Chronic Pain
Conditions
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.
Interventions
DEVICETcPRF
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.
DEVICEPlacebo
In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.
Sponsors
Swiss Paraplegic Research, Nottwil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological status - Change between Baseline and Follow-up 1 | Baseline; Follow-up 1 (+2-4 days) | physiological status, assessed by the heart rate variability (HRV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2 | 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 |
| Intensity of pain - Change between Baseline and Follow-up 1 & 2 | 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 |
Countries
Switzerland
Outcome results
None listed