Physical Therapy in Addition to Standard Care Following C-Section

NCT02804139 | Completed

• 1 other identifier: 2003233
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Pelvic Pain; Scar Tissue; Adhesions

Keywords

Cesarean Section; Postpartum issues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Visual Analogue Pain Scale Rating.

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

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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

Other: Standard Care

Standard care plus physical therapy

EXPERIMENTAL

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

Interventions

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 plus physical therapy

Standard Care OTHER

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

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caesarean section delivery, English speaking

You may not qualify if:

• Heart problems, postpartum eclampsia, any medical issue which contraindicates exercise, active untreated infection, chronic narcotic use

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Low Back Pain; Pelvic Pain; Cicatrix; Tissue Adhesions

Interventions

Standard of Care; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Rehabilitation

Study Officials

• Jennifer Stone, PT, DPT, OCS

  University of Missouri Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor, Clinical Rehabilitation Services

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: June 17, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)