- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07693465
Impact of Spinal Alignment on Pelvic Floor Efficiency
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Pelvic floor dysfunction (PFD) may extend beyond the pelvic region by inducing myofascial disturbances in anatomically distant structures connected through the myofascial network. Among these, low back pain (LBP) is one of the most frequently reported musculoskeletal conditions associated with PFD. This relationship is thought to arise from lumbopelvic instability and altered coordination of the core musculature. The pelvic floor muscles (PFMs), together with the transversus abdominis, diaphragm, and multifidus, form an integrated stabilizing system that contributes to spinal stability and postural control. Consequently, dysfunction of the transversus abdominis may compromise not only pelvic floor function but also overall lumbopelvic stability. Women with LBP have been shown to exhibit reduced PFM contraction strength despite preserved transversus abdominis activation, suggesting that impaired PFM function may play a more prominent role in the development of LBP than deficits in the abdominal muscles alone. Conversely, inadequate activation or endurance of the transversus abdominis has also been associated with impaired PFM function. Furthermore, altered movement patterns, dysfunctional breathing, and postural deviations can disrupt load transfer through the lumbopelvic region, thereby increasing the risk of PFD.
There is a dearth of knowledge regarding the effect of spinal alignment on pelvic floor efficiency in nulliparous women. This study, therefore, contributes valuable insights into a relatively unexplored area of nulliparous women's health. By assessing the pelvic floor muscles in nulliparous women with different spinal alignment patterns, including lordosis, kyphosis, and scoliosis, this study may enhance the well-being of nulliparous women, provide a more comprehensive approach to health improvement, help protect them from future pelvic floor dysfunction, and broaden the scope of physiotherapy in women's health.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Giza, Egypt
- Faculty of Physical Therapy, Cairo University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Nulliparous women.
- Their ages will range from 25 to 35 years old.
- Their body mass index (BMI) will not exceed 29.9 Kg/m2.
Exclusion Criteria:
- Female with congenital spinal deformity.
- Female with a history of neuromuscular disease.
- Female Diagnosed with any systemic disease .
- Female with a history of malignancy and/or ongoing treatment.
- Female with a history of urogenital diseases and surgical history.
- Female with previous spinal surgery.
- Female with previous pregnancy .
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Nulliparous women with thoracolumbar scoliosis
Twenty nulliparous women with thoracolumbar scoliosis.
They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.
|
Ingen inngrep
|
|
Nulliparous women with hyperlordosis
Twenty nulliparous women with hyperlordosis.
They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.
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Ingen inngrep
|
|
Nulliparous women with thoracic kyphosis
Twenty nulliparous women with thoracic kyphosis.
They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.
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Ingen inngrep
|
|
Nulliparous women with normal spinal alignment
Twenty nulliparous women with normal spinal alignment.
They will undergo assessment using Formetric analysis and vaginal pressure biofeedback.
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Ingen inngrep
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pelvic floor muscle strength
Tidsramme: Baseline
|
Pelvic floor muscle strength was measured using vaginal pressure biofeedback (maximum voluntary contraction pressure).
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Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pelvic floor muscle endurance
Tidsramme: Baseline
|
Pelvic floor muscle endurance was assessed using vaginal pressure biofeedback (duration of sustained maximal voluntary contraction).
|
Baseline
|
|
Spinal alignment angle
Tidsramme: Baseline
|
It was measured using the DIERS Formetric 4D system.
|
Baseline
|
|
Pelvic floor dysfunction symptoms
Tidsramme: Baseline
|
Total score and domain scores (bladder, bowel, prolapse, and sexual function) were assessed using the Australian Pelvic Floor Questionnaire (APFQ).
|
Baseline
|
|
Health-related quality of life
Tidsramme: Baseline
|
It was assessed by using Free online SF-12 Health Survey Version 2 (SF-12v2) score calculator.
The SF-12V2 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
|
Baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Afaf Mohamed Mahmoud Botla, PhD, Professor, Cairo University
- Studieleder: Amira Nagy Abd Ellatief Hamad, PhD, Lecturer, Cairo University
- Studieleder: Amal Abd Elrahman Mohamed Elborady, Assist. Professor, Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P.T.REC/012/005314
Legemiddel- og utstyrsinformasjon, studiedokumenter
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