Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06270940 |
| Other study ID # |
2023.0922 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 4, 2024 |
| Est. completion date |
February 28, 2026 |
Study information
| Verified date |
April 2024 |
| Source |
Amsterdam UMC, location VUmc |
| Contact |
Katrin Stoecklein, Dr |
| Phone |
0031 20 444 386 |
| Email |
k.stoecklein[@]amsterdamumc.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
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.
A) 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.
B) 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.
C) 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.
D) 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.
E) 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.
F) 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.
G) Writing and publishing: For each manuscript, a structured subfolder has been created.
H) 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.
