Low Back PainLBPNCT06814704
Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability
A study testing Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercises and heat therapy, pharmacological therapy, progressive strengthening exercises in people with Low Back Pain, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercises and heat therapy, pharmacological therapy, progressive strengthening exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
38 postpartum women with abnormal hyperlordosis. The women were then divided into two equal groups. Group A(n=19) received hypopressive abdominal exercise along with traditional treatment for lower back pain (LBP), while Group B(n=19) received the same treatment without hypopressive exercise. The main outcomes measured were the the Revised Short McGill Pain Questionnaire Version-2, the lumbar lordotic angle, and the patient-specific functional scale.
- Conditions
- Low Back Pain
- Being tested
- Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercises, heat therapy, pharmacological therapy, progressive strengthening exercises
- Keywords
- postpartum, low back pain, Quality of life
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercisesOther
20 subjects combined HE with traditional treatments for low back pain (heat therapy, medication, and progressive strength training).
heat therapy, pharmacological therapy, progressive strengthening exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: heat therapy, pharmacological therapy, progressive strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
pain: The Revised Short McGill Pain Questionnaire will be used to assess both groups before and after the study.
Measured: Pain assessment at the end of the study up to 8 weeks
Secondary outcomes (1)
Assessment of functional disability
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.
Measured: This scale will be done for each case at the end of the study up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa A. Shawat, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814704
- Sponsor's protocol ID
- Hypopressive Exercises
- Acronym
- LBP
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it need to have a permission from the faculty and university first
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability
- ClinicalTrials.gov ID
- NCT06814704
- Acronym / sponsor ID
- LBP / Hypopressive Exercises
- Conditions
- Low Back Pain
- Keywords
- postpartum, low back pain, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
38 postpartum women with abnormal hyperlordosis. The women were then divided into two equal groups. Group A(n=19) received hypopressive abdominal exercise along with traditional treatment for lower back pain (LBP), while Group B(n=19) received the same treatment without hypopressive exercise. The main outcomes measured were the the Revised Short McGill Pain Questionnaire Version-2, the lumbar lordotic angle, and the patient-specific functional scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Other: Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercisesGroup 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. |
| Group (B) | Placebo comparator | Other: heat therapy, pharmacological therapy, progressive strengthening exercisesGroup 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercises20 subjects combined HE with traditional treatments for low back pain (heat therapy, medication, and progressive strength training). | Other | Group (A) |
| heat therapy, pharmacological therapy, progressive strengthening exercisesHypopressive 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 | Other | Group (B) |
Primary outcome
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.
1 secondary outcome
Assessment of functional disability
Time frame: This scale will be done for each case at the end of the study up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No. it need to have a permission from the faculty and university first
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypopressive exercises , hot packs, acetaminophen, progressive strengthening exercises and heat therapy, pharmacological therapy, progressive strengthening exercises in people with Low Back Pain, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: Pain assessment at the end of the study up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.