Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-11-30
2018-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
TcPRF
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.
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.
Placebo
In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.
Interventions
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TcPRF
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.
Placebo
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* chronic pain (Duration of three Months or more) patients of the Pain Center, Swiss Paraplegic Center, Nottwil
Exclusion Criteria
* severe mental disorders such as severe depression or schizophrenia
* patients with pacemakers or with atrial fibrillation
* Women who are pregnant or breast-feeding
18 Years
65 Years
ALL
Yes
Sponsors
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Swiss Paraplegic Research, Nottwil
NETWORK
Responsible Party
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Principal Investigators
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Daniel Lacher, Dr. phil.
Role: PRINCIPAL_INVESTIGATOR
Pain Center, Swiss Paraplegic Center
Locations
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Pain Center, Swiss Paraplegic Center
Nottwil, Canton of Lucerne, Switzerland
Countries
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Other Identifiers
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2015-12
Identifier Type: -
Identifier Source: org_study_id
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