Effect of Hypopressive Exercises on Postpartum Backache and Functional Disability

Low Back Pain Clinical Trial

— LBP  

Official title:

Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06259474
• Other study ID #: Hypopressive Exerrcises
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Kafrelsheikh University
• Contact: Salwa Ali Shawat
• Phone: +20101860049
• Email: salwaashawat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 47
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Once at the start and once at the end if the study
Secondary	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 ?=4 arc tan 2 h/L	Once at the start and once at the end if the study