UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022736 |
|---|---|
| Receipt number | R000026174 |
| Scientific Title | Efficacy of ultrasound-guided pulsed radiofrequency treatment on the saphenous nerve in knee osteoarthritis patients with refractory knee pain: A Randomized, double-blinded, pracebo-controlled trial |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2019/06/26 17:28:38 |
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Basic information
Public title
Efficacy of ultrasound-guided pulsed radiofrequency treatment on the saphenous nerve in knee osteoarthritis patients with refractory knee pain: A Randomized, double-blinded, pracebo-controlled trial
Acronym
Efficacy of ultrasound-guided pulsed radiofrequency treatment for refractory knee pain in knee osteoarthritis patients
Scientific Title
Efficacy of ultrasound-guided pulsed radiofrequency treatment on the saphenous nerve in knee osteoarthritis patients with refractory knee pain: A Randomized, double-blinded, pracebo-controlled trial
Scientific Title:Acronym
Efficacy of ultrasound-guided pulsed radiofrequency treatment for refractory knee pain in knee osteoarthritis patients
Region
| Japan |
Condition
Condition
refractory knee pain in knee osteoarthritis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this RCT is to assess the efficacy of ultrasound-guided pulsed radiofrequency treatment (PRF) on knee osteoarthritis (OA) pain, which was not effectively managed with conventional non-pharmacologicapharmacological treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity using VAS, which were recorded at 12 weeks post procedure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ultrasound-guided pulsed radiofrequensy to the saphenous nerve (4.5V,2Hz,42 degree C for 8 minutes)
Interventions/Control_2
placebo (0.3V electrical stimulation to the saphenous nerve with 2Hz currnet for 8 minutes)
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible patients were
1. male or female, 45-85 years of age
2. diagosed with radiologic tibiofemoral osteoarithritis (Kellgren-Lawrence grade 2-4)
3. with anterior-medial knee pain of moderate intensity or greater for 3 months ( VAS 40-100mm)
4. with refractory knee pain to conventional treatment (such as muscle strength traing, biomechanical intervention, pharmacological treatments, intra-articular corticosteroids or hyaluronic acids)
5. not plan to undergo surgery within 3 months.
Key exclusion criteria
1. Acute knee pain
2. Other connective tissue diseases (such as RA)
3. Serious neurologic or psychiatric disorders
4. Intra-articular injection with steroids or hyaluronic acids during the previous 3 months
5. Anticoagulant and/or antiplatelet medications
6. pacemakers
7. Prior electroacupuncture treatment
8. A person who are determined ineligible by the clinical investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Uematsu |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
Address
2-2, Yamadaoka, Suita, Osaka 565-0871 JAPAN
TEL
06-6879-3133
Uhironobu@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Uematsu |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
Address
2-2, Yamadaoka, Suita, Osaka 565-0871 JAPAN
TEL
06-6879-3133
Homepage URL
Uhironobu@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Jude Medical Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Anshin Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 06 | Month | 15 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 07 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026174
