Pain Relief Effect of Low-intensity Continuous Ultrasound... | NCT05657535

Studies
Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Knee Arthritis

NCT05657535

Sponsor

Kyu Jae Lee

Status

Completed

Last Update Posted

Dec 29, 2022Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Osteoarthritis, Knee

Interventions

Low-intensity continuous ultrasound stimulator

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-51-0458	Other Grant/Funding Number	Mailtech Co.

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2022Actual

Primary Completion Date

Nov 23, 2022Actual

Completion Date

Dec 6, 2022Actual

First Submitted Date

Dec 8, 2022

First Submission Date that Met QC Criteria

Dec 15, 2022

First Posted Date

Dec 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 25, 2022

Last Update Posted Date

Dec 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to test low-intensity continuous ultrasound stimulator(LICUS) for patients suffering from knee arthritis. it aims to evaluate the pain relief effect of LICUS.

35 participants were recruited, treated by LICUS on the knee joint for 5 minutes, 3 times a day for 4 weeks.

This study has single group and is for a before and after comparison of clinical treatment.

Detailed Description

Subject: 35 osteoarthritis patients Evaluation measure: Visual Analogue Scale (VAS), McMaster Universities Osteoarthritis Index (WOMAC) Method: A total of 35 subjects were selected in consideration of the dropout rate of 20%. Selected subjects were treated as a single group without randomization, and an appropriate amount of gel was applied to the knee OA pain area for 4 weeks. A blinded evaluation at baseline and after treat-ment was made. Primary outcome was pain on movement assessed by the VAS index. Secondary outcomes consisted of the WOMAC scores.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Other	Single treatment group for evaluation pain relief before and after LICUS treatment	Device: Low-intensity continuous ultrasound stimulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low-intensity continuous ultrasound stimulator	Device	Stimulation 5 minutes, 3 times a day for 4 weeks on the knee	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analogue scale(VAS)	Evaluation of pain on movement assessed by the VAS index	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Evaluation of pain on movement assessed by the WOMAC	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 40 to 60 years with pain due to OA of the knee and able to walk voluntarily
Those who have more than one osteophyte in the tibiofemoral joint on radiographic findings (Kellgren-Lawrence gradesⅡ,Ⅲ)
At visit 1 (screening) and visit 2, the pain status during knee OA activity was 100 mm pain VAS, as a result, those who are over 40mm
If the Kellgren & Lawrence Grades are the same, target the one with the higher 100mm pain VAS
Patients who are willing or able to follow the doctor's instructions, including joint movements
Persons who can comply with concomitantly permitted drugs, prohibited drugs, and relief drugs
Persons who can maintain the same exercise and activity during the clinical trial period
Fully understand the purpose and procedure of this clinical trial

Exclusion Criteria:

Those who have a history of rheumatoid arthritis or gouty arthritis or who have peripheral pain other than the knee joint patient.
Those with fractures or dislocations on simple radiological examination.
Those who are identified, or those with a similar risk of neuromuscular disease
Those who have participated in other clinical trials within 6 months of participating in clinical trials.
Patients with severe pain in the knee joint other than angular deformity, instability, and index knee in the knee joint
Patients with other tumors other than degenerative knee arthrosis
Persons with systemic symptoms that may affect knee pain
Pregnant and lactating women

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases