Pulsed Radiofrequency for Emotional Stress (TcPRF)

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Placebo; Device: TcPRF

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02972099

2015-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

TcPRF Group

Experimental group

Description:

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.

Treatment:

Device: TcPRF

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo