Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Primary Endpoint
- Change in androgens
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 44 Years (Adult)
- Sex
- 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.
Arms & Interventions
No intervention
No OMT, yoga, acupuncture, or other interventions.
OMT intervention
Weekly OMT for 3 months
Intervention: OMT (Other)
Yoga intervention
Yoga 3 times per week for 3 months
Intervention: Yoga (Other)
Outcomes
Primary Outcomes
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
- Change in heart rate recovery(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in heart rate variability(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in menstrual cycle length(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in acne(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in BMI(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in waist:hip ratio(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in fasting blood glucose(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in blood pressure(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in fasting insulin(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in depression score(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
- Change in anxiety(After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months))
Investigators
Diana Speelman, Ph.D.
Principal Investigator
Lake Erie College of Osteopathic Medicine