Physical Therapy in Addition to Standard Care Following C-Section
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Change in Oswestry Disability Index
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Caesarean section delivery, English speaking
Exclusion Criteria
- •Heart problems, postpartum eclampsia, any medical issue which contraindicates exercise, active untreated infection, chronic narcotic use
Arms & Interventions
Standard care
Standard Care after C-section with no additional physical therapy.
Intervention: Standard Care (Other)
Standard care plus physical therapy
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
Intervention: Standard care plus physical therapy (Other)
Outcomes
Primary Outcomes
Change in Oswestry Disability Index
Time Frame: 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.
Secondary Outcomes
- Change in Visual Analogue Pain Scale Rating.(8 weeks, 14 weeks, 6 months, 1 year, and 1.5 years after C-section)
Investigators
Jennifer Y Stone
Supervisor, Clinical Rehabilitation Services
University of Missouri-Columbia