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Completed

NCT Number: NCT02972099

Pulsed Radiofrequency for 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pain Center, Swiss Paraplegic Center

Nottwil, Canton of Lucerne, 6207, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TcPRF

Device

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

Device

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

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

Acronym: TcPRF

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 23, 2016
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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