Pulsed Radiofrequency for Emotional Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Psychological Effects of Transcutaneous Pulsed Radiofrequency (TcPRF) in Patients With Emotional Stress

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: TcPRF
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 - 65 chronic pain (Duration of three Months or more) patients of the Pain Center, Swiss Paraplegic Center, Nottwil Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TcPRF Group<br>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. | Device: TcPRF<br>* 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. It is used in the daily clinical practice in the Pain Center of the Swiss Paraplegic Center.<br>* Other names: TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan);|
| Placebo Comparator: Placebo Group<br>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. | Device: Placebo<br>* In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.<br>* Other names: TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological status - Change between Baseline and Follow-up 1 | physiological status, assessed by the heart rate variability (HRV) | Baseline; Follow-up 1 (+2-4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2 | Secondary outcome is the subjective well-being, as assessed by the FW-7 questionnaire | 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 | the intensity of pain is assessed by the Numeric Rating Scale for pain (NRS) score by a 7-point Likert scale | Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post) |