Pulsed Radiofrequency for Emotional Stress (TcPRF)

August 2, 2018 updated by: Swiss Paraplegic Centre Nottwil

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Luzern
      • Nottwil, Luzern, Switzerland, 6207
        • Pain Center, Swiss Paraplegic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)
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:
  • TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Lacher, Dr. phil., Pain Center, Swiss Paraplegic Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

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)?

No

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.

Clinical Trials on Chronic Pain

3
Subscribe