Clinical trial NCT03383484: Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
Official title: Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
hyperandrogenism
nonpharmacological
yoga
osteopathic manipulative medicine
Lead sponsor: Lake Erie College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in androgens
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary outcomes:
measure: Change in menstrual cycle length
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in acne
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in BMI
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in waist:hip ratio
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in fasting blood glucose
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in fasting insulin
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in depression score
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in anxiety
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in blood pressure
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in heart rate recovery
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
measure: Change in heart rate variability
timeFrame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Other outcomes:
Locations:
Study officials:
affiliation: Lake Erie College of Osteopathic Medicine
name: Diana Speelman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis SE, Hendryx J, Menezes C, Bouwer S, Menezes H, Patel V, Bostick Smith CA, Speelman DL. Weekly Osteopathic Manipulative Treatment to Improve Measures of Sympathetic Tone in Women With Polycystic Ovary Syndrome: A Randomized, Controlled Pilot Study. J Am Osteopath Assoc. 2020 May 1;120(5):310-321. doi: 10.7556/jaoa.2020.051.
citation: Patel V, Menezes H, Menezes C, Bouwer S, Bostick-Smith CA, Speelman DL. Regular Mindful Yoga Practice as a Method to Improve Androgen Levels in Women With Polycystic Ovary Syndrome: A Randomized, Controlled Trial. J Am Osteopath Assoc. 2020 Apr 14. doi: 10.7556/jaoa.2020.050. Online ahead of print.
citation: Davis SE, Hendryx J, Bouwer S, Menezes C, Menezes H, Patel V, Speelman DL. Correlation Between Physiologic and Osteopathic Measures of Sympathetic Activity in Women With Polycystic Ovary Syndrome. J Am Osteopath Assoc. 2019 Jan 1;119(1):7-17. doi: 10.7556/jaoa.2019.004.