NCT07495085

Manual Therapy in Improving Quality of Life in Women With Dyspareunia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Trás-os-Montes and Alto Douro · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Health-related quality of life refers to how a person feels in their daily life. It includes the body, the mind, emotions, daily activities, and relationships with other people. All of this depends on how each person perceives their own health. One of these problems is dyspareunia, which is pain during vaginal penetration. This condition affects many women worldwide, between 3% and 18% of the population. In Portugal, sexual dysfunctions may affect up to 70% of women. Dyspareunia is more common after vaginal childbirth that causes injuries to the intimate area. Many women feel embarrassed or afraid to talk about their sexual health. Because of this, they avoid discussing these issues with doctors and other health professionals. This difficulty in talking about the problem can cause the pain to continue and may also lead to anxiety and depression. Some habits and factors also increase the risk of these problems, such as lack of physical activity, poor sleep quality, sexual abuse, type of childbirth, and obesity. In the case of superficial dyspareunia, the pain may be related to tense muscles in the pelvic floor, which supports organs such as the bladder and the uterus. Although dyspareunia is a common problem, more studies are needed to identify the most effective treatments. One treatment option is fascial manipulation, a manual therapy technique used to treat muscle pain. Another technique is perineal massage, which is applied to the intimate area. So far, there are no studies that examine the effect of combining fascial manipulation with perineal massage for this type of pain. Therefore, the aim of this study is to assess whether the combined use of fascial manipulation and perineal massage provides more benefits than perineal massage alone in women with superficial dyspareunia. The study will be conducted with Portuguese women receiving care at the Guimarães Health Center and at the Hospital of Guimarães. Research methods combining numerical data and participants' personal reports will be used. To evaluate the results, questionnaires will be used to measure sexual function, pain, emotional well-being (such as anxiety, depression, and stress), as well as physical activity levels and sleep quality. The participants will be divided into two groups: Group 1: will receive both treatments combined (fascial manipulation and perineal massage). Group 2: will receive only perineal massage. The treatments will take place once a week for five weeks. Evaluations will be carried out before the start of treatment, in the 6th week, and in the 12th week. In addition to the questionnaires, some women will take part in interviews, where they can describe how they felt during the treatment. This will help to better understand their experiences and the effects of the therapies.

Detailed description

Sexual health, recognized by the World Health Organization (WHO) as a fundamental aspect of overall quality of life, is crucial for both men and women. Sexual health is defined as a state of physical, emotional, cultural, and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction, or infirmity. In this context, sexual dysfunction (SD) is identified as a significant public health issue due to its prevalence and substantial impact on quality of life and interpersonal relationships. According to the Diagnostic and Statistical Manual of Mental Disorders, sexual dysfunctions are classified into three categories, one of which is genito-pelvic pain/penetration disorder, under which dyspareunia is included. Dyspareunia is characterized by pain experienced exclusively during sexual intercourse, which may occur either during attempted vaginal penetration or during full penetration. This pain may be localized at the vaginal entrance or vaginal introitus and is referred to as superficial dyspareunia. Superficial dyspareunia is considered the most common and painful form, generally resulting from musculoskeletal factors. Studies indicate that between 10% and 20% of women of reproductive age may experience dyspareunia, and it is a common occurrence in the postpartum period, particularly following vaginal delivery with perineal trauma. Women with postpartum dyspareunia report discomfort lasting up to one year or longer, and experiencing dyspareunia during pregnancy increases its postpartum prevalence. In addition, other intrinsically important factors associated with the development of sexual dysfunction include low levels of physical activity (PA), a high prevalence of sedentary behavior (SB), and poor sleep quality. Previous studies, indicate that the incidence of sexual dysfunction in women with low PA levels and SB reaches 78.9%. This spectrum of sexual dysfunction includes issues such as reduced sexual desire and satisfaction, insufficient sexual arousal, lubrication problems, and dyspareunia. These problems are less prevalent among women who adopt an active lifestyle. Superficial dyspareunia not only compromises sexual function but may also have significant negative consequences for mental and emotional health, contributing to a cycle of sexual avoidance, anxiety, depression, and chronic pelvic pain. Consequently, it can disrupt intimate relationships, impacting family dynamics and overall well-being. Many women are reluctant to discuss pain during sexual intercourse with healthcare professionals, often due to feelings of embarrassment or the belief that the pain is a normal and temporary symptom. This perception is frequently reinforced by physicians themselves. Such hesitation can hinder effective diagnosis and treatment, exacerbating rather than alleviating the condition. This reality is reflected in the author's clinical practice, particularly in the follow-up of postpartum women in primary healthcare settings, where urinary incontinence emerges as the predominant complaint, often leading to referrals to specialist consultations. Another common difficulty-typically discussed only when explicitly addressed-is pain during sexual intercourse, a symptom many patients report having experienced even before pregnancy. When questioned about their reluctance to discuss this issue with their family physicians, the most common responses include embarrassment, particularly when the physician is male, or the belief that pain is a normal condition. Furthermore, the few patients who do report this symptom often receive inadequate guidance, such as suggestions to relax through alcohol consumption, highlighting a lack of proper medical recognition of the problem. Some studies corroborates this reality, illustrating how women with dyspareunia face challenges in obtaining medical legitimacy for their diagnoses and frequently encounter the minimization of their symptoms, often attributed to psychosocial causes and undervalued due to gender bias. Through the analysis of research and experiences related to the barriers women face in receiving appropriate assessment and treatment for sexual health complaints, also acknowledged these challenges. The authors identified persistent social stigma in Western culture, combined with embarrassment surrounding such a sensitive and intimate topic, as the main barriers preventing discussion of these symptoms with healthcare professionals. Additionally, they highlighted a lack of awareness and health literacy among both women and healthcare providers regarding the availability of safe and effective treatments. Consequently, the authors concluded that practical solutions exist to overcome the barriers obstructing effective patient-physician interaction. This pattern underscores the need to adopt more proactive and sensitive approaches during medical consultations in order to identify and treat these problems effectively and in a timely manner. To improve care and provide these women with a "voice," it is imperative to implement effective strategies. Among these, the introduction of screening protocols during routine primary care consultations for postpartum women is particularly important, aiming to identify issues such as sexual pain. This can be achieved through the use of specific questionnaires integrated into routine assessments. Additionally, early interventions are crucial to prevent symptom worsening and reduce the risk of complications in future deliveries. These measures not only facilitate early diagnosis and treatment but also promote more effective follow-up and comprehensive care for women. Within the context of advanced therapeutic approaches, fascial manipulation (FM) using the Stecco method provides a significant example of how specialized techniques can be integrated into healthcare to treat specific conditions. This manual therapy technique focuses on the deep muscular fascia-a layer of connective tissue that surrounds muscles, bones, and organs-and conceptualizes the myofascial system as a three-dimensional continuum. Fascia may become stiff and restrictive as a result of injury, inflammation, disease, or chronic pain conditions. The Stecco method aims to identify points of fascial densification, known as coordination centers (CCs) and fusion centers (FCs), which are considered primary contributors to musculoskeletal pain and dysfunction. Once identified, these points are treated with specific pressures to generate mechanical and chemical stimuli within the connective tissue. A localized increase in temperature may affect the ground substance of the deep fascia at CCs and FCs, thereby restoring fascial elasticity and movement, improving mobility, and reducing pain. This approach is grounded in a detailed understanding of fascial anatomy and requires a thorough examination to map areas of fascial tension and dysfunction. In addition to this technique, perineal massage (PM)-which involves stretching and massaging the pelvic floor muscles and perineal tissue-is frequently recommended as preparation for childbirth but also has therapeutic applications in conditions such as superficial dyspareunia. PM may help relieve muscle tension, increase local blood circulation, promote tissue healing, and improve tissue elasticity, thereby reducing discomfort and pain during sexual activity, as demonstrated in some studies. When integrated into healthcare, these techniques exemplify the positive impact of specialized interventions on women's quality of life. While the effectiveness of these two techniques when applied individually is already recognized, the focus of this research is to explore the benefits of their combined application. Therefore, the aim of this study is to investigate whether the combination of Stecco-method fascial manipulation and perineal massage is more effective than perineal massage alone in Portuguese women with superficial dyspareunia across the following dimensions: 1. pain assessment, 2. sexual function, 3. psychological risks such as anxiety, stress, and depression, 4. levels of physical activity, and 5. sleep quality. The research seeks to examine the effectiveness of these integrated therapies within a holistic treatment framework, aiming to offer a new and sustainable therapeutic approach for women suffering from superficial dyspareunia. To achieve a more comprehensive and holistic understanding of the topic under investigation, a mixed-methods study design will be adopted, incorporating both quantitative and qualitative approaches. This methodological combination will allow for rigorous analysis of numerical data as well as detailed interpretation of narrative content, facilitating a deeper evaluation of the studied variables. As detailed later in this project, participants will be recruited through various local healthcare sources and randomly assigned to two experimental groups. The first group will receive combined FM and PM treatment, while the second group will receive PM only. Before the intervention and at two subsequent time points after the completion of treatment, participants will be asked to complete questionnaires designed to assess multiple dimensions, including sexual function, pain experience, psychological aspects such as anxiety, depression, and stress, physical activity levels, and sleep quality. In addition, participants will take part in semi-structured interviews, enabling an in-depth qualitative analysis of experiences related to dyspareunia and perceptions of the therapeutic interventions. This research is justified by the urgent need to address superficial dyspareunia, a condition that, despite its high prevalence, remains frequently underdiagnosed and undertreated. The consequences of dyspareunia extend beyond physical discomfort, significantly affecting psychological well-being and patients' quality of life. This reality underscores the urgency of developing and implementing effective therapeutic approaches for the treatment of this condition. Based on the literature reviewed to date, there is a lack of studies incorporating Stecco-method fascial manipulation as a specific intervention strategy for superficial dyspareunia, a gap identified by some authors. While PM and FM are emerging approaches with therapeutic potential, the existing literature reveals significant gaps regarding the effectiveness of their combined application and their impact on health-related quality of life. This study aims to address these gaps by providing a detailed evaluation of the benefits of these integrated therapies and thereby contributing to the improvement of clinical practices in the management of superficial dyspareunia

Conditions

• Female
• Dyspareunia

Interventions

Type	Name	Description
PROCEDURE	Experimental Group 1 (GE1) - Fascial Manipulation and Perineal Massage	Experimental Group 1 (GE1) - Fascial Manipulation and Perineal Massage Description: Patients assigned to treatment with the Stecco Fascial Manipulation method underwent a protocol of 5 weekly sessions, each lasting 60 minutes. The intervention focuses on the lumbar, pelvic, and thigh segments, and the treatment points (CC and CF) will be defined individually, based on the identification of the most dysfunctional and painful areas of the deep fascia. The manipulation consists of deep friction with the elbow, applied for 2 to 4 minutes at each point, until tissue densification is reduced. Effectiveness will be assessed by increased tissue mobility and decreased pain. After fascial manipulation, patients underwent perineal massage performed in the lithotomy position, with pressure adjusted to the patient's comfort, for five minutes on each side.
PROCEDURE	Experimental group 2 (GE2) - Perineal massage	Participants in Experimental Group 2 (EG2) will receive perineal massage exclusively, maintaining the same procedure and positioning described for EG1 in the previous section. The principal investigator of the study will be responsible for administering these therapies, and due to the specific nature of the interventions, she cannot be unfamiliar with the type of treatment administered. Anonymity will be maintained with respect to the other investigators, ensuring the methodological integrity of the study.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-12-15
• Completion: 2026-01-15
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Portugal