Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

Conditions
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Low Back Pain, Pregnancy

Intervention / Treatment
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* Other: Osteopathic Manipulative Treatment
* Other: Placebo Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Placebo Ultrasound<br>In addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT. The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects. | Other: Placebo Ultrasound<br>* In addition to controlling for physician attention during the treatment visit, the SUT used a nonfunctional ultrasound therapy unit that was modified for research purposes to provide both visible and auditory cues that could potentially elicit a placebo response. The physician provided the SUT by placing the applicator head over the subject's clothing and applying sufficient pressure for tactile stimulation of the skin and underlying tissues in the same anatomical distributions as would generally be addressed if the subject were being treated with OMT. The subjects assigned to the UOBC only group did not receive any study treatments beyond conventional obstetrical care; however, they were expected to complete data collection forms on the same schedule as all other trial subjects.<br>* Other names: Sham Ultrasound Therapy;|
| Active Comparator: Osteopathic Manipulative Treatment<br>OMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning. | Other: Osteopathic Manipulative Treatment<br>* OMT is a complementary and alternative body-based treatment method in which the patient is evaluated and treated including the musculoskeletal system to improve physiologic functioning and remove impediments to optimal health and functioning.<br>|
| No Intervention: Standard Care<br>Subject only receives care from her OB provider. Subjects were allowed to receive conventional obstetrical care with the exception of OMT, massage therapy, physical therapy, chiropractic manipulation, or therapeutic ultrasound intended to treat musculoskeletal disorders. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris Low Back Pain and Disability Questionnaire at each visit. |  | 5 years | 
| Quadruple Visual Analog Scale at each visit. |  | 5 years | 
| Ware's Short Form-12 (SF-12)at each visit. |  | 5 years | 
| PHYSIOLOGICAL STUDY -All measures at visit 1 (30 weeks) and visit 4 (36 weeks) |  | 5 years | 
| Heart rate and blood pressure variability as measured by ECG and power spectral analysis. |  | 5 years | 
| BIOMECHANICAL STUDY - All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks) |  | 5 years | 
| Step length as measured by the GAITRite walkway. |  | 5 years | 
| Foot angle of progression as measured by the GAITRite walkway. |  | 5 years | 
| Gait Symmetry as measured by the GAITRite walkway. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CLINICAL STUDY |  | 5 years | 
| Subject Confidence in Treatment Assessment at visits 1,7,and 9. |  | 5 yers | 
| Meconium staining of the amniotic fluid as recorded on the delivery record. |  | 5 years | 
| 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. |  | 5 years | 
| PHYSIOLOGICAL STUDY-All measures at visit 1 (30 weeks) and visit 4 (36 weeks) |  | 5 years | 
| Heart rate as measured by ECG. |  | 5 years | 
| Arterial pressure as measured by finger photoplethysmographic monitor. |  | 5 years | 
| Respiration as measured by a strain gauge belt. |  | 5 years | 
| Saphenous vein diameter and flow as measured by surface ultrasound. |  | 5 years | 
| Calf muscle EMG as measured by surface electromyographic activity of the gastrocnemius |  | 5 years | 
| Total leg volume as estimated by strain gauge plethysmography. |  | 5 years | 
| Tissue water content as measured by surface dielectric probe. |  | 5 years | 
| Venous flow rate as measured by calf plethysmography. |  | 5 years | 
| BIOMECHANICAL STUDY -All measures taken at visit 1 (30 weeks) and visit 4 (36 weeks) |  | 5 years | 
| Gait cadence as measured by the GAITRite walkway. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic Manipulative Medicine, Osteopathic Manipulative Treatment, Pregnancy, Physiologic, Gait, Low back pain, Heart rate variability