- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07919548
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain (Pubic Pain)
The aim of this study is to investigate the effects of pelvic floor muscle training and a modified lumbopelvic belt on pain, kinesiophobia, and functional status in pregnant women with symphysis pubis pain.Although the power analysis yielded a relatively small minimum sample size, the target sample size was increased to account for potential loss to follow-up and missing data, as may occur in clinical research. Accordingly, the study was planned to include at least 30 pregnant women in the final analysis, and 40 pregnant women will be recruited to allow for potential attrition and withdrawal.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
The reported prevalence of symphysis pubis dysfunction (SPD) during pregnancy varies across the literature. Data from the general population indicate that SPD affects approximately 3-8% of pregnant women. The incidence of symphysis pubis diastasis, a more severe clinical condition, has been reported across a wide range, from 1 in 300 to 1 in 30,000 pregnancies. However, recent studies report that the prevalence of SPD may exceed 30% among pregnant women with pelvic pain. This variability may be attributed to differences in diagnostic criteria, assessment methods, and sample characteristics.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Asiya Uzun, Asisstant Proffesor
- Numero di telefono: +90(344) 300-2621
- Email: asiyauzun@ksu.edu.tr
Luoghi di studio
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Kahramanmaraş, Turchia (Türkiye)
- Reclutamento
- Kahramanmaraş Sütçü İmam Üniversitesi hastanesi
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Contatto:
- Asiya Uzun, Asisstant Proffesor
- Numero di telefono: +90(344) 300-2621
- Email: asiyauzun@ksu.edu.tr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria
Participants must:
- Be pregnant and aged 18-40 years.
- Have experienced pubic symphysis pain for at least 2 weeks, with pain more severe than any accompanying posterior pelvic pain.
- Have positive findings on at least two of the following tests: pubic symphysis palpation, modified Trendelenburg test, and active straight leg raise test.
- Provide written informed consent.
Exclusion criteria
Participants will be excluded for:
- High-risk pregnancy or a medical contraindication to pelvic support belt use.
- Serious systemic bone disease or a history of serious lumbar or pelvic trauma.
- Current systemic corticosteroid use or active pelvic treatment/orthosis.
- Neurological or cognitive conditions that prevent clinical testing or participation in the exercise program.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Symphysis Pubis Dysfunction group
The first group will be designated as the intervention group and will receive comprehensive physiotherapy education in conjunction with the use of a modified lumbopelvic belt. As part of a structured education program, participants will receive pelvic floor muscle training and diaphragmatic breathing training, as well as guidance on protective and symptom-relieving modifications to activities of daily living and relevant ergonomic and behavioral recommendations. |
intervention group and will receive comprehensive physiotherapy education in conjunction with the use of a modified lumbopelvic belt.As part of a structured education program, participants will receive pelvic floor muscle training and diaphragmatic breathing training, as well as guidance on protective and symptom-relieving modifications to activities of daily living and relevant ergonomic and behavioral recommendations. |
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Comparatore attivo: control group
The second group will be designated as the comparison group and will receive an educational program that includes pelvic floor muscle training, diaphragmatic breathing training, modifications to activities of daily living, and protective strategies. No belt will be used in this group. |
educational program that includes pelvic floor muscle training, diaphragmatic breathing training, modifications to activities of daily living, and protective strategies |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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VAS pain assesment
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
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Pain intensity will be assessed using a 10-cm visual analog scale (VAS), ranging from 0 to 10. A score of 0 indicates no pain, whereas a score of 10 indicates unbearable pain. The VAS is widely used to assess pain intensity. Pain intensity will be classified as mild (1-4), moderate (5-7), or severe (8-10). Pain in the lower back, back, and pelvic girdle will be assessed separately during activity, at rest, and during sleep at night. |
From enrollment to the end of treatment at 4 weeks
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Pain threshold measurement (algometer)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
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An algometer has long been used to measure soft-tissue pain associated with trigger points (11). An algometer will be used to assess the pressure pain threshold. The device has a blunt, non-sharp probe with a contact surface area of 1 cm². Pressure will be applied perpendicular to the midpoint of the muscle. Before the procedure, participants will be informed about the assessment and instructed to report when they first feel pain as the pressure is gradually increased. Measurements will be taken with the participant in a supine position. The pressure value at which the participant first experiences pain will be recorded as the pain threshold. Three measurements will be taken at 1-minute intervals, and the mean will be calculated (12). The assessment will be performed by applying pressure over the pubic symphysis. |
From enrollment to the end of treatment at 4 weeks
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Pelvic Girdle Questionnaire (PGQ)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
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The PGQ was developed by Stuge et al. (13). It is a condition-specific measure for assessing activity limitations and symptoms in individuals with pelvic girdle pain. It was developed for use in pregnant and postpartum individuals with pelvic girdle pain and can be used in both research and clinical practice. Its Turkish validity and reliability were established by Yelvar et al. |
From enrollment to the end of treatment at 4 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Oswestry Disability Index (ODI)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
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The ODI is a questionnaire developed specifically for individuals with low back pain to assess the degree of functional limitation in daily life. Its Turkish version has been tested for validity and reliability. It consists of 10 items addressing pain, personal care, lifting, standing, walking, sitting, traveling, sexual activity, and social life. Each item is scored from 0 to 5, with 0 representing the best level of function and 5 the worst |
From enrollment to the end of treatment at 4 weeks
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Tampa Scale for Kinesiophobia (TSK)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
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The Tampa Scale for Kinesiophobia was used to assess the severity of kinesiophobia in pregnant women. The TSK is a 17-item scale developed to measure fear of movement or reinjury. The original scale was developed by Miller, Kori, and Todd in 1991.The scale uses a four-point Likert response format: strongly disagree = 1, disagree = 2, agree = 3, and strongly agree = 4. To calculate the total score, items 4, 8, 12, and 16 are reverse-scored, and all item scores are summed. The total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia. |
From enrollment to the end of treatment at 4 weeks
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World Health Organization Quality of Life Questionnaire-Brief Version (WHOQOL-BREF)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
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The WHOQOL-BREF is a multidimensional self-report measure developed by the World Health Organization (WHO) to assess quality of life from a biopsychosocial perspective. A shorter version of the original WHOQOL-100, it was published in 1998. The WHOQOL-BREF consists of 26 items covering four domains of quality of life: physical health, psychological health, social relationships, and environment. Each item uses a five-point Likert scale to assess the respondent's perception of their quality of life over the previous two weeks. Scores are calculated separately for each domain and converted to a scale ranging from 0 to 100; higher scores indicate better quality of life. The WHOQOL-BREF enables comprehensive assessment of quality of life in both the general population and specific patient groups. It is widely used as a valid and reliable measure in health, psychology, rehabilitation, and public health research. |
From enrollment to the end of treatment at 4 weeks
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Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
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Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026/047
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