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

9 sierpnia 2026 zaktualizowane przez: Doaa Abdel Naser Abd El-Hady, Cairo University

Impact of Transcutaneous Tibial Nerve Stimulation on Lumbopelvic Mechanics and Sexual Function in Females With Sexual Dysfunctions and Low Back Pain: a Randomized Controlled 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Female sexual dysfunction is a term used to describe various sexual problems, such as low desire or interest, diminished arousal, orgasmic difficulties, and dyspareunia. Female sexual dysfunction is considered common, with a widely quoted prevalence estimate of 43% from the U.S. Low back pain is one of the most common adult musculoskeletal disorders, impacting up to 65% of people per year.

Specifically, low back pain negatively impacts sexual activity due to discomfort during sexual relations that leads to a decrease in the frequency of sexual intercourse and alters feelings in the relationship with the partner, leading to a lack of desire or sexual activity.

Transcutaneous Tibial Nerve Stimulation (TTNS) is a non-invasive, low-risk electrical stimulation technique that modulates the sacral nerve plexus via stimulation of the posterior tibial nerve, with pelvic floor innervation. TTNS has demonstrated promising outcomes in managing overactive bladder, pelvic pain, and pelvic floor dysfunctions by improving neuromuscular activation, enhancing blood flow, and regulating sensory signaling pathways. Despite growing evidence supporting TTNS in pelvic health, its potential influence on spinal mechanics-such as lumbar angle, spinal mobility, and trunk inclination-remains underexplored, particularly in women experiencing low back pain associated with sexual dysfunction.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 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
  • They had regular menstruation.

Exclusion Criteria:

  • 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.
  • Diastasis recti, diabetes, intrauterine device.
  • Surgery related to the spine, abdomen or pelvis as well as skin disease that interferes with the usage of TTNS.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Pelvic floor exercise group
Kegel exercises will be performed for all participants for six weeks
Inny: Pelvic floor exercise
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.
Inne nazwy:
  • Kegel exercise
Eksperymentalny: Transcutaneous tibial nerve stimulation and pelvic floor exercise group
Transcutaneous tibial nerve stimulation will be applied for the participants in the experimental group, for 20 minutes, 3 sessions weekly, along with pelvic floor exercises for 6 weeks
Inny: Pelvic floor exercise
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.
Inne nazwy:
  • Kegel exercise
Urządzenie: transcutaneous tibial nerve stimulation
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Female Sexual Function Index (FSFI)
Ramy czasowe: 6 weeks
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).
6 weeks
Pelvic inclination angle
Ramy czasowe: 6 weeks
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.
6 weeks
lumbar lordotic angle
Ramy czasowe: 6 weeks
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.
6 weeks
Spinal mobility
Ramy czasowe: 6 weeks
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.
6 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pelvic floor muscle activity
Ramy czasowe: 6 weeks

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.
6 weeks
Pain intensity
Ramy czasowe: 6 weeks
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" .
6 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Cairo University

Współpracownicy

Deraya University

Śledczy

  • Krzesło do nauki: Amel Youssef, professor, Cairo University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

15 listopada 2026

Ukończenie studiów (Szacowany)

30 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

9 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

14 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • P.T.REC/012/003690

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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