Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
2 other identifiers
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedDecember 26, 2017
December 1, 2017
11 months
December 12, 2017
December 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
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)
- +6 more secondary outcomes
Study Arms (3)
No intervention
NO INTERVENTIONNo OMT, yoga, acupuncture, or other interventions.
OMT intervention
EXPERIMENTALWeekly OMT for 3 months
Yoga intervention
EXPERIMENTALYoga 3 times per week for 3 months
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 32337566DERIVEDPatel 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.
PMID: 32285088DERIVEDDavis 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.
PMID: 30615047DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana Speelman, Ph.D.
Lake Erie College of Osteopathic Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 12, 2017
First Posted
December 26, 2017
Study Start
October 1, 2016
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
December 26, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share