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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383484
• Other study ID #: 23-156
• Secondary ID: 181627705
• Status: Completed
• Phase: N/A
• First received: December 12, 2017
• Last updated: December 19, 2017
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Lake Erie College of Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• OMT
Weekly manipulation of Chapman points and rib raising techniques (osteopathic manipulative treatment)
• Yoga
Yoga practice 3 times per week for 1 hour each time; hatha yoga poses, asanas, and breathing techniques

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diana Speelman, Ph.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in androgens	Change in serum androgen levels with intervention	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in menstrual cycle length	Change in average time between day 1 of consecutive menstrual cycles after intervention	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in acne	Acne score after intervention (none, mild, moderate, severe)	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in BMI	BMI value after intervention	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in waist:hip ratio	Waist:hip ratio after intervention	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in fasting blood glucose	Serum glucose levels after intervention	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in fasting insulin	Serum insulin levels after intervention	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in depression score	Beck Depression Index II score after intervention (total score 0 to 63, lower score means better outcome)	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in anxiety	Beck Anxiety index score after intervention (total score 0 to 63, lower score means better outcome)	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in blood pressure	Blood pressure after intervention	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in heart rate recovery	Heart rate recovery from exercise after intervention	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary	Change in heart rate variability	Heart rate variability measured by EKG after intervention	After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)