跳至主要内容
临床试验/NCT06820827
NCT06820827尚未招募不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
28
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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/m
  • •All of them should have symptoms for at least two weeks postnatal

排除标准

  • •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

研究组 & 干预措施

Myofascial release group

Active Comparator

The participants will receive myofascial release three times/week for eight weeks.

干预措施: Myofascial release (Other)

Myofascial release and high-power pain threshold ultrasound group

Experimental

The participants will receive myofascial release in addition to a high-power pain threshold ultrasound on the sacroiliac joint for 20 minutes three times a week for eight weeks.

干预措施: Myofascial release (Other)

Myofascial release and high-power pain threshold ultrasound group

Experimental

The participants will receive myofascial release in addition to a high-power pain threshold ultrasound on the sacroiliac joint for 20 minutes three times a week for eight weeks.

干预措施: High-power pain threshold ultrasound (Device)

结局指标

主要结局

Pain intensity

时间窗: 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).

Pressure pain threshold (PPT)

时间窗: 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.

次要结局

  • Function disability(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Mohamed Hassan

Principal investigator

Cairo University

研究点 (1)

Loading locations...

相似试验