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临床试验/NCT07790848
NCT07790848尚未招募不适用

Effects Of Multimodal Physical Therapy Intervention On Musculoskeletal Function And Low Back Pain In Postpartum Women

Riphah International University0 个研究点目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Low Back Pain Intensity

研究概览

简要总结

Postpartum low back pain is a common musculoskeletal problem that affects women's functional ability, childcare activities, and quality of life after childbirth. Hormonal, biomechanical, and muscular changes during pregnancy and the postpartum period, including reduced core stability and pelvic floor weakness, contribute to persistent lumbopelvic pain and disability. In Pakistan, awareness and access to postpartum physiotherapy rehabilitation remain limited despite the high prevalence of postpartum low back pain.

Evidence suggests that multimodal physiotherapy interventions, including core stabilization exercises, pelvic floor training, manual therapy, ergonomic advice, and patient education, can effectively reduce pain and improve functional outcomes in postpartum women. However, limited randomized controlled trials have been conducted in Pakistan to evaluate these interventions.

The aim of this study is to determine the effects of a multimodal physical therapy intervention on low back pain, musculoskeletal function, core endurance, fatigue, and quality of life in postpartum women.

This study will be conducted as a single-blinded, two-arm parallel randomized controlled trial at Ayub Medical Complex Abbottabad and CMH Abbottabad. A total of 40 postpartum women aged 20-40 years with low back pain within six months after delivery will be recruited and randomly allocated into experimental and control groups.

The experimental group will receive a six-week multimodal physiotherapy program consisting of core stabilization exercises, pelvic floor muscle training, manual therapy, posture correction, ergonomic education, and home exercise guidance. The control group will receive routine postpartum care only.

Outcome measures will include the Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), core endurance tests, SF-36 Quality of Life Questionnaire, and PROMIS® Fatigue Short Form. Assessments will be conducted at baseline, post-intervention, and follow-up.

Data will be analyzed using SPSS version 29 with appropriate statistical tests for within-group and between-group comparisons. Ethical approval and informed consent procedures will be ensured before data collection.

This study is expected to provide evidence regarding the effectiveness of multimodal physiotherapy in improving pain, function, and quality of life among postpartum women and may support the integration of physiotherapy into routine maternal healthcare services in Pakistan.

详细描述

Postpartum low back pain is a common musculoskeletal condition that significantly affects women's physical function, mobility, childcare activities, emotional well-being, and quality of life after childbirth. During pregnancy and the postpartum period, women experience several hormonal, biomechanical, and musculoskeletal changes, including ligamentous laxity, altered posture, weakened abdominal and pelvic floor muscles, reduced core stability, and changes in spinal alignment, all of which may contribute to persistent lumbopelvic pain and functional limitations. Repetitive infant care activities such as lifting, carrying, breastfeeding, bending, prolonged sitting, and sleep-related postural stress may further aggravate symptoms and delay recovery. Despite the high prevalence of postpartum low back pain, rehabilitation services for postpartum women remain limited in Pakistan due to inadequate awareness, sociocultural barriers, lack of structured physiotherapy programs, and limited integration of rehabilitation within maternal healthcare systems. Consequently, many women continue to experience untreated pain, fatigue, disability, reduced physical performance, and impaired quality of life during the postpartum period. Current evidence supports the effectiveness of multimodal physiotherapy interventions for postpartum musculoskeletal dysfunction, particularly approaches combining core stabilization exercises, pelvic floor muscle training, manual therapy, ergonomic education, posture correction, activity modification, and patient counseling. However, most available evidence originates from high-income countries, and there is limited research evaluating the effectiveness of structured multimodal rehabilitation programs in Pakistani postpartum women. Therefore, this study aims to evaluate the effects of a multimodal physical therapy intervention on low back pain and musculoskeletal function in postpartum women. Secondary outcomes include assessment of core muscle endurance, functional disability, fatigue, and health-related quality of life. The study will be conducted using a single-blinded, two-arm parallel randomized controlled trial design in tertiary healthcare settings. Eligible postpartum women experiencing low back pain within six months after delivery will be recruited and randomly allocated into either an intervention group or a control group. The intervention group will receive a structured six-week multimodal physiotherapy program consisting of supervised core stabilization exercises, pelvic floor muscle activation and strengthening, manual therapy techniques, ergonomic training, posture correction, pain management education, safe lifting techniques, breastfeeding posture guidance, sleep positioning advice, and home exercise instruction. The control group will receive routine postpartum care without supervised physiotherapy intervention. Outcome measures will include pain intensity, functional disability, core muscle endurance, fatigue, and quality of life assessed using standardized clinical tools at baseline, post-intervention, and follow-up. Ethical approval and informed consent procedures will be ensured prior to commencement of the study, and participant confidentiality will be maintained throughout the research process. The findings of this study may contribute to the development of evidence-based postpartum rehabilitation protocols, improve awareness regarding women's health physiotherapy, support integration of physiotherapy services into routine maternal healthcare practices, and enhance postpartum recovery, functional independence, and quality of life among women in Pakistan.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Within six months postpartum following vaginal or caesarean delivery.
  • Experiencing low back pain or lumbopelvic pain after childbirth.
  • Pain intensity ≥3 on the Numeric Pain Rating Scale during activity or rest.
  • Able to attend supervised physiotherapy sessions for six consecutive weeks.
  • Willing to provide informed consent and participate in follow-up assessments.

排除标准

  • History of spinal surgery or diagnosed structural spinal deformities such as scoliosis, spondylolisthesis, or disc herniation.
  • Severe postpartum complications including postpartum haemorrhage, infection, or wound dehiscence limiting physical activity.
  • Pelvic organ prolapse grade II or above or severe pelvic floor dysfunction requiring specialized care.
  • Uncontrolled systemic illness such as diabetes mellitus, hypertension, or thyroid dysfunction affecting exercise tolerance.
  • Current participation in another structured physiotherapy or rehabilitation program for low back pain.
  • Neurological disorders or musculoskeletal conditions unrelated to postpartum low back pain that may affect outcomes.

结局指标

主要结局

Low Back Pain Intensity

时间窗: Baseline (Week 0), Post-intervention (Week 6), and Follow-up (Week 8)

Low back pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 ("no pain") to 10 ("worst imaginable pain"). The scale will be used to evaluate changes in pain severity in postpartum women receiving multimodal physical therapy intervention compared with routine postpartum care.

次要结局

  • Functional Disability due to Low Back Pain(Baseline (Week 0), Week 6, and Week 8)
  • Core Endurance Tests(4 months)

研究者

申办方类型
Other
责任方
Sponsor

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