Status:
COMPLETED
Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
Lead Sponsor:
Diana Speelman, Ph.D.
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
20-44 years
Phase:
NA
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 st...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03383484
Start Date
October 1 2016
End Date
December 1 2017
Last Update
December 26 2017
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