- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06814704
Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability (LBP)
The purpose of this study was to evaluate the effectiveness of hypopressive exercise in postpartum females with abnormal hyperlordosis and back pain.
Hypopressive exercises are safe and beneficial for new moms, as they can be started soon after delivery. They help strengthen postural muscles, reduce back pain, and manage pain by reducing intra-abdominal pressure, increasing activity of postural musculature, and normalizing myofascial tension.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kafr Ash Shaykh, Egypt
- Kafrelsheikh University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- participants must have a healthy pregnancy, a typical vaginal birth, LBP that existed 24 weeks after giving birth, and functional limitations in daily activities. The study only allowed women aged 20-35 with no more than two prior pregnancies and a BMI of less than 25 kg/m2 to participate.
Exclusion Criteria:
- women who under pharmacological or psychological treatment, had pelvic tumors, lumbar disk herniation, heart disease, hypertension, lumbar spine tumors, chronic uterine prolapse, chronic pelvic pain, lumbar spondylosis, or lumbar spondylolisthesis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group (A)
Group A will receive 1. hypopressive abdominal exercises 2. traditional treatment for low back pain (Pharmacological treatment (paracetamol 0.5-1g 3times/day),Heat therapy Continuous low-level heat wrap(electrical) 3. Progressive strength training.
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20 subjects combined HE with traditional treatments for low back pain (heat therapy, medication, and progressive strength training).
|
|
Placebo Comparator: Group (B)
Group B will receive 1. traditional treatment for low back pain (Pharmacological treatment (paracetamol 0.5-1g 3times/day),Heat therapy Continuous low-level heat wrap(electrical) 2. Progressive strength training.
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Hypopressive exercises :The women were instructed to hold breath with chest extension for approximately 10 seconds before they began to breathe again.
Then, using a series of upper and lower limb positions, the subjects were shown how to apply a series of "hypopressive postures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain assessment
Time Frame: Pain assessment at the end of the study up to 8 weeks
|
pain: The Revised Short McGill Pain Questionnaire will be used to assess both groups before and after the study.
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Pain assessment at the end of the study up to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of functional disability
Time Frame: This scale will be done for each case at the end of the study up to 8 weeks
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The Patient-Specific Functional Scale (PSFS) will be used to assess functional changes in patients with musculoskeletal illnesses using self-reported data.
Patients rated to five activities on an 11-point scale based on their current level of difficulty.
|
This scale will be done for each case at the end of the study up to 8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of lumbar lordotic angle
Time Frame: It will be done for each case at the end of the study up to 8 weeks
|
The angle will be measured using flexible ruler once before and once after the study by the primary examiner, who repeated each measurement three times.
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It will be done for each case at the end of the study up to 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypopressive Exercises
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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