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Factors Associated With Disability in Postpartum Lumbopelvic Pain

3. september 2026 oppdatert av: Seda Saka, Halic University

Clinical, Biomechanical, Psychological, and Biochemical Factors Associated With Functional Disability in Women With Postpartum Lumbopelvic Pain: A Cross-Sectional Study

Postpartum lumbopelvic pain may affect functional ability, daily activities, physical performance, psychological well-being, and health-related quality of life. The aim of this observational cross-sectional study is to investigate clinical, biomechanical, psychological, and biochemical factors associated with functional disability in women with postpartum lumbopelvic pain.

Approximately 45 women aged 18 to 50 years who are 6 to 15 months postpartum and have persistent low back pain and/or pelvic girdle pain will be enrolled. General functional disability will be assessed using the Oswestry Disability Index (ODI), and pelvic-girdle-specific symptoms and activity limitations will be assessed using the Pelvic Girdle Questionnaire (PGQ). Pain intensity during activity, at rest, and at night will be evaluated using visual analogue scales (VAS).

Psychological status will be evaluated using the Edinburgh Postnatal Depression Scale (EPDS), and health-related quality of life will be assessed using the physical and mental component scores of the 12-item Short Form Health Survey (SF-12). Biomechanical assessments will include diastasis recti abdominis and trunk muscle endurance using flexor endurance, extensor endurance, prone plank, right side-plank, and left side-plank tests.

Mode of delivery will also be recorded. Biochemical evaluation will include circulating C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-alpha), and cortisol. The study will examine the relationships between functional disability and these clinical, biomechanical, psychological, and biochemical variables.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

This observational cross-sectional study is designed to comprehensively evaluate clinical, biomechanical, psychological, and biochemical factors associated with functional disability in women with postpartum lumbopelvic pain.

Women aged 18 to 50 years who are between 6 and 15 months postpartum and have experienced persistent low back pain and/or pelvic girdle pain for at least three months will be screened for eligibility. Participants meeting the predefined inclusion and exclusion criteria will undergo a standardized clinical assessment.

General functional disability will be evaluated using the Oswestry Disability Index (ODI). Pelvic-girdle-specific symptoms and activity limitations will be assessed using the Pelvic Girdle Questionnaire (PGQ). Pain intensity will be evaluated separately during activity, at rest, and at night using 0-100 mm visual analogue scales (VAS).

Psychological status will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). Health-related quality of life will be evaluated using the physical and mental component scores of the 12-item Short Form Health Survey (SF-12).

Biomechanical assessment will include evaluation of diastasis recti abdominis and trunk muscle endurance. Diastasis recti abdominis will be assessed during an abdominal curl-up. Trunk endurance will be evaluated using flexor endurance, extensor endurance, prone plank, right side-plank, and left side-plank tests. Mode of delivery will also be recorded.

Biochemical assessment will include circulating C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-alpha (TNF-alpha), and cortisol. Blood samples will be obtained at approximately 10:00 a.m. and analyzed by specialist biochemistry personnel.

The primary objective of the study is to examine the relationship between functional disability and clinical, biomechanical, psychological, and biochemical factors. Additional analyses will investigate associations among ODI, PGQ, pain intensity, EPDS, SF-12 physical and mental health scores, trunk endurance, diastasis recti status, mode of delivery, and circulating biomarkers.

Studietype

Observasjonsmessig

Registrering (Antatt)

45

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
    • Kocaeli
      • İzmit, Kocaeli, Tyrkia (Türkiye), 41040
        • ANTE SAĞLIK Op. Dr. Bilge Öğütçüoğlu Clinic
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Women aged 18 to 50 years who are 6 to 15 months postpartum and attend routine follow-up at the study center will be screened after examination by an obstetrics and gynecology specialist. Eligible participants will have postpartum lumbopelvic pain, defined as persistent low back pain and/or pelvic girdle pain lasting for at least three months, and will meet the predefined inclusion and exclusion criteria.

Beskrivelse

Inclusion Criteria:

Female participants aged 18 to 50 years. Having given birth 6 to 15 months before study enrollment. Diagnosis of postpartum lumbopelvic pain by an obstetrics and gynecology specialist.

Low back pain and/or pelvic girdle pain persisting for at least 3 months. Pain intensity of at least 5/10 on the Visual Analogue Scale (VAS). Willingness to participate in the study and provide written informed consent.

Exclusion Criteria:

History of low back pain or pelvic girdle pain before pregnancy. Multiple pregnancy. Receipt of another therapy or medication for the condition during the study period.

History of serious trauma. Musculoskeletal injury or bone fracture. Myofascial pain syndrome or fibromyalgia. Osteoarthritis. Neurological disease, including radiculopathy or myelopathy. Chronic inflammatory disease. History of cancer. Osteoporosis.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Women With Postpartum Lumbopelvic Pain
Women aged 18 to 50 years who are 6 to 15 months postpartum and have persistent low back pain and/or pelvic girdle pain for at least three months. Participants will meet the predefined eligibility criteria and undergo clinical, biomechanical, psychological, and biochemical assessments.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oswestry Disability Index (ODI)
Tidsramme: At the single study assessment
General functional disability will be assessed using the Oswestry Disability Index (ODI). The ODI consists of 10 sections scored from 0 to 5, producing a raw score from 0 to 50. The raw score will be converted to a percentage score ranging from 0 to 100%, with higher scores indicating greater disability.
At the single study assessment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pelvic Girdle Questionnaire (PGQ)
Tidsramme: At the single study assessment
Pelvic-girdle-specific symptoms and activity limitations will be assessed using the Pelvic Girdle Questionnaire (PGQ). The total score ranges from 0 to 100, with higher scores indicating greater symptoms and activity limitations related to pelvic girdle pain.
At the single study assessment
Pain Intensity During Activity - Visual Analogue Scale (VAS)
Tidsramme: At the single study assessment
Pain intensity during activity will be assessed using a 100-mm Visual Analogue Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity during physical activity.
At the single study assessment
Pain Intensity at Rest - Visual Analogue Scale (VAS)
Tidsramme: At the single study assessment
Pain intensity at rest will be assessed using a 100-mm Visual Analogue Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity while at rest.
At the single study assessment
Night Pain - Visual Analogue Scale (VAS)
Tidsramme: At the single study assessment
Night pain will be assessed using a 100-mm Visual Analogue Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity experienced during the night.
At the single study assessment
Edinburgh Postnatal Depression Scale (EPDS)
Tidsramme: At the single study assessment
Postnatal depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item self-reported questionnaire designed to assess depressive symptoms during the postnatal period. The total score ranges from 0 to 30, with higher scores indicating a greater level of depressive symptoms.
At the single study assessment
12-Item Short Form Health Survey - Physical Component Score (SF-12 PCS)
Tidsramme: At the single study assessment
Perceived physical health and health-related quality of life will be assessed using the Physical Component Score of the 12-item Short Form Health Survey (SF-12). Higher scores indicate better perceived physical health and physical health-related quality of life.
At the single study assessment
12-Item Short Form Health Survey - Mental Component Score (SF-12 MCS)
Tidsramme: At the single study assessment
Perceived mental health and health-related quality of life will be assessed using the Mental Component Score of the 12-item Short Form Health Survey (SF-12). Higher scores indicate better perceived mental health and mental health-related quality of life.
At the single study assessment
Diastasis Recti Abdominis Status
Tidsramme: At the single study assessment
Diastasis recti abdominis will be assessed by palpation 2 cm above the umbilicus while the participant performs an abdominal curl-up in the supine position. The examiner will place the fingers transversely across the linea alba to estimate the separation between the medial borders of the rectus abdominis muscles. Diastasis recti will be classified as present when the inter-recti distance is at least two fingerbreadths and absent when the distance is less than two fingerbreadths.
At the single study assessment
Trunk Flexor Endurance
Tidsramme: At the single study assessment
Trunk flexor endurance will be evaluated using a McGill-based flexor endurance test. Participants will sit with the hips and knees positioned at 90 degrees and the trunk initially supported at approximately 60 degrees. Timing will begin when the support is removed and will end when the participant can no longer maintain the standardized position. Endurance duration will be recorded in seconds. Three trials will be performed and the mean duration will be used for analysis. Higher values indicate greater trunk flexor endurance.
At the single study assessment
Trunk Extensor Endurance
Tidsramme: At the single study assessment
Trunk extensor endurance will be assessed with a McGill-based extensor endurance test. The participant will be positioned prone with the pelvis and lower limbs stabilized while the unsupported trunk is maintained in a horizontal position. Timing will stop when the participant can no longer maintain the required horizontal position. Endurance duration will be recorded in seconds. Three trials will be performed and the mean duration will be used for analysis. Higher values indicate greater trunk extensor endurance.
At the single study assessment
Right Side-Plank Endurance
Tidsramme: At the single study assessment
Right lateral trunk endurance will be evaluated using the side-plank endurance test. The participant will maintain the standardized side-plank position while supported on the elbow and feet. The duration for which the correct position can be maintained will be recorded in seconds. Three trials will be performed and the mean duration will be used for analysis. Higher values indicate greater right lateral trunk endurance.
At the single study assessment
Left Side-Plank Endurance
Tidsramme: At the single study assessment
Left lateral trunk endurance will be evaluated using the side-plank endurance test. The participant will maintain the standardized side-plank position while supported on the elbow and feet. The duration for which the correct position can be maintained will be recorded in seconds. Three trials will be performed and the mean duration will be used for analysis. Higher values indicate greater left lateral trunk endurance.
At the single study assessment
Prone Plank Endurance
Tidsramme: At the single study assessment
Anterior trunk endurance will be evaluated using the prone plank test. Participants will maintain a standardized plank position with the body aligned and supported on the forearms and toes. Timing will end when the standardized position can no longer be maintained. Endurance duration will be recorded in seconds. Three trials will be performed and the mean duration will be used for analysis. Higher values indicate greater trunk endurance.
At the single study assessment
C-Reactive Protein (CRP)
Tidsramme: At the single study assessment
Circulating C-reactive protein (CRP) concentration will be measured from blood samples obtained at approximately 10:00 a.m. and analyzed by specialist biochemistry personnel. CRP will be recorded in mg/L.
At the single study assessment
Interleukin-6 (IL-6)
Tidsramme: At the single study assessment
Circulating interleukin-6 (IL-6) will be measured from blood samples obtained at approximately 10:00 a.m. and analyzed by specialist biochemistry personnel. IL-6 will be recorded in pg/mL.
At the single study assessment
Interleukin-10 (IL-10)
Tidsramme: At the single study assessment
Circulating interleukin-10 (IL-10) will be measured from blood samples obtained at approximately 10:00 a.m. and analyzed by specialist biochemistry personnel. IL-10 will be recorded as a percentage (%), according to the laboratory reporting method.
At the single study assessment
Tumor Necrosis Factor-Alpha (TNF-alpha)
Tidsramme: At the single study assessment
Circulating tumor necrosis factor-alpha (TNF-alpha) will be measured from blood samples obtained at approximately 10:00 a.m. and analyzed by specialist biochemistry personnel. TNF-alpha will be recorded as a percentage (%), according to the laboratory reporting method.
At the single study assessment
Total Cortisol
Tidsramme: At the single study assessment
Total circulating cortisol will be measured from blood samples obtained at approximately 10:00 a.m. and analyzed by specialist biochemistry personnel. Cortisol concentration will be recorded in micrograms per deciliter (µg/dL).
At the single study assessment

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Sponsor

Halic University

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

3. september 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

3. september 2026

Først innsendt som oppfylte QC-kriteriene

3. september 2026

Først lagt ut (Faktiske)

9. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AYO-Postpartum-CS-2026-09

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

There is currently no prespecified plan to share individual participant data (IPD) with external researchers. Study findings will be reported in aggregate form.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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