UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043401 |
|---|---|
| Receipt number | R000049554 |
| Scientific Title | COMPARISON OF RADIOFREQUENCY AND CORTICOSTEROID INJECTION FOR TREATMENT OF LUMBAR FACET JOINT PAIN: A META-ANALYSIS |
| Date of disclosure of the study information | 2021/03/27 |
| Last modified on | 2021/02/21 21:19:52 |
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Basic information
Public title
COMPARISON OF RADIOFREQUENCY AND CORTICOSTEROID INJECTION FOR TREATMENT OF LUMBAR FACET JOINT PAIN: A META-ANALYSIS
Acronym
COMPARISON OF RADIOFREQUENCY AND CORTICOSTEROID INJECTION FOR TREATMENT OF LUMBAR FACET JOINT PAIN
Scientific Title
COMPARISON OF RADIOFREQUENCY AND CORTICOSTEROID INJECTION FOR TREATMENT OF LUMBAR FACET JOINT PAIN: A META-ANALYSIS
Scientific Title:Acronym
COMPARISON OF RADIOFREQUENCY AND CORTICOSTEROID INJECTION FOR TREATMENT OF LUMBAR FACET JOINT PAIN
Region
| Asia(except Japan) |
Condition
Condition
Lumbar pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to perform a meta-analysis to compare the effectiveness of corticosteroid injection and RF ablation for LFJ pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
including pain intensity and functional disability at 3, 6, and 12-month measurement period
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All RCTs comparing the pain intensity of corticosteroid injection to RF ablation for LFJ pain were eligible for inclusion. RF ablation procedure could be either continuous or pulse radiofrequency
Key exclusion criteria
All studies investigating other than patients with LFJ pain were excluded.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Ardyan |
| Middle name | |
| Last name | Wardhana |
Organization
Faculty of Medicine, Universitas Surabaya
Division name
Faculty of Medicine
Zip code
60293
Address
Jl. Raya Kalirungkut
TEL
6282138433032
ardyanwardhana@staff.ubaya.ac.id
Public contact
Name of contact person
| 1st name | Ardyan |
| Middle name | |
| Last name | Wardhana |
Organization
Faculty of Medicine, Universitas Surabaya
Division name
Faculty of Medicine
Zip code
60293
Address
Jl. Raya Kalirungkut
TEL
6282138433032
Homepage URL
ardyanwardhana@staff.ubaya.ac.id
Sponsor or person
Institute
Faculty of Medicine, Universitas Surabaya
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
Health Research Ethics Committee Universitas Surabaya
Address
Jl. Raya Kalirungkut
Tel
62312981353
kedokteran@unit.ubaya.ac.id
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
| 2021 | Year | 03 | Month | 27 | 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
200
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was conducted by searching for all randomized controlled trials comparing the effect of corticosteroid injection and RF ablation on LFJ pain in Cochrane Central Register of Controlled Trials and PubMed database. We performed inverse-variance weighted meta-analysis of outcomes including pain intensity and functional disability at 3, 6, and 12-month measurement period using RevMan 5.3.
Management information
Registered date
| 2021 | Year | 02 | Month | 21 | Day |
Last modified on
| 2021 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049554
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
