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Does Osteopathy Help During Pregnancy?

By February 23, 2015Blog

Results from one of the largest randomized controlled trials ever conducted on the effectiveness of osteopathic manipulative medicine says it can.

“Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: the PROMOTE study”; American Journal of Obstetrics and Gynecology; July 25, 2015; DOI: http://dx.doi.org/10.1016/j.ajog.2014.07.043.

Primary Objective:

Evaluate the influence of OMT on self-reported pain and back-related functioning. A secondary objective was to corroborate an earlier study that found a relationship between receiving OMT during the third trimester and a decrease in meconium-stained amniotic fluid.

Methods:

This study was carried out in 3 obstetric clinics in Tarrant County, Texas and overseen by the University of North Texas Health Science Center. It was a randomized controlled trial in which pregnant women 18-35 years old who had reached gestational week 30 were randomly assigned to one of 3 groups:

  1. Osteopathic Manipulative Treatment + Usual Obstetric Care (OMT)

  2. Placebo Ultrasound Treatment + Usual Obstetric Care (PUT)

  3. Usual Obstetric Care Only (UCO)

Women with high risk conditions, such as preeclampsia/eclampsia, vaginal bleeding, oligohydramnios, gestational diabetes and hypertension, were excluded from the trial.

Seven study visits were scheduled to correspond with ongoing routine prenatal care at weeks 30, 32, 34, 37, 38, 39. The OMT provided was based on a set protocol of a specific regimen of treatments and carried out by physicians board-eligible or certified by the American Board of Neuromusculoskeletal Medicine and trained in the PROMOTE protocol.

OMT techniques applied:

  1. Seated thoracic articulation

  2. Cervical soft tissue

  3. Occipito-atlantal decompression

  4. Thoracic inlet myofascial release

  5. Lateral recumbent scapulothoracic soft tissue

  6. Lateral recumbent lumbar soft tissue

  7. Abdominal diaphragm myofascial release

  8. Pelvic Diaphragm myofascial release

  9. Sacroiliac articulation

  10. Pubic symphysis decompression

  11. Frog-leg sacral release

  12. Compression of the fourth ventricle (CV4)

  • The PUT provided tactile and manual stimulation over the same regions as OMT. The ultrasound wand was applied with a circular, steady contact for approximately 2 minutes to each of the specified areas, which resulted in treatment duration similar to OMT. Although the ultrasound machine made noises as if it was truly on it did not emit any ultrasound waves.

  • A sample size of 110 subjects per treatment group was estimated for 80% power at a 5% significance (P<.05) to detect a 62% reduction in the incidence of meconium staining.

  • Analysis was first performed with an intention-to-treat approach. An additional per-protocol analysis was performed on subjects who completed all 7 treatments. Finally, logistic regression was used for analysis of the secondary outcome of meconium staining.

Results:

Total of 400 subjects were randomly assigned:

  1. OMT= 136 women

  2. PUT= 131 women

  3. UCO=133 women

Of this total 99 (25%) women completed all 7 treatment visits and were considered to have completed the protocol.

“Analysis of primary outcomes used an intention-to-treat model to examine changes in pain and back-related functioning for each group across the study (n=400). The intention-to-treat analysis included all randomly assigned subjects, regardless of the number of visits completed. These findings indicated significant treatment effects for both pain as assessed by CPI and back-related functioning as assessed by Roland-Morris Low Back Pain and Disability Questionaire (P<.001 for both). Specifically, OMT was effective for mitigating the progression of pain and deterioration of back-related functioning compared with the UCO group alone.”

“Although there was an effect of treatment and OMT was different from UCO, it is important to note that OMT outcomes did not differ significantly from those of the PUT group.”

“Analyses of secondary outcomes focused on objective delivery measures. For the 329 women with available delivery information, only 61 women (18.5%) had meconium staining documented. Logistic regression indicated meconium staining was not influenced by treatment group; the overall model was not significant (P=.611). Analysis of gestational age at delivery indicated no difference based on group, with mean gestational age of 39 weeks 2 days. Conversion to high-risk status occurred for 12.5% of the women (OMT=11, PUT=19 and UCO=20). In a logistic regression model that used conversion to high-risk status as an indirect measure of safety, there was no higher likelihood of conversion to high risk based on treatment group(P=.141)”

Comments:

“Our results show that OMT has benefits compared to usual obstetric care only and demonstrate clinically and statistically improvements in pain and back-related functioning scores.”

“ In addition, incidences of conversion to high-risk status and meconium staining were not higher in the OMT group, which suggests that there is no additional risk associated with OMT for pregnant women in the third trimester. Additonally, there were fewer conversions to high-risk status in the OMT group, which may be clinically important, even though it was not statistically significant.”

“PROMOTE has confirmed earlier findings of safety and the slowing of progression of back-related disability and demonstrated significance for pain outcomes. With few options for safely treating LBP during pregnancy, these findings are clinically meaningful. A common treatment for LBP is acetaminophen; however, considering the recent controversy that associated acetaminophen use during pregnancy with childhood asthma, adverse neurodevelopmental outcomes, and serious skin reaction, it emphasizes the need to provide safe, effective, noninvasive treatments for women who seek nonpharmacologic options to reduce pain and increase back-related function. Based on these finding, obstetric providers should consider adding body-based treatments for LBP into the care of pregnant women.”

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