UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058865 |
|---|---|
| Receipt number | R000065847 |
| Scientific Title | Evaluation of Bedside Quantitative Sensory Testing for Predicting the Prognosis of PRF in Acute Herpes Zoster Patients |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/22 11:46:46 |
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Basic information
Public title
Evaluation of Bedside Quantitative Sensory Testing for Predicting the Prognosis of PRF in Acute Herpes Zoster Patients
Acronym
Evaluation of Bedside Quantitative Sensory Testing for Predicting the Prognosis of PRF in Acute Herpes Zoster Patients
Scientific Title
Evaluation of Bedside Quantitative Sensory Testing for Predicting the Prognosis of PRF in Acute Herpes Zoster Patients
Scientific Title:Acronym
Evaluation of Bedside Quantitative Sensory Testing for Predicting the Prognosis of PRF in Acute Herpes Zoster Patients
Region
| Japan |
Condition
Condition
Herpes Zoster
Classification by specialty
| Dermatology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Zoster associated pain is characterized by intense neuropathic pain from the early stages of onset. Inadequate treatment during the acute to subacute phase may lead to the development of postherpetic neuralgia, a form of chronic intractable pain that significantly impairs patients' quality of life. Pulsed radiofrequency treatment, which modulates the function of the dorsal root ganglion without causing neural destruction, has been utilized as a minimally invasive and effective option for both ZAP and PHN. However, PRF is not uniformly effective. Some studies have reported that a proportion of patients treated with DRG targeted PRF still develop PHN, and to date, there are no established predictors for identifying patients who are most likely to benefit from this intervention. This research seeks to clarify the potential role of QST as a predictive tool for PRF responsiveness in the early stages of herpes zoster-associated neuropathic pain.
Basic objectives2
Others
Basic objectives -Others
Quantitative sensory testing (QST) is an objective method to assess sensory abnormalities and may be useful in predicting treatment outcomes. It evaluates parameters such as thermal thresholds, pressure pain threshold, vibration detection, dynamic mechanical allodynia, and temporal summation. Previous studies have shown that QST-based sensory phenotypes are associated with different responses to neuropathic pain treatments. Recent findings also suggest that certain QST indicators may predict pulsed radiofrequency (PRF) outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Quantitative Sensory Testing (QST) items measured at the initial visit between the effective and ineffective groups of PRF therapy.
Items and Measurements:
PPT Ratio (Affected side/Unaffected side): Pressure Pain Threshold ratio.
VDT Ratio (Affected side/Unaffected side): Vibration Detection Threshold ratio.
TS (WUR): Temporal Summation, recorded as Wind-up Ratio.
DMA: Dynamic Mechanical Allodynia (presence/absence, VAS score).
Measurement Timings of QST:
At the initial visit.
Three months after the onset of symptoms.
Comparison:
A pre- and post-treatment comparison of the QST items listed above will be performed between the two groups.
Efficacy Determination:
Effective Group: Maximum VAS score less than 40 mm at three months after the onset of symptoms.
Ineffective Group: Maximum VAS score of 40 mm or more at three months after the onset of symptoms.
Key secondary outcomes
Secondary outcomes included changes in QST parameters between the initial visit and three months after rash onset, specifically: PPT ratio, VDT ratio, temporal summation (TS, recorded as wind-up ratio [WUR]), and the presence and severity of dynamic mechanical allodynia (DMA).
Additional measures included changes in maximum and average visual analog scale (VAS) scores over the same period, as well as changes in scores on the following multidimensional questionnaires:
neuropathic pain screening questionnaire
Hospital Anxiety and Depression Scale (HADS)
Pain Catastrophizing Scale (PCS)
EQ-5D-5L (a measure of health-related quality of life)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible participants were patients aged 20 years or older who presented to the Sendai Pain Clinic for an initial consultation with acute to subacute zoster-associated pain (ZAP) involving the thoracic region (Th2 to Th12) within three months of rash onset, and who provided informed consent to undergo pulsed radiofrequency (PRF) treatment.
Key exclusion criteria
(1) patients with severe psychiatric disorders, including cognitive impairment
(2) patients with unidentified chronic pain conditions unrelated to herpes zoster
(3) patients with severe cardiovascular, respiratory, renal, or hepatic diseases
(4) patients with poorly controlled diabetes mellitus (defined as HbA1c > 8.0%)
(5) patients with known allergies to local anesthetics or corticosteroids
(6) patients who had received neurolytic blocks related to herpes zoster within the past month
(7) patients with severe dermatological conditions or active infections at the QST measurement sites.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University
Division name
Niigata University Graduate School of Medical and Dental Sciences, Division of Anesthesiology
Zip code
9518510
Address
1-757 Asahimachidori, Chuo-ku, Niigata City, Niigata 951-8510, Japan
TEL
+81-25-227-2200
deepimpact034@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Kohashi |
Organization
Niigata University
Division name
Niigata University Graduate School of Medical and Dental Sciences, Division of Anesthesiology
Zip code
9518510
Address
1-757 Asahimachidori, Chuo-ku, Niigata City, Niigata 951-8510, Japan
TEL
+81-25-227-2200
Homepage URL
n24b114a@mail.niigata-u.ac.jp
Sponsor or person
Institute
Sendai Pain Clinic
Institute
Department
Personal name
Funding Source
Organization
This study is self-funded.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
1-757 Asahimachidori, Chuo-ku, Niigata City, Niigata 951-8510, Japan
Tel
+81-25-227-2200
ethics@adm.niigata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center prospective observational study
Management information
Registered date
| 2025 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065847
