Clinical trial NCT02972099: Pulsed Radiofrequency for Emotional Stress
Official title: The Psychological Effects of Transcutaneous Pulsed Radiofrequency (TcPRF) in Patients With Emotional Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2016-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Physiological status - Change between Baseline and Follow-up 1
timeFrame: Baseline; Follow-up 1 (+2-4 days)
Secondary outcomes:
measure: Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2
timeFrame: Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)
measure: Intensity of pain - Change between Baseline and Follow-up 1 & 2
timeFrame: Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Pain Center, Swiss Paraplegic Center
state: Luzern
Study officials:
affiliation: Pain Center, Swiss Paraplegic Center
name: Daniel Lacher, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References: