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Physical Therapy in Addition to Standard Care Following C-Section

Primary Purpose

Low Back Pain, Pelvic Pain, Scar Tissue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard care plus physical therapy
Standard Care
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Cesarean Section, Postpartum issues

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Missouri Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Standard care plus physical therapy

Arm Description

Standard Care after C-section with no additional 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

Outcomes

Primary Outcome Measures

Change in Oswestry Disability Index
The change in the Oswestry Disability Index from 8 week baseline to subsequent time points.

Secondary Outcome Measures

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

Full Information

First Posted
May 10, 2016
Last Updated
April 29, 2019
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02804139
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Pelvic Pain, Scar Tissue, Adhesions
Keywords
Cesarean Section, Postpartum issues

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Standard Care after C-section with no additional physical therapy.
Arm Title
Standard care plus physical therapy
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Standard care plus physical therapy
Intervention Description
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 Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Standard Care after C-section with no additional physical therapy.
Primary Outcome Measure Information:
Title
Change in Oswestry Disability Index
Description
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
Secondary Outcome Measure Information:
Title
Change in Visual Analogue Pain Scale Rating.
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Stone, PT, DPT, OCS
Organizational Affiliation
University of Missouri Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Therapy in Addition to Standard Care Following C-Section

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