UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025690 |
|---|---|
| Receipt number | R000029484 |
| Scientific Title | Effect of pulsed radiofrequency for neuropathic pain |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2022/03/22 16:47:15 |
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Basic information
Public title
Effect of pulsed radiofrequency for neuropathic pain
Acronym
Effect of pulsed radiofrequency for neuropathic pain
Scientific Title
Effect of pulsed radiofrequency for neuropathic pain
Scientific Title:Acronym
Effect of pulsed radiofrequency for neuropathic pain
Region
| Japan |
Condition
Condition
intractable lumbosacral radicular pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to assess the efficacy of pulsed radiofrequency (PRF) for intractable lumbosacral radicular pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numeric Rating Scale (NRS) pain assessment at 4 weeks after PRF.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The target is an impedence of less than 400 ohms; this is achieved by injecting 1mL of saline through the needle into each patient prior to PRF treatment(Group S).
Interventions/Control_2
The target is an impedence of less than 400 ohms; this is achieved by injecting 1mL of 1% lidocainethrough the needle into each patient prior to PRF treatment(Group L).
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with monosegmental chronic lumbosacral radicular pain of L3~L5 or S1.
2.The area of pain is concordant with MRI scan findings anatomically.
3.After a diagnostic nerve root block, the pain intensity reduced for at least 2 days.
Key exclusion criteria
1.A history of cancer, fractures of the lumbar vertebrae and myelopathy
2.The use of anticoagulants
3.Pregnancy
4.Patients with area 4 on Cornell Medical Index
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Tanaka |
Organization
Junwakai Memorial Hospital
Division name
Department of Pain Clinic
Zip code
8802112
Address
Komatsu 1119, Miyazaki
TEL
0985-47-5555
nobuhiko_tanaka@junwakai.com
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Tanaka |
Organization
Junwakai Memorial Hospital
Division name
Department of Pain Clinic
Zip code
880-2112
Address
Komatsu 1119, Miyazaki
TEL
0985-47-5555
Homepage URL
nobut8789@me.com
Sponsor or person
Institute
Junwa Rihabiriteshon Shinryou Kenkyuujo
Institute
Department
Personal name
Funding Source
Organization
Junwa Rihabiriteshon Shinryou Kenkyuujo
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Junwakai Memorial Hospital
Address
Komatsu 1119, Miyazaki
Tel
0985-47-5555
sumie_takasu@junwakai.com
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
| 2017 | Year | 01 | Month | 25 | 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
12
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 22 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 22 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 16 | Day |
Last modified on
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029484
