Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus
ConditionVaginismus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-35
SponsorCairo University
About this trial
This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pelvic floor training
Other interventionIt 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
DeviceEach 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
BehavioralThe patients in both groups will follow general advice to help vaginismus for 8 weeks
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Pelvic floor trainingActive comparator 2 interventions
Group B: Interferential currentExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Eight weeks2
Quantification of pressure pain threshold in the perineum.
The pressure pain threshold in the perineum region will be evaluated with a pressure algometer.
Time frame
Eight weeks3
Assessment of pelvic floor muscle tone.
It will be assessed by biofeedback perineometer.
Time frame
Eight weeksSecondary outcomes
1
Measurement of cognition regarding vaginal penetration in women with lifelong vaginismus.
The Vaginal Penetration Cognition Scale (VPCQ) will be used to evaluate cognition regarding to vaginal penetration for all participants in both groups before and after the end of the treatment program.
Time frame
Eight weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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