Pulsed Radiofrequency for Emotional Stress

Chronic Pain Clinical Trial

— TcPRF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972099
• Other study ID #: 2015-12
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2018
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Stress, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Pain Center, Swiss Paraplegic Center	Nottwil	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological status - Change between Baseline and Follow-up 1	physiological status, assessed by the heart rate variability (HRV)	Baseline; Follow-up 1 (+2-4 days)
Secondary	Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2	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)
Secondary	Intensity of pain - Change between Baseline and Follow-up 1 & 2	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)