Neuropathic PainPURPOSENCT06270940
Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy
An observational study of Neuropathic Pain, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Pulsed Radiofrequency (PRF) Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Mar 2024to 28 Feb 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this data collection consists of patients who will receive PRF treatment for chronic peripheral neuropathic pain (duration of pain ≥ 6 months).
Who may be able to join
- Adult patients ≥ 18
- Dutch speaking
- Chronic peripheral neuropathic pain lasting ≥ 6 months with mean NRS pain score of ≥ 4
- Patients who are scheduled for an ultrasound guided PRF treatment on a peripheral nerve
- Willing and able to sign consent
Who cannot join
- Inability to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, 1081 HV
Katrin Stoecklein, Dr, 0031 20 444 386, k.stoecklein@amsterdamumc.nl
About this study
Official title: Prospective Study Upon Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy
Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes.
Read the detailed description
Patients with chronic peripheral neuropathic pain visiting the outpatient pain clinic and who will be scheduled for PRF treatment will be considered for inclusion by the treating pain physician. When meeting the inclusion criteria and none of the exclusion criteria, the patient will receive verbal information (during the patient visit or by phone) and will be asked to participate in this data collection. Signed informed consent will be obtained during the outpatient pain clinic consultation.
This study follows a Data Management Plan which provides relevant information regarding data management requirements.
- Study Preparation: The dataset is encoded via a unique, meaningless code (Subject ID). Data are de-identified within the study database. Data acquisition has been registered with the Data Protection Officer (DPO). An informed consent procedure has been established that describes the dataset, the timeframe for data retention, information on data sharing, and making data available for future research. A central location for all digital and hard copy study documents exists.
- Data acquisition: Reuse of existing data, such as patient characteristics in the patient's medical record system in EPIC, is covered by the subject's informed consent.
- Data collection: The Castor EDC system is used for data collection. Licensing and processing agreements have been arranged. The researchers are trained in using this system, and documentation of their training is available. The database was designed before being built, and a data dictionary was created. Validation checks for completeness, correctness, and consistency are incorporated into the data collection system and have been documented. The data collection system has been tested by both the study team and an independent party. Access to the data collection system is based on individual login with only the necessary access rights and is managed under supervision and documented by the Principal Investigator (PI). Users are trained in the data collection system.
- Data storage: Raw, interim, final, and key files are stored on the department's M-drive. Raw and final files are stored on the data storage facility at Amsterdam University Medical Center and on the Castor storage facility.
- Data collection: A site signature and delegation log of all people involved in the data collection are kept by the PI. Checks for completeness, correctness, and consistency are built into the system. An audit trail and track changes functionality are used in the applied system. All changes in the design will be documented to ensure an impact assessment of these changes is performed. Approval and the reason for locking the data collection have been documented.
- Processing and statistical analysis: The data are stored in a generic and machine-actionable format, such as CSV, and also stored in SPSS as a read-only file. All data processing and analysis are programmed in syntax or script files.
- Writing and publishing: For each manuscript, a structured subfolder has been created.
- Data sharing and archiving: Metadata (documentation on study procedures, data dictionary, data validation, and derivation plan) and final data will be published. For verification purposes, all data are stored internally. A de-identified dataset will be made available upon request to the corresponding author. The request must include ethics approval and a statistical analysis plan. The embargo period is at least 1 year after the publication of the original study. For data reuse, a Data Sharing Agreement will be set up. Digital data (metadata, raw data files, final data files), and documentation will be preserved for 10 years. A subject identification log is archived and kept separate from other study-related data. This does not conflict with the subject's informed consent. Paper documentation will be preserved for 10 years.
- Conditions
- Neuropathic Pain
- Being tested
- Pulsed Radiofrequency (PRF) Treatment
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Radiofrequency (PRF) TreatmentProcedure or surgery
PRF treatment maintains a temperature below 42°C and does not produce structural tissue damage around the needle. PRF exposure to the Dorsal Root Ganglion (DRG) induces c-Fos gene expression in the dorsal horn, which suggests a cellular response to the electric forces generated within the DRG. PRF has been found to relieve neuropathic pain by inducing long-term depression of synaptic transmission in the spinal cord, leading to a decrease in allodynia and hyperalgesia. It also modulates the inflammatory response in the injured area by decreasing the expression of pro-inflammatory cytokines, such as TNF-α, in the peripheral nerve and spinal cord, which is a major player in the development and maintenance of neuropathic pain. PRF is characterized by a 500 kHz current applied for 2 pulses per second, with each pulse lasting 20 milliseconds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration PRF
Duration PRF: 4 or 8 minutes
Measured: Procedure
Type of PRF
2 Hz of 5 Hz / 5 ms or 20 ms / Monopolar or bipolar / Voltage / Temperature / Resistance / Current
Measured: Procedure
Pain intensity
Pain with NRS (Numeric Rating Scale): Min=0 / Max=10 / Low score is better
Measured: Baseline, 6 weeks, 3 months, 6 months
Health Related Quality of life
EQ-5D-5L (EuroQol Quality of life) questionnaire: Index=Patient health state / Min=-0.446 / Max=1 / Higher is better / Patient self rated health: Min=0% / Max=100% / High scores are better
Measured: Baseline, 6 weeks, 3 months, 6 months
Patient Global Impression of Change: PGIC
Patient Global Impression of Change: 7-point likert scale / Much better to much worse
Measured: 6 weeks, 3 months, 6 months
Use of opioids
Change of opioid medication (mg) / Min=0 mg / Max=not set / Lower values are better
Measured: Baseline, 6 weeks, 3 months, 6 months
PROMIS-29
PROMIS: Profile-29 questionnaire; Standardized t-scoring with mean=50 and SD=10 in Dutch reference population
Measured: Baseline, 6 weeks, 3 months, 6 months
PROMIS Global-10
ROMIS Global 10: Consists of ten (10) items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life. Standardized t-scoring with mean=50 and SD=10 in Dutch reference population.
Measured: Baseline, 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start4 Mar 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrin Stoecklein, Amsterdam UMC, location VUmc
- Investigators
- Monique Steegers, Prof, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270940
- Sponsor's protocol ID
- 2023.0922
- Acronym
- PURPOSE
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Upon Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy
- ClinicalTrials.gov ID
- NCT06270940
- Acronym / sponsor ID
- PURPOSE / 2023.0922
- Conditions
- Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 21 Feb 2024 (actual)
- 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.
Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes.
Detailed description
Patients with chronic peripheral neuropathic pain visiting the outpatient pain clinic and who will be scheduled for PRF treatment will be considered for inclusion by the treating pain physician. When meeting the inclusion criteria and none of the exclusion criteria, the patient will receive verbal information (during the patient visit or by phone) and will be asked to participate in this data collection. Signed informed consent will be obtained during the outpatient pain clinic consultation.
This study follows a Data Management Plan which provides relevant information regarding data management requirements.
- Study Preparation: The dataset is encoded via a unique, meaningless code (Subject ID). Data are de-identified within the study database. Data acquisition has been registered with the Data Protection Officer (DPO). An informed consent procedure has been established that describes the dataset, the timeframe for data retention, information on data sharing, and making data available for future research. A central location for all digital and hard copy study documents exists.
- Data acquisition: Reuse of existing data, such as patient characteristics in the patient's medical record system in EPIC, is covered by the subject's informed consent.
- Data collection: The Castor EDC system is used for data collection. Licensing and processing agreements have been arranged. The researchers are trained in using this system, and documentation of their training is available. The database was designed before being built, and a data dictionary was created. Validation checks for completeness, correctness, and consistency are incorporated into the data collection system and have been documented. The data collection system has been tested by both the study team and an independent party. Access to the data collection system is based on individual login with only the necessary access rights and is managed under supervision and documented by the Principal Investigator (PI). Users are trained in the data collection system.
- Data storage: Raw, interim, final, and key files are stored on the department's M-drive. Raw and final files are stored on the data storage facility at Amsterdam University Medical Center and on the Castor storage facility.
- Data collection: A site signature and delegation log of all people involved in the data collection are kept by the PI. Checks for completeness, correctness, and consistency are built into the system. An audit trail and track changes functionality are used in the applied system. All changes in the design will be documented to ensure an impact assessment of these changes is performed. Approval and the reason for locking the data collection have been documented.
- Processing and statistical analysis: The data are stored in a generic and machine-actionable format, such as CSV, and also stored in SPSS as a read-only file. All data processing and analysis are programmed in syntax or script files.
- Writing and publishing: For each manuscript, a structured subfolder has been created.
- Data sharing and archiving: Metadata (documentation on study procedures, data dictionary, data validation, and derivation plan) and final data will be published. For verification purposes, all data are stored internally. A de-identified dataset will be made available upon request to the corresponding author. The request must include ethics approval and a statistical analysis plan. The embargo period is at least 1 year after the publication of the original study. For data reuse, a Data Sharing Agreement will be set up. Digital data (metadata, raw data files, final data files), and documentation will be preserved for 10 years. A subject identification log is archived and kept separate from other study-related data. This does not conflict with the subject's informed consent. Paper documentation will be preserved for 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this data collection consists of patients who will receive PRF treatment for chronic peripheral neuropathic pain (duration of pain ≥ 6 months).
Key inclusion criteria (5 listed)
- Adult patients ≥ 18
- Dutch speaking
- Chronic peripheral neuropathic pain lasting ≥ 6 months with mean NRS pain score of ≥ 4
- Patients who are scheduled for an ultrasound guided PRF treatment on a peripheral nerve
- Willing and able to sign consent
Key exclusion criteria (1 listed)
- Inability to complete the questionnaires
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 |
|---|---|---|
| Pulsed Radiofrequency (PRF) TreatmentPRF treatment maintains a temperature below 42°C and does not produce structural tissue damage around the needle. PRF exposure to the Dorsal Root Ganglion (DRG) induces c-Fos gene expression in the dorsal horn, which suggests a cellular response to the electric forces generated within the DRG. PRF has been found to relieve neuropathic pain by inducing long-term depression of synaptic transmission in the spinal cord, leading to a decrease in allodynia and hyperalgesia. It also modulates the inflammatory response in the injured area by decreasing the expression of pro-inflammatory cytokines, such as TNF-α, in the peripheral nerve and spinal cord, which is a major player in the development and maintenance of neuropathic pain. PRF is characterized by a 500 kHz current applied for 2 pulses per second, with each pulse lasting 20 milliseconds. | Procedure or surgery | – |
Primary outcome
Duration PRF
Time frame: Procedure
Duration PRF: 4 or 8 minutes
Type of PRF
Time frame: Procedure
2 Hz of 5 Hz / 5 ms or 20 ms / Monopolar or bipolar / Voltage / Temperature / Resistance / Current
Pain intensity
Time frame: Baseline, 6 weeks, 3 months, 6 months
Pain with NRS (Numeric Rating Scale): Min=0 / Max=10 / Low score is better
Health Related Quality of life
Time frame: Baseline, 6 weeks, 3 months, 6 months
EQ-5D-5L (EuroQol Quality of life) questionnaire: Index=Patient health state / Min=-0.446 / Max=1 / Higher is better / Patient self rated health: Min=0% / Max=100% / High scores are better
Patient Global Impression of Change: PGIC
Time frame: 6 weeks, 3 months, 6 months
Patient Global Impression of Change: 7-point likert scale / Much better to much worse
Use of opioids
Time frame: Baseline, 6 weeks, 3 months, 6 months
Change of opioid medication (mg) / Min=0 mg / Max=not set / Lower values are better
PROMIS-29
Time frame: Baseline, 6 weeks, 3 months, 6 months
PROMIS: Profile-29 questionnaire; Standardized t-scoring with mean=50 and SD=10 in Dutch reference population
PROMIS Global-10
Time frame: Baseline, 6 weeks, 3 months, 6 months
ROMIS Global 10: Consists of ten (10) items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life. Standardized t-scoring with mean=50 and SD=10 in Dutch reference population.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- 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.
Monique Steegers, Prof principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. 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 Netherlands. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrin Stoecklein, Dr (0031 20 444 386, k.stoecklein@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration PRF (time frame: Procedure). The study lists 8 primary outcomes in all. 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 24 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.