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

Email

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


Email

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


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 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


Research Plan
Registered date File name
2016/10/25 深澤_計画書_20161013.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name