Clinical trial NCT06820827: Effect of High Power Pain Threshold Ultrasound on Postnatal Sacroiliac Joint Pain
Official title: Effect of High Power Pain Threshold Ultrasound on Postnatal Sacroiliac Joint Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the effect of high-power pain threshold ultrasound on postnatal sacroiliac joint pain.

Detailed description: Sacroiliac joint pain (SIJ) in the pregnant and postpartum females is susceptible to dysfunction due to multiple biomechanical changes that happen over the course of gestation. This includes an increased angle of lordosis, weight gain, and structural trauma due to the physiologic process of childbirth, biomechanical changes, along with hormonal fluctuations through each trimester, particularly with increased levels of estrogen and relaxin, have been found to decrease the stability of the joint leading to sustained postpartum back pain that may necessitate surgical intervention if conservative treatment fails.

PGP can result in significant physical disability and has important psychosocial implications, including extended leave from work during pregnancy and postnatal, poorer quality of life (as a result of being unable to carry out normal roles, affecting their ability to care for their children and the new baby) and predisposition to chronic pain.

There are side effects to using medical treatment for PGP, such as bruising, bleeding, stomach upset (including bleeding in the stomach), peptic (stomach) ulcers, blurred vision, constipation, dry mouth, fatigue, headaches, insomnia, mood changes, nausea, urination problems, and weight gain. So, using other treatment methods, such as ultrasound therapy to treat PGP is beneficial.

Ultrasound therapy is a non-invasive treatment in which sound waves penetrate soft tissues, increasing blood flow; this can help relieve pain, improve circulation, and promote tissue healing. As such, ultrasound therapy is often used to treat injuries, muscle spasms, and chronic issues like neck or back pain.

No previous study has investigated the effect of high-power pain ultrasound on sacroiliac pain in postpartum women. So, this study aims to investigate the effect of high-power ultrasound on postnatal sacroiliac joint pain.

Eligibility criteria: Inclusion Criteria:

* Postpartum women diagnosed with sacroiliac joint pain and referred by an orthopedist.
* Their ages will range from 20 to 30 years old.
* Their body mass index (BMI) will range from 25 to 29.9 kg/m2.
* All of them should have symptoms for at least two weeks postnatal

Exclusion Criteria:

* Kidney diseases like stones or renal failure
* History of ischemic heart diseases or Myocardial infarction
* Severe vitamin D3 deficiency
* Severe liver diseases or hepatitis
* Psychological distress

Primary outcomes:
measure: Pain intensity
timeFrame: 8 weeks
measure: Pressure pain threshold (PPT)
timeFrame: 8 weeks
Secondary outcomes:
measure: Function disability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Mohamed
Study officials:
affiliation: Cairo University
name: Mai Ali, PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Doaa Osman, Professor
role: STUDY_CHAIR
References: