An interventional study of Standard care plus physical therapy and Standard Care in Low Back Pain, Pelvic Pain and Scar Tissue, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-01.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
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.
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's enrollment of 125 is above the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
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Exclusion Criteria:
Standard Care after C-section with no additional physical therapy.
Other: Standard Care
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
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.
Standard Care after C-section with no additional physical therapy.
Change in Oswestry Disability Index
The change in the Oswestry Disability Index from 8 week baseline to subsequent time points.
Time frame: 8 weeks, 14 weeks, 6 months, 1 year, and 1.5 years after C-section
Change in Visual Analogue Pain Scale Rating.
The change in visual analogue pain scale ratings from 8 week baseline to subsequent time points for the neck, shoulders, low back, pelvis / hips, lower legs and "other" body area
Time frame: 8 weeks, 14 weeks, 6 months, 1 year, and 1.5 years after C-section
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Missouri-Columbia