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Factors Associated With Disability in Postpartum Lumbopelvic Pain

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07809685
Enrollment
45
Registered
2026-09-09
Start date
2026-09-03
Completion date
2026-12-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Lumbopelvic Pain

Keywords

Postpartum, Pelvic Girdle Pain, Low Back Pain, Functional Disability, Diastasis Recti Abdominis, Inflammatory Biomarkers

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Halic University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oswestry Disability Index (ODI)At the single study assessmentGeneral 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.

Secondary

MeasureTime frameDescription
Total CortisolAt the single study assessmentTotal 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).
Interleukin-10 (IL-10)At the single study assessmentCirculating 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.
Interleukin-6 (IL-6)At the single study assessmentCirculating 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.
Pelvic Girdle Questionnaire (PGQ)At the single study assessmentPelvic-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.
Pain Intensity During Activity - Visual Analogue Scale (VAS)At the single study assessmentPain 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.
Pain Intensity at Rest - Visual Analogue Scale (VAS)At the single study assessmentPain 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.
Night Pain - Visual Analogue Scale (VAS)At the single study assessmentNight 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.
Edinburgh Postnatal Depression Scale (EPDS)At the single study assessmentPostnatal 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.
12-Item Short Form Health Survey - Physical Component Score (SF-12 PCS)At the single study assessmentPerceived 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.
12-Item Short Form Health Survey - Mental Component Score (SF-12 MCS)At the single study assessmentPerceived 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.
Diastasis Recti Abdominis StatusAt the single study assessmentDiastasis 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.
Trunk Flexor EnduranceAt the single study assessmentTrunk 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.
Trunk Extensor EnduranceAt the single study assessmentTrunk 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.
Right Side-Plank EnduranceAt the single study assessmentRight 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.
Left Side-Plank EnduranceAt the single study assessmentLeft 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.
Prone Plank EnduranceAt the single study assessmentAnterior 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.
Tumor Necrosis Factor-Alpha (TNF-alpha)At the single study assessmentCirculating 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.
C-Reactive Protein (CRP)At the single study assessmentCirculating 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTSeda Saka, Associate Professor
sedasaka@halic.edu.tr0544 780 3417
CONTACTAbdullah Yahya Okur, PT
fzt.abdullahokur@gmail.com05349573147

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026