- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972099
Pulsed Radiofrequency for Emotional Stress (TcPRF)
The Psychological Effects of Transcutaneous Pulsed Radiofrequency (TcPRF) in Patients With Emotional Stress
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Luzern
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Nottwil, Luzern, Switzerland, 6207
- Pain Center, Swiss Paraplegic Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
Other Names:
|
Placebo Comparator: 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.
|
In the Placebo Treatment, no current will be delivered.
Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiological status - Change between Baseline and Follow-up 1
Time Frame: Baseline; Follow-up 1 (+2-4 days)
|
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
Time Frame: 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
|
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
Time Frame: 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
|
Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Lacher, Dr. phil., Pain Center, Swiss Paraplegic Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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