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

9. August 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Pelvic floor exercise group
Kegel exercises will be performed for all participants for six weeks
Sonstiges: 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.
Andere Namen:
  • Kegel exercise
Experimental: 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
Sonstiges: 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.
Andere Namen:
  • Kegel exercise
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Female Sexual Function Index (FSFI)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pelvic floor muscle activity
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Cairo University

Mitarbeiter

Deraya University

Ermittler

  • Studienstuhl: Amel Youssef, professor, Cairo University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

15. November 2026

Studienabschluss (Geschätzt)

30. November 2026

Studienanmeldedaten

Zuerst eingereicht

9. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. August 2026

Zuerst gepostet (Tatsächlich)

14. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • P.T.REC/012/003690

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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