Clinical, Biomechanical, Psychological, and Biochemical Factors Associated With Functional Disability in Women With Postpartum Lumbopelvic Pain: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 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.
次要结局
- Total Cortisol(At the single study assessment)
- 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)
- 12-Item Short Form Health Survey - Physical Component Score (SF-12 PCS)(At the single study assessment)
- 12-Item Short Form Health Survey - Mental Component Score (SF-12 MCS)(At the single study assessment)
- Diastasis Recti Abdominis Status(At the single study assessment)
- Trunk Flexor Endurance(At the single study assessment)
- Trunk Extensor Endurance(At the single study assessment)
- Right Side-Plank Endurance(At the single study assessment)
- Left Side-Plank Endurance(At the single study assessment)
- Prone Plank Endurance(At the single study assessment)
- C-Reactive Protein (CRP)(At the single study assessment)
- Interleukin-6 (IL-6)(At the single study assessment)
- Interleukin-10 (IL-10)(At the single study assessment)
- Tumor Necrosis Factor-Alpha (TNF-alpha)(At the single study assessment)
研究者
Seda Saka
Associate Professor, Department of Physiotherapy and Rehabilitation
Halic University