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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Low-intensity continuous ultrasound stimulator
Sponsored by
Kyu Jae Lee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wonju College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment group

Arm Description

Single treatment group for evaluation pain relief before and after LICUS treatment

Outcomes

Primary Outcome Measures

Visual analogue scale(VAS)
Evaluation of pain on movement assessed by the VAS index

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Evaluation of pain on movement assessed by the WOMAC

Full Information

First Posted
December 8, 2022
Last Updated
December 25, 2022
Sponsor
Kyu Jae Lee
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1. Study Identification

Unique Protocol Identification Number
NCT05657535
Brief Title
Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Knee Arthritis
Official Title
Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Patients Suffering From Knee Arthritis; A Single-arm Pilot Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
November 23, 2022 (Actual)
Study Completion Date
December 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kyu Jae Lee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after of treatment in single group
Masking
None (Open Label)
Masking Description
No need of blinding
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Other
Arm Description
Single treatment group for evaluation pain relief before and after LICUS treatment
Intervention Type
Device
Intervention Name(s)
Low-intensity continuous ultrasound stimulator
Intervention Description
Stimulation 5 minutes, 3 times a day for 4 weeks on the knee
Primary Outcome Measure Information:
Title
Visual analogue scale(VAS)
Description
Evaluation of pain on movement assessed by the VAS index
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
Evaluation of pain on movement assessed by the WOMAC
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Jae Lee, Ph.D.
Organizational Affiliation
Department of Convergence Medicine, Wonju College of Medicine, Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonju College of Medicine
City
Wonju
State/Province
Ganwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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