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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OMT
Yoga
Sponsored by
Diana Speelman, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrome, hyperandrogenism, nonpharmacological, yoga, osteopathic manipulative medicine

Eligibility Criteria

20 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    No intervention

    OMT intervention

    Yoga intervention

    Arm Description

    No OMT, yoga, acupuncture, or other interventions.

    Weekly OMT for 3 months

    Yoga 3 times per week for 3 months

    Outcomes

    Primary Outcome Measures

    Change in androgens
    Change in serum androgen levels with intervention

    Secondary Outcome Measures

    Change in menstrual cycle length
    Change in average time between day 1 of consecutive menstrual cycles after intervention
    Change in acne
    Acne score after intervention (none, mild, moderate, severe)
    Change in BMI
    BMI value after intervention
    Change in waist:hip ratio
    Waist:hip ratio after intervention
    Change in fasting blood glucose
    Serum glucose levels after intervention
    Change in fasting insulin
    Serum insulin levels after intervention
    Change in depression score
    Beck Depression Index II score after intervention (total score 0 to 63, lower score means better outcome)
    Change in anxiety
    Beck Anxiety index score after intervention (total score 0 to 63, lower score means better outcome)
    Change in blood pressure
    Blood pressure after intervention
    Change in heart rate recovery
    Heart rate recovery from exercise after intervention
    Change in heart rate variability
    Heart rate variability measured by EKG after intervention

    Full Information

    First Posted
    December 12, 2017
    Last Updated
    December 19, 2017
    Sponsor
    Diana Speelman, Ph.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03383484
    Brief Title
    Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
    Official Title
    Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    September 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Diana Speelman, Ph.D.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    polycystic ovary syndrome, hyperandrogenism, nonpharmacological, yoga, osteopathic manipulative medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No intervention
    Arm Type
    No Intervention
    Arm Description
    No OMT, yoga, acupuncture, or other interventions.
    Arm Title
    OMT intervention
    Arm Type
    Experimental
    Arm Description
    Weekly OMT for 3 months
    Arm Title
    Yoga intervention
    Arm Type
    Experimental
    Arm Description
    Yoga 3 times per week for 3 months
    Intervention Type
    Other
    Intervention Name(s)
    OMT
    Intervention Description
    Weekly manipulation of Chapman points and rib raising techniques (osteopathic manipulative treatment)
    Intervention Type
    Other
    Intervention Name(s)
    Yoga
    Intervention Description
    Yoga practice 3 times per week for 1 hour each time; hatha yoga poses, asanas, and breathing techniques
    Primary Outcome Measure Information:
    Title
    Change in androgens
    Description
    Change in serum androgen levels with intervention
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Secondary Outcome Measure Information:
    Title
    Change in menstrual cycle length
    Description
    Change in average time between day 1 of consecutive menstrual cycles after intervention
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in acne
    Description
    Acne score after intervention (none, mild, moderate, severe)
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in BMI
    Description
    BMI value after intervention
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in waist:hip ratio
    Description
    Waist:hip ratio after intervention
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in fasting blood glucose
    Description
    Serum glucose levels after intervention
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in fasting insulin
    Description
    Serum insulin levels after intervention
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in depression score
    Description
    Beck Depression Index II score after intervention (total score 0 to 63, lower score means better outcome)
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in anxiety
    Description
    Beck Anxiety index score after intervention (total score 0 to 63, lower score means better outcome)
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in blood pressure
    Description
    Blood pressure after intervention
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in heart rate recovery
    Description
    Heart rate recovery from exercise after intervention
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
    Title
    Change in heart rate variability
    Description
    Heart rate variability measured by EKG after intervention
    Time Frame
    After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diana Speelman, Ph.D.
    Organizational Affiliation
    Lake Erie College of Osteopathic Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32337566
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    32285088
    Citation
    Patel 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.
    Results Reference
    derived
    PubMed Identifier
    30615047
    Citation
    Davis 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.
    Results Reference
    derived

    Learn more about this trial

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

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