Effects of Vibrational Therapy on Pelvic Floor Muscle Strength and Tone in Healthy Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High frequency vibration group, Moderate frequency vibration group, Low frequency vibration group.
- Who it may be relevant to
- Registry conditions: Healhty. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Mechanical Vibration Applied to the Pelvic Floor Musculature: A Quasi-Experimental Study
Overview
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
Interventions
- Other High frequency vibration group
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. - Other Moderate frequency vibration group
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 - Other Low frequency vibration group
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.
Primary outcome measures
- Pelvic floor muscle tone [Time frame: Baseline (before intervention) and Post-intervention (after 8 weeks of treatment).]
Secondary outcome measures (4)
- Pelvic floor muscle strength [Time frame: Baseline (before intervention) and Post-intervention (after 8 weeks of treatment).]
- Biomechanical properties of pelvic floor musculature [Time frame: Baseline (before intervention) and Post-intervention (after 8 weeks of treatment)]
- Pelvic floor dysfunction impact [Time frame: Baseline (before intervention) and Post-intervention (after 8 weeks of treatment).]
- Tolerance to the vibration therapy [Time frame: Throughout the intervention (ongoing during each session) and Post-intervention (after 8 weeks of treatment).]
Eligibility criteria
Inclusion criteria
- Throughout the intervention (ongoing during each session) and Post-intervention (after 8 weeks of treatment).
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 27787476
- 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. PMID 28812109
- 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. PMID 31468357
Identifiers
NCT: NCT07494903 · 26/138-IC_P_CE