UMIN-CTR Clinical Trial

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
Email	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
Email	Uhironobu@anes.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026174