Physical Therapy in Addition to Standard Care Following C-Section

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.

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Key information

Conditions

Low Back Pain Adhesions Back Pain Cicatrix Fibrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Scar Tissue Signs and Symptoms Tissue Adhesions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care plus physical therapy

Other

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

Other

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

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.

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

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

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Jun 17, 2016
Registry last updated: May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed