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Osteopathic Manipulative Treatment During the Third Trimester of Pregnancy

  • John C. Licciardone
Published/Copyright: May 1, 2017
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Journal of Osteopathic Medicine
From the journal Journal of Osteopathic Medicine Volume 117 Issue 5

To the Editor:

Dr Hensel and colleagues recently published the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study protocol1 and findings.2 The protocol included 12 osteopathic manipulative treatment (OMT) techniques used to complement usual obstetric care (UOC) during the third trimester. The primary outcomes were numerical ratings of low back pain and the Roland-Morris Disability Questionnaire (RMDQ). This trial was large, with 400 women randomly assigned to OMT+UOC, placebo ultrasound therapy+UOC, or UOC only.2 Nevertheless, it failed to demonstrate a significant benefit in any primary outcome in women receiving OMT as compared with those receiving placebo ultrasound therapy.2(Table 4) In fact, women who received OMT reported worse outcomes on both the composite measure of pain and RMDQ. Although significant benefits were reported for composite pain and RMDQ when comparing OMT+UOC vs UOC,2(Table 4) neither outcome reflected a treatment effect that was clinically relevant according to evidence standards.3

My colleagues and I initially reported that OMT was efficacious in achieving statistically significant and clinically important benefits in pain reduction and back-specific functioning during the third trimester.4 A responder analysis of these trial data, not cited by Dr Hensel and colleagues, provides insight on OMT efficacy in preventing back-specific dysfunction.5 Using Cochrane Back Review Group criteria, OMT+UOC was associated with a medium treatment effect vs sham ultrasound therapy+UOC, and a large treatment effect vs UOC only. Responder analysis is now recommended in addition to reporting mean scores for back pain and related outcomes to avoid the skewing of trial results by patients who are clearly insensitive to treatment.6 Such responder analysis has been used to develop an OMT targeting strategy for patients with chronic low back pain.7,8

The PROMOTE study findings bring into question the conclusion reached by the authors that its protocol appears to be an “effective way to manage low back pain and its associated disability during pregnancy.”1 Although clinical trials involving well-trained practitioners have not clearly identified any safety risk in women treated with OMT during the third trimester,1,4,9 such risks may emerge if OMT were to become widely used in obstetrical practice or administered by less experienced practitioners under the presumption that the techniques are “relatively simple and easily taught.”1 Thus, it is premature to recommend that the PROMOTE study protocol be implemented in obstetrics as indicated by Dr Hensel and colleagues.1 A safer and more practical approach would be to target treatment by experienced practitioners at pregnant women who have favorable OMT response profiles based on emerging research and evidence standards.

Professor and Osteopathic Heritage Foundation Richards-Cohen Distinguished Chair in Clinical Research, University of North Texas Health Science Center-Texas College of Osteopathic Medicine, Fort Worth

References

1. Hensel KL , CarnesMS, StollST. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: the PROMOTE study protocol. J Am Osteopath Assoc. 2016;116(11):716-724. doi:10.7556/jaoa.2016.142Search in Google Scholar PubMed

2. Hensel KL , BuchananS, BrownSK, RodriguezM, CruserdA. Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: the PROMOTE study. Am J Obstet Gynecol. 2015;212(1):108.e101-108.e109. doi:10.1016/j.ajog.2014.07.043Search in Google Scholar PubMed PubMed Central

3. Furlan AD , PennickV, BombardierC, van TulderM. 2009 Updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine (Phila Pa 1976). 2009;34(18):1929-1941. doi:10.1097/BRS.0b013e3181b1c99fSearch in Google Scholar PubMed

4. Licciardone JC , BuchananS, HenselKL, KingHH, FuldaKG, StollST. Osteopathic manipulative treatment of back pain and related symptoms during pregnancy: a randomized controlled trial. Am J Obstet Gynecol. 2010;202(1):43.e41-43.e48. doi:10.1016/j.ajog.2009.07.057Search in Google Scholar PubMed PubMed Central

5. Licciardone JC , AryalS. Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria. J Am Osteopath Assoc. 2013;113(10):728-736. doi:10.7556/jaoa.2013.043Search in Google Scholar PubMed

6. Deyo RA , DworkinSF, AmtmannD, et al. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014;15(6):569-585.10.1016/j.jpain.2014.03.005Search in Google Scholar PubMed PubMed Central

7. Licciardone JC , GatchelRJ, AryalS. Recovery from chronic low back pain after osteopathic manipulative treatment: a randomized controlled trial. J Am Osteopath Assoc. 2016;116(3):144-155. doi:10.7556/jaoa.2016.031Search in Google Scholar PubMed

8. Licciardone JC , GatchelRJ, AryalS. Targeting patient subgroups with chronic low back pain for osteopathic manipulative treatment: responder analyses from a randomized controlled trial. J Am Osteopath Assoc. 2016;116(3):156-168. doi:10.7556/jaoa.2016.032Search in Google Scholar PubMed

9. Hensel KL , RoaneBM, ChaphekarAV, Smith-BarbaroP. PROMOTE study: safety of osteopathic manipulative treatment during the third trimester by labor and delivery outcomes. J Am Osteopath Assoc. 2016;116(11):698-703. doi:10.7556/jaoa.2016.140Search in Google Scholar PubMed

Published Online: 2017-05-01
Published in Print: 2017-05-01

© 2017 American Osteopathic Association

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Articles in the same Issue

  1. EDITORIAL
  2. 10.7556/jaoa.2017.049
  3. LETTERS TO THE EDITOR
  4. Osteopathic Manipulative Treatment During the Third Trimester of Pregnancy
  5. RESPONSE
  6. Response
  7. CORRECTION
  8. Correction
  9. AOA COMMUNICATION
  10. Official Call: 2017 Annual Business Meeting of the American Osteopathic Association
  11. ORIGINAL CONTRIBUTION
  12. Employer-Funded Complete Health Improvement Program: Preliminary Results of Biomarker Changes
  13. EVIDENCE-BASED CLINICAL REVIEW
  14. Vitamin D Deficiency, Its Role in Health and Disease, and Current Supplementation Recommendations
  15. CLINICAL PRACTICE
  16. An Osteopathic Approach to Chronic Pain Management
  17. MEDICAL EDUCATION
  18. Preparing Physicians for Rural-Based Primary Care Practice: A Preliminary Evaluation of Rural Training Initiatives at OSU-COM
  19. SPECIAL COMMUNICATION
  20. Introducing High School Students to Careers in Osteopathic Medicine
  21. THE SOMATIC CONNECTION
  22. Cardiorespiratory Benefit of Aerobic Exercise for Patients With Asthma
  23. Cost-Effective Management of Low Back and Joint Pain by Specialty
  24. Benefit of OMT in Patients Who Underwent Heart Surgery
  25. Addition of Osteopathic Visceral Manipulation to OMT for Low Back Pain Decreases Pain and Increases Quality of Life
  26. Effectiveness of OMT and OCMM for Temporomandibular Disorders
  27. Noninvasive Interventions Efficacious in Reducing Symptoms of Low Back Pain
  28. The Fundamental Frequency: A New Approach to Concussion Diagnosis in Children
  29. CLINICAL IMAGES
  30. Pacemaker Twiddler Syndrome
  31. Retroperitoneal Fibrosis
https://doi.org/10.7556/jaoa.2017.050
Creative Commons
BY-NC-ND 4.0

Articles in the same Issue

  1. EDITORIAL
  2. 10.7556/jaoa.2017.049
  3. LETTERS TO THE EDITOR
  4. Osteopathic Manipulative Treatment During the Third Trimester of Pregnancy
  5. RESPONSE
  6. Response
  7. CORRECTION
  8. Correction
  9. AOA COMMUNICATION
  10. Official Call: 2017 Annual Business Meeting of the American Osteopathic Association
  11. ORIGINAL CONTRIBUTION
  12. Employer-Funded Complete Health Improvement Program: Preliminary Results of Biomarker Changes
  13. EVIDENCE-BASED CLINICAL REVIEW
  14. Vitamin D Deficiency, Its Role in Health and Disease, and Current Supplementation Recommendations
  15. CLINICAL PRACTICE
  16. An Osteopathic Approach to Chronic Pain Management
  17. MEDICAL EDUCATION
  18. Preparing Physicians for Rural-Based Primary Care Practice: A Preliminary Evaluation of Rural Training Initiatives at OSU-COM
  19. SPECIAL COMMUNICATION
  20. Introducing High School Students to Careers in Osteopathic Medicine
  21. THE SOMATIC CONNECTION
  22. Cardiorespiratory Benefit of Aerobic Exercise for Patients With Asthma
  23. Cost-Effective Management of Low Back and Joint Pain by Specialty
  24. Benefit of OMT in Patients Who Underwent Heart Surgery
  25. Addition of Osteopathic Visceral Manipulation to OMT for Low Back Pain Decreases Pain and Increases Quality of Life
  26. Effectiveness of OMT and OCMM for Temporomandibular Disorders
  27. Noninvasive Interventions Efficacious in Reducing Symptoms of Low Back Pain
  28. The Fundamental Frequency: A New Approach to Concussion Diagnosis in Children
  29. CLINICAL IMAGES
  30. Pacemaker Twiddler Syndrome
  31. Retroperitoneal Fibrosis
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