Effects of Transcutaneous Nerve Electrostimulation (TENS) of Acupuncture Points on Pulmonary Function and Dyspnea Symptoms in Patients With Pulmonary Nodules Treated at a Referral Service: A Randomized Single Blind Study

Hospital Santa Marcelina2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2019年8月6日最近更新: 2019年8月12日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Hospital Santa Marcelina
入组人数: 60
试验地点: 2
主要终点: Evaluate the effects of TENS on dyspnea symptoms.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The ancient use of acupuncture as a treatment modality of traditional Chinese medicine has also been proven effective in Western medicine. The use of this treatment tool for pain control is already proven in the literature and today is considered an important adjuvant for this purpose. However, the ancient texts of acupuncture also report the use of certain points to tonify organs functions, despite of pain control. According to these texts there are some points that allow the treatment of lung diseases improving respiratory function.

In order to investigate the effects of stimulation of such points using electric field application, the effect of these procedure on pulmonary function and the impact of this practice on dyspnea symptoms, the investigators will conduct a randomized study with 60 patients (1: 1 randomization) distributed in 2 arms (intervention arm-BI and control arm-BC). Transcutaneous neural stimulation of acupuncture points of the BI patients will be performed. For the BC arm the investigators will place the electrodes over the points without turn on the device to produce a placebo effect. Pulmonary function test, Borg scale application and 6 min walk test will be performed before and after the intervention in each group for subsequent data comparison.

详细描述

Introduction:

The use of acupuncture for pain management is well defined and fully established. The stimulation of acupuncture points using needles, electrical stimuli, thermal or laser stimuli produce local effects at the point (nociceptor stimulation and release of inflammatory mediators) that generate systemic effects (serotonin release and endorphins in the Central Nervous System). leading to the state of body relaxation, well-being, changes in heart rate, blood pressure and analgesia.

However, acupuncture can trigger other effects beyond pain control. In ancient texts dealing with the subject there are descriptions of points capable of promoting improvement of specific organic functions such as pulmonary function. 2 This effect is due to changes generated by the action of acupuncture on the autonomic nervous system promoting bronchodilation and decreased mucus production. Some studies of effects of acupuncture in patients with chronic obstructive pulmonary disease have shown promising results related to improved lung function and reduced symptoms.

Transcutaneous nerve electrostimulation (TENS) can be used to stimulate acupuncture points as an alternative to needles. This modality of stimulation prevents the occurrence of serious complications such as pneumothorax secondary to needle application to thoracic points. This practice turns the procedure safer allowing any trainned healthcare professional to do it.

Goals:

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: Double (Participant, Outcomes Assessor)

盲法说明

. To minimize the impact of non-blinding investigators, will be designated a specific investigator who will be responsible for randomizing participants at the time of TENS application and performing the intervention do not allowing the investigators responsible for data collection know whether the patient will be BI or BC. After data collection, the same investigator will segregate the information from BC and BI keeping the subgroups identification in secret do not allowing the investigator who will perform the statistical analysis know what are the groups.

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•patients with pulmonary nodules attended at Santa Marcelina Hospital.

排除标准

•Patients with pacemakers
•patients unable to read, understand and sign the informed consent form
•patients with mobility restrictions
•patients with chest pain
•patients who have previously used TENS

研究组 & 干预措施

Intervention Arm (BI)

Experimental

The BI participants will initially undergo simple spirometry and a 6-minute walk test and Borg scale application upon admission to the thoracic surgery department. Immediately after the exams, they will undergo a TENS application session over the acupuncture points: Feishu, Zhongfu, Taiyuan and Dingchuan using a frequency of 200Hz and a pulse time of 80 seconds of sufficient intensity to cause a slight sensation of local numbness without muscle fasciculations. The TENS application time will be 30 minutes. Immediately after the TENS application, the participants will be submitted to a new spirometry, a new 6-minute walk test and again to the Borg scale.

干预措施: transcutaneous nerve electrostimulation (TENS) of acupuncture points (Other)

Control Arm (BC)

Placebo Comparator

The BC participants will undergo the same steps as BI, however when applying TENS to these participants investigators will place the electrodes over the points without turning on the device in order to obtain the effect of a placebo.

干预措施: transcutaneous nerve electrostimulation (TENS) of acupuncture points (Other)