Test-Retest Reliability of an Experimental Model of Shoulder Muscle Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Pressure pain threshold (PPT)
研究概览
简要总结
High frequency oscillations of non-ionizing electromagnetic fields range can heat deep tissues in a well-localized region. Recently, a new SWD-based model showed to be a promising tool for investigating muscle pain in humans. The main advantages of the model are its noninvasiveness, the ability to control stimulation parameters, and the convenience of the time frame in which pain and hyperalgesia are developed. This study assess the reliability of SWD pain model to induced transient and intensity-controlled muscle soreness on shoulder in healthy volunteers.
详细描述
This Test-Retest Reliability study comprises a sample of 31 healthy volunteers. Volunteers will be invited to participate in the study through social networks and e-mail.
Experimental pain model assessment
The radiofrequency electromagnetic fields can be produced in the range of 3 kHz to 300 GHz, but frequencies around 27 MHz (short-wave) are preferred to heat deep tissues. Deep tissue heating by means of RF is a safe and extensively used technique in palliative treatment of pain and as a healing agent in soft tissues. This study assess the reliability of SWD to induce soreness. The study will be conducted in two experimental sessions on different days, at least 48 to 72 hours apart each other in order to avoid carryover effects. In each experimental session, several measures will be performed to assess different physiological parameters, including: pressure pain thresholds (PPT), specific self-report questionnaire, isometric muscle strength, pain distribution and myoelectric activity.
In the first session (Test), participants will be interviewed to collect anthropometric data and health history. Basic upper quadrant physical examination will be performed to check inclusion and exclusion criteria. Before and after the application of SWD, several assessments will be performed. Among the different assessment, myoelectric activity of infraspinatus and deltoid muscle will be recorded during isometric arm lifting task. The isometric task will consist in maintaining the arm in 90 degree elevation in the scapular plane (arm flexion) for 8 seconds. This task will be repeated 5 times with 15 seconds of rest between each trial. Finally, a fatiguing motor task will be performed, consisting of flexion and extension of the arm executed cyclically in a range of motion between 30 and 90 degree in the scapular plane. To ensure fatigue, volunteers will perform the task with an additional weight. The size of the weight will be calculated according to each volunteer body mass (1.25 kg in participants under 68 kg and 2.5 kg in participants over 68 kg). The arm flexion and extension speed will be guided using a 60 beats/s metronome. Same process will be repeated in the second session (Retest).
Sample size considerations:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understanding of the content and scope of the experiment, and compliance with the experiment's instructions.
- •To have signed the informed consent.
排除标准
- •Pregnancy.
- •Previous history of neurological or musculoskeletal disorders or chronic pain.
- •Previous history of addictive behavior, defined as abuse of alcohol, cannabis, opioids or other drugs.
- •Previous history of thermosensitivity disorders.
- •Previous history of mental illness.
- •Presence of fever, tuberculosis, tumors, infectious processes, or acute inflammatory processes.
- •Implantation of peacemaker or metallic prosthesis.
- •Use of analgesics within 24 h prior to the experiment.
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers that fulfill the inclusion criteria. Intervention: Short-wave diathermy (Radiation)
干预措施: Intervention: Short-wave diathermy (Other)
结局指标
主要结局
Pressure pain threshold (PPT)
时间窗: At baseline and 30 - 60 minutes after of SWD.
Change in the PPT (kPa) will be assessed bilaterally over the medial portion of the infraspinatus muscle using a digital algometer (Somedic SenseLab AB, Sweden) with a 1-cm2 round tip. Pressure will be gradually increased from 0 kPa at a rate of approximately 50 kPa/s (maximal achievable pressure: 2,000 kPa). The volunteers will be asked to press the button when they perceive that the pressure changes to pain, stopping the estimation at this point. The assessment will be repeated 3 times for each sides, alternating sides between measurements. Each measure will be performed at 30-second intervals.
次要结局
- Pain distribution(At 30 - 60 minutes after the application of SWD.)
- Modified Likert scale(At 30 - 60 minutes after the application of SWD.)
- Isometric muscle strength(At baseline and 30 - 60 minutes after the application of SWD.)
- Myoelectrical activity (EMG)(At 10 minutes before and 30 - 60 minutes after the application of SWD.)
- Visual analog scale(During the application of SWD.)
研究者
Leonardo Intelangelo
Head of the University Center for Assistance, Teaching and Research
University of Gran Rosario