UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053530 |
|---|---|
| Receipt number | R000061014 |
| Scientific Title | Heart rate variability analysis in postherpetic neuralgia patients undergoing pulsed radiofrequency nerve root block: before and after treatment |
| Date of disclosure of the study information | 2024/02/05 |
| Last modified on | 2024/01/31 14:59:06 |
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Basic information
Public title
Analysis of the autonomic nervous system before and after treatment for postherpetic neuralgia
Acronym
PHNP study
Scientific Title
Heart rate variability analysis in postherpetic neuralgia patients undergoing pulsed radiofrequency nerve root block: before and after treatment
Scientific Title:Acronym
PHNP study
Region
| Japan |
Condition
Condition
postherpetic neuralgia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of pulsed radiofrequency nerve root block on postherpetic neuralgia on heart rate variability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of pre-treatment - post-treatment heart rate variability (HF, LF/HF) in the pulsed radiofrequency treatment effective group
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients treated with pulsed radiofrequency therapy at the Department of Anesthesiology, Kinki University Hospital
2) Patients with postherpetic neuralgia
Key exclusion criteria
1) AST (GOT) or ALT (GPT) > 100 IU/L
2) Child-Pugh classification B or C
3) Serum creatinine greater than 2.0 mg/dL
4) Patients with a cardiac pacemaker or ICD
5) Patients with a clinical history of ischemic heart disease, arrhythmia, respiratory disease, infectious disease, metabolic disease, or autoimmune disease
6) Patients who have expressed their refusal (including verbal refusal) to this study
7) Patients who are deemed inappropriate by the principal investigator
8) Patients who are taking autonomic nerve-acting drugs, anti-arrhythmic drugs, or benzodiazepines
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Haruyuki |
| Middle name | |
| Last name | Yuasa |
Organization
Faculty of Medicine, Kindai University
Division name
Department of Anesthesiology
Zip code
5890014
Address
377-2 Ohonohigashi Osaka-sayama city Osaka Japan
TEL
072-366-0221
h-yuasa@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Haruyuki |
| Middle name | |
| Last name | Yuasa |
Organization
Faculty of Medicine, Kindai University
Division name
Depertment of Anesthesiology
Zip code
5890014
Address
377-2 Ohonohigashi Osaka-sayama city Osaka, Japan
TEL
072-366-0221
Homepage URL
h-yuasa@med.kindai.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kindai University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kindai university faculty of medicine of Ethics Committe
Address
377-2 Ohonohigashi Osaka-sayama city Osaka Japan
Tel
072-366-0221
zizen@med.kindai.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
近畿大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 05 | 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
| 2023 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is believed that in chronic pain conditions, pain causes autonomic imbalance and decreases heart rate variability. However, it is unclear how heart rate variability changes when these chronic pain patients are treated for the purpose of pain relief.
We will measure heart rate variability before and after treatment in patients with postherpetic neuralgia, one of the chronic pain conditions, who underwent pulsed high-frequency nerve root block, to clarify the changes in autonomic balance.
Management information
Registered date
| 2024 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061014
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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