UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015416 |
|---|---|
| Receipt number | R000017928 |
| 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. |
| Date of disclosure of the study information | 2014/10/13 |
| Last modified on | 2019/04/16 23:50:46 |
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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
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
im35@kochi-u.ac.jp
Public contact
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
im35@kochi-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Kochi Medical School, Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017928
