Chronic PainTcPRFNCT02972099
Pulsed Radiofrequency for Emotional Stress
A study testing TcPRF in people with Chronic Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- TcPRF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2016to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 - 65
- chronic pain (Duration of three Months or more) patients of the Pain Center, Swiss Paraplegic Center, Nottwil
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Pain Center, Swiss Paraplegic Center
Nottwil, Canton of Lucerne, 6207
About this study
Official title: The Psychological Effects of Transcutaneous Pulsed Radiofrequency (TcPRF) in Patients With Emotional Stress
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- TcPRF, Placebo
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TcPRFDevice
Also called TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)
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.
PlaceboDevice
Also called TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)
In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TcPRF |
| 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. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological status - Change between Baseline and Follow-up 1
physiological status, assessed by the heart rate variability (HRV)
Measured: Baseline; Follow-up 1 (+2-4 days)
Secondary outcomes (2)
Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2
Secondary outcome is the subjective well-being, as assessed by the FW-7 questionnaire
Measured: 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
the intensity of pain is assessed by the Numeric Rating Scale for pain (NRS) score by a 7-point Likert scale
Measured: Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Daniel Lacher, Dr. phil., Principal investigator, Pain Center, Swiss Paraplegic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972099
- Sponsor's protocol ID
- 2015-12
- Acronym
- TcPRF
- Status last verified
- Aug 2018
- First submitted
- 18 Nov 2016
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychological Effects of Transcutaneous Pulsed Radiofrequency (TcPRF) in Patients With Emotional Stress
- ClinicalTrials.gov ID
- NCT02972099
- Acronym / sponsor ID
- TcPRF / 2015-12
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TcPRF Group | Experimental | Device: TcPRFAccording 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. |
| Placebo Group | Placebo comparator | Device: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 - 65
- chronic pain (Duration of three Months or more) patients of the Pain Center, Swiss Paraplegic Center, Nottwil
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TcPRFAlso: TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)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. | Device | TcPRF Group |
| PlaceboAlso: TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference. | Device | Placebo Group |
Primary outcome
Physiological status - Change between Baseline and Follow-up 1
Time frame: Baseline; Follow-up 1 (+2-4 days)
physiological status, assessed by the heart rate variability (HRV)
2 secondary outcomes
Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2
Time frame: 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
Time frame: Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lacher, Dr. phil. principal investigator
Pain Center, Swiss Paraplegic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TcPRF in people with Chronic Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological status - Change between Baseline and Follow-up 1 (time frame: Baseline; Follow-up 1 (+2-4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.