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

NCT ID: NCT06486896

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2024-11-20

Brief Summary

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

Detailed Description

Vaginismus is a common sexual problem with a prevalence of 20% in Egyptian women, that has a significant impact on a person's life, affecting their physical, emotional, and psychological well-being, as well as their relationships and overall quality of life.

There were previous studies that studied the effect of pelvic floor rehabilitation on vaginismus and found that there was a highly significant decrease in pain and pelvic floor muscle spasms, as well as a highly significant increase in sexual function. Also, only one previous protocol explored the effect of interferential current on treating vaginismus. But, till now, there is no prior study that investigated the impact of adding interferential current to pelvic floor muscle training on treating vaginismus. this trial has two groups; one will receive interferential current, and the other group will receive interferential current + pelvic floor muscle training

Conditions

Vaginismus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pelvic floor training

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

Group Type: ACTIVE_COMPARATOR

Pelvic floor training

Intervention Type: 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.

General advice

Intervention Type: BEHAVIORAL

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

Interferential current

Patients will receive interferential current+pelvic floor training+advice

Group Type: EXPERIMENTAL

Pelvic floor training

Intervention Type: 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

Intervention Type: 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

General advice

Intervention Type: BEHAVIORAL

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

Interventions

Pelvic floor training

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.

Intervention Type: OTHER

Interferential current

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

Intervention Type: DEVICE

General advice

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Women suffer from primary vaginismus with a duration of marriage ranging from 1 to 12 months. They are diagnosed and referred by the gynecologist.

2. Their pain level is ≥ 4 on the visual analogue scale.

3. They have a sedentary lifestyle.

Exclusion Criteria

1. Vaginismus requiring surgical treatment.

2. Any gynecological diseases such as pelvic organ prolapse, vulvar vestibulitis, vulvar pain, clitorodynia, vulvar dysesthesia, or any pelvic inflammatory diseases.

3. Lower urinary tract infection.

4. Husband with sexual dysfunction that prevents penetration.

5. Diseases involving nerves and muscles, such as myasthenia gravis.

6. Severe psychiatric disorder or cognitive relegation.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rana

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doaa A. Osman, PHD

Role: STUDY_CHAIR

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

Central Contacts

Rana Zaky, Student

Role: CONTACT

Ranazaky1993@gmail.com

01102628352

Manal El-Shafeay, PHD

Role: CONTACT

manal.ahmed@pt.cu.edu.eg

01220664518

Other Identifiers

P.T.REC/012/004953

Identifier Type: -

Identifier Source: org_study_id