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Physical Therapy in Addition to Standard Care Following C-Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804139
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Y Stone, University of Missouri-Columbia

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Pelvic Pain Scar Tissue Adhesions Other: Standard care plus physical therapy Other: Standard Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Therapy in Addition to Standard Care Following C-Section
Actual Study Start Date : December 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard care
Standard Care after C-section with no additional physical therapy.
Other: Standard Care
Standard Care after C-section with no additional physical therapy.

Experimental: 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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804139


Locations
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United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Jennifer Stone, PT, DPT, OCS University of Missouri Health Care
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Responsible Party: Jennifer Y Stone, Supervisor, Clinical Rehabilitation Services, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02804139    
Other Study ID Numbers: 2003233
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jennifer Y Stone, University of Missouri-Columbia:
Cesarean Section
Postpartum issues
Additional relevant MeSH terms:
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Low Back Pain
Pelvic Pain
Back Pain
Pain
Neurologic Manifestations