Pelvic Girdle Pain
Conditions
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
Support Belts
Sponsors
Study design
Intervention model description
All patients receive an SIJ belt.
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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
| Arm | Count |
|---|---|
| Sacroiliac Joint Belt All patients receive an SIJ belt | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Sacroiliac Joint Belt |
|---|---|
| Age, Continuous | 29.94 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 type | EG000 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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | 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 |
| Week 4 | Change From Baseline in Functioning on the Active Straight Leg Rise (ASLR) Scale at 4 Weeks. | 2.92 score on a scale | Standard Deviation 2.43 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks | 6.10 score on a scale | Standard Deviation 1.93 |
| Week 4 | Change From Baseline in Pain on the Numeric Rating Scale (NRS) at 4 Weeks | 4.18 score on a scale | Standard Deviation 2.28 |