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临床试验/NCT04501575
NCT04501575已完成不适用

A Feasibility Study of a Randomized Controlled Trial to Assess the Efficacy of the Osteopathic Consultation on Neck-shoulder Pain in Computer Users

Universidade do Porto2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Differences in electrical activity during typing task using surface electromyography

研究概览

简要总结

This study investigates the feasibility of conducting a large scale Randomized Controlled Trial (RCT) to analyze the efficacy of the osteopathic consultation in reducing the intensity of pain and changing electromyographic activity in the musculature of the neck-shoulder region for the computer user's population.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Uses computer for over five hours daily, for over one year
  • Reports non-specific pain over the neck-shoulder region

排除标准

  • No neurologic signs or symptoms
  • No known pathology that could mask the reported pain
  • No knowledge or experience with osteopathy

结局指标

主要结局

Differences in electrical activity during typing task using surface electromyography

时间窗: baseline and after 2-4 days of the treatment

Surface electromyography (sEMG) was used to retrieve the electrical activity of the Upper Trapezius (UT) muscles. The electrical signal was normalized through the maximum isometric voluntary contraction (MIVC) and expressed as a percentage of MIVC. sEMG data will be collect at 4 different moments of the 15 minutes typing task. Electrodes placement, data collection and processing was performed according to SENIAM standards.

Differences in Pressure-pain Threshold (PPT)

时间窗: baseline and after 2-4 days of the treatment

A Digital Pressure Algometer (Wagner FORCE ONE FDIX 50', Wagner Instruments, Greenwich, CT, USA) was used on the trapezius muscle, superior fibers, both sides. The exact location on the muscles was defined as 2cm above the medial electrode, on the muscle fiber direction. During the collection of the PPT, the participant stopped the typing task and rested arms on the legs. The algometer pointer was placed perpendicular to the points marked for evaluation, and then, vertical compression force was applied. That force was increased continuously at a rate of 1 kg/cm2 until pain was reported. Measurements were made in the seating position, immediately before and after the writing task. To ensure the maximum reading was obtained, the C-Peak option of the device was enabled. Participants were instructed of the procedures in advance, and simulation on their forearm was performed before the data collection.

Difference in the self-reported intensity of pain using the numerical rating scale (NRS)

时间窗: baseline, after 2-4 days of the treatment and after 1 week of the treatment

This numeric scale, is used on its 11-point version. NRS represents a simple, 1-dimensional measuring instrument for the assessment of pain intensity (0 = no pain, 10 = unbearable pain). Participants were asked to visualize the quantity of pain they were experiencing at that precise moment over the shoulder-neck region, both sides.

次要结局

  • Satisfaction Level with the experience(1 week after data collection for all participants.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rui José Gomes de Pinho Santiago

PhD Student

Universidade do Porto

研究点 (2)

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