Pulsed Radiofrequency for Emotional Stress (TcPRF)

• ClinicalTrials.gov Identifier: NCT02972099
• Recruitment Status: Completed
• First Posted: November 23, 2016
• Last Update Posted: August 3, 2018
• Sponsor: Swiss Paraplegic Centre Nottwil
• Information provided by (Responsible Party): Swiss Paraplegic Centre Nottwil

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Device: TcPRF; Device: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: The Psychological Effects of Transcutaneous Pulsed Radiofrequency (TcPRF) in Patients With Emotional Stress
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: July 31, 2018

Arms and Interventions

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.	Device: 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.; Other Name: 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.	Device: 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 Name: TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Switzerland

Pain Center, Swiss Paraplegic Center

Nottwil, Luzern, Switzerland, 6207

Sponsors and Collaborators

Swiss Paraplegic Centre Nottwil

Investigators

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

More Information

• Responsible Party: Swiss Paraplegic Centre Nottwil
• ClinicalTrials.gov Identifier: NCT02972099
• Other Study ID Numbers: 2015-12
• First Posted: November 23, 2016
• Last Update Posted: August 3, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations