Osteopathic Manipulative Therapy
ABSTRACT & COMMENTARY
Osteopathic Manipulation in Pregnancy: Benefits for Low Back Pain
By David Kiefer, MD
Summary Points
- Osteopathic manipulative therapy (OMT) during the third trimester appears to help prevent the progression of back pain and the loss of back functioning with time.
- OMT and a placebo ultrasound treatment have comparable effects on back pain and functioning.
SOURCE: Hensel KL, et al. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE study a randomized controlled trial. Am J Obstet Gynecol 2014 Jul 25. pii: S0002-9378(14)00792-3. doi: 10.1016/j.ajog.2014.07.043 [Epub ahead of print].
This research study, called PROMOTE (Pregnancy Research in Osteopathic Manipulation Optimizing Treatment Effects), randomized 400 women in their third trimester to usual obstetrical care (n = 133), usual care plus osteopathic manipulative therapy (OMT) (n = 136), or usual care plus a placebo ultrasound treatment (n = 131). The OMT and placebo ultrasound treatments involved seven approximately 20-minute treatments over 9 weeks, both over the same body regions, areas such as the thoracic and lumbosacral paraspinal musculature, hip, and anterior pelvis. The primary outcomes were self-assessments for pain and back-related outcomes. In addition, medical records were reviewed for delivery outcomes, most notably the presence of meconium-stained amniotic fluid, a decrease that is postulated to represent less maternal stress from pain and less fetal stress. The back pain and functioning scales used were the Quadruple Visual Analog Scale, Characteristic Pain Intensity, and the Roland-Morris Low Back Pain and Disability Questionnaire.
Women aged 18-35 with an estimated gestational age of at least 30 weeks were recruited for this study from three OB-Gyn clinics in Texas. Exclusion criteria included the presence of any high-risk conditions (such as gestational diabetes, pre-eclampsia/eclampsia, oligohydramnios, or vaginal bleeding) or the use of any other body-based therapies such as massage, chiropractic, physical therapy, or additional OMT.
Only 99 women completed all seven treatment visits and were analyzed according to an intention-to-treat analysis. According to this analysis, OMT significantly moderated the progression of back pain and deterioration of functioning (P < 0.001 for both); alternatively stated, the usual care group showed a worsening of pain and functioning as time progressed. The OMT effects, interestingly, were comparable to the placebo ultrasound group. A per-protocol analysis was done for women who completed at least four of the seven visits (n = 357), in order to use the data collected on women who delivered before term. These results agreed with the intention-to-treat analysis for the 99 women as previously described.
Meconium staining information was available on 329 women; a logistic regression indicated that there was no difference between the three groups with respect to risk of meconium staining. One interpretation of this offered by the authors is that OMT causes no additional risk in women in their third trimester.
COMMENTARY
The authors of this study make a compelling case for their investigations, namely that 70% of women have back pain during pregnancy, and many of the options available (i.e., pharmaceuticals) may not be safe for the woman or fetus. One class of integrative therapy, manipulative body-based approaches, avoids the concerns about ingested substances during pregnancy, and includes several techniques, including OMT. The authors define OMT as "the therapeutic application of manually guided forces by an osteopathic physician to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction." They further quote studies that pin part of the mechanisms of action of OMT on "increasing range of motion, improving tissue texture, and decreasing pain."
With this as a background, these results show that OMT during the third trimester appears to help prevent the progression of back pain and the loss of back functioning with time. And, if meconium staining of amniotic fluid as an indirect measurement of safety is believed, OMT appears not to be harmful for women or fetuses. An equally important component of the results of this study is the fact that the OMT group and the placebo ultrasound group had a similar attenuation of the progression of back pain and loss of back functioning. The authors ascribe this to the known benefits of "time, touch, intention, and interaction" present in both groups. Such an effect, surely, is consistent with many clinicians’ sense as well as with other studies on the increased benefits beyond pharmaceutical treatments that manipulative therapies provide for pain.1
Should all women in their third trimester receive OMT? The equivalence with the placebo ultrasound therapy speaks pretty strongly in favor of all women in their third trimester receiving some body-based therapy. This study didn’t analyze the effect of massage or chiropractic (in the exclusion criteria), but a reasonable extrapolation would include such treatments as ones that might help women progress less in back pain and loss of functioning. Cost and inconvenience might be the only two reasons not to suggest this avenue of treatment and prevention for women heading into their third trimester. Another compelling aspect to this work is the fact that this demographic has limited options for the treatment of pain; it is nice to be able to offer something.
REFERENCE
- Curts P. Evidence-Based Medicine & Complementary and Alternative Medicine. NIH NCCAM Module, 2003. Grant No. 5-R25-AT00540-01, Univ. of North Carolina.
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