UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) for the treatment of chronic low back pain originating in lumbar facet joint osteoarthritis of elderly patients.
Acronym	Safety and efficacy of MRgFUS for the treatment of chronic lumbar facet joint pain
Scientific Title	Safety and efficacy of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) for the treatment of chronic low back pain originating in lumbar facet joint osteoarthritis of elderly patients.
Scientific Title:Acronym	Safety and efficacy of MRgFUS for the treatment of chronic lumbar facet joint pain
Region	Japan

Condition
Condition	Chronic low back pain (LBP), Facet joint osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of MRgFUS for the treatment of chronic low back pain originating in lumbar facet joint osteoarthritis of elderly patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Adverse events [Time frame: 6 months]
Key secondary outcomes	Pain scores on Numeric Rating Scale (NRS) Quality of life, measured by the Oswestry Disability index (ODI), Brief Pain Inventory-interference scale (BPI-QoL) and EuroQOL-5 dimension (EQ-5D) [Time frame: 6 months]

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	MRgFUS treatment using ExAblate 2000 system
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Men and women age 65 years and older 2) Patients who are able and willing to give consent and able to attend all study visits 3) Patients with chronic low back pain (LBP) for at least 6 months 4) Patients with LBP worst score >= 4 on NRS (0-10 scale) 5) Patients must have chronic LBP originating in lumbar facet joints 6) Patients with localized pressure pain on the facet joints (<= 2)
Key exclusion criteria	1) Patients with evidence of lumbosacral radiculopathy on MRI or physical exam findings, including radicular leg pain 2) Patients with motor deficit or any other indication for surgical intervention 3) Patients with existing malignancy 4) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >113 kg) 5) Patients on dialysis 6) Patients with an active infection or severe hematological, neurological, or other uncontrolled disease 7) Patients with unstable cardiac status 8) Patients with severe hypertension 9) Patients with severe cerebrovascular disease 10) Patients with severe coagulation disorder or on anticoagulant and antiplatelet therapy 11) Patients unable to communicate with the investigator and staff 12) Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.) 13) Any patients disqualified by a study physician because of medical, psychological, or any other reason
Target sample size	25

Research contact person
Last name of lead principal investigator	1st name Motohiro Middle name Last name Kawasaki
Organization	Kochi Medical School, Kochi University
Division name	Department of Orthopaedic Surgery
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL	0888-80-2386
Email	im35@kochi-u.ac.jp

Public contact
1st name of contact person	1st name Motohiro Middle name Last name Kawasaki
Organization	Kochi Medical School, Kochi University
Division name	Department of Orthopaedic Surgery
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL	0888-80-2386
Homepage URL
Email	im35@kochi-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Kochi Medical School, Kochi University
Institute
Department

Funding Source
Organization	Kochi Medical School Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Trial Center, Kochi University
Address	Kohasu, Oko-cho, Nankoku, Kochi
Tel	088-880-2719
Email	im62@kochi-u.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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 13 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	No longer recruiting
Date of protocol fixation	2008 Year 10 Month 30 Day
Date of IRB	2008 Year 10 Month 30 Day
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 12 Day
Last modified on	2019 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017928