Effects of Visceral Osteopathic Massage on Semen Parameters and Hemodynamics Factors in Varicocele

Официальное название

Investigation of the Effects of Visceral Osteopathic Massage Techniques on Semen Parameters and Hemodynamic Factors in Men With Varicocele: A Randomized Controlled Study

Обзор

The project aims to evaluate the effects of a visceral osteopathic manual therapy (VOM) protocol on semen parameters and testicular hemodynamic indicators in men diagnosed with varicocele. Varicocele, the most common correctable cause of male infertility, is a progressive vascular pathology characterized by dilation of the pampiniform plexus veins and venous reflux. Multifactorial mechanisms such as venous valve insufficiency, increased intra-abdominal pressure, microcirculatory impairment, and oxidative stress play a role in the pathophysiology of varicocele. Therefore, the present study investigates the clinical effectiveness of a non-invasive rehabilitation approach aimed at regulating intra-abdominal pressure and improving pelvic venous drainage. The study will be conducted using a prospective, randomized controlled clinical design, including male participants aged 18-45 years diagnosed with varicocele. The intervention group will receive visceral osteopathic manual therapy techniques two times per week for eight weeks, while the control group will receive lifestyle recommendations only. Before and after the intervention, semen analysis results, sperm morphology, motility parameters, and testicular venous hemodynamic measurements obtained by color Doppler ultrasonography will be compared. Parametric and non-parametric statistical methods will be used in the analyses. This project aims to generate clinical evidence regarding conservative, complementary medicine-based treatment options in the field of male infertility. Compared to studies on female reproductive health, research focusing on male reproductive health is more limited; therefore, this study is expected to contribute to the literature in this area. The results are anticipated to support the development of a cost-effective and accessible model for infertility treatment processes. In addition, the project aims to provide scientific data for the development of sustainable reproductive health approaches in terms of health economics in Türkiye. The study seeks to determine the effects of visceral osteopathic manual therapy on varicocele-related semen parameters and hemodynamic variables and to contribute to the development of new evidence-based approaches in the management of male infertility.

Подробное описание

Fertility is defined as the potential to achieve pregnancy naturally. Infertility, on the other hand, is defined as the inability to achieve pregnancy after 12 months or more of regular unprotected sexual intercourse. Infertility negatively affects individuals' quality of life and has implications for societal demographics. In developed countries, infertility is an important social problem, with approximately 15% of couples unable to achieve pregnancy within one year. About 25% of infertility cases are attributed solely to male factors, while 30-40% involve both male and female factors. Overall, in roughly half of couples unable to conceive, the primary cause of infertility is of male origin. When examining male-related causes, varicocele has been shown to be the most common cause of both primary and secondary infertility. Moreover, this condition is considered the most common correctable cause of infertility. Surgical treatment is regarded as the gold standard in correcting varicocele. However, not every individual diagnosed with varicocele is suitable for surgery, and in many cases, follow-up is preferred until deterioration or progression in sperm parameters is observed.

Varicocele is a vascular pathology characterized by abnormal dilatation of the pampiniform plexus veins within the spermatic cord and venous reflux, which can show progressive features. Clinical and experimental studies reveal that multifactorial mechanisms such as venous valve insufficiency, increased hydrostatic pressure, elevated renal vein pressure, impaired testicular microcirculation, and oxidative stress play a role in the development of varicocele. Chronic elevation of intra-abdominal pressure, considered one of the predisposing factors of this disease, affects its progression. Increased intra-abdominal pressure can hinder venous return and contribute to stasis in the testicular venous system, potentially triggering varicocele pathogenesis. Chronic intra-abdominal pressure elevation may be associated with heavy lifting, prolonged straining, and certain postural dysfunctions. Impaired testicular venous drainage can disrupt testicular parenchymal temperature regulation, leading to increased scrotal temperature and adversely affecting spermatogenesis.

According to data published by TÜİK in May 2025, the total fertility rate in Turkey has recently fallen below 2.1, the level required for population replacement, highlighting risks for demographic sustainability. The decline in population growth may lead, in the long term, to a reduced proportion of working-age population, increased burden on the social security system, and negative effects on economic productivity. In this context, supporting reproductive health is of strategic importance not only individually but also socially and economically. Another negative aspect of infertility is the financial burden of its treatment. Assisted reproductive technologies such as in vitro fertilization (IVF), commonly used in infertility treatment, incur high costs at each stage and are often applied multiple times, as reported in the literature. This situation creates a significant economic burden both for individuals and public health expenditures. In Turkey, spending on infertility treatments has been increasing, highlighting the growing need for cost-effective and early intervention approaches.

Osteopathy is a discipline that addresses the interaction between structure and function in a holistic approach, aiming to support the body's self-healing mechanisms. According to osteopathic theory, for internal organs to maintain their physiological functions properly, they must possess mobility and motility compatible with surrounding tissues. This perspective challenges the conventional notion that a disease is limited to the tissue where it appears and has increased awareness in modern medicine that the human body should be considered as a whole. When varicocele pathology is examined from this perspective, the abdominal cavity is regarded as a dynamic hydraulic system, and any factor disrupting the pressure balance within this system may lead to functional impairments in anatomically related organs.

In light of these findings, studies have been reviewed: a meta-analysis examined the effects of osteopathic manual therapy techniques on the symptoms of endometriosis in women and found low to moderate levels of evidence. It was also reported that limited participant numbers and lack of control groups could lead to misleading evidence. Another study applied thoracic diaphragm release, pelvic and urogenital diaphragm release, pubococcygeal ligament release, and mobilization of the uterus and surrounding organs in women with endometriosis, resulting in significantly improved quality of life. However, similar studies in male subjects are extremely limited.

The originality of our study stems from the fact that although male factors contribute to approximately half of infertility cases, research on conservative and complementary approaches in this field is almost nonexistent. While the literature contains various studies on female infertility and pelvic organ function using manual and complementary therapy approaches, similar research in male infertility, particularly in the context of varicocele management, is extremely limited. In this regard, the project aims to fill a significant gap in the literature and to be the first systematic study focusing on the regulation of intra-abdominal pressure and the support of pelvic organ functions in the management of varicocele.

Вмешательства

• Другое Visceral Osteopathic Massage Techiques
  Thoracic Diaphragm Release: Patient supine; therapist applies gentle pressure under the costal arch during expiration to enhance diaphragmatic mobility and regulate intra-abdominal pressure. Renal Vein \& Sigmoid Colon Mobilization: Manual oscillatory pressure is applied to abdominal organs following their natural motility to reduce fascial restrictions and support vascular/lymphatic flow. Indirect Inguinal Canal Release: Tissues are held in a position of least tension for up to one minute to

Первичные конечные точки

• Semen Parameters [Срок оценки: Baseline and at the end of 8 weeks.]
• Semen Parameters [Срок оценки: Baseline and at the end of 8 weeks.]
• Semen Parameters [Срок оценки: Baseline and at the end of 8 weeks.]
• Semen Parameters [Срок оценки: Baseline and at the end of 8 weeks.]
• Venous Hemodynamics [Срок оценки: Baseline and at the end of 8 weeks.]
• Venous Hemodynamics [Срок оценки: Baseline and at the end of 8 weeks.]

Вторичные конечные точки (2)

• Pain Intensity (VAS) [Срок оценки: Baseline and at the end of 8 weeks]
• Respiratory Pattern [Срок оценки: Baseline and at the end of 8 weeks.]

Критерии участия

Критерии включения

• Male individuals aged 18-45 years.
• Diagnosis of varicocele confirmed by clinical examination and Doppler Ultrasound.
• Not being considered a candidate for surgery by a urology specialist.
• Following a follow-up protocol based on spermiogram results.
• Having at least one varicocele-related abnormality in spermiogram parameters according to WHO 2021 standards.
• Providing voluntary consent to participate in the study.

Критерии исключения

• History of prior inguinal or scrotal surgery.
• Presence of active urogenital infection or malignancy.
• History of spinal or abdominal surgery that would contraindicate complementary medicine interventions.
• Having systemic inflammatory, rheumatologic, or endocrinologic diseases.
• Receiving additional medical or surgical intervention during the study period beyond routine medical treatment.
• Sperm quality changes due to hypogonadotropic causes.
• Use of prescribed purified flavonoid fraction venotonics for venous congestion and endothelial dysfunction.
• Use of antioxidant supplements (e.g., L-carnitine, L-acetylcarnitine, Ubiquinol, etc.) intended to improve sperm quality.
• Refusal to participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Etlik Lokman Hekim Hospital, Clinic of Urology — Ankara

Публикации

• Courtney, R. (2009). The functions of breathing and its dysfunctions and their relationship to breathing therapy. International Journal of Osteopathic Medicine, 12(3), 78-85. https://doi.org/10.1016/j.ijosm.2009.04.002
• Wojcik M, Kampioni M, Hudakova Z, Siatkowski I, Kedzia W, Jarzabek-Bielecka G. The Effect of Osteopathic Visceral Manipulation on Quality of Life and Postural Stability in Women with Endometriosis and Women with Pelvic Organ Prolapse: A Non-Controlled Before-After Clinical Study. J Clin Med. 2025 Jan 24;14(3):767. doi: 10.3390/jcm14030767. PMID 39941438
• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Ho PMID 22588748
• Baazeem A, Belzile E, Ciampi A, Dohle G, Jarvi K, Salonia A, Weidner W, Zini A. Varicocele and male factor infertility treatment: a new meta-analysis and review of the role of varicocele repair. Eur Urol. 2011 Oct;60(4):796-808. doi: 10.1016/j.eururo.2011.06.018. Epub 2011 Jul 5. PMID 21733620
• Kuchera, M. L., & Kuchera, W. A. (1994). Osteopathic principles in practice (2nd ed.). Greyden Press.
• Chaitow, L. (2013). Muscle energy techniques (4th ed.). Churchill Livingstone.
• Jones, L. H., Kusunose, R., & Goering, E. K. (1995). Strain and counterstrain. Jones Strain-Counterstrain Inc.
• Barral, J. P. (2007). Visceral osteopathy. Eastland Press.

Идентификаторы

NCT: NCT07665905 · BA_VARICOCELE_03/126

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗