NCT06259474

Brief Summary

The purpose of this study was to evaluate the effectiveness of hypopressive exercise in postpartum females with abnormal hyperlordosis and back pain.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
47

participants targeted

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

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

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 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on 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
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 6, 2024

Last Update Submit

February 23, 2024

Conditions

Keywords

Hypopressive Exercises

Outcome Measures

Primary Outcomes (1)

  • Assessment of pain

    The Revised Short McGill Pain Questionnaire consists of 22 pain descriptions rated on a scale from 0 to 10. A score of 0 indicates no pain, whereas a score of 10 represents the most severe pain ever experienced by the patient. The questionnaire includes four subscales. The four subacales were combined to create an overall score, with higher scores indicating greater discomfort.

    Once at the start and once at the end of the stufy

Secondary Outcomes (2)

  • Assessment of functional disability

    Once at the start and once at the end if the study

  • Assessment of lumbar lordotic angle

    Once at the start and once at the end if the study

Study Arms (2)

Group A

EXPERIMENTAL

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

Combination Product: Hypopressive Exercises and (heat therapy, medication, and progressive strength training)

Group B

ACTIVE COMPARATOR

Group (B) :20 subjects received the same conventional treatment for low back pain as group (A), including heat therapy, medication, and progressive strength training.

Combination Product: Hypopressive Exercises and (heat therapy, medication, and progressive strength training)

Interventions

20 subjects combined HE with traditional treatments for LBP (heat therapy, medication, and progressive strength training). Each session consisted of 5 to 10 HEs. Participants were instructed not to hold their breath or perform PFMS contractions during the HEs. Traditional treatment for low back pain typically involved using medications like acetaminophen (0.5-1 g three times daily) and heat therapy, which consisted of using a continuous heat wrap for 2 hours, 3 times per week at 40 °C, one hour before and after the session

Also known as: Hypopressive abdominal gymnastics
Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • Participants must have a healthy pregnancy Normal vaginal birth LBP that existed 24 weeks after giving birth Functional limitations in daily activities. Participants' age from 20 to 35 years

You may not qualify if:

  • No more than two prior pregnancies BMI of less than 25 kg/m2 to participate. Women who were 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

MeSH Terms

Conditions

Low Back Pain

Interventions

DiathermyDosage Forms

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeuticsPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Central Study Contacts

Salwa Ali Shawat

CONTACT

Fayiz El-Shamy, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study was designed as randomized, single blind pretest and posttest controlled trial. Approval was granted by the Ethical Committee of the Faculty of Physiotherapy at Kafr El Sheikh University under the number (T/ WH /2/2023/38). Each participant signed a written informed consent agreeing to adhere to the treatment plan for two months after discussing the benefits, goals and strategy of this study. They were also free to leave the study whenever they wished, for any reason. The principal investigator placed copies of the subjects' numbers in a vase and randomly assigned them to groups (A, B). 2.2. Subjects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

March 1, 2024

Primary Completion

September 1, 2024

Study Completion

November 1, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02