- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Asiya Uzun, Asisstant Proffesor
- Telefonszám: +90(344) 300-2621
- E-mail: asiyauzun@ksu.edu.tr
Tanulmányi helyek
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Kahramanmaraş, Törökország (Türkiye)
- Toborzás
- Kahramanmaraş Sütçü İmam Üniversitesi hastanesi
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Kapcsolatba lépni:
- Asiya Uzun, Asisstant Proffesor
- Telefonszám: +90(344) 300-2621
- E-mail: asiyauzun@ksu.edu.tr
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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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Aktív összehasonlító: 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 |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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VAS pain assesment
Időkeret: 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)
Időkeret: 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)
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Oswestry Disability Index (ODI)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2026/047
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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