The Effect of Pulse Frequency and Pad Size of Transcutaneous Electrical Nerve Stimulation (TENS) on Experimental Blunt Pressure Pain in Healthy Participants

Chang Gung University1 个研究点分布在 1 个国家目标入组 180 人开始时间: 2010年3月1日最近更新: 2021年12月22日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Chang Gung University
入组人数: 180
试验地点: 1
主要终点: blunting pressure pain threshold

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 purpose of this study is to determine the antalgic of surface electrical stimulation with pulse frequencies and pad sizes on blunting pressure pain on healthy human due to various temporal and spatial summations of the stimulation.

详细描述

Potential participants expressing interest in the study will be given to read the contraindications for the pain tests and the stimulation intervention, which has been documented on the consent form. All participants meeting entry requirements will be invited to participate in the experiments which take place on a separate occasion.

Each participant will sign the consent form and will be told again that they can withdraw from the study at any time and without explanation. Each participant will be required to experience a 10-minute pre-stimulation period, a 30 minute TENS intervention, a 30 minute follow-up period.

Participants will be seated on a chair with arm support provided by a side table. The investigator will be then informed the stimulation intervention and used pad size on the stimulation periods in written form contained in a sealed envelope. After the participant's verbal permission is obtained, the investigator will apply the pads on the dorsal forearm area.

Either the large size pad, 5cm x 10cm, or the small size,2.5cm x 2.5cm, will be choose to place on the dorsal side of the forearm to straddle the site for blunt pressure pain. The muscle bellies of the forearm are mainly located on the proximal half part. The proximal pad will be attached to the lateral epi-condyle of the elbow, and the distal electrode will be placed 3cm distal to the proximal one along the line between the lateral part of elbow and the mid-point of the wrist. The pads will be then connected to the intervention stimulator. The investigator will relay instructions to the participants using cue cards displayed 30 seconds before any required action.

Before each blunting pressure pain test, the participant will sit comfortably and place their right upper extremity on a side table with the shoulder abduction, elbow flexion, the forearm pronation. The test will be induced using a pressure algometer with a flat circular probe, measuring 1.1cm in diameter (1cm2 on skin surface). Force will be displayed digitally in increments of 0.1 Newton. The algometer will be applied to the mid-point between the intervention pads. The rate of the pressure algometer application will be around 6 Newtons per second on average. The participants will be asked to concentrate on the sensations in the forearm. When the pressure becomes definitely painful, the participant will state "Pain!" and the force will be stopped. The pain threshold will be taken twice in a minute for one test and each measurement will take no more than 30 seconds.

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, Investigator)

盲法说明

The group allocation for each participant was sealed in an envelope prepared by an investigator. Just before the start of the second visit, a second investigator opened the envelope to confirm the allocation of TENS groups for individual participants and applied the TENS. For better blinding, a third investigator assessed the blunt pressure pain threshold (BPPT) for the baseline value.

入排标准

年龄范围: 18 Years 至 26 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy and aged 18 years or over

排除标准

•Any open wound around the arm or hand area, including edema or inflammation;
•Cardiac or vascular problems (such as coronary artery disease, coronary thrombosis, or angina pain, high blood pressures, phlebitis, and pacemaker implantation);
•Any dermatological problems or infections around the hand, forearm, or arm area (such as dermatitis or eczema, bacterial or fungal infections);
•Any history of neoplasm or malignancy;
•Bleeding diseases on the arm or hand (such as haemorrhage); Menstruation or pregnancy;
•Abnormal neurological signs in the upper limbs (such as altered skin sensations);
•Hypersensitivity or phobia to electrical application;
•Any current medication regime.