Trial Outcomes & Findings for Predictive Value of the Active Straight Leg Raise on the Efficacy of a SJB in Posterior PGP During Pregnancy (NCT NCT03518840)

NCT ID: NCT03518840

Last Updated: 2020-11-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: Baseline and 4 weeks
• Results posted on: 2020-11-24

Participant Flow

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

Participant milestones

Measure	Sacroiliac Joint Belt All patients receive an SIJ belt
Overall Study STARTED	63
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Sacroiliac Joint Belt All patients receive an SIJ belt
Overall Study Lost to Follow-up	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sacroiliac Joint Belt n=63 Participants All patients receive an SIJ belt
Age, Continuous	29.94 years STANDARD_DEVIATION 4.93 • n=93 Participants
Sex: Female, Male Female	63 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race/Ethnicity, Customized Race · Black or African American	13 Participants n=93 Participants
Race/Ethnicity, Customized Race · White	27 Participants n=93 Participants
Race/Ethnicity, Customized Race · Other	23 Participants n=93 Participants
Region of Enrollment United States	63 Participants n=93 Participants
Employment Employed	42 Participants n=93 Participants
Employment Stay at home parent	16 Participants n=93 Participants
Employment Unemployed	5 Participants n=93 Participants
Previous mode of delivery Vaginal	34 Participants n=93 Participants
Previous mode of delivery C-section	10 Participants n=93 Participants
Previous mode of delivery Both	2 Participants n=93 Participants
Previous mode of delivery Not reported	17 Participants n=93 Participants
Previous abdominal surgery No	49 Participants n=93 Participants
Previous abdominal surgery Yes	13 Participants n=93 Participants
Previous abdominal surgery Not reported	1 Participants n=93 Participants
History of low back pain No	41 Participants n=93 Participants
History of low back pain Yes	22 Participants n=93 Participants
Prior physical therapy for lower back pain No	59 Participants n=93 Participants
Prior physical therapy for lower back pain Yes	4 Participants n=93 Participants
Prior pelvic pain No	52 Participants n=93 Participants
Prior pelvic pain Yes	11 Participants n=93 Participants
Physical activity level Not physically active	10 Participants n=93 Participants
Physical activity level Mildly physically active	29 Participants n=93 Participants
Physical activity level Moderately physically active	22 Participants n=93 Participants
Physical activity level Extremely physically active	2 Participants n=93 Participants
Smoker status Non-smoker	43 Participants n=93 Participants
Smoker status Smoker	20 Participants n=93 Participants
History of depression No	52 Participants n=93 Participants
History of depression Yes	11 Participants n=93 Participants
History of anxiety No	52 Participants n=93 Participants
History of anxiety Yes	11 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Baseline n=63 Participants All patients received an SIJ belt and had their ASLR score recorded at baseline	Week 4 n=52 Participants At week 4, 52 women returning completed the ASLR assessment
Change From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 4 Weeks.	4.87 score on a scale Standard Deviation 1.85	2.92 score on a scale Standard Deviation 2.43

SECONDARY outcome

Timeframe: 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.

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".

Outcome measures

Measure	Baseline n=63 Participants All patients received an SIJ belt and had their ASLR score recorded at baseline	Week 4 n=57 Participants At week 4, 52 women returning completed the ASLR assessment
Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks	6.10 score on a scale Standard Deviation 1.93	4.18 score on a scale Standard Deviation 2.28

Adverse Events

Sacroiliac Joint Belt

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sacroiliac Joint Belt n=63 participants at risk All patients receive an SIJ belt
Injury, poisoning and procedural complications Pinched nerve	1.6% 1/63 • Number of events 1 • Adverse event data were collected for six weeks

Additional Information

Colleen Fitzgerald, M.D., M.S.

Loyola University Chicago

Phone: 708-216-3380

Email: CFITZGERALD@lumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place