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临床试验/NCT07036393
NCT07036393招募中不适用

Acupuncture Versus Transcutaneous Electrical Nerve Stimulation on Pain Post Upper Abdominal Surgeries

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
assessment of change of postoperative quality of recovery

研究概览

简要总结

This study was done to:

  • Determine the therapeutic efficacy of acupuncture as physical therapy approach in minimizing pain post upper abdominal surgeries.
  • Determine the therapeutic efficacy of transcutaneous electrical nerve stimulation in minimizing pain post upper abdominal surgeries.
  • Compare the efficacy and safety of Transcutaneous electrical nerve stimulation versus acupuncture in minimizing pain post upper abdominal surgeries.

详细描述

Postoperative pain is caused by tissue damage from surgical incisions, triggering acute nociceptive activity in sensory nerve endings. Pain sensations reach the brain through dorsal horn, where it is recognized and interpreted. Management modalities include pharmacologic and non-pharmacologic methods. This study aims to provide a guideline on the effect of acupuncture and transcutaneous electrical nerve stimulation on pain reduction after upper abdominal surgeries.

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
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who will have pain after upper abdominal surgery.
  • •Adult patients will be between 20 and 45 years of age.
  • •Both sexes will be included.
  • •Patients have no contraindications for acupuncture or transcutaneous electrical nerve stimulation.
  • •Patients with good compliance and fit for treatment.
  • •This study will be applied on upper abdominal surgeries [laparoscopic cholecystectomy, Gastrectomy].
  • •Physical therapy will be used for up to 48 hours after surgery or until the time of discharge.

排除标准

  • •Patients with other causes of pain other than that after upper abdominal surgery.
  • •Patients who will have any contraindication for both therapies used.
  • •Patients with cardiovascular disease, liver, or renal disease.
  • •Patients with malignant tumors.
  • •Patients with metal or electronic implants.
  • •Patients with autoimmune disease.
  • •Pregnancy, postpartum period, breastfeeding.
  • •Patients with recent injury in the treatment area

研究组 & 干预措施

Acupuncture

Experimental

This group includes 20 patients who will receive Acupuncture 4 weeks (3times/week) and medical treatment

干预措施: Acupuncture (Other)

Acupuncture

Experimental

This group includes 20 patients who will receive Acupuncture 4 weeks (3times/week) and medical treatment

干预措施: drugs (Other)

Transcutaneous electrical nerve stimulation

Active Comparator

This group includes 20 patients who will receive Transcutaneous electrical nerve stimulation 4 weeks (3times/week) and medical treatment

干预措施: Transcutaneous electrical nerve stimulation (Other)

Transcutaneous electrical nerve stimulation

Active Comparator

This group includes 20 patients who will receive Transcutaneous electrical nerve stimulation 4 weeks (3times/week) and medical treatment

干预措施: drugs (Other)

结局指标

主要结局

assessment of change of postoperative quality of recovery

时间窗: At baseline and 4 weeks

The Postoperative Quality of Recovery Scale is a verbal scale designed to assess the quality of recovery in six domains: physiology, nociceptive, emotional, activities of daily living, cognitive, and overall patient perspective. It measures systolic blood pressure, heart rate, temperature, respiratory rate, oxygen saturation, and airway control, aiming to assess physiologic safety and home readiness for day care surgery. It also assesses pain and nausea using a 1-5% Likert rating scale. Emotional domain measures feelings of anxiety and depression. Activities of daily living assess physical return to normality through daily activities, with scores ranging from 3 to 1. Cognitive domain measures orientation, verbal memory, executive functioning, attention, and concentration. Performance variability tolerance factors are applied to ensure participants are not included in subsequent analysis if baseline scores are equal to or less than the tolerance factor.

次要结局

  • assessment of change of pressure pain threshold(At baseline and 4 weeks)

研究者

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

Samar Saad Nazim Mohamed

principal investigator

Cairo University

研究点 (1)

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