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
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
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
NCT ID
NCT03383484
First Posted
December 12, 2017
Last Updated
December 19, 2017
Sponsor
Diana Speelman, Ph.D.
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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