Low Back PainLBPNCT06259474
Effect of Hypopressive Exercises on Postpartum Backache and Functional Disability
A study testing Hypopressive Exercises and (heat therapy, medication, and progressive strength training) in people with Low Back Pain, run by Kafrelsheikh University.
Trial summary
The purpose of this study was to evaluate the effectiveness of hypopressive exercise in postpartum females with abnormal hyperlordosis and back pain. 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 and (heat therapy, medication, and progressive strength training)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to Nov 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 Normal vaginal birth LBP that existed 24 weeks after giving birth Functional limitations in daily activities. Participants' age from 20 to 35 years
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability
The purpose of this study was to evaluate the effectiveness of hypopressive exercise in postpartum females with abnormal hyperlordosis and back pain.
Read the detailed description
More than half of new mothers suffer from lower back pain , with one-third of these occurring within three months of delivery. In addition, 40% of women report moderate to severe disability due to this pain . Persistent low back pain not only causes discomfort, but can also lead to a lower quality of life, decreased fitness levels, and fear of exercise. Women with chronic low back pain may find it difficult to manage housework, hobbies, and work . Stress, both physical and psychological, triggers the release of cortisol by the hypothalamic-pituitary-adrenal axis (HPAA) to suppress inflammation. If left untreated, low back pain can cause cortisol dysfunction, inflammation, and pain . Excessive pain can interfere with milk transfer in lactating women, while medical trreatments as sedating medications can cause respiratory depression in infants . Studies have shown that age, gender, pregnancy, and obesity may influence the degree of lumbar lordosis which can lead to postural pain, radiculopathy, and facet joint pain . Changes in the curvature and spinal segments of the anterior-posterior axis contribute to the unloading of the pelvic organs by sympathetic (T10-L2) and parasympathetic (S2-S4) nerves, resulting in a lower pain threshold. The birthing process exerts the most pressure on the hip joint, pelvis, and abdominal muscles, which in turn affects the back, pelvis, and sacroiliac joints. Vaginal birth has been found to affect the strength and stiffness of the pelvic floor . The still enlarged levator hiatus is unable to withstand the increased pressure on the abdomen, which may lead to the development of several disorders in the future . Physical therapy, stabilization belts, nerve stimulation, medications, acupuncture, massage, relaxation techniques, and yoga are all viable options for treating low back pain. Weight loss has been shown to decrease the likelihood and severity of low back pain (Bailey, 2009). While conventional treatments such as medications or surgery, while promising, are also associated with significant side effects, such as diarrhea, nausea, vomiting, leg cramps or other muscle spasms, insomnia, headaches, and abnormal dreams.
The American College of Obstetricians and Gynecologists (ACOG) points out that exercise is a good way to reduce stress, prevent postpartum depression, increase energy, strengthen and tone abdominal muscles, and promote better sleep . The diaphragm and pelvic floor are synergistic muscles that work with the transversus abdominis to maintain intra-abdominal pressure and maintain various postures .
Theoretically, the goal of HE is to decrease intra-abdominal pressure, while the basal tone of the deep abdominal muscles and pelvic floor muscles (PFM) is increased without conscious activation . The authors claim that a decrease in abdominal pressure with a latency of a few seconds triggers type I reflex activity in the abdominal wall and pelvic floor muscles. These exercises gradually activate the abdominal and pelvic floor muscles and cause direct activation of the transversus abdominal muscle, which strengthens the abdominal girdle, stabilizes the spine , and contracts bilaterally, forming fascial bands that contract like a brace . This deep muscle contributes to stability in three ways: it modulates intra-abdominal pressure, transmits force to the lumbar spine via the thoracolumbar fascia, and increases lumbar spine stiffness Considering the current stage of maternal life, we aimed to determine the effects of this exercise on low back pain, functional limitations, and lumbar angle.
- Conditions
- Low Back Pain
- Being tested
- Hypopressive Exercises and (heat therapy, medication, and progressive strength training)
- Keywords
- Hypopressive Exercises
- 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 and (heat therapy, medication, and progressive strength training)Combination product
Also called Hypopressive abdominal gymnastics
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group (A): 20 subjects combined HE with traditional treatments for low back pain (heat therapy, medication, and progressive strength training). Receives: 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. Receives: Combination Product: Hypopressive Exercises and (heat therapy, medication, and progressive strength training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once at the start and once at the end of the stufy
Secondary outcomes (2)
Assessment of functional disability
The Patient-Specific Functional Scale (PSFS) assessed 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.The Patient-Specific Functional Scale (PSFS) assessed 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: Once at the start and once at the end if the study
Assessment of lumbar lordotic angle
The angle was measured using flexible ruler once before and once after the study by the primary examiner, who repeated each measurement three times.The angle was determined by calculating the lengths of the h and L lines and using the formula θ=4 arc tan 2 h/L
Measured: Once at the start and once at the end if the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
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.
- 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
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (estimated)
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
- NCT06259474
- Sponsor's protocol ID
- Hypopressive Exerrcises
- Acronym
- LBP
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. 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
- NCT06259474
- Acronym / sponsor ID
- LBP / Hypopressive Exerrcises
- Conditions
- Low Back Pain
- Keywords
- Hypopressive Exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 14 Feb 2024 (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.
Detailed description
More than half of new mothers suffer from lower back pain , with one-third of these occurring within three months of delivery. In addition, 40% of women report moderate to severe disability due to this pain . Persistent low back pain not only causes discomfort, but can also lead to a lower quality of life, decreased fitness levels, and fear of exercise. Women with chronic low back pain may find it difficult to manage housework, hobbies, and work . Stress, both physical and psychological, triggers the release of cortisol by the hypothalamic-pituitary-adrenal axis (HPAA) to suppress inflammation. If left untreated, low back pain can cause cortisol dysfunction, inflammation, and pain . Excessive pain can interfere with milk transfer in lactating women, while medical trreatments as sedating medications can cause respiratory depression in infants . Studies have shown that age, gender, pregnancy, and obesity may influence the degree of lumbar lordosis which can lead to postural pain, radiculopathy, and facet joint pain . Changes in the curvature and spinal segments of the anterior-posterior axis contribute to the unloading of the pelvic organs by sympathetic (T10-L2) and parasympathetic (S2-S4) nerves, resulting in a lower pain threshold. The birthing process exerts the most pressure on the hip joint, pelvis, and abdominal muscles, which in turn affects the back, pelvis, and sacroiliac joints. Vaginal birth has been found to affect the strength and stiffness of the pelvic floor . The still enlarged levator hiatus is unable to withstand the increased pressure on the abdomen, which may lead to the development of several disorders in the future . Physical therapy, stabilization belts, nerve stimulation, medications, acupuncture, massage, relaxation techniques, and yoga are all viable options for treating low back pain. Weight loss has been shown to decrease the likelihood and severity of low back pain (Bailey, 2009). While conventional treatments such as medications or surgery, while promising, are also associated with significant side effects, such as diarrhea, nausea, vomiting, leg cramps or other muscle spasms, insomnia, headaches, and abnormal dreams.
The American College of Obstetricians and Gynecologists (ACOG) points out that exercise is a good way to reduce stress, prevent postpartum depression, increase energy, strengthen and tone abdominal muscles, and promote better sleep . The diaphragm and pelvic floor are synergistic muscles that work with the transversus abdominis to maintain intra-abdominal pressure and maintain various postures .
Theoretically, the goal of HE is to decrease intra-abdominal pressure, while the basal tone of the deep abdominal muscles and pelvic floor muscles (PFM) is increased without conscious activation . The authors claim that a decrease in abdominal pressure with a latency of a few seconds triggers type I reflex activity in the abdominal wall and pelvic floor muscles. These exercises gradually activate the abdominal and pelvic floor muscles and cause direct activation of the transversus abdominal muscle, which strengthens the abdominal girdle, stabilizes the spine , and contracts bilaterally, forming fascial bands that contract like a brace . This deep muscle contributes to stability in three ways: it modulates intra-abdominal pressure, transmits force to the lumbar spine via the thoracolumbar fascia, and increases lumbar spine stiffness Considering the current stage of maternal life, we aimed to determine the effects of this exercise on low back pain, functional limitations, and lumbar angle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Combination Product: Hypopressive Exercises and (heat therapy, medication, and progressive strength training)Group (A): 20 subjects combined HE with traditional treatments for low back pain (heat therapy, medication, and progressive strength training). |
| Group B | Active comparator | Combination Product: Hypopressive Exercises and (heat therapy, medication, and progressive strength training)Group (B) :20 subjects received the same conventional treatment for low back pain as group (A), including heat therapy, medication, and 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 Normal vaginal birth LBP that existed 24 weeks after giving birth Functional limitations in daily activities. Participants' age from 20 to 35 years
Key exclusion criteria (1 listed)
- 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.
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 and (heat therapy, medication, and progressive strength training)Also: Hypopressive abdominal gymnastics20 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 | Combination product | Group A, Group B |
Primary outcome
Assessment of pain
Time frame: Once at the start and once at the end of the stufy
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.
2 secondary outcomes
Assessment of functional disability
Time frame: Once at the start and once at the end if the study
Assessment of lumbar lordotic angle
Time frame: Once at the start and once at the end if the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hypopressive Exercises and (heat therapy, medication, and progressive strength training) in people with Low Back Pain, run by Kafrelsheikh University.
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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salwa Ali Shawat (+20101860049, salwaashawat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain (time frame: Once at the start and once at the end of the stufy). 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 26 Feb 2024.