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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03518840
Enrollment
63
Registered
2018-05-08
Start date
2017-11-07
Completion date
2019-03-21
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Girdle Pain

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.

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:

Interventions

DEVICESIJ Belt

Support Belts

Sponsors

Loyola University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

All patients receive an SIJ belt.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 4 Weeks.Baseline and 4 weeksThe 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

MeasureTime frameDescription
Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 WeeksBaseline and 4 weeksThe 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.

Countries

United States

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.

Participants by arm

ArmCount
Sacroiliac Joint Belt
All patients receive an SIJ belt
63
Total63

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up6

Baseline characteristics

CharacteristicSacroiliac Joint Belt
Age, Continuous29.94 years
STANDARD_DEVIATION 4.93
Employment
Employed
42 Participants
Employment
Stay at home parent
16 Participants
Employment
Unemployed
5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
28 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
35 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
History of anxiety
No
52 Participants
History of anxiety
Yes
11 Participants
History of depression
No
52 Participants
History of depression
Yes
11 Participants
History of low back pain
No
41 Participants
History of low back pain
Yes
22 Participants
Physical activity level
Extremely physically active
2 Participants
Physical activity level
Mildly physically active
29 Participants
Physical activity level
Moderately physically active
22 Participants
Physical activity level
Not physically active
10 Participants
Previous abdominal surgery
No
49 Participants
Previous abdominal surgery
Not reported
1 Participants
Previous abdominal surgery
Yes
13 Participants
Previous mode of delivery
Both
2 Participants
Previous mode of delivery
C-section
10 Participants
Previous mode of delivery
Not reported
17 Participants
Previous mode of delivery
Vaginal
34 Participants
Prior pelvic pain
No
52 Participants
Prior pelvic pain
Yes
11 Participants
Prior physical therapy for lower back pain
No
59 Participants
Prior physical therapy for lower back pain
Yes
4 Participants
Race/Ethnicity, Customized
Race
Black or African American
13 Participants
Race/Ethnicity, Customized
Race
Other
23 Participants
Race/Ethnicity, Customized
Race
White
27 Participants
Region of Enrollment
United States
63 Participants
Sex: Female, Male
Female
63 Participants
Sex: Female, Male
Male
0 Participants
Smoker status
Non-smoker
43 Participants
Smoker status
Smoker
20 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 63
other
Total, other adverse events
1 / 63
serious
Total, serious adverse events
0 / 63

Outcome results

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.

Time frame: Baseline and 4 weeks

Population: 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.

ArmMeasureValue (MEAN)Dispersion
BaselineChange From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 4 Weeks.4.87 score on a scaleStandard Deviation 1.85
Week 4Change From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 4 Weeks.2.92 score on a scaleStandard Deviation 2.43
Comparison: The null hypothesis is that there is no change in the baseline ASLR score following four weeks of SIJ belt therapy.p-value: <0.00195% CI: [-2.6299, -1.2932]paired t-test, 2 sided
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.

Time frame: Baseline and 4 weeks

Population: 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.

ArmMeasureValue (MEAN)Dispersion
BaselineChange From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks6.10 score on a scaleStandard Deviation 1.93
Week 4Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks4.18 score on a scaleStandard Deviation 2.28
Comparison: The null hypothesis is that there is no change in the baseline NRS score following four weeks of SIJ belt therapy.p-value: <0.00195% CI: [-2.619, -1.2757]paired t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026