Manual Therapy in Improving Quality of Life in Women With Dyspareunia

NCT07495085 | Completed

• 1 other identifier: 144/2024 - CAF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Female; Dyspareunia

Keywords

manual therapy; pain; dyspareunia; sexual function; quality of life

Outcome Measures

Primary Outcomes (8)

• To assess and compare the sexual functionality of the participants.

  \- For sexual function: using the Female Sexual Function Index (FSFI-19); The Female Sexual Function Index (FSFI), validated for the Portuguese context, is a self-administered questionnaire that focuses on the essential dimensions of female sexual functioning. With a score ranging from 2 to 36, high values indicate healthy sexual functioning, while scores equal to or lower than 26.55 indicate potential sexual dysfunction.

  All scales will be applied before starting treatment, and six and twelve weeks after the start of treatment.

• To assess and compare psychological risk factors such as anxiety among the participants

  For psychological aspects: DASS 21 Scale The DASS 21 scale, a self-administered questionnaire, measures the dimension of Anxiety through 21 items, with scores ranging from "0" (absence of symptoms) to "21" (intense presence of negative affective symptoms).

  It will be applied before the start of treatment and 6 and 12 weeks after the start of treatment.

• Assess and compare pain perception of the participants.

  for pain experience: McGill Pain Questionnaire and visual numerical pain scale The McGill Pain Questionnaire, adopted worldwide, provides participants with an opportunity to accurately and comprehensively describe their pain experience. In addition to categorizing pain into its various dimensions - sensory, affective, and evaluative - this instrument facilitates the standardization of pain communication, functioning as a universal tool. The maximum achievable score is 78 points, with a high score correlating with the severity of the pain experienced.

  It will be applied before the start of treatment and 6 and 12 weeks after the start of treatment.

• To study and compare the physical activity levels of the participants.

  for physical activity levels: Actigraph GT3X+ To characterize physical activity levels, an Actigraph GT3X+ accelerometer (Ford Walton Beach, Florida, USA) will be used, which will be worn for a period of 4 days. It will be programmed for 6:00 AM on the first day of evaluation, and recordings will be made in 15-second intervals. All participants will be provided with a registration sheet to indicate the times of application and removal of the accelerometer. The data will be downloaded and processed using version 6.13.4 of the ActiLife software (Ford Walton Beach, Florida, USA), with a daily record of at least 10 hours being mandatory. The variables considered for characterizing physical activity levels are: sedentary activity time (min/week), light physical activity time (min/week), moderate-vigorous physical activity time (min/week), very vigorous physical activity time (min/week), total physical activity time (min/week), and daily steps (number).

  It will be applied before the start of treatment and 6 and 12 weeks after the start of treatment.

• To investigate and compare the sleep quality of the participants

  for sleep quality: Actigraph GT3X+ To characterize sleep quality, an Actigraph GT3X+ accelerometer (Ford Walton Beach, Florida, USA) will be used, which will be worn for a period of 4 days. It will be programmed for 6:00 AM on the first day of evaluation, and recordings will be made in 15-second intervals. All participants will be provided with a recording sheet to indicate the times of application and removal of the accelerometer. The data will be downloaded and processed using version 6.13.4 of the ActiLife software (Ford Walton Beach, Florida, USA). Parameters related to sleep duration and quality (efficiency, latency, and sleep fragmentation index) will be measured over 4 nights.

  It will be applied before the start of treatment and 6 and 12 weeks after the start of treatment.

• To assess and compare the participants´ perception of pain.

  The Numerical visual Scale is a pain assessment tool widely used in clinical practice. It consists of a scale from 0 to 10, where patients are asked to rate the intensity of their pain, with each number representing a specific pain level. The scale is described as follows: 0: No pain; 1-3: Mild pain; 4-6: Moderate pain; 7-9: Severe pain; 10: The worst pain imaginable.

  This scale will be applied before the start of the intervention and 6 and 12 weeks after the start of the intervention.

• Assess and compare psychological risk factors, such as depression, among the participants.

  For psychological aspects: the DASS-21 scale. The DASS-21 scale is a self-administered questionnaire that measures the dimension of depression through 21 items, with scores ranging from "0" (absence of symptoms) to "21" (intense presence of negative affective symptoms).

  before the intervention, and at 6 and 12 weeks after the start of the intervention

• Assess and compare psychological risk factors, such as stress, among the participants.

  The DASS-21 scale is a self-administered questionnaire that measures the dimension of stress through 21 items, with scores ranging from "0" (absence of symptoms) to "21" (intense presence of negative affective symptoms).

  before the intervention, and at 6 and 12 weeks after the start of the intervention

Study Arms (2)

Experimental group 1 (GE1) - Fascial manipulation and perineal massage

EXPERIMENTAL

Experimental: Experimental Group 1 (EG1) - Fascial Manipulation and Perineal Massage Arm Description: Participants in the Fascial Manipulation group (Stecco method) will undergo five weekly sessions of 45 to 60 minutes, with intervention in the lumbar, pelvic, and thigh segments. Treatment points will focus on coordination and fusion centers and will be defined individually based on clinical assessment and pain sensitivity, applying deep friction until fascial densification and pain are reduced. After fascial manipulation, perineal massage will be performed, for approximately 20 minutes, along the muscle fibers of the pelvic floor muscles, in the lithotomy position, with weekly application for five consecutive weeks.

Procedure: Experimental Group 1 (GE1) - Fascial Manipulation and Perineal Massage

Experimental group 2 (GE2) - Perineal massage

EXPERIMENTAL

Participants in Experimental Group 2 (EG2) will exclusively receive perineal massage, for approximately 20 minutes, along the muscle fibers of the pelvic floor muscles, maintaining the same procedure and positioning described for EG1 in the previous section.

Procedure: Experimental group 2 (GE2) - Perineal massage

Interventions

Experimental Group 1 (GE1) - Fascial Manipulation and Perineal Massage PROCEDURE

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.

Experimental group 1 (GE1) - Fascial manipulation and perineal massage

Experimental group 2 (GE2) - Perineal massage PROCEDURE

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.

Experimental group 2 (GE2) - Perineal massage

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only women who have had children and are in a postpartum situation for up to one year.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- I. Adult women over 18 years of age;
• II. With symptoms of penetration dyspareunia, attributed to spasms of the pelvic floor muscles, with a history of pain during sexual intercourse persisting for a minimum period of six months;
• III. Sexually active;
• IV. With positive results for sexual dysfunction in the short version of the FSFI-6 (Female Sexual Function Index)

You may not qualify if:

• Endometriosis
• Deep dyspareunia
• Women in perimenopause and menopause
• Pregnant women
• With untreated vaginal infection
• Women undergoing pelvic physiotherapy treatment
• Who had 2 consecutive absences during treatment
• Cognitive difficulty in understanding the questionnaires applied
• Painful bladder syndrome
• Presence of genital prolapse greater than or equal to grade III
• Interstitial cystitis
• Surgery on pelvic organs

Sponsors & Collaborators

• University of Trás-os-Montes and Alto Douro: lead

Study Sites (1)

Centro de Saúde de Urgezes

Guimarães, Guimarães, 4810-503, Portugal

Location

Related Publications (1)

• pilot study: Amaro RF, Moreira MHR, Santos PCR, Gabriel RE. Avaliação do efeito da manipulação fascial no tratamento da dispareunia feminina: série de casos. Rev Pesqui Fisioter. 2025;15:e6036. https://doi.org/10.17267/2238-2704rpf.2025.6036

  BACKGROUND

MeSH Terms

Conditions

Dyspareunia; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronaldo C Gabriel, Professor

  Universidade de Trás-os-Montes e Alto Douro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization and Interventions All women considered for inclusion in the study must strictly meet the criteria defined in the screening phase. The allocation of participants to the two intervention groups will be carried out by randomization, ensuring random distribution, equity between the groups and minimization of biases. Entry into the study will occur in order of admission, with the assignment to the group being determined randomly. Participation in the study will be conditional upon signing the Informed Consent Form, previously approved by the Ethics Committee of the Academic and Training Center of the Local Health Unit of Alto Ave, ensuring compliance with the ethical and legal principles of research with human beings.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Experimental Group 1 - Fascial Manipulation + Perineal Massage Participants allocated to GE1 will undergo a protocol of 5 weekly fascial manipulation sessions, lasting 60 minutes each, focusing on the lumbar, pelvic, and thigh segments in the sagittal, frontal, and horizontal planes. The intervention will be performed on specific points of fascial densification (CC and CF), selected based on individual clinical assessment. After fascial manipulation, participants will receive perineal massage, , performed once a week for five consecutive weeks. Experimental Group 2 - Perineal Massage Participants in GE2 will receive exclusively perineal massage, following the same protocol, positioning, and duration applied to GE1, with one session per week over five weeks.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: March 27, 2026
• Study Start: February 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: January 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)