Pelvic Girdle Pain
Conditions
Keywords
Sciatica, Pelvic girdle pain
Brief summary
The purpose of this study is to see if pelvic girdle pain can be more effectively treated with the use of injectable anti-inflammatory medication plus physical therapy compared with physical therapy and a saline injection.
Detailed description
Pelvic girdle pain (PGP) in pregnancy is common with prevalence estimates of 45%.1 It is defined as pain experienced between the posterior iliac crest and the gluteal fold, particularly in the region of the sacroiliac joint.2 Pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. In PGP, the endurance capacity for standing, walking and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes and must be reproducible by specific clinical tests. While various pain mechanisms including mechanical, hormonal, inflammatory, and neural have been proposed in the development of PGP, the etiology and pathogenesis is poorly understood. It is possible that musculoskeletal changes influenced by hormonal (Relaxin) elevation in pregnancy predispose pregnant women to acute musculoskeletal injury presenting clinically as PGP. An inflammatory response in other acute musculoskeletal injuries has been well described3 and may also occur in pregnancy related PGP particularly given the musculoskeletal vulnerability during this time. Though PGP is common in pregnancy, no study to date has investigated the efficacy of anti-inflammatory treatment in pregnancy related PGP in order to better establish the contribution of inflammation in the etiology of pregnancy related PGP.
Interventions
DRUGCorticosteroid
40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine
DRUGPlacebo Injection
A placebo injection
Sponsors
American Academy of Physical Medicine and Rehabilitation
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants are assigned to receive either an injection of methylprednisolone acetate plus lidocaine or to receive an injection of saline with lidocaine using a randomized block design with a 1:1 allocation.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women who are not doing other therapies for pain (physical therapy, chiropractic management, pool) * Women between age 21 and 50 who plan to deliver at Loyola or Gottlieb * Pain Numeric Rating Scale (NRS) on average of greater than or equal to 5/10 at Visit 1 * 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 * 2/4 positive physical examination tests on the symptomatic side including the P4 test, the LDL test, pubic symphysis palpation and the acute straight leg rise (ASLR)
Exclusion criteria
* Women presenting with PGP in the first or third trimester (\<13 weeks gestation or \>28 weeks gestation) * Women with pubic symphysis (anterior) pain alone * Women who do not plan to deliver a baby at Loyola or Gottlieb * Pain above the upper level of the iliac crest * History of lumbar or pelvic fracture, neoplasm, inflammatory disease, active urogenital infection or active gastrointestinal illness, current physical therapy or other therapies for PGP, or previous surgery of the lumbar spine, pelvic girdle, hip joint or femur * History or signs of radiculopathy or other systemic neurologic disease * Women with diabetes or gestational diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Functioning | 8 weeks | 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. |
| Disability | 8 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Treatment Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine | 2 |
| Placebo Participant's randomized to this condition receive a saline injection with lidocaine. | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Treatment | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 2 / 2 | 0 / 0 |
| serious Total, serious adverse events | 1 / 2 | 0 / 0 |
Outcome results
Primary
Change in Pain
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.
Time frame: 8 weeks
Population: The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Change in Pain | -3 change score on the NRS pain scale |
Secondary
Disability
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.
Time frame: 8 weeks
Population: The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Disability | -15.25 change score on the ODI scale |
Secondary
Pelvic Functioning
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.
Time frame: 8 weeks
Population: The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Pelvic Functioning | -35.5 change score on the PGQ scale |