Acupuncture vs TENS for Gag Reflex
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Severity of gag reflex
研究概览
简要总结
This study examines if acupuncture or TENS of P-6 and St-36 acupoints has a measurable effect on gag tolerance.
详细描述
The gag reflex is a normal protective mechanism, and portion of the population has an exaggerated reflex that can present major problems in dentistry as well as endoscopy. Early studies with acupuncture have been promising, but these studies are limited as has not been a way to objectively measure the response to gag reflex. Recent work by Drs. Karibe and Goddard has determined a novel way of measuring gag reflex in healthy subjects, which makes it possible to study the effects of an intervention on gag reflex.
Acupuncture has been demonstrated to be effective for treating gag reflex, but this effect has not been objectively demonstrated using this novel method. As such, this study investigates the effect of acupuncture against placebo on gag reflex. Practically speaking, these findings are unlikely to be of high value since the availability of acupuncturists at dental offices is limited. For this reason, the investigators added a third arm to evaluate the use of a transcutaneous electrical nerve stimulator (TENS) device on the same acupuncture points as a treatment intervention to see if this is non-inferior to acupuncture. TENS is an FDA regulated treatment for the treatment of pain, and has been 510K cleared for other uses including nausea. The placebo arm uses a TENS device that has the wire severed, so that the light will continue to blink but no current will be applied.
60 total subjects will be recruited and randomized into one of these three groups: acupuncture, TENS and Sham-TENS.
Passive EKG readings will be collected using the FirstBeat Bodyguard 2, which is a 2-lead EKG device that the subject will wear during the study. This is to later evaluate vagal tone by analyzing the spectral analysis of heart rate variability.
Once this device is affixed to the front of the patient's chest, the gag reflex will be measured. The subject will then undergo the appropriate treatment (acupuncture, TENS or Sham-TENS for a total of 20 minutes, with a subsequent gag reflex measurement. The subject will then rest for at least 5 minutes at the end of the study to collect final EKG data, then given a gift card for her time.
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, Care Provider)
盲法说明
Masking of the participant:
The subject is randomized to one of three groups: 1: acupuncture, 2: TENS, and 3: sham-TENS. While those assigned to the acupuncture group are aware of their group assignment, groups 2 and 3 receive an identical TENS pad placement. A sham-TENS unit is used with disconnected wires to provide a blinking light without an electrical signal. Participants are advised that that the sensation of electrical tingling is not necessary.
Masking of the examiner:
The acupuncture or TENS/sham/TENS is performed by one examiner. A second examiner will enter the room to perform the gag reflex measurement, both before and after the treatment
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English Speaking
排除标准
- •bleeding dyscrasias
- •severe needlephobia
- •pacemaker or other implanted electrical device
结局指标
主要结局
Severity of gag reflex
时间窗: immediately after procedure
Subjects are also be asked to report the severity of their gagging on a scale of 1-10, with 1 representing the minimum and 10 representing the maximum
Insertion length
时间窗: immediately after procedure
A standard saliva ejector with a stopper made of heavy-body addition silicone impression putties is inserted into the participants' mouth at the maxillary central incisor, and gradually guided down the participant's throat along the palate. The participants are asked to inform the examiner when their maximum tolerance has been reached by pushing a button that beeps. The examiner then stopped inserting the saliva ejector, remove it, and measure the insertion distance of the saliva ejector from the maxillary central incisor using digital calipers. This distance is recorded as an index of the gag reflex.
次要结局
未报告次要终点
研究者
Andrew Shubov, MD
Assistant Clinical Professor
University of California, Los Angeles