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临床试验/NCT05875545
NCT05875545已完成不适用

Investigation of the Clinical Effects of Breathing Exercises Combined With Pelvic Floor Exercises in Women With Chronic Pelvic Pain

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change from Baseline Pelvic Floor Muscle Activity (PFMA) at 8 weeks

研究概览

简要总结

The primary cause of the complex interaction of chronic pelvic pain originates from the visceral organs in the pelvic cavity, and it has been observed that musculoskeletal dysfunctions (such as increased muscle activity in the pelvic floor muscles) are often accompanied by visceral painful stimuli in the pelvic region as a result of shared innervation and visceral-somatic convergence.

This study aims to investigate the effect of breathing exercises combined with pelvic floor exercises on pain, pelvic floor muscle activity, psychological factors, and quality of life in women with chronic pelvic 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 (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Be diagnosed with chronic pelvic pain (CPA)
  • •Having pelvic pain for at least 6 months
  • •18-45 years old
  • •Having high resting activity of the pelvic floor (>2 microvolts based on superficial EMG (sEMG) readings)

排除标准

  • •Having a history of pelvic cancer and/or surgery
  • •Receiving radiotherapy and/or chemotherapy
  • •Having a neurological and/or psychiatric pathology
  • •Have a urinary tract infection
  • •Menopause
  • •Presence of current pregnancy status
  • •History of miscarriage and ectopic pregnancy
  • •Presence of prolapse
  • •Being >30 kg/cm2 according to body mass index (BMI)
  • •Have received treatment for the pelvic area including manual therapy and electrotherapy in the last 6 months
  • •Having had botulinum toxin injections in the pelvic region in the last 6 months
  • •Having a communication problem

研究组 & 干预措施

Breathing Exercise Group

Active Comparator

Combined breathing and pelvic floor exercises

干预措施: Breathing Exercises (Other)

Breathing Exercise Group

Active Comparator

Combined breathing and pelvic floor exercises

干预措施: Pelvic Floor Exercises (Other)

Control Group

Active Comparator

Pelvic floor exercises

干预措施: Pelvic Floor Exercises (Other)

结局指标

主要结局

Change from Baseline Pelvic Floor Muscle Activity (PFMA) at 8 weeks

时间窗: at the baseline and end of the 8 weeks (16 sessions)

PFMA measurement will be performed with the sEMG NeuroTrac MyoPlus Pro (Verity Medical Ltd, UK) device integrated with computer software for digital analysis and report generation.

Change from Baseline Visual Analogue Scale (VAS) at 8 weeks

时间窗: at the baseline and end of the 8 weeks (16 sessions)

Pain severity will be evaluated with the VAS.

Change from Baseline McGill Pain Scale- Short Form at 8 weeks

时间窗: at the baseline and end of the 8 weeks (16 sessions)

The scale consists of 3 parts. In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part, there were five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the current pain intensity of the patient was evaluated using a visual comparison scale.

次要结局

  • Global Pelvic Floor Disorder Questionnaire(at the baseline and end of the 8 weeks)
  • Corbin Postural Rating Scale(at the baseline and end of the 8 weeks)
  • Pelvic Pain Impact Questionnaire(at the baseline and end of the 8 weeks)
  • Short Form-36(at the baseline and end of the 8 weeks)
  • Depression, Anxiety and Stress Scale(at the baseline and end of the 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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