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临床试验/NCT07334938
NCT07334938进行中(未招募)不适用

Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short Term Prognosis of Head and Neck Cancer Patients Receiving Curative Treatment

Buddhist Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
90
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

The goal of this clinical trial is to determine whether far-infrared therapy and transcutaneous electrical nerve stimulation (TENS) can improve postoperative side effects in patients with head and neck cancer. The main questions this study aims to answer are:

Can far-infrared therapy and transcutaneous electrical nerve stimulation reduce pain and improve neck range of motion?

Can far-infrared therapy and transcutaneous electrical nerve stimulation reduce inflammation?

Researchers will compare three groups:

Group A: control group; Group B: transcutaneous electrical nerve stimulation; Group C: far-infrared therapy combined with transcutaneous electrical nerve stimulation, to evaluate differences in pain, neck range of motion, and inflammation.

Participants will receive the assigned intervention in the morning and evening for five consecutive days. Outcome measurements will be conducted on the first and fifth days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 30 to 85 years with a confirmed diagnosis of head and neck cancer.
  • Patients scheduled to undergo surgical resection.
  • Patients who are conscious, able to communicate verbally or in writing, and willing to complete questionnaires and comply with all study procedures.

排除标准

  • Presence of open wounds or skin lesions at the sites where transcutaneous acupoint electrical stimulation electrodes would be applied.
  • Contraindications to transcutaneous acupoint electrical stimulation, including a history of epilepsy, brain tumors, arteriovenous malformations, or implanted cardiac pacemakers or defibrillators, to avoid potential adverse effects of electrical stimulation.

研究组 & 干预措施

Control Group

No Intervention

routine care

Transcutaneous Electrical Nerve Stimulation (TENS)

Active Comparator

干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)

TENS Combined With Far-Infrared Therapy

Experimental

干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)

TENS Combined With Far-Infrared Therapy

Experimental

干预措施: Far-Infrared Therapy (Device)

结局指标

主要结局

Pain intensity

时间窗: Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15

Pain intensity will be assessed using a numeric rating scale (NRS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).

次要结局

  • Neck range of motion (ROM)(Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15)
  • Inflammatory markers (LMR, NLR)(Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15)

研究者

发起方
Buddhist Tzu Chi General Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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