6%
History of low back pain (Count of Participants)
No	41 65.1%
Yes	22 34.9%
Prior physical therapy for lower back pain (Count of Participants)
No	59 93.7%
Yes	4 6.3%
Prior pelvic pain (Count of Participants)
No	52 82.5%
Yes	11 17.5%
Physical activity level (Count of Participants)
Not physically active	10 15.9%
Mildly physically active	29 46%
Moderately physically active	22 34.9%
Extremely physically active	2 3.2%
Smoker status (Count of Participants)
Non-smoker	43 68.3%
Smoker	20 31.7%
History of depression (Count of Participants)
No	52 82.5%
Yes	11 17.5%
History of anxiety (Count of Participants)
No	52 82.5%
Yes	11 17.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Sixty-three women who signed an informed consent document were available at baseline and 52 women returning for the week 4 follow-up visit completed the ASLR assessment.

Arm/Group Title	Baseline	Week 4
Arm/Group Description	All patients received an SIJ belt and had their ASLR score recorded at baseline	At week 4, 52 women returning completed the ASLR assessment
Measure Participants	63	52
Mean (Standard Deviation) [score on a scale]	4.87 (1.85)	2.92 (2.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baseline, Week 4
	Comments	The null hypothesis is that there is no change in the baseline ASLR score following four weeks of SIJ belt therapy.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	paired t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.9615
	Confidence Interval	(2-Sided) 95%; -2.6299 to -1.2932
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3329
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks
Description	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".
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

Sixty-three women who signed an informed consent document were available at baseline and 57 women returning for the week 4 follow-up visit completed the NRS.

Arm/Group Title	Baseline	Week 4
Arm/Group Description	All patients received an SIJ belt and had their pain score recorded at baseline	At week 4, 57 women completed the NRS assessment
Measure Participants	63	57
Mean (Standard Deviation) [score on a scale]	6.10 (1.93)	4.18 (2.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Baseline, Week 4
	Comments	The null hypothesis is that there is no change in the baseline NRS score following four weeks of SIJ belt therapy.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	paired t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-1.9474
	Confidence Interval	(2-Sided) 95%; -2.6190 to -1.2757
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3353
	Estimation Comments

Adverse Events

Time Frame	Adverse event data were collected for six weeks
Arm/Group Title	Sacroiliac Joint Belt
Arm/Group Description	All patients receive an SIJ belt
All Cause Mortality
	Sacroiliac Joint Belt
	Affected / at Risk (%)	# Events
Total	0/63 (0%)
Serious Adverse Events
	Sacroiliac Joint Belt
	Affected / at Risk (%)	# Events
Total	0/63 (0%)
Other (Not Including Serious) Adverse Events
	Sacroiliac Joint Belt
	Affected / at Risk (%)	# Events
Total	1/63 (1.6%)
Injury, poisoning and procedural complications
Pinched nerve	1/63 (1.6%)	1

Limitations/Caveats

There are no limitations or caveats to report.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.