Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The overall goals of this project are to assess the efficacy of non-pharmacological,
      complementary therapies to improve outcomes in the treatment of women with polycystic ovary
      syndrome (PCOS). The studies proposed herein are designed to assess the efficacy of
      osteopathic manipulative medicine (OMM) in the assessment of sympathetic tone in these women,
      and the effectiveness of non-pharmacologic therapeutic interventions in improving participant
      metabolic, endocrine, reproductive, and psychological health.
    

Detailed description: 
      Question 1: Can osteopathic structural assessment identify increased sympathetic tone in
      women with PCOS? Specific Aim 1: To use palpation of Chapman points and spinal viscerosomatic
      reflex regions to assess the presence and degree of increased sympathetic tone in women with
      PCOS.

      Chapman points and viscerosomatic reflexes reflect visceral dysfunction and are mediated by
      the sympathetic nervous system, and can be a very useful clinical diagnostic tool. There is
      increased sympathetic tone in women with PCOS as well as in obese individuals, as previously
      determined by physiologic measures. Increased sympathetic tone in the study population will
      be assessed by osteopathic structural assessment and confirmed by physiologic measures of
      heart rate, heart rate variability, resting blood pressure, and blood pressure and heart rate
      recovery following exercise.

      Hypothesis: Chapman points will be palpable at regions for the heart, adrenal glands, and
      ovaries to indicate hyperactivity of the sympathetic nervous system and will correlate with
      physiologic evidence of increased sympathetic tone.

      Hypothesis: Alterations of viscerosomatic reflexes associated with the heart, adrenal glands,
      and ovaries will reflect hyperactivity of the sympathetic nervous system and will correlate
      with physiologic evidence of increased sympathetic tone.

      Question 2: Can regular, sympathetic nervous system-targeted osteopathic manipulative
      treatment (OMT) improve endocrine and reproductive parameters, and sympathetic tone, in women
      with PCOS? Specific Aim 2: To use weekly manipulation of Chapman points and spinal regions
      associated with viscerosomatic reflexes in women with PCOS for improvement of endocrine and
      reproductive parameters, and sympathetic tone, after 3 months of treatment.

      Chapman points and viscerosomatic reflexes are useful in diagnosis, and may be manipulated to
      restore somatovisceral health.

      Hypothesis: Completion of 3 months of weekly manipulation of Chapman points and
      viscerosomatic reflexes will improve sympathetic tone (as assessed by both osteopathic
      structural assessment and physiologic parameters), androgen levels, and menstrual cycle
      length compared to women with PCOS and no intervention.

      Question 3: Can regular yoga improve metabolic, endocrine, reproductive, and psychological
      parameters in women with PCOS? Specific Aim 3: To use thrice-weekly yoga practice with
      mindfulness techniques in women with PCOS to improve metabolic, endocrine, reproductive, and
      psychological parameters after 3 months of intervention.

      The benefits of moderate and high-intensity aerobic activity on metabolic and overall health
      for women with PCOS have been reported, but the effects of low-impact exercise are less
      studied. Women with PCOS will participate in a yoga class with integrated mindfulness
      techniques 3 times per week for 3 months.

      Hypothesis: Thrice weekly yoga intervention for 3 months will result in an improvement in
      androgen levels, fasting blood glucose, menstrual cycle length, and patient-reported anxiety,
      compared to women with PCOS and no intervention.
    

Intervention name(s): OMT; Yoga
Intervention type(s): Other; Other
Intervention description(s): Weekly manipulation of Chapman points and rib raising techniques (osteopathic manipulative treatment); Yoga practice 3 times per week for 1 hour each time; hatha yoga poses, asanas, and breathing techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: polycystic ovary syndrome; hyperandrogenism; nonpharmacological; yoga; osteopathic manipulative medicine