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Not Yet RecruitingNCT07494903

Effects of Vibrational Therapy on Pelvic Floor Muscle Strength and Tone in Healthy Women

Effects of Mechanical Vibration Applied to the Pelvic Floor Musculature: A Quasi-Experimental Study

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Universidad Europea de Madrid · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

This quasi-experimental study aims to evaluate the effects of mechanical vibration applied to the pelvic floor musculature in healthy women aged 18-45. The intervention involves vibrational therapy targeting the central fibrous nucleus of the perineum, with the goal of assessing changes in muscle tone, strength, and biomechanical properties. The study will also examine the tolerance to this technique, with data collected at baseline and after 8 weeks of treatment.

Detailed description

his study investigates the effects of mechanical vibration applied to the pelvic floor musculature in healthy women aged 18 to 45 years. The intervention involves applying vibrational therapy to the central fibrous nucleus of the perineum, with the objective of assessing its impact on muscle tone, strength, and biomechanical properties such as rigidity, elasticity, and muscle stiffness. The study will also explore the tolerance of participants to this therapeutic technique. The study follows a quasi-experimental design with a blinded evaluator. A total of 60 participants will be randomly assigned to one of four groups: three intervention groups receiving vibration at different frequencies (138 Hz, 41.5 Hz, and 24.9 Hz), and one control group receiving no intervention. The intervention will be administered twice a week for 8 weeks, with each session lasting 20 minutes. Primary outcomes include changes in the tone and strength of the pelvic floor muscles, measured using various instruments such as the MyotonPro® for biomechanical parameters, the IEase XFT0010 for manometric measurements, and the Pelvimeter Phénix for dynamometry. Secondary outcomes include the evaluation of the vibration's impact on muscle elasticity, rigidity, and other biomechanical properties, as well as the participant's tolerance to the treatment. The study is conducted in compliance with ethical principles set out in the Declaration of Helsinki, and participant data will be handled confidentially according to data protection regulations. The results of this research may contribute valuable insights into non-invasive treatments for pelvic floor dysfunctions, which are common in women and often impact their physical and mental well-being

Conditions

Interventions

TypeNameDescription
OTHERHigh frequency vibration groupz. The treatment will be administered twice a week for 8 weeks, with each session lasting 20 minutes. The primary aim is to evaluate the effects of high-frequency vibration on the tone, strength, and biomechanical properties of the pelvic floor muscles.
OTHERModerate frequency vibration groupParticipants in this group will receive mechanical vibration applied to the central fibrous nucleus of the perineum at a frequency of 41.5 Hz. The treatment will be administered twice a week for 8 weeks, with each session lasting 20 minutes. The focus is to assess the effects of moderate-frequency vibration on the muscle tone, strength, and biomechanical parameters of the pelvic floor musculature
OTHERLow frequency vibration groupParticipants in this group will receive mechanical vibration applied to the central fibrous nucleus of the perineum at a frequency of 24.9 Hz. The treatment will be administered twice a week for 8 weeks, with each session lasting 20 minutes. The goal is to evaluate how low-frequency vibration impacts the pelvic floor muscle tone, strength, and biomechanical properties compared to the other groups.

Timeline

Start date
2026-06-01
Primary completion
2026-10-01
Completion
2026-12-01
First posted
2026-03-27
Last updated
2026-03-27

Source: ClinicalTrials.gov record NCT07494903. Inclusion in this directory is not an endorsement.