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Not yet recruiting NCT06820827

Effect of High Power Pain Threshold Ultrasound on Postnatal Sacroiliac Joint Pain

No phase Interventional Sacroiliac Joint Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Myofascial release, High-power pain threshold ultrasound.
Who it may be relevant to
Registry conditions: Sacroiliac Joint Dysfunction. Basic parameters: 20 years — 30 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Myofascial release
    The participants will receive myofascial release (MFR) on erector spinae, quadratus lumborum, piriformis and gluteus medius. The duration of MFR for each muscle will be 90 to 120 seconds, three times/week for eight weeks.
  • Device High-power pain threshold ultrasound
    The participants will receive high-power pain threshold ultrasound on sacroiliac joint, 20 minutes, three times/week for eight weeks.

Primary outcome measures

  • Pain intensity [Time frame: 8 weeks]
  • Pressure pain threshold (PPT) [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Function disability [Time frame: 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ahmed Mohamed Mohamed — Cairo

Identifiers

NCT: NCT06820827 · P.T.REC/012/005376

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗