跳至主要内容
临床试验/NCT07010627
NCT07010627已完成不适用

Evaluation of the Application of Auricular Laserpuncture in the Treatment of Chronic Pain

Universidade do Vale do Paraíba2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Comparative efficacy evaluation between the application of auricular laser acupuncture and the use of mustard seeds in the treatment of chronic pain

研究概览

简要总结

The objective of the study to evaluate the effectiveness of a treatment protocol using auricular acupuncture point stimulation with laser , compared to the use of mustard seeds, for reducing chronic pain in the elderly. With this research, the researches hope to obtain results that allow us to establish a non-invasive, easy, quick-to-apply, and painless treatment protocol to minimize chronic pain in the lumbar spine, shoulders, and knees, thereby improving the quality of life of the target population in this study.

In the first session and before the start of the treatment protocol, three questionnaires will be applied for evaluation of the subjects: the first to assess quality of life (SF-36), and the others to evaluate pain intensity (Visual Analog Scale for pain and the McGill Pain Questionnaire). The pain location will be assessed using a thermografic camara that evaluates skin temperature, as well as a Traditional Chinese Medicine device (Ryodoraku) that measures the energy flow in the body's meridians. The same evaluation protocol will be repeated before the fifth session and after the tenth session.

详细描述

This study will analyze the effectiveness of treatment protocols A or B for chronic pain in the shoulder, knee, or lumbar spine regions in elderly individuals. The protocol A involves the application of low-power red laser therapy on auriculotherapy acupoints. The protocol B involves the application of mustard seeds . To assess the qualitative aspect of the study, the McGill Pain Questionnaire and the Visual Analog Scale will be used to evaluate chronic pain, while the SF-36 instrument will assess the participants' quality of life before and after the treatment protocol. For the quantitative evaluation, thermographic imaging and the Ryodoraku System will be used. All proposed tools will be applied before the first treatment session, before the fifth session ,and at the end of the tenth session.

Risks and Benefits During the study, participants will be subject to risks related to physical and psychological discomfort due to the proposed therapeutic protocol. All procedures will be performed individually in an appropriate and private room to ensure the participant's comfort and privacy. Each participant will be provided with protective goggles, which must be worn throughout the laser application period. These goggles will be sanitized before each session, and the laser device tip will be covered with PVC film, replaced after each session.

Although rare, stimulation of the auricular pavilion may cause transient side effects such as local pain, fatigue, dizziness, nausea, and headaches. The use of the laser may generate slight discomfort, such as mild warming, but this effect is temporary and has no serious consequences. If a participant experiences any of these symptoms or any other physical discomfort, the protocol will be immediately interrupted, and the participant will remain under observation by the researcher until they feel better. The use of mustard seeds may cause mild pain at the application site, but this typically subsides over time. Participants will be informed that if a seed falls off prematurely, it will not affect the treatment, and they should continue stimulating the remaining seeds three times a day and remove them one day before the next session.

Psychological discomfort may also arise when participants answer the questionnaires. The questionnaire will be administered in a private setting with only the participant and the researcher present. If the participant feels uncomfortable, they may request to withdraw from the study.

To minimize the risk of exposure of participants' personal data, the researcher commits to storing all collected data in password-protected digital files accessible only to the research team. Each participant will be assigned an individual identification code to prevent any possibility of access or identification.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged between 60 and 90 years;
  • Both sexes;
  • Report of chronic pain in the lumbar region, shoulders, or knees;
  • Sign the Informed Consent Form.

排除标准

  • Undergoing treatment similar to the proposed research protocol at another facility or physiotherapy service;
  • Using analgesic or anti-inflammatory medications;
  • Unable to fully understand the protocol proposed by the researcher;
  • Unwilling to participate in the study and/or unavailable to attend all proposed treatment sessions;
  • Presence of lesions on the auricular pavilion;
  • Wearing earrings or piercings in the acupoint regions targeted for laser stimulation.

研究组 & 干预措施

Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red light

Active Comparator

"Stimulation using a laser programmed in continuous mode, emitting red light (4 J of energy) at the following auricular acupoints:

  1. Chronic shoulder pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, shoulder region, adrenal;
  2. Chronic knee pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, knee region, adrenal;
  3. Chronic lumbar pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, lumbar region, adrenal."

干预措施: Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red light (Procedure)

"Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds."

Active Comparator

The conventional clinical practice treatment will be carried out, consisting of the application of mustard seeds to stimulate the following auricular acupoints:

  1. Chronic shoulder pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, shoulder region, adrenal;
  2. Chronic knee pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, knee region, adrenal;
  3. Chronic lumbar pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, lumbar region, adrenal.

干预措施: "Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds." (Procedure)

结局指标

主要结局

Comparative efficacy evaluation between the application of auricular laser acupuncture and the use of mustard seeds in the treatment of chronic pain

时间窗: Untill the completion of the study which take approximately 12 months

The collected data will be entered and tabulated in Excel 2010 and analyzed using the Statistical Package for the Social Sciences (SPSS), version 17.0. The Shapiro-Wilk test will be performed on numerical variables to determine whether they follow a normal distribution. A significance level of 0.05 will be adopted to assess normality. For normally distributed data, Pearson's correlation coefficient (r) will be used to measure the magnitude and degree of relationship between variables, and Student's t-test will be applied to evaluate significant differences between the means of two conditions.

次要结局

未报告次要终点

研究者

发起方
Universidade do Vale do Paraíba
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验