Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06820827

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Sacroiliac Joint Dysfunction

Age range

20 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Mohamed Mohamed

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myofascial Release

Other

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.

High-power pain threshold ultrasound

Device

The participants will receive high-power pain threshold ultrasound on sacroiliac joint, 20 minutes, three times/week for eight weeks.

Primary outcomes

  1. Pain intensity

    Time frame: 8 weeks

    A numerical rating scale will be used to evaluate pain intensity for all participants before and after the end of the treatment program. It will be given to each participant to rate her intensity of pain. 0 indicates no Pain, 1-3 indicates mild pain (nagging, annoying, interfering little with activity of daily living (ADLs), 4-6 indicates moderate pain (interferes significantly with ADLs), and 7-10 indicates severe pain (disabling; unable to perform ADLs).

  2. Pressure pain threshold (PPT)

    Time frame: 8 weeks

    A pressure algometry (Force Dial model FDK 20 Push Pull Force Gage, Wagner Instruments, Greenwich CT, USA) will be used to assess pain sensitivity by measuring pressure pain thresholds (PPT) at five selected points in the sacroiliac joint region of the affected side. The first examined point will be 1 cm medial and inferior to the posterior superior iliac spine, while the other four examined points will be 2 cm lateral, medial, superior, and inferior to the first point. Each point was measured three times with a ten-second interval between them; the mean of them will be then calculated for each point to be utilized for statistical analysis.

Secondary outcomes

  1. Function disability

    Time frame: 8 weeks

    Pelvic Pain Impact Questionnaire (PPIQ) will be used to assess function disability. It consists of 8 questions that get scored 0-4, for a total of 32. 0 indicates no at all and 4 indicates great deal.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed, Master

CONTACT

[email protected]

+201128588083

Mohamed fawzy, Professor

CONTACT

[email protected]

+201001414404

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.