Physical Therapy in Addition to Standard Care Following C-Section

Low Back Pain Clinical Trial

Official title:

Physical Therapy in Addition to Standard Care Following C-Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804139
• Other study ID #: 2003233
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adhesions
• Back Pain
• Low Back Pain
• Pelvic Pain
• Scar Tissue

Intervention

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

Locations

Country	Name	City	State
United States	University of Missouri Health Care	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oswestry Disability Index	The change in the Oswestry Disability Index from 8 week baseline to subsequent time points.	8 weeks, 14 weeks, 6 months, 1 year, and 1.5 years after C-section
Secondary	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	8 weeks, 14 weeks, 6 months, 1 year, and 1.5 years after C-section