Clinical trial NCT00426244: Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
Official title: Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Pregnancy
Keywords: Osteopathic Manipulative Medicine
Osteopathic Manipulative Treatment
Pregnancy
Physiologic
Gait
Low back pain
Heart rate variability
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: American Osteopathic Association
name: American Academy of Osteopathy
name: Med Ed Foundation of the Am Coll of Osteopathic Obstetricians & Gynecologists
name: Osteopathic Heritage Foundations
First posted: 2007-01-24
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine to what extent and by what physiological mechanisms Osteopathic Manipulative Medicine (OMM) affects selected conditions related to pregnancy, labor and delivery.

Detailed description: The osteopathic philosophy of health is built on a model in which basic body functions are coordinated and integrated by the musculoskeletal system. Osteopathic medical students are taught to consider these aspects in assessing, diagnosing, and treating the individual patient. As a treatment method that reflects the osteopathic philosophy, osteopathic manipulative medicine (OMM) is a body-based modality in which the patient is evaluated and treated as a whole to improve physiologic functioning and remove impediments to optimal health and functioning.

During pregnancy, a woman's body is challenged by significant and extensive physiological and biomechanical changes. Some physiological changes, such as increased fluid volume and sympathetic tone, may lead to consequences such as edema, preterm labor, and meconium-staining of the amniotic fluid. The biomechanical state of the woman's body is also drastically affected; as the fetus grows and the uterus expands, the center of gravity shifts forward, rotating the pelvis anteriorly and increasing the lordosis of the low back, and may also affect the motion of the hips and legs. These postural changes also have consequences such as low back pain, decreased functional status, and altered gait. Both these physiologic and biomechanical consequences can have a significant long-term impact on the health of the mother and child.

OMM is theorized to facilitate the body's adjustment to the physiological and biomechanical demands of pregnancy and improve the outcomes of pregnancy, labor and delivery. Clinical case studies report reduced back pain, shorter labor, and fewer incidences of peripartum complications in patients who receive prenatal OMM. However, to date we have found no published systematic investigations of the efficacy of OMM in managing the adverse effects that pregnancy has on a woman's musculoskeletal system, nor have we found any published systematic studies to prove the mechanisms of action of OMM in managing pain, edema, or gait in pregnant patients.

Thus, the overall question that guides this proposal is: to what extent and by what physiological mechanisms does Osteopathic Manipulative Medicine (OMM) affect selected conditions related to pregnancy, labor and delivery? Based on the principles and theories of OMM and the limited previous studies, the hypothesis of this study is that OMM improves clinical outcomes including low back pain, functional status, incidence of meconium-stained amniotic fluid, and complications of labor and delivery, and that the physiological changes related to improved autonomic regulation, peripheral hemodynamic regulation, and biomechanical changes related to gait are, in part, responsible for these clinical benefits.

Eligibility criteria: Inclusion Criteria:

* The woman must have medical clearance from her obstetrician at each study visit
* Must be less than or at 30 weeks gestation at the start of the study

Exclusion Criteria:

* Deemed high risk by the obstetrician (including but not limited to: abruptio placenta, placenta previa, severe pre-eclampsia/eclampsia, vaginal bleeding, gestational diabetes)
* Age 17 years or younger. Females 17 years of age and younger are considered pediatric high risk pregnancies and therefore ineligible for inclusion
* If a patient receives any other manual therapies such as massage, physical therapy, or chiropractic therapy, during the trial, she will be dropped from the study
* Subjects with a history of syncope either before or during this pregnancy will be excluded from participation in the substudy

Primary outcomes:
measure: Roland-Morris Low Back Pain and Disability Questionnaire at each visit.
timeFrame: 5 years
measure: Quadruple Visual Analog Scale at each visit.
timeFrame: 5 years
measure: Ware's Short Form-12 (SF-12)at each visit.
timeFrame: 5 years
measure: PHYSIOLOGICAL STUDY -All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
timeFrame: 5 years
measure: Heart rate and blood pressure variability as measured by ECG and power spectral analysis.
timeFrame: 5 years
measure: BIOMECHANICAL STUDY - All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
timeFrame: 5 years
measure: Step length as measured by the GAITRite walkway.
timeFrame: 5 years
measure: Foot angle of progression as measured by the GAITRite walkway.
timeFrame: 5 years
measure: Gait Symmetry as measured by the GAITRite walkway.
timeFrame: 5 years
Secondary outcomes:
measure: CLINICAL STUDY
timeFrame: 5 years
measure: Subject Confidence in Treatment Assessment at visits 1,7,and 9.
timeFrame: 5 yers
measure: Meconium staining of the amniotic fluid as recorded on the delivery record.
timeFrame: 5 years
measure: Other outcomes of pregnancy, labor and delivery including incidence of high-risk status, incidence of pre-term labor, length of labor, use of forceps or suction device, and pain medication use as recorded in the prenatal and delivery record.
timeFrame: 5 years
measure: PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks)
timeFrame: 5 years
measure: Heart rate as measured by ECG.
timeFrame: 5 years
measure: Arterial pressure as measured by finger photoplethysmographic monitor.
timeFrame: 5 years
measure: Respiration as measured by a strain gauge belt.
timeFrame: 5 years
measure: Saphenous vein diameter and flow as measured by surface ultrasound.
timeFrame: 5 years
measure: Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius
timeFrame: 5 years
measure: Total leg volume as estimated by strain gauge plethysmography.
timeFrame: 5 years
measure: Tissue water content as measured by surface dielectric probe.
timeFrame: 5 years
measure: Venous flow rate as measured by calf plethysmography.
timeFrame: 5 years
measure: BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks)
timeFrame: 5 years
measure: Gait cadence as measured by the GAITRite walkway.
timeFrame: 5 years
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
Study officials:
affiliation: University of North Texas Health Science Center
name: Kendi Hensel, D.O., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kristiansson P, Svardsudd K, von Schoultz B. Back pain during pregnancy: a prospective study. Spine (Phila Pa 1976). 1996 Mar 15;21(6):702-9. doi: 10.1097/00007632-199603150-00008.
citation: Franklin ME, Conner-Kerr T. An analysis of posture and back pain in the first and third trimesters of pregnancy. J Orthop Sports Phys Ther. 1998 Sep;28(3):133-8. doi: 10.2519/jospt.1998.28.3.133.
citation: Kristiansson P, Svardsudd K, von Schoultz B. Serum relaxin, symphyseal pain, and back pain during pregnancy. Am J Obstet Gynecol. 1996 Nov;175(5):1342-7. doi: 10.1016/s0002-9378(96)70052-2.
citation: Daly JM, Frame PS, Rapoza PA. Sacroiliac subluxation: a common, treatable cause of low-back pain in pregnancy. Fam Pract Res J. 1991 Jun;11(2):149-59.
citation: Lynch FW. The pelvic articulations during pregnancy, labor and the puerperium: An X-ray study. Surgery, Gynecology, and Obstetrics 30: 575-580, 1920.
citation: Ostgaard HC, Andersson GB, Schultz AB, Miller JA. Influence of some biomechanical factors on low-back pain in pregnancy. Spine (Phila Pa 1976). 1993 Jan;18(1):61-5. doi: 10.1097/00007632-199301000-00010.
citation: Treadwell RC, Magnus WW. Sacral shear: Review and a new treatment method for obstetricial patients. AAO Journal (Spring): 16-18, 1996.
citation: Perkins J, Hammer RL, Loubert PV. Identification and management of pregnancy-related low back pain. J Nurse Midwifery. 1998 Sep-Oct;43(5):331-40. doi: 10.1016/s0091-2182(98)00032-9.
citation: Heckman JD, Sassard R. Musculoskeletal considerations in pregnancy. J Bone Joint Surg Am. 1994 Nov;76(11):1720-30. doi: 10.2106/00004623-199411000-00018. No abstract available.
citation: McIntyre IN, Broadhurst NA. Effective treatment of low back pain in pregnancy. Aust Fam Physician. 1996 Sep;25(9 Suppl 2):S65-7.
citation: Brandy RE, Rottman J, Kappler RE, Veith EK. Forty first Annual AOA Research Conference Abstracts, 1997: Part 1: Osteopathic Manipulation to Treat Musculoskeletal Pain Associated with Pregnancy. JAOA 97(8): 479, 1997.
citation: Diakow PR, Gadsby TA, Gadsby JB, Gleddie JG, Leprich DJ, Scales AM. Back pain during pregnancy and labor. J Manipulative Physiol Ther. 1991 Feb;14(2):116-8.
citation: Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W, Swift J Jr. Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1355-62. doi: 10.1097/01.BRS.0000067110.61471.7D.
citation: Andersson GB, Lucente T, Davis AM, Kappler RE, Lipton JA, Leurgans S. A comparison of osteopathic spinal manipulation with standard care for patients with low back pain. N Engl J Med. 1999 Nov 4;341(19):1426-31. doi: 10.1056/NEJM199911043411903.
citation: MacDonald RS, Bell CM. An open controlled assessment of osteopathic manipulation in nonspecific low-back pain. Spine (Phila Pa 1976). 1990 May;15(5):364-70. doi: 10.1097/00007632-199005000-00005.
citation: Koes BW, Assendelft WJ, van der Heijden GJ, Bouter LM. Spinal manipulation for low back pain. An updated systematic review of randomized clinical trials. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2860-71; discussion 2872-3. doi: 10.1097/00007632-199612150-00013.
citation: Cherkin DC, Sherman KJ, Deyo RA, Shekelle PG. A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med. 2003 Jun 3;138(11):898-906. doi: 10.7326/0003-4819-138-11-200306030-00011.
citation: Wang SM, Dezinno P, Maranets I, Berman MR, Caldwell-Andrews AA, Kain ZN. Low back pain during pregnancy: prevalence, risk factors, and outcomes. Obstet Gynecol. 2004 Jul;104(1):65-70. doi: 10.1097/01.AOG.0000129403.54061.0e.
citation: Cleary GM, Wiswell TE. Meconium-stained amniotic fluid and the meconium aspiration syndrome. An update. Pediatr Clin North Am. 1998 Jun;45(3):511-29. doi: 10.1016/s0031-3955(05)70025-0.
citation: March of Dimes. Prenatal Overview: PeriStats (2005). Retrieved January 21, 2005, from www.marchofdimes.com/peristats.
citation: Klingner MC, Kruse J. Meconium aspiration syndrome: pathophysiology and prevention. J Am Board Fam Pract. 1999 Nov-Dec;12(6):450-66. doi: 10.3122/jabfm.12.6.450.
citation: King HH, Tettambel MA, Lockwood MD, Johnson KH, Arsenault DA, Quist R. Osteopathic manipulative treatment in prenatal care: a retrospective case control design study. J Am Osteopath Assoc. 2003 Dec;103(12):577-82.
citation: Whiting LM. Can the Length of Labor be Shortened by Osteopathic Treatment. Journal of the American Osteopathic Association (11): 917-921, 1911.
citation: Whiting LM. The osteopathic management of pregnancy and the reduction of obstetrical mortality. Journal of the American Osteopathic Association 33(8): 531-533, 1934.
citation: Still, EM. Osteopathic Obstetrics. Journal of Osteopathy 4(4): 203-204, 1897.
citation: Dooley W. Osteopathy's Contribution to Prenatal Care. Journal of the American Osteopathic Association 46(1): 6-7, 1946.
citation: Guthrie RA, Martin RH. Effect of pressure applied to the upper thoracic (placebo) versus lumbar areas (osteopathic manipulative treatment) for inhibition of lumbar myalgia during labor. J Am Osteopath Assoc. 1982 Dec;82(4):247-51. No abstract available.
citation: Guthrie RA. Lumbar inhibitory pressure for lumbar myalgia during contractions of the gravid uterus at term. J Am Osteopath Assoc. 1980 Dec;80(4):264-6. No abstract available.
citation: Hart LM. Obstetrical practice. Journal of American Osteopathic Association (July): 609-614, 1918.
citation: King HH, Osteopathic manipulative treatment in prenatal care: Evidence supporting improved outcomes and health policy implications. The American Academy of Osteopathy Journal (Summer): 25-33, 2000.
citation: TAYLOR GW. The osteopathic management of nausea and vomiting of pregnancy. J Am Osteopath Assoc. 1949 Jul;48(11):581. No abstract available.
citation: Troyanovich S. Pregnancy and the Chiropractic Advantage. Today's Chiropractic, 21(6): 46-48, 1992.
citation: Laman J, King M. Promoting healthy babies. NCSL Legisbrief National Conference of State Legislatures. February 1994.
citation: Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
citation: Greenwood JP, Stoker JB, Walker JJ, Mary DA. Sympathetic nerve discharge in normal pregnancy and pregnancy-induced hypertension. J Hypertens. 1998 May;16(5):617-24. doi: 10.1097/00004872-199816050-00009.
citation: McLean M, Smith R. Corticotrophin-releasing hormone and human parturition. Reproduction. 2001 Apr;121(4):493-501. doi: 10.1530/rep.0.1210493.
citation: Hobel C, Culhane J. Role of psychosocial and nutritional stress on poor pregnancy outcome. J Nutr. 2003 May;133(5 Suppl 2):1709S-1717S. doi: 10.1093/jn/133.5.1709S.
citation: Current Obstetric & Gynecologic Diagnosis & Treatment, 8th Edition. Cardiovasvular System. Chapter 7, 150-154.
citation: Kuchera ML, Kuchera WA. (1994).Osteopathic Considerations in Systemic Dysfunction, revised 2nd Ed. Greyden Press; Columbus, OH; pp 55, 85, 187, 193.
citation: Smutny CJ, Wells WR, Bosak A. Osteopathic Considerations in Parkinson's Disease. Journal of the American Osteopathic Association 98 (7): 389, 1998.
citation: Wells MR, Giantinoto S, D'Agate D, Areman RD, Fazzini EA, Dowling D, Bosak A. Standard osteopathic manipulative treatment acutely improves gait performance in patients with Parkinson's disease. J Am Osteopath Assoc. 1999 Feb;99(2):92-8. doi: 10.7556/jaoa.1999.99.2.92.
citation: Wells MR, McCarty CL, Smutny CJ, Scandalis TA, Dittrich F, Fazzini EA Osteopathic Manipulation in the Management of Parkinson's Disease: Preliminary Findings. The Journal of the American Osteopathic Association 100(8): 522, 2000.
citation: Guadagnino MR. Spinal manipulative therapy for 12 pregnant patients suffering from low back pain. Journal of Chiropractic Technique 11(3): 108-112, 1999.
citation: Smith ML, Raven PB. Cardiovascular responses to lower body negative pressure in endurance and static exercise-trained men. Med Sci Sports Exerc. 1986 Oct;18(5):545-50.
citation: Carter R 3rd, Watenpaugh DE, Wasmund WL, Wasmund SL, Smith ML. Muscle pump and central command during recovery from exercise in humans. J Appl Physiol (1985). 1999 Oct;87(4):1463-9. doi: 10.1152/jappl.1999.87.4.1463.
citation: Ogoh S, Volianitis S, Nissen P, Wray DW, Secher NH, Raven PB. Carotid baroreflex responsiveness to head-up tilt-induced central hypovolaemia: effect of aerobic fitness. J Physiol. 2003 Sep 1;551(Pt 2):601-8. doi: 10.1113/jphysiol.2003.046029. Epub 2003 Jun 17.
citation: Yoshiuchi K, Quigley KS, Ohashi K, Yamamoto Y, Natelson BH. Use of time-frequency analysis to investigate temporal patterns of cardiac autonomic response during head-up tilt in chronic fatigue syndrome. Auton Neurosci. 2004 Jun 30;113(1-2):55-62. doi: 10.1016/j.autneu.2004.05.001.
citation: Butler GC, Yamamoto Y, Xing HC, Northey DR, Hughson RL. Probing heart rate and blood pressure control mechanisms during graded levels of lower body negative pressure (LBNP). Microgravity Q. 1992 Apr;2(2):133-40.
citation: Webster KE, Wittwer JE, Feller JA. Validity of the GAITRite walkway system for the measurement of averaged and individual step parameters of gait. Gait Posture. 2005 Dec;22(4):317-21. doi: 10.1016/j.gaitpost.2004.10.005. Epub 2004 Dec 10.
citation: Hitchcock ME. Osteopathic Care in Pregnancy. Osteopathic Annals (December): 19-30, 1976.
citation: Graham KE, Shaw HH, Mills M, Cotton L. Pregnancy, 3rd Trimester and Pre-Delivery: Goals of OMM in Pregnant Patient during Third Trimester and Pre-Delivery. Anatomic and Physiologic Basis of Osteopathic Manipulative Medicine in Visceral Disease. 1st Edition, 74-75, 2001.
citation: Stiles EG. Osteopathic manipulation in a hospital environment. J Am Osteopath Assoc. 1976 Dec;76(4):243-58. No abstract available.
citation: Berg G, Hammar M, Moller-Nielsen J, Linden U, Thorblad J. Low back pain during pregnancy. Obstet Gynecol. 1988 Jan;71(1):71-5.
citation: Price DD, Harkins SW. Psychophysical Approaches to Pain Measurement and Assessment. In Turk DC, Melzack R, Editors: Handbook of Pain Assessment, New York: Guliford Press, 1992: 11-132.
citation: Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
citation: Stratford PW, Binkley J, Solomon P, Gill C, Finch E. Assessing change over time in patients with low back pain. Phys Ther. 1994 Jun;74(6):528-33. doi: 10.1093/ptj/74.6.528.
citation: Beurskens AJHM, de Vet HCW, Koke AJA. Responsiveness of functional status in low back pain: a comparison of different instruments. Pain. 1996 Apr;65(1):71-76. doi: 10.1016/0304-3959(95)00149-2.
citation: Parati G, Saul JP, Di Rienzo M, Mancia G. Spectral analysis of blood pressure and heart rate variability in evaluating cardiovascular regulation. A critical appraisal. Hypertension. 1995 Jun;25(6):1276-86. doi: 10.1161/01.hyp.25.6.1276.
citation: Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.
citation: Malliani A, Lombardi F, Pagani M. Power spectrum analysis of heart rate variability: a tool to explore neural regulatory mechanisms. Br Heart J. 1994 Jan;71(1):1-2. doi: 10.1136/hrt.71.1.1. No abstract available.
citation: Gotshall RW, Davrath LR. Bioelectric impedance as an index of thoracic fluid. Aviat Space Environ Med. 1999 Jan;70(1):58-61.
citation: Johnson JM. Exercise and the cutaneous circulation. Exerc Sport Sci Rev. 1992;20:59-97.
citation: Nuutinen J, Lahtinen T, Turunen M, Alanen E, Tenhunen M, Usenius T, Kolle R. A dielectric method for measuring early and late reactions in irradiated human skin. Radiother Oncol. 1998 Jun;47(3):249-54. doi: 10.1016/s0167-8140(97)00234-x.
citation: Nuutinen J, Ikaheimo R, Lahtinen T. Validation of a new dielectric device to assess changes of tissue water in skin and subcutaneous fat. Physiol Meas. 2004 Apr;25(2):447-54. doi: 10.1088/0967-3334/25/2/004.
citation: Gamble J, Joyner MJ, Dietz NM, Shepherd JT. A restrospective perspective. J Appl Physiol (1985). 2005 Feb;98(2):762; author reply 762-3. doi: 10.1152/japplphysiol.00773.2004.
citation: Welsch MA, Alomari M, Parish TR, Wood RH, Kalb D. Influence of venous function on exercise tolerance in chronic heart failure. J Cardiopulm Rehabil. 2002 Sep-Oct;22(5):321-6. doi: 10.1097/00008483-200209000-00002.
citation: Johnson K. An Integrated Approach for Treating the OB Patient: Treating the Five Diaphrams of the Body, Part I. American Academy of Osteopathy Journal (Winter): 6-9, 1991.
citation: Schobel HP, Fischer T, Heuszer K, Geiger H, Schmieder RE. Preeclampsia -- a state of sympathetic overactivity. N Engl J Med. 1996 Nov 14;335(20):1480-5. doi: 10.1056/NEJM199611143352002.
citation: Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000.
citation: Hensel KL, Roane BM, Chaphekar AV, Smith-Barbaro P. PROMOTE Study: Safety of Osteopathic Manipulative Treatment During the Third Trimester by Labor and Delivery Outcomes. J Am Osteopath Assoc. 2016 Nov 1;116(11):698-703. doi: 10.7556/jaoa.2016.140.