Impact of Tibial Nerve Stimulation on Lumbopelvic Mechanics and Sexual Function in Females With Sexual Dysfunctions
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Doaa Abdel Hady, PHD
- Número de telefone: 01023600507
- E-mail: Doaaabdlnaser@gmail.com
Estude backup de contato
- Nome: Mahitab Yosri, PHD
- Número de telefone: 01222606996
- E-mail: mahitab.yosri@pt.cu.edu.eg
Locais de estudo
-
-
-
Cairo, Egito
- Cairo University
-
Contato:
- Doaa Abdel Hady, PHD
- Número de telefone: 01023600507
- E-mail: Doaaabdlnasser@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Pelvic floor exercise group
Kegel exercises will be performed for all participants for six weeks
|
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.
Outros nomes:
|
|
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
|
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.
Outros nomes:
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Female Sexual Function Index (FSFI)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pelvic floor muscle activity
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Amel Youssef, professor, Cairo University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- P.T.REC/012/003690
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .