Pulsed Radiofrequency for Emotional Stress
- Conditions
- Chronic Pain
- Registration Number
- NCT02972099
- Lead Sponsor
- Swiss Paraplegic Research, Nottwil
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- age 18 - 65
- chronic pain (Duration of three Months or more) patients of the Pain Center, Swiss Paraplegic Center, Nottwil
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Physiological status - Change between Baseline and Follow-up 1 Baseline; Follow-up 1 (+2-4 days) physiological status, assessed by the heart rate variability (HRV)
- Secondary Outcome Measures
Name Time Method Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2 Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post) Secondary outcome is the subjective well-being, as assessed by the FW-7 questionnaire
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) the intensity of pain is assessed by the Numeric Rating Scale for pain (NRS) score by a 7-point Likert scale
Trial Locations
- Locations (1)
Pain Center, Swiss Paraplegic Center
🇨🇭Nottwil, Luzern, Switzerland
Pain Center, Swiss Paraplegic Center🇨🇭Nottwil, Luzern, Switzerland