Clinical trial NCT02804139: Physical Therapy in Addition to Standard Care Following C-Section
Official title: Physical Therapy in Addition to Standard Care Following C-Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Pelvic Pain
Scar Tissue
Adhesions
Keywords: Cesarean Section
Postpartum issues
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Oswestry Disability Index
timeFrame: 8 weeks, 14 weeks, 6 months, 1 year, and 1.5 years after C-section
Secondary outcomes:
measure: Change in Visual Analogue Pain Scale Rating.
timeFrame: 8 weeks, 14 weeks, 6 months, 1 year, and 1.5 years after C-section
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
Study officials:
affiliation: University of Missouri Health Care
name: Jennifer Stone, PT, DPT, OCS
role: PRINCIPAL_INVESTIGATOR
References: