Impact of Tibial Nerve Stimulation on Lumbopelvic Mechanics and Sexual Function in Females With Sexual Dysfunctions

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-35
SponsorCairo University

About this trial

This study will be conducted to examine the effects of Transcutaneous Tibial Nerve Stimulation (TTNS) on lumbopelvic mechanics and sexual function in females with sexual dysfunctions and low back pain

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Females are diagnosed with low back pain combined with female sexual dysfunction.

Their ages will be ranged from 25 to 35 years.

Their body mass index (BMI) will be ranged from 23-28 kg/m2.

Patients with a number of normal deliveries ≤ three times

Disqualifiers

Prior history of disc prolapse and sacroiliac joints, symphysis pubic joint as well as lower limb problems.

Genital prolapse.

Leg length discrepancy.

Urinary tract infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pelvic floor exercise

    Other intervention

    The first step in doing Kegel exercises was identifying the muscles and the right muscle contraction, followed by both fast and slow contractions. Slow contractions of Kegel exercises that assist in pelvic floor strengthening were: (1) lifting the pelvic floor muscle for ten seconds and (2) holding the muscles tight while counting to ten, doing three repetitions of ten contractions (hold for 10 seconds and relax for 10 seconds) with a two-minute break in between. All individuals were told to relax their abdominals and gluteal muscles, not to hold their breath, and not to strain during pelvic floor muscle contractions.

  • transcutaneous tibial nerve stimulation

    Device

    Transcutaneous tibial nerve stimulation (TTNS), using an electrical stimulation device, model 5200, IOT Japan, was administered for 20 minutes, while the patient was lying supine on the bed with her head resting on a pillow. The electrodes were secured using tape; one was just posterior to the ankle's medial malleolus, and the other was roughly 10 cm above that. To guarantee that the electrodes activate the tibial nerve, a 10 Hz current frequency with a pulse length of 200 μs was delivered initially, with a gradual increase in the intensity to confirm a rhythmic hallux flexion movement.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Pelvic floor exercise groupActive comparator 1 intervention
Group B: Transcutaneous tibial nerve stimulation and pelvic floor exercise groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Female Sexual Function Index (FSFI)

The Female Sexual Function Index (FSFI) is a 19-item, self-report questionnaire used to assess female sexual function over the past 4 weeks. It is widely recognized as the gold standard instrument in both clinical trials and epidemiological studies. The index measures sexual functioning across six distinct areas: Desire: Frequency and level of sexual interest or drive. Arousal: Frequency, level, and confidence in becoming sexually excited. Lubrication: Ease and frequency of vaginal wetness during sexual activity. Orgasm: Frequency, difficulty, and satisfaction with reaching climax, Satisfaction: Level of satisfaction with closeness, partner, and overall sex life. Pain: Level of discomfort or pain during or after vaginal penetration. Total Score Range: The sum of all six weighted domain scores ranges from 2.0 to 36.0.Clinical Cut-off: A total score of 26.55 or lower indicates a risk for female sexual dysfunction (FSD).

Time frame
6 weeks
2

Pelvic inclination angle

The pelvic inclination angle defines the spatial orientation of the pelvis relative to a vertical line or the horizontal plane. the spinal mouse system will be used to measure it. The device records the raw angle when it passes over the sacral base, specifically between the first sacral vertebra (S1) and the top of the natal cleft. Normal Standing Range: 10 to 25 degrees . More than 25 degrees indicates excessive anterior pelvic tilt. Less than 10 degrees indicates posterior pelvic tilt.

Time frame
6 weeks
3

lumbar lordotic angle

Spinal Mouse system is a safe, non-invasive electronic device that measures lumbar lordosis and spinal mobility by rolling along the skin over the spinous processes. It provides a radiation-free, quick, and reliable alternative to X-rays for clinical posture assessment. Software uses a mathematical algorithm to calculate the local angle of each vertebral segment. The system sums these local segments to provide the global lumbar lordotic angle in degrees.

Time frame
6 weeks
4

Spinal mobility

Spinal mobility is calculated by the Spinal Mouse system as the change in angular position between different postural states, specifically measuring the spine's capacity to bend forward and backward.

Time frame
6 weeks

Secondary outcomes

1

Pelvic floor muscle activity

An Ultrasound imaging unit with a convex transducer will be used at a frequency of 5 MHz for evaluating the thickness and voluntary pelvic floor muscle (PFM) contractions' force (strength) of all patients. The measurements will be taken with a full bladder while the woman is in crock position, with the lumbar spine neutrally positioned, and the hips and knees bent to 60°. The ultrasound transducer is inserted transversely across the midline of the abdomen directly superior to the symphysis pubis, with an angle of about 60° from vertical. A marker (X) was placed on the image of the bladder at the junction of the hyper- and hypoechoic structures. Another marker was placed at the end of the muscle, and then the measurement will be taken as the distance between the two points. Women will perf three maximal contractions so that displacement of the posterior bladder wall, as a result of PFM contraction, could be measured. The mean of the three measures will be taken and analyzed.

Time frame
6 weeks
2

Pain intensity

A Visual Analog Scale (VAS) will be used to measure low back pain intensity. It is a horizontal line, usually 10 cm long, whose ends are labeled as the extreme 0 "no pain" and 10 "severe pain" .

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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Cairo University

Lead sponsor

Deraya University

Collaborator

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