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

ConditionHealhty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversidad Europea de Madrid

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Throughout the intervention (ongoing during each session) and Post-intervention (after 8 weeks of treatment).

Disqualifiers

1. Urogenital Infections: Presence of any active urogenital infections. 2. Abdominal or Pelvic Surgery: History of abdominal or pelvic surgery. 3. Active Menstruation: Women who are menstruating at the time of the study. 4. Breastfeeding: Participants who are actively breastfeeding. 5. Mictrurition Symptoms: Presence of any urinary symptoms. 6. Pain: Pain upon palpation of the central fibrous nucleus of the perineum. 7. Sensory Alterations: Presence of altered sensitivity such as hypoalgesia, hyperalgesia, or allodynia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • High frequency vibration group

    Other intervention

    z. 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.

  • Moderate frequency vibration group

    Other intervention

    Participants 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

  • Low frequency vibration group

    Other intervention

    Participants 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: High frequency vibration groupExperimental treatment 1 intervention
Group B: Moderate frequency vibration groupActive comparator 1 intervention
Group C: Low frequency vibration groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pelvic floor muscle tone

The tone of the pelvic floor muscles will be measured using the MyotonPro® device, which assesses the frequency of oscillation (Hz) of the muscle. The tone will be evaluated at baseline and post-intervention to determine any changes resulting from the vibrational therapy.

Time frame
Baseline (before intervention) and Post-intervention (after 8 weeks of treatment).

Secondary outcomes

1

Pelvic floor muscle strength

Pelvic floor muscle strength will be assessed using two methods: Manometry (with the IEase XFT0010) to measure the pressure in mmHg during voluntary contraction, and Dynamometry (with the Pelvimeter Phénix) to measure force in Newtons (N) during vaginal contraction. These assessments will help evaluate changes in the muscle's ability to contract before and after the intervention.

Time frame
Baseline (before intervention) and Post-intervention (after 8 weeks of treatment).
2

Biomechanical properties of pelvic floor musculature

Biomechanical properties such as muscle rigidity (N/m), elasticity (logarithmic decrement), and fluency (number of Deborah) will be measured using the MyotonPro®. This will help evaluate changes in the muscle's stiffness and viscoelastic properties resulting from the vibrational therapy.

Time frame
Baseline (before intervention) and Post-intervention (after 8 weeks of treatment)
3

Pelvic floor dysfunction impact

The Pelvic Floor Distress Inventory (PFDI-20) questionnaire will be administered to measure the degree of pelvic floor dysfunction symptoms and their impact on the participant's daily life. This includes symptoms related to urinary incontinence, pelvic organ prolapse, and other pelvic health issues

Time frame
Baseline (before intervention) and Post-intervention (after 8 weeks of treatment).
4

Tolerance to the vibration therapy

Participants will be asked to rate their tolerance to the vibration therapy, including any discomfort or adverse effects experienced during the intervention. This will be recorded to assess the safety and acceptability of the treatment.

Time frame
Throughout the intervention (ongoing during each session) and Post-intervention (after 8 weeks of treatment).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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