Low Back Pain Clinical Trial
Official title:
Effect of a Core Strengthening Program on Diastasis Rectus Abdominus in Postpartum Women
NCT number | NCT03595696 |
Other study ID # | 2017-1999 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | July 16, 2019 |
Verified date | November 2019 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will prospectively measure the effectiveness of a core strengthening program on reducing the inter-rectus distance (IRD) and abdominal wall muscle contraction in postpartum women with diastasis rectus abdominus (DRA). Additionally, this study will aim to investigate and clarify the association between IRD and low back pain.
Status | Completed |
Enrollment | 56 |
Est. completion date | July 16, 2019 |
Est. primary completion date | July 16, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Healthy women who have given birth within the last 36 months but are at least 12 weeks postpartum - Not currently pregnant - Current DRA diagnosed using ultrasound with an IRD of at least 2.0 cm Exclusion Criteria: - History of ventral/umbilical hernia prior to pregnancy - >36 months postpartum - Currently pregnant - Beighton's score >5/9 - Unable to participate in a regular core strengthening program - Unable to attend the three data collection sessions |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in inter-recti distance (IRD) | Change in IRD will be measured using palpation and musculoskeletal ultrasound. | Up to 24 weeks | |
Secondary | Abdominal wall muscle function | Measured using musculoskeletal ultrasound at rest and during contraction (abdominal draw-in maneuver). | Up to 24 weeks | |
Secondary | Low back pain | Measured using the Quebec Back Pain Disability Scale. Scores range from 0 to 100, with 100 representing higher disability. | Up to 24 weeks | |
Secondary | Pelvic function | Measured using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function. Scores range from 0 to 48, with a higher score representing greater impairment. | Up to 24 weeks | |
Secondary | Stress urinary incontinence | Measured using the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form. Scores range from 0 to 21, with higher scores indicating increased severity. | Up to 24 weeks | |
Secondary | Body image | Measured using the Body Shape Questionnaire. Scores range from 16 to 96, with a higher score representing impairment. | Up to 24 weeks |
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