UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024490 |
|---|---|
| Receipt number | R000026524 |
| Scientific Title | Compared to the effects of the saphenous nerve block and hyaluronic acid intra-articular injection for osteoarthritis of the knee |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2017/06/07 15:43:23 |
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Basic information
Public title
Compared to the effects of the saphenous nerve block and hyaluronic acid intra-articular injection for osteoarthritis of the knee
Acronym
Study of the effectiveness of the saphenous nerve block for osteoarthritis of the knee
Scientific Title
Compared to the effects of the saphenous nerve block and hyaluronic acid intra-articular injection for osteoarthritis of the knee
Scientific Title:Acronym
Study of the effectiveness of the saphenous nerve block for osteoarthritis of the knee
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect and safety of the saphenous nerve block for osteoarthritis of knee
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neumerical rating scale(NRS)
Key secondary outcomes
Western Ontario and McMaster Universities osteoarthritis index(WOMAC)
Tampa Scale for Kinesiophobia(TSK)
Accidental disease
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Saphenous nerve block
Using 1%mepibacaine 4ml,4 times per week.
Under the ultrasound.
Interventions/Control_2
Hyaluronic acid intra-articular injection
Using Purified Sodium Hyaluronate,4 times per week.
Under the ultrasound.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.40 years of age or older
2.Having knee pain
3.Kellgren Lawrence classification grade 1 to 4
4.Neumericl Rating Scale more than 3
5.Agree has been obtained in writing
Key exclusion criteria
1.There is a surgical history of knee
2.With the inside of the knee joint infection
3.There is a local anesthetic allergy
4.Having the following diseases,same side of the Hunter tunnel syndrome, lumbar radiculopathy, shingles-related pain, iliopsoas syndrome,and maignant tumor,active infection diseases,sufficient mental illness that prevents communication
5.Using the following agents,steroids,immunosuppressive agent
6.What principal investigator is determined to unsuitable for safely carrying out the present test
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Fukazawa |
Organization
Saku Central Hospital
Division name
Pain Clinic
Zip code
Address
Usuda 197 Saku, Nagano 384-0301 Japan
TEL
0267-82-3131
mame197931@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Niimi |
Organization
Saku Central Hospital
Division name
Clinical research and study center
Zip code
Address
Usuda 197 Saku, Nagano 384-0301 Japan
TEL
0267-82-3131
Homepage URL
ctroffice@sakuhp.or.jp
Sponsor or person
Institute
Saku Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 10 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 19 | Day |
Last modified on
| 2017 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026524
