The Psychological Effects of Transcutaneous Pulsed Radiofrequency (TcPRF) in Patients With Emotional Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Physiological status - Change between Baseline and Follow-up 1
研究概览
简要总结
The objective of the study is to assess the short-term and long-term effects of transcutaneous pulsed radio frequency treatment on the physiological status, subjective well-being, and on the intensity of pain. Category A Transcutaneous Pulsed Radiofrequency is a method that is widely used for control of pain. There are no known complications. In this study a Radiofrequency generator will be used that has a separate outlet for transcutaneous use. Patients will be recruited within the clinic population of patients.
详细描述
Data will be assessed in at three times, the baseline testing, the first and the second follow-up meeting (+2-4 days of intervention; as well as + 40 days via post/email)
The inclusion criteria are: Inclusion:
- age 18 - 65
- chronic pain (Duration of three Months or more) patients of the Pain Center Nottwil, Swiss Paraplegic Center
The following criteria will lead to an exclusion of the study:
- severe medical issues, such as cancer or comparable diseases
- severe mental disorders such as severe depression or schizophrenia
- patients with pacemakers or with atrial fibrillation
- Women who are pregnant or breast-feeding The primary outcome assessed is the physiological status, assessed by the heart rate variability (HRV). Secondary outcomes are the subjective well-being, as assessed by the "Marburger questionnaire regarding habitual well-being" (FW-7) questionnaire as well as the intensity of pain, as assessed by the numeric rating scale for pain intensity (NRS) score and by a 7-point Likert scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •age 18 - 65
- •chronic pain (Duration of three Months or more) patients of the Pain Center, Swiss Paraplegic Center, Nottwil
排除标准
- •severe medical issues, such as cancer or comparable diseases
- •severe mental disorders such as severe depression or schizophrenia
- •patients with pacemakers or with atrial fibrillation
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
TcPRF Group
According to the standard application of the device, for the PRF procedure one 5 x 13 cm skin electrode will be placed over the forehead, the other one over the posterior aspect of the neck. PRF with a duty load of 14.8 msec/sec and an average pulse frequency of 5.11 Hz will be applied for 25min. The voltage will be set to generate a current of 1 A.
Voltage and impedance will be monitored continuously during treatment and if necessary the voltage will be corrected to ensure the proper current.
干预措施: TcPRF (Device)
Placebo Group
The setup will be made as for active treatment but no current will be delivered. The patients will not be able to feel any difference to the real treatment.
干预措施: Placebo (Device)
结局指标
主要结局
Physiological status - Change between Baseline and Follow-up 1
时间窗: Baseline; Follow-up 1 (+2-4 days)
physiological status, assessed by the heart rate variability (HRV)
次要结局
- Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2(Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post))
- Intensity of pain - Change between Baseline and Follow-up 1 & 2(Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post))