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

Sponsor

Diana Speelman, Ph.D. (Other)

Overall Status

Completed

CT.gov ID

NCT03383484

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Other: OMT Other: Yoga	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No intervention No OMT, yoga, acupuncture, or other interventions.
Experimental: OMT intervention Weekly OMT for 3 months	Other: OMT Weekly manipulation of Chapman points and rib raising techniques (osteopathic manipulative treatment)
Experimental: Yoga intervention Yoga 3 times per week for 3 months	Other: Yoga Yoga practice 3 times per week for 1 hour each time; hatha yoga poses, asanas, and breathing techniques

Arm

Intervention/Treatment

No Intervention: No intervention

No OMT, yoga, acupuncture, or other interventions.

Experimental: OMT intervention

Weekly OMT for 3 months

Other: OMT

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

Experimental: Yoga intervention

Yoga 3 times per week for 3 months

Other: Yoga

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

Outcome Measures

Primary Outcome Measures

Change in androgens [After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)]
Change in serum androgen levels with intervention

Secondary Outcome Measures

Change in menstrual cycle length [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
Change in acne [After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)]
Acne score after intervention (none, mild, moderate, severe)
Change in BMI [After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)]
BMI value after intervention
Change in waist:hip ratio [After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)]
Waist:hip ratio after intervention
Change in fasting blood glucose [After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)]
Serum glucose levels after intervention
Change in fasting insulin [After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)]
Serum insulin levels after intervention
Change in depression score [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)
Change in anxiety [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)
Change in blood pressure [After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)]
Blood pressure after intervention
Change in heart rate recovery [After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)]
Heart rate recovery from exercise after intervention
Change in heart rate variability [After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)]
Heart rate variability measured by EKG after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.