Skip to main content
OpenTrials
Completed

NCT Number: NCT03383484

Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females between the ages of 20-44, with a body mass index (BMI) of 20-48, who had a confirmed diagnosis of PCOS from their provider, and exhibited the 2003 Rotterdam criteria for PCOS diagnosis, defined as at least two out of the following three features: clinical or biochemical hyperandrogenism (moderate acne or a modified Ferriman-Gallwey score > 6 or free testosterone > 5 pg/mL), polycystic ovaries (> 12 cysts on one ovary by ultrasound or ovarian volume > 10 mL for one ovary), and menstrual irregularity (defined as < 8 menstrual periods per year or cycles averaging > 35 days in length).

Exclusion criteria

  • Females who were smokers, had used hormone-based medications within the last 3 months (hormonal contraception, ovulation inducers, anti-androgens) or who were on insulin-sensitizing agents, had another endocrine disorder diagnosis, were pregnant or breastfed within the last 6 months, were diagnosed with a major psychiatric disorder or were on anti-psychotic medication, or who were currently practicing yoga or receiving osteopathic manipulative treatment or acupuncture on a regular basis.

Treatment and study plan

OMT

Other

Weekly manipulation of Chapman points and rib raising techniques (osteopathic manipulative treatment)

yoga

Other

Yoga practice 3 times per week for 1 hour each time; hatha yoga poses, asanas, and breathing techniques

Primary outcomes

  1. Change in androgens

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Change in serum androgen levels with intervention

Secondary outcomes

  1. Change in menstrual cycle length

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Change in average time between day 1 of consecutive menstrual cycles after intervention

  2. Change in acne

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Acne score after intervention (none, mild, moderate, severe)

  3. Change in BMI

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    BMI value after intervention

  4. Change in waist:hip ratio

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Waist:hip ratio after intervention

  5. Change in fasting blood glucose

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Serum glucose levels after intervention

  6. Change in fasting insulin

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Serum insulin levels after intervention

  7. Change in depression score

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Beck Depression Index II score after intervention (total score 0 to 63, lower score means better outcome)

  8. Change in anxiety

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Beck Anxiety index score after intervention (total score 0 to 63, lower score means better outcome)

  9. Change in blood pressure

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Blood pressure after intervention

  10. Change in heart rate recovery

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Heart rate recovery from exercise after intervention

  11. Change in heart rate variability

    Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    Heart rate variability measured by EKG after intervention

Sponsors and collaborators

Lead sponsor

Diana Speelman, Ph.D.

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 26, 2017
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.