Factors Associated With Disability in Postpartum Lumbopelvic Pain

NCT07809685 | Not Yet Recruiting

• 1 other identifier: AYO-Postpartum-CS-2026-09
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Lumbopelvic Pain

Keywords

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

Outcome Measures

Primary Outcomes (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.

  At the single study assessment

Secondary Outcomes (18)

• Pelvic Girdle Questionnaire (PGQ)

  At the single study assessment

• Pain Intensity During Activity - Visual Analogue Scale (VAS)

  At the single study assessment

• Pain Intensity at Rest - Visual Analogue Scale (VAS)

  At the single study assessment

• Night Pain - Visual Analogue Scale (VAS)

  At the single study assessment

• Edinburgh Postnatal Depression Scale (EPDS)

  At the single study assessment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

ANTE SAĞLIK Op. Dr. Bilge Öğütçüoğlu Clinic

İzmit, Kocaeli, 41040, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 20593205 BACKGROUND

• 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.

  PMID: 41155855 BACKGROUND

• 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.

  PMID: 35627771 BACKGROUND

MeSH Terms

Conditions

Pelvic Girdle Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Back Pain

Central Study Contacts

Seda Saka, Associate Professor

CONTACT

0544 780 3417; sedasaka@halic.edu.tr

Abdullah Yahya Okur, PT

CONTACT

05349573147; fzt.abdullahokur@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 3, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)