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To evaluate the efficacy and safety of the newly developed low-intensity ultrasound-transcutaneous nerve stimulation combined therapy for knee pain with osteoarthritis for 20 minutes, 3 times a day (more than 10 times a week) for a total of 8 weeks Single-institution, double-blind, randomized, parallel design, study-based clinical trials

Status Approved

First Submitted Date

2017/09/12
Registered Date

2019/05/03
Last Updated Date

2019/04/26

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003883
Unique Protocol ID	CBNUH_MDCTC_2017_GM003
Public/Brief Title	To evaluate the efficacy and safety of the newly developed low-intensity ultrasound-transcutaneous nerve stimulation combined therapy for knee pain with osteoarthritis for 20 minutes, 3 times a day (more than 10 times a week) for a total of 8 weeks Single-institution, double-blind, randomized, parallel design, study-based clinical trials
Scientific Title	To evaluate the efficacy and safety of the newly developed low-intensity ultrasound-transcutaneous nerve stimulation combined therapy for knee pain with osteoarthritis for 20 minutes, 3 times a day (more than 10 times a week) for a total of 8 weeks Single-institution, double-blind, randomized, parallel design, study-based clinical trials
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CUH 2017-08-005-002
Approval Date	2017-09-11
Institutional Review Board Name	CHONBUK NATIONAL UNIVERSITY HOSPITAL IRB
Institutional Review Board Address	CHONBUK Jeonju si Geongi ro 20
Institutional Review Board Telephone	063-259-3339
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	KO MYOUNG HWAN
Title	Professor
Telephone	+82-63-259-1795
Affiliation	Jeonbuk National University Hospital
Address	20, GeonJi-ro, Deokjin-gu, Jeonju, Jeonbuk
Contact Person for Public Queries
Name	SEUNG-ROK KANG
Title	Manager
Telephone	+82-63-259-3458
Affiliation	Jeonbuk National University Hospital
Address	20, GeonJi-ro, Deokjin-gu, Jeonju, Jeonbuk
Contact Person for Updating Information
Name	SEUNG-ROK KANG
Title	Manager
Telephone	+82-63-259-3458
Affiliation	Jeonbuk National University Hospital
Address	20, GeonJi-ro, Deokjin-gu, Jeonju, Jeonbuk

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2017-11-10 Actual
Target Number of Participant	40
Primary Completion Date	2018-08-16 , Actual
Study Completion Date	2018-08-16 , Actual
Name of Study	Jeonbuk National University Hospital
Recruitment Status	Completed
Date of First Enrollment	2017-11-10 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Jeonbuk National University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this study is to compare the effects of pain relief and functional improvement after treatment by applying low - intensity ultrasound - transcutaneous nerve stimulation therapy and transcutaneous nerve stimulation therapy to knee pain patients. Percutaneous nerve stimulation therapy and low-intensity ultrasound therapy are one of the medical devices commonly used for chronic pain management. The medical device used in this study is a combined product of percutaneous nerve stimulator and low-intensity ultrasound therapy device, which is expected to be better than monotherapy. Subjects participating in this study will be assessed for safety and efficacy after being assigned to each group and used within 20 days per day, 10 times per week

Study Summary Information

Lay Summary

The purpose of this study is to compare the effects of pain relief and functional improvement after treatment by applying low - intensity ultrasound - transcutaneous nerve stimulation therapy and transcutaneous nerve stimulation therapy to knee pain patients.
Percutaneous nerve stimulation therapy and low-intensity ultrasound therapy are one of the medical devices commonly used for chronic pain management. The medical device used in this study is a combined product of percutaneous nerve stimulator and low-intensity ultrasound therapy device, which is expected to be better than monotherapy.
Subjects participating in this study will be assessed for safety and efficacy after being assigned to each group and used within 20 days per day, 10 times per week

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	The mediation used in this study Device name: Low intensity ultrasound - transcutaneous nerve stimulation combined therapy device Permission: medical combination stimulator (grade 2) Applicable conditions: 20 minutes / times, 3 times / day, more than 10 times / week, total 8 weeks Difference between arbitration groups Control group was a single group of transcutaneous nerve stimulation therapy, not low - intensity ultrasound - transdermal nerve stimulation group.
Number of Arms	2
Arm 1	Arm Label Low Intensity Ultrasound - Percutaneous Nerve Stimulation Combined Therapy Device
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Device name: Low intensity ultrasound - transcutaneous nerve stimulation combined therapy device Permission: medical combination stimulator (grade 2) Applicable conditions: 20 minutes / times, 3 times / day, more than 10 times / week, total 8 weeks
Arm 2	Arm Label Percutaneous nerve stimulation stimulation therapy device
	Target Number of Participant 20
	Arm Type Active comparator
	Arm Description Name: Percutaneous nerve stimulation combined therapy device Permission: Percutaneous nerve stimulator (grade 2) Applicable conditions: 20 minutes / times, 3 times / day, more than 10 times / week, total 8 weeks

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M13.96)Arthritis, unspecified, lower leg Osteoarthritis (Unique ID : D010003 )
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~65Year
	Description 1) Adults aged 19 and over, under 65 years of age 2) who were diagnosed with Kellgren-Lawrence (K-L) scale on anteroposterior plane radiograph of the knee in standing posture 3) Those who fully understand the purpose of the research and wish to participate in the clinical research through voluntary consent
Exclusion Criteria	1) Those who do not meet the age criteria 2) Persons suspected of having neurological disorders on physical examination 3) Those who appeal for sensory depression 4) Those who underwent knee surgery within the last 6 months 5) Those who have undergone lower limb surgery and cortisone injections treatment within the past month (including steroids, nonsteroidal anti-inflammatory drugs, etc.)
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Visual analog scale
Timepoint	Before and after treatment
Secondary Outcome(s) 1
Outcome	Western Ontario and McMaster Universities Osteoarthritis Index
Timepoint	Before and after treatment

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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