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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High frequency vibration group | Experimental | Participants in this group will receive mechanical vibration applied to the central fibrous nucleus of the perineum at a frequency of 138 Hz. 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. |
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| Moderate frequency vibration group | Active Comparator | 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 |
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| Low frequency vibration group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High frequency vibration group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (before intervention) and Post-intervention (after 8 weeks of treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
8. Spinal Lesions: History of spinal cord injuries. 9. Neurological Conditions: Any neurological disorders. 10. Pelvic Organ Prolapse: Diagnosed prolapse of pelvic organs. 11. Obesity: Body Mass Index (BMI) ≥ 30 kg/m². 12. Active Oncology Treatment: Any current or recent cancer treatments. 13. Pregnancy: Women who are pregnant. 14. Pelvic Floor Pathologies: Diagnosed pelvic floor dysfunctions. 15. Ongoing Pelvic Floor Treatment: Participants currently receiving active pelvic floor treatments.
16. Dermatological Pathologies: Any active vulvar dermatological conditions.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Romero PhD, PhD | Contact | +34696879745 | carlos.romero@universidadeuropea.es |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27787476 | Result | Lee J, Lee K, Song C. Determining the Posture and Vibration Frequency that Maximize Pelvic Floor Muscle Activity During Whole-Body Vibration. Med Sci Monit. 2016 Oct 27;22:4030-4036. doi: 10.12659/msm.898011. | |
| 28812109 | Result | Rodrigues MP, Paiva LL, Ramos JGL, Ferla L. Vibratory perineal stimulation for the treatment of female stress urinary incontinence: a systematic review. Int Urogynecol J. 2018 Apr;29(4):555-562. doi: 10.1007/s00192-017-3444-y. Epub 2017 Aug 15. |
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| Moderate frequency vibration group | Other | 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 |
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| Low frequency vibration group | Other | 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. |
|
| Baseline (before intervention) and Post-intervention (after 8 weeks of treatment). |
| 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. | Baseline (before intervention) and Post-intervention (after 8 weeks of treatment) |
| 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 | Baseline (before intervention) and Post-intervention (after 8 weeks of treatment). |
| 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. | Throughout the intervention (ongoing during each session) and Post-intervention (after 8 weeks of treatment). |
| 31468357 | Result | Barassi G, Bellomo RG, Frondaroli F, Frondaroli S, Santarelli A, Di Felice PA, Supplizi M, Palermo T, Saggini R. Integrated Rehabilitation Approach with Manual and Mechanic-Acoustic Vibration Therapies for Urinary Incontinence. Adv Exp Med Biol. 2019;1211:41-50. doi: 10.1007/5584_2019_436. |