Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus

NCT06486896 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004953
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus.

Conditions

Vaginismus

Keywords

Interferential, pelvic floor training, vaginismus

Outcome Measures

Primary Outcomes (3)

• Assessment of pain intensity.

  The visual analogue scale (VAS): will be used to measure pain intensity for each woman in both groups. Each woman will be asked to mark the point on the scale that represents her pain level.

  Eight weeks

• Quantification of pressure pain threshold in the perineum.

  The pressure pain threshold in the perineum region will be evaluated with a pressure algometer.

  Eight weeks

• Assessment of pelvic floor muscle tone.

  It will be assessed by biofeedback perineometer.

  Eight weeks

Secondary Outcomes (1)

• Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus.

  Eight weeks

Study Arms (2)

Pelvic floor training

ACTIVE COMPARATOR

The patients will receive pelvic floor training exercise+ advice 3 times/weekly for 8 weeks

Other: Pelvic floor training; Behavioral: General advice

Interferential current

EXPERIMENTAL

Patients will receive interferential current+pelvic floor training+advice

Other: Pelvic floor training; Device: Interferential current; Behavioral: General advice

Interventions

Pelvic floor training OTHER

It will be in the form of pelvic floor relaxation with biofeedback, as well as stretching exercises for the pelvic floor and the adjacent muscles. The patient will be asked to lie in a comfortable crock lying position. She will be instructed to do diaphragmatic breathing exercises. The vaginal electrode of the biofeedback will be gently introduced into the vagina to start pelvic floor relaxation training. Then, the patient will be asked to perform pelvic floor relaxation by slightly contracting the pubococcygeus muscle. After 10 minutes of pelvic floor relaxation training, the patient will then be instructed to return to the active state gradually, the treatment procedure will be performed 3 times/ week for 8 weeks. Stretching exercises for the pelvic floor and the adjacent muscles: Levator ani \& perineal muscles stretch, hip adductor muscles stretch, piriform muscle stretch, hip flexor muscles stretch, and obturator internus muscle stretch.

Interferential current; Pelvic floor training

Interferential current DEVICE

Each female in the experimental group will receive interferential current, 3o minutes per session, 2 sessions per week, for 8 weeks. The applied parameters will be a frequency of 2000Hz, a modulated amplitude of frequency of 80Hz, pulse width of 200μs, and the intensity is modulated according to the sensory level of each participant. While the participant is in a comfortable crock lying position with abducted hips, the position of the electrodes will be maintained in all sessions

Interferential current

General advice BEHAVIORAL

The patients in both groups will follow general advice to help vaginismus for 8 weeks

Interferential current; Pelvic floor training

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women suffer from primary vaginismus with a duration of marriage ranging from 1 to 12 months. They are diagnosed and referred by the gynecologist.
• Their pain level is ≥ 4 on the visual analogue scale.
• They have a sedentary lifestyle.

You may not qualify if:

• Vaginismus requiring surgical treatment.
• Any gynecological diseases such as pelvic organ prolapse, vulvar vestibulitis, vulvar pain, clitorodynia, vulvar dysesthesia, or any pelvic inflammatory diseases.
• Lower urinary tract infection.
• Husband with sexual dysfunction that prevents penetration.
• Diseases involving nerves and muscles, such as myasthenia gravis.
• Severe psychiatric disorder or cognitive relegation.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Vaginismus

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Doaa A. Osman, PHD

  Department of Women's Health, Faculty of Physical Therapy, Cairo University

  STUDY CHAIR

Central Study Contacts

Rana Zaky, Student

CONTACT

01102628352; Ranazaky1993@gmail.com

Manal El-Shafeay, PHD

CONTACT

01220664518; manal.ahmed@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: July 20, 2024
• Primary Completion: October 20, 2024
• Study Completion: November 20, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-06