Clinical trial · Interventional
Use of Osteopathic Principles for Nonpharmacologic, Therapeutic Interventions in Women With Polycystic Ovary Syndrome
NCT03383484CI-TRIAL-00030903completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OMT | Other | — | UNRESOLVED |
| Yoga | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- No intervention
- description
- No OMT, yoga, acupuncture, or other interventions.
- type
- EXPERIMENTAL
- label
- OMT intervention
- description
- Weekly OMT for 3 months
- interventionNames
- Other: OMT
- type
- EXPERIMENTAL
- label
- Yoga intervention
- description
- Yoga 3 times per week for 3 months
- interventionNames
- Other: Yoga
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 44 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDDavis 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 32337566
- DERIVEDPatel 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 32285088
- DERIVEDDavis 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 30615047