Polycystic Ovary SyndromeNCT03383484
Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
A study testing OMT and Yoga in people with Polycystic Ovary Syndrome, run by Diana Speelman, Ph.D..
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). Read more about this study
- Who is it for?
- Ages 20 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- OMT and Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- OMT, Yoga
- Keywords
- polycystic ovary syndrome, hyperandrogenism, nonpharmacological, yoga, osteopathic manipulative medicine
- Medical subject headings
- Polycystic Ovary Syndrome, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMTOther
Weekly manipulation of Chapman points and rib raising techniques (osteopathic manipulative treatment)
YogaOther
Yoga practice 3 times per week for 1 hour each time; hatha yoga poses, asanas, and breathing techniques
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | No OMT, yoga, acupuncture, or other interventions. |
| OMT intervention | Experimental | Weekly OMT for 3 months Receives: Other: OMT |
| Yoga intervention | Experimental | Yoga 3 times per week for 3 months Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in androgens
Change in serum androgen levels with intervention
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Secondary outcomes (11)
Change in menstrual cycle length
Change in average time between day 1 of consecutive menstrual cycles after intervention
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in acne
Acne score after intervention (none, mild, moderate, severe)
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in BMI
BMI value after intervention
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in waist:hip ratio
Waist:hip ratio after intervention
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in fasting blood glucose
Serum glucose levels after intervention
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in fasting insulin
Serum insulin levels after intervention
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in depression score
Beck Depression Index II score after intervention (total score 0 to 63, lower score means better outcome)
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in anxiety
Beck Anxiety index score after intervention (total score 0 to 63, lower score means better outcome)
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in blood pressure
Blood pressure after intervention
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in heart rate recovery
Heart rate recovery from exercise after intervention
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in heart rate variability
Heart rate variability measured by EKG after intervention
Measured: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study startOct 2016
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diana Speelman, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diana Speelman, Ph.D., Lake Erie College of Osteopathic Medicine
- Investigators
- Diana Speelman, Ph.D., Principal investigator, Lake Erie College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383484
- Sponsor's protocol ID
- 23-156
- Other IDs
- 181627705
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32337566Patel 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.
PubMed 32285088Davis 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.
PubMed 30615047
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03383484
- Acronym / sponsor ID
- 23-156
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, hyperandrogenism, nonpharmacological, yoga, osteopathic manipulative medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Diana Speelman, Ph.D.University, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –No OMT, yoga, acupuncture, or other interventions. |
| OMT intervention | Experimental | Other: OMTWeekly OMT for 3 months |
| Yoga intervention | Experimental | Other: YogaYoga 3 times per week for 3 months |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMTWeekly manipulation of Chapman points and rib raising techniques (osteopathic manipulative treatment) | Other | OMT intervention |
| YogaYoga practice 3 times per week for 1 hour each time; hatha yoga poses, asanas, and breathing techniques | Other | Yoga intervention |
Primary outcome
Change in androgens
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in serum androgen levels with intervention
11 secondary outcomes
Change in menstrual cycle length
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in acne
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in BMI
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in waist:hip ratio
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in fasting blood glucose
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in fasting insulin
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in depression score
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in anxiety
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in blood pressure
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in heart rate recovery
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Change in heart rate variability
Time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Derived from this study: PubMed 32337566Davis 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.
- Derived from this study: PubMed 32285088Patel 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.
- Derived from this study: PubMed 30615047Davis 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.
- Individual participant dataSharing planned: No
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Speelman, Ph.D. principal investigator
Lake Erie College of Osteopathic Medicine
Questions about this trial
What is this clinical trial studying?
A study testing OMT and Yoga in people with Polycystic Ovary Syndrome, run by Diana Speelman, Ph.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in androgens (time frame: After 3 month intervention (immediately after 3 month intervention) compared with pre intervention (initial = 0 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03383484, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.