A Feasibility Study of a Randomized Controlled Trial to Assess the Efficacy of the Osteopathic Consultation on Neck-shoulder Pain in Computer Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Osteopathic consultation
It consists of 1 session. Each osteopathic session is based on a structural evaluation and treatment tailored to the participant-specific complains
干预措施: Osteopathic Consultation (Other)
Osteopathic sham consultation
Osteopathic Sham treatment was applied using manual contact on specific bony surfaces using very light pressure. The practitioner was counting the seconds up to 1 minute between the areas where to apply the light touch without any intention to treat or diagnose.
干预措施: Sham Osteopathic Consultation (Other)
Usual Care
Participants will be on a waiting list, and meanwhile, they are advised to deal with their pain in the way they would, but without using any sort of Manual Therapy.
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
Rui José Gomes de Pinho Santiago
PhD Student
Universidade do Porto