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
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.
연구 개요
상태
상태
정황
정황
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Seda Saka, Associate Professor
- 전화번호: 0544 780 3417
- 이메일: sedasaka@halic.edu.tr
연구 연락처 백업
- 이름: Abdullah Yahya Okur, PT
- 전화번호: 05349573147
- 이메일: fzt.abdullahokur@gmail.com
연구 장소
-
-
Kocaeli
-
İzmit, Kocaeli, 터키 (Türkiye), 41040
- ANTE SAĞLIK Op. Dr. Bilge Öğütçüoğlu Clinic
-
연락하다:
- ABDULLAH OKUR, PT
- 전화번호: 05349573147
- 이메일: fzt.abdullahokur@gmail.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Oswestry Disability Index (ODI)
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pelvic Girdle Questionnaire (PGQ)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- AYO-Postpartum-CS-2026-09
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .