The Impact of Transcutaneous Electrical Stimulation on Facial Pain, Jaw Mobility, and Oral Health in Individuals With Motor Neuron Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale for Pain
研究概览
简要总结
The goal of this clinical trial is to evaluate the impact of non-invasive electrical stimulation, when placed on the facial muscles can reduce facial pain and improve jaw mobility, and chewing in individuals with Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS). The secondary goal is to evaluate the impact of non-invasive electrical stimulation on patient reported difficulty performing oral hygiene tasks in individuals with ALS and PLS. Participants will attend one in-person clinic visit and participate in one telephone interview 24 hours after the treatment. The clinic visit will include pre-intervention assessments, a single 30-minute treatment of electrical stimulation followed by post-intervention assessments.
The assessments will include a self-rating of jaw and facial pain, a range of motion test where participants will be asked to open their jaw as wide and as far to the side as possible, and a chewing efficiency test using a saltine cracker. Twenty-four hours later, participants will receive a follow-up phone call to self-rate their facial pain and report any difficulty performing oral hygiene tasks.
The treatment consists of a single 30-minute electrical stimulation session. Electrode pads will be placed on the participant's facial region, specifically over the masseter muscle belly and the TMJ area, while the participant is seated comfortably. The pads will be connected to an FDA-approved electrical stimulator, and the current will be adjusted to the participant's comfort level. Once set, the participant will remain seated for 30 minutes. At the end of the session, the stimulator will be turned off and the electrode pads removed.
详细描述
In this prospective, cross-sectional study, individuals with ALS and PLS will participate in one in-person clinic visit, followed by a telephone interview 24 hours post-treatment. During the clinic visit, pre-intervention assessments will be conducted to evaluate facial pain, jaw range of motion (jROM), mastication efficiency, and patient-reported difficulty with oral hygiene tasks. Following these assessments, participants will receive a single 30-minute TENS treatment. The PI or Co-PI will be present throughout the intervention, monitoring for any discomfort and providing participants the option to discontinue treatment if needed using a predetermined signal.
Post-intervention assessments, identical to the pre-intervention evaluations, will then take place. The entire clinic visit is expected to take approximately 90 minutes. A brief telephone interview 24 hours after the intervention will collect subjective feedback, including patient-reported pain levels and perceived difficulty of performing oral hygiene tasks.
The primary outcome measure will be patient-reported pain, defined by the International Association for the Study of Pain "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage," localized to the jaw region and assessed using a Numeric Rating Scale (NRS). Secondary outcome measures will include jROM, the ability to chew solid foods, and participants' perceived difficulty with oral hygiene tasks, as outlined below.
Participants.
Participants will be identified and recruited during weekly ALS/PLS multidisciplinary clinic visits. The study will enroll 10 pALS/pPLS between the ages of 25 and 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited) OR diagnosis of definite PLS by the treating neurologist and based on the consensus diagnostic criteria for PLS
- •Subjective report of jaw pain, indicated by a NRS score of > or = 3/10.
排除标准
- •history of head or neck cancer
- •history of CVA
- •history of past facial surgery with hardware placement
- •history of pacemaker
- •diagnosis of significant cognitive impairment by the treating physician
- •history of seizures or diagnosis of epilepsy
- •open wound at the area of electrode placement
- •complete loss of sensation at the area of electrode placement
研究组 & 干预措施
Transcutaneous electrical stimulation to reduce facial pain and improve jaw ROM in ALS and PLS.
All 10 participants will receive a single TENS intervention, with electrodes placed over the masseter and TMJ regions. This intervention is designed to evaluate TENS as a potential treatment for reducing facial pain and improving jaw mobility and chewing function in individuals with ALS and PLS..
干预措施: Transcutaneous Electrical Nerve Stimulation to reduce facial pain and improve jaw range of motion in ALS and PLS (Device)
结局指标
主要结局
Numerical Rating Scale for Pain
时间窗: Baseline, immediately post-intervention and 24 hours post-intervention
0-10 numeric rating scale where participants will self rate their pain on a scale of 0-10 with 0 = no pain and 10 = worst possible pain.
次要结局
- Jaw Range of Motion (jROM) Assessment(Baseline and immediately post-intervention)
- Test of Mastication and Swallowing Solids (TOMASS)(Baseline and immediately post-intervention)
- Numeric Rating Scale for Oral Hygiene(Baseline and 24 hours post intervention.)