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临床试验/NCT05391685
NCT05391685Unknown不适用

EFFECT OF SCAR RELEASE TECHNIQUES ON CHRONIC SCAR PAIN AND MOBILITY POST CESAREAN SECTION

Cairo University0 个研究点目标入组 40 人开始时间: 2022年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Scar adherence

研究概览

简要总结

Purpose of the study:

The aim of this study is to determine the effect of scar release techniques on chronic scar pain and mobility post cesarean section.

Hypothesis:

  • H0: There is no effect of scar release techniques on chronic scar pain and mobility post cesarean section.
  • HA: There is effect of scar release techniques on chronic scar pain and mobility post cesarean section.

详细描述

A vicious impediment on quality of life including psychological and functional disability, and interference with baby care and bonding may occur among women who experience chronic post-caesarean section pain (CPCSP) .

Structural alterations of the skin and subcutaneous tissues with scarring result in reduced mobility and viscoelasticity that could cause compression of the sensory receptors and nerve fibers and disrupt their signaling. The viscoelastic properties could potentially be modified when the skin and scars are stressed and/or strained by manual therapies and this can affect the sensitivity threshold of the mechanosensitive and nociceptive receptors.

There are limited studies about the effect of various scar release techniques on chronic post cesarean section scar pain and mobility and their impact on quality of life on the affected women . So, this study will be helpful and of valuable benefits for medical services organizations and increase body of knowledge of physical therapists in scientific field.

This study will be conducted on forty women suffering from chronic post cesarean section scar pain and restricted scar mobility , they will be referred from department of Obestetrics and Gynaecology in Elmansoura International Hospital, Egypt.

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 (Investigator)

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women with a well healed, old , transverse cesarean section scar (more than 6 months resulted in chronic scar pain).
  • •Pain can be intermittent or constant at rest or with activity, and it is reported to be at least at a level of about 3/ 10 on visual analogue scale at recording sites will be marked on the C-section scar at 2.5 cm intervals .
  • •Women identified that the pain is either located in the cesarean section scar or caused by palpation of scar and it presents since the time of surgery not prior to the cesarean section.
  • •Their ages will range from 25-35 years old.
  • •Their BMI will be 18.5-29.9 kg/ m².
  • •Voluntary acceptance to participate in the study.

排除标准

  • •Women will be excluded if they have :
  • •Acute and subacute cesarean section.
  • •Delayed wound healing.
  • •History of abdominal or pelvic cancer.
  • •Active pelvic or abdominal infection.
  • •Skin irritation/inflammation at the site of scar.
  • •Currently pregnant women.

研究组 & 干预措施

therapeutic ultrasound

Experimental

Control group will be treated by therapeutic ultrasound only

干预措施: Scar release techniques + therapeutic ultrasound (Other)

therapeutic ultrasound+scar release techniques

Experimental

Study group will be treated by various scar release techniques in addition to therapeutic ultrasound

干预措施: Scar release techniques + therapeutic ultrasound (Other)

结局指标

主要结局

Scar adherence

时间窗: up to 4 weeks

post cesarean section scar adherence will be assessted by an adheremeter for both groups before and after the end of treatment program. A mark will be made on the tightest part of the scar in four directions (superior, inferior, right and left). As there is no a contralateral side to abdominal tissue to be used as a reference range, we will use multi-directional scar mobility (MDM) . Scar mobility measurements across the points will be averaged for each participating women .

pain intensity

时间窗: up to 4 weeks

The pain intensity will be assessed through visual analouge scale( VAS )for all participating women in both groups before and after the end of the treatment program. Each woman will be asked to mark a point on the line between the extremes that is related to her pain intensity.

Patient and Observer Scar Assessment Scale (POSAS)

时间窗: up to 4 weeks

It will be used pre and post- treatment to assess the symptoms of pain and pruritus at the cesarean section scar for all participanting women of both groups before and after the end of the treatment program.

Pressure pain threshold

时间窗: up to 4 weeks

A pressure algometer will be used to measure pressure pain threshold (PPT)for all participating women in both groups before and after the end of the treatment program. PPT recording sites will be marked on the C-section scar at 2.5 cm intervals. This resulted in from 5 to 8 measurement points along the scar. Following, the marked points will be used to record PPTs in all time points for the PPT assessment; a 1-cm2 pressure probe will be positioned perpendicularly to the skin and pressed at a rate of 30kPa/s.Two measures will be collected for each area, with 30 second rest between point testing. Average pressure pain threshold (AvPPPT) (pressure points across worst 3 points on scar averaged) will be used for the analysis of the PPT data

次要结局

  • Quality of life(up to 4 weeks.)

研究者

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

Nabiha Mahmoud Ahmed Mahmoud

Specialist of physical therapy at Elmansoura International hospital

Cairo University

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