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临床试验/NCT02804139
NCT02804139已完成不适用

Physical Therapy in Addition to Standard Care Following C-Section

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2015年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
1
主要终点
Change in Oswestry Disability Index

研究概览

简要总结

The purpose of this study is to determine whether a physical therapy program which includes scar management, core retraining, and lumbar and pelvic joint mobilization will significantly impact the postpartum recovery following Cesarean section during the immediate postpartum period and during the first 1.5 years following childbirth.

All patients who enroll in the study will receive standard treatment following a C-section delivery. Subjects will be randomized into one of two groups; one group will receive physical therapy in addition to standard post C-section treatment, and the other group will receive standard post C-section treatment with no additional physical therapy. Both groups will complete questionnaires regarding their pain and recovery from C-section delivery to determine if there is a difference in recovery between the group receiving physical therapy and the group not receiving physical therapy.

详细描述

Cesarean section (C-section) represents the most commonly performed inpatient surgical procedure, with recent prevalence estimates of 1.3 million annually (approximately 22% of first births) in the United States. Currently, postoperative recovery support is typically characterized by verbal and written instructions regarding lifting and pelvic rest as well as slow return to activity and exercise.

There are multiple known complications during and after the postpartum period following Cesarean section deliveries. Some of the most common are back pain (up to 53% prevalence reported), bowel and bladder issues (20-30% prevalence reported), and scar tissue/adhesions. Multiple studies have indicated a higher incidence of low back and pelvic girdle pain in patients following Cesarean section compared to an unassisted vaginal delivery (estimates range from 2-5 times increase).

The purpose of this study is to determine whether a physical therapy program which includes scar management, core retraining, and lumbar and pelvic joint mobilization will significantly impact the postpartum recovery following Cesarean section during the immediate postpartum period and during the first 1.5 years following childbirth.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Caesarean section delivery, English speaking

排除标准

  • •Heart problems, postpartum eclampsia, any medical issue which contraindicates exercise, active untreated infection, chronic narcotic use

研究组 & 干预措施

Standard care

Active Comparator

Standard Care after C-section with no additional physical therapy.

干预措施: Standard Care (Other)

Standard care plus physical therapy

Experimental

Subjects attend 1 to 2 physical therapy sessions per week for 6 weeks beginning 8-10 weeks post-C section. The physical therapy program includes scar management, core retraining, and lumbar and pelvic joint mobilization

干预措施: Standard care plus physical therapy (Other)

结局指标

主要结局

Change in Oswestry Disability Index

时间窗: 8 weeks, 14 weeks, 6 months, 1 year, and 1.5 years after C-section

The change in the Oswestry Disability Index from 8 week baseline to subsequent time points.

次要结局

  • Change in Visual Analogue Pain Scale Rating.(8 weeks, 14 weeks, 6 months, 1 year, and 1.5 years after C-section)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Y Stone

Supervisor, Clinical Rehabilitation Services

University of Missouri-Columbia

研究点 (1)

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