Trial Outcomes & Findings for Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain (NCT NCT02044991)

NCT ID: NCT02044991

Last Updated: 2018-08-08

Results Overview

Pain is measured using the Pain Numeric Rating Scale (NRS), which ranges from 0 to 10 with higher scores indicating greater pain. This measure is recorded at baseline (0 weeks) and 8 weeks. The change in pain between these two time points (i.e., the difference score) is compared between the two groups.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-08-08

Participant Flow

Recruitment for this trial began in May 2015 and ended in May 2016 (12 months). The trial was terminated in February 2017 due to poor recruitment

Participant milestones

Participant milestones
Measure	Treatment Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine	Placebo Participant's randomized to this condition receive a saline injection with lidocaine.
Overall Study STARTED	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=2 Participants Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine	Placebo Participant's randomized to this condition receive a saline injection with lidocaine.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.

Outcome measures

Outcome measures
Measure	Treatment n=2 Participants Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine	Placebo Participant's randomized to this condition receive a saline injection with lidocaine.
Change in Pain	-3 change score on the NRS pain scale Interval -5.0 to -1.0	—

SECONDARY outcome

Timeframe: 8 weeks

Population: The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.

Pelvic functioning is measured at baseline (0 weeks) and week 8 using the Pelvic Girdle Questionnaire (PGQ), which ranges from 0 to 100 points with higher scores revealing greater pelvic girdle pain. The change in pelvic functioning between these two time points (i.e., the difference score) is compared between the two groups.

Outcome measures

Outcome measures
Measure	Treatment n=2 Participants Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine	Placebo Participant's randomized to this condition receive a saline injection with lidocaine.
Pelvic Functioning	-35.5 change score on the PGQ scale Interval -75.0 to 4.0	—

SECONDARY outcome

Timeframe: 8 weeks

Population: The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.

Disability is measured at baseline (0 weeks) and week 8 using the Oswestry Disability Index (ODI), which is a measure of low back pain that ranges from 0 points to 100 with higher scores indicating greater disability. The change in disability between these two time points (i.e., the difference score) is compared between the two groups.

Outcome measures

Outcome measures
Measure	Treatment n=2 Participants Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine	Placebo Participant's randomized to this condition receive a saline injection with lidocaine.
Disability	-15.25 change score on the ODI scale Interval -44.5 to 14.0	—

Adverse Events

Treatment

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=2 participants at risk Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine	Placebo Participant's randomized to this condition receive a saline injection with lidocaine.
Pregnancy, puerperium and perinatal conditions Premature birth	50.0% 1/2 • Number of events 1 • Adverse event data were collected for 1 year, 7 months For the placebo arm, the number of participants at risk for an adverse event, serious adverse event, and all-cause mortality is zero. This is because no participants were assigned to placebo. In this study, only two individuals were assigned to an intervention and both received the injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine.	— 0/0 • Adverse event data were collected for 1 year, 7 months For the placebo arm, the number of participants at risk for an adverse event, serious adverse event, and all-cause mortality is zero. This is because no participants were assigned to placebo. In this study, only two individuals were assigned to an intervention and both received the injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine.

Other adverse events

Other adverse events
Measure	Treatment n=2 participants at risk Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine	Placebo Participant's randomized to this condition receive a saline injection with lidocaine.
Respiratory, thoracic and mediastinal disorders Bronchitis	50.0% 1/2 • Number of events 1 • Adverse event data were collected for 1 year, 7 months For the placebo arm, the number of participants at risk for an adverse event, serious adverse event, and all-cause mortality is zero. This is because no participants were assigned to placebo. In this study, only two individuals were assigned to an intervention and both received the injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine.	— 0/0 • Adverse event data were collected for 1 year, 7 months For the placebo arm, the number of participants at risk for an adverse event, serious adverse event, and all-cause mortality is zero. This is because no participants were assigned to placebo. In this study, only two individuals were assigned to an intervention and both received the injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine.
Pregnancy, puerperium and perinatal conditions Premature contractions	50.0% 1/2 • Number of events 1 • Adverse event data were collected for 1 year, 7 months For the placebo arm, the number of participants at risk for an adverse event, serious adverse event, and all-cause mortality is zero. This is because no participants were assigned to placebo. In this study, only two individuals were assigned to an intervention and both received the injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine.	— 0/0 • Adverse event data were collected for 1 year, 7 months For the placebo arm, the number of participants at risk for an adverse event, serious adverse event, and all-cause mortality is zero. This is because no participants were assigned to placebo. In this study, only two individuals were assigned to an intervention and both received the injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine.

Additional Information

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

Loyola University

Phone: 708-216-2180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place