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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.
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:
The following criteria will lead to an exclusion of the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TcPRF Group | Experimental | 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. |
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| Placebo Group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Intensity of pain - Change between Baseline and Follow-up 1 & 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Lacher, Dr. phil. | Pain Center, Swiss Paraplegic Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Center, Swiss Paraplegic Center | Nottwil | Canton of Lucerne | 6207 | Switzerland |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
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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) |