Clinical trial NCT06259474: Effect of Hypopressive Exercises on Postpartum Backache and Functional Disability
Official title: Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Hypopressive Exercises
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 47
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of pain
timeFrame: Once at the start and once at the end of the stufy
Secondary outcomes:
measure: Assessment of functional disability
timeFrame: Once at the start and once at the end if the study
measure: Assessment of lumbar lordotic angle
timeFrame: Once at the start and once at the end if the study
Other outcomes:
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Study officials:
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