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Postpartum Lumbopelvic PainNCT07809685

Factors Associated With Disability in Postpartum Lumbopelvic Pain

An observational study of Postpartum Lumbopelvic Pain, run by Halic University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Postpartum Lumbopelvic Pain
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Sep 2026to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Seda Saka, Associate Professor contact

0544 780 3417

sedasaka@halic.edu.tr

Abdullah Yahya Okur, PT contact

05349573147

fzt.abdullahokur@gmail.com

Turkey (Türkiye)1 site
  • ANTE SAĞLIK Op. Dr. Bilge Öğütçüoğlu Clinic

    İzmit, Kocaeli, 41040

    ABDULLAH OKUR, PT, 05349573147, fzt.abdullahokur@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: 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).

Read more

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.

Read the 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.

Keywords
Postpartum, Pelvic Girdle Pain, Low Back Pain, Functional Disability, Diastasis Recti Abdominis, Inflammatory Biomarkers
Medical subject headings
Pelvic Girdle Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07809685
Study groupRoleWhat they receive
Women With Postpartum Lumbopelvic PainWomen 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oswestry Disability Index (ODI)

    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.

    Measured: At the single study assessment

Secondary outcomes (18)
  1. Pelvic Girdle Questionnaire (PGQ)

    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.

    Measured: At the single study assessment

  2. Pain Intensity During Activity - Visual Analogue Scale (VAS)

    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.

    Measured: At the single study assessment

  3. Pain Intensity at Rest - Visual Analogue Scale (VAS)

    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.

    Measured: At the single study assessment

  4. Night Pain - Visual Analogue Scale (VAS)

    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.

    Measured: At the single study assessment

  5. Edinburgh Postnatal Depression Scale (EPDS)

    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.

    Measured: At the single study assessment

  6. 12-Item Short Form Health Survey - Physical Component Score (SF-12 PCS)

    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.

    Measured: At the single study assessment

  7. 12-Item Short Form Health Survey - Mental Component Score (SF-12 MCS)

    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.

    Measured: At the single study assessment

  8. Diastasis Recti Abdominis Status

    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.

    Measured: At the single study assessment

  9. Trunk Flexor Endurance

    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.

    Measured: At the single study assessment

  10. Trunk Extensor Endurance

    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.

    Measured: At the single study assessment

  11. Right Side-Plank Endurance

    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.

    Measured: At the single study assessment

  12. Left Side-Plank Endurance

    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.

    Measured: At the single study assessment

  13. Prone Plank Endurance

    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.

    Measured: At the single study assessment

  14. C-Reactive Protein (CRP)

    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.

    Measured: At the single study assessment

  15. Interleukin-6 (IL-6)

    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.

    Measured: At the single study assessment

  16. Interleukin-10 (IL-10)

    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.

    Measured: At the single study assessment

  17. Tumor Necrosis Factor-Alpha (TNF-alpha)

    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.

    Measured: At the single study assessment

  18. Total Cortisol

    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).

    Measured: At the single study assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start3 Sep 2026 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07809685
Sponsor's protocol ID
AYO-Postpartum-CS-2026-09
Status last verified
Sep 2026
First submitted
3 Sep 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is currently no prespecified plan to share individual participant data (IPD) with external researchers. Study findings will be reported in aggregate form.

Publications

  • Gutke A, Lundberg M, Ostgaard HC, Oberg B. Impact of postpartum lumbopelvic pain on disability, pain intensity, health-related quality of life, activity level, kinesiophobia, and depressive symptoms. Eur Spine J. 2011 Mar;20(3):440-8. doi: 10.1007/s00586-010-1487-6. Epub 2010 Jul 1.

    PubMed 20593205
  • Jimenez-de-Ory I, Mazur A, Oliva-Pascual-Vaca A, Benito-de-Pedro M, Fernandez-Rodriguez T, Rodriguez-Lopez ES. Psychological and Behavioral Predictors of Postpartum Lumbopelvic Pain: A Multivariate Analysis. Medicina (Kaunas). 2025 Oct 17;61(10):1869. doi: 10.3390/medicina61101869.

    PubMed 41155855
  • Starzec-Proserpio M, Rejano-Campo M, Szymanska A, Szymanski J, Baranowska B. The Association between Postpartum Pelvic Girdle Pain and Pelvic Floor Muscle Function, Diastasis Recti and Psychological Factors-A Matched Case-Control Study. Int J Environ Res Public Health. 2022 May 20;19(10):6236. doi: 10.3390/ijerph19106236.

    PubMed 35627771

Questions about this trial

What is this clinical trial studying?

An observational study of Postpartum Lumbopelvic Pain, run by Halic University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seda Saka, Associate Professor (0544 780 3417, sedasaka@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (ODI) (time frame: At the single study assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07809685, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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