NCT06814704

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 14, 2024

Last Update Submit

February 5, 2025

Conditions

Keywords

postpartumlow back painQuality of life

Outcome Measures

Primary Outcomes (1)

  • Pain assessment

    pain: The Revised Short McGill Pain Questionnaire will be used to assess both groups before and after the study.

    Pain assessment at the end of the study up to 8 weeks

Secondary Outcomes (1)

  • Assessment of functional disability

    This scale will be done for each case at the end of the study up to 8 weeks

Other Outcomes (1)

  • Assessment of lumbar lordotic angle

    It will be done for each case at the end of the study up to 8 weeks

Study Arms (2)

Group (A)

EXPERIMENTAL

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.

Other: Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercises

Group (B)

PLACEBO COMPARATOR

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.

Other: heat therapy, pharmacological therapy, progressive strengthening exercises

Interventions

20 subjects combined HE with traditional treatments for low back pain (heat therapy, medication, and progressive strength training).

Group (A)

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

Group (B)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh university

Kafr ash Shaykh, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

AcetaminophenDiathermy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHyperthermia, InducedTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 7, 2025

Study Start

March 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

it need to have a permission from the faculty and university first

Locations