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Factors Associated With Disability in Postpartum Lumbopelvic Pain

3 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

45

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Seda Saka, Associate Professor
  • Numéro de téléphone: 0544 780 3417
  • E-mail: sedasaka@halic.edu.tr

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Turquie (Türkiye)
    • Kocaeli
      • İzmit, Kocaeli, Turquie (Türkiye), 41040
        • ANTE SAĞLIK Op. Dr. Bilge Öğütçüoğlu Clinic
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Oswestry Disability Index (ODI)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pelvic Girdle Questionnaire (PGQ)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Halic University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

3 septembre 2026

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

3 septembre 2026

Première soumission répondant aux critères de contrôle qualité

3 septembre 2026

Première publication (Réel)

9 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AYO-Postpartum-CS-2026-09

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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