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

Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Patients Suffering From Knee Arthritis; A Single-arm Pilot Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Low-intensity continuous ultrasound stimulator

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ganwon-do
    • Wonju, Ganwon-do, Korea, Republic of, 26426
      • Wonju College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment group; Single treatment group for evaluation pain relief before and after LICUS treatment	Device: Low-intensity continuous ultrasound stimulator; Stimulation 5 minutes, 3 times a day for 4 weeks on the knee

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kyu Jae Lee
• Investigators: Principal Investigator: Kyu-Jae Lee, Ph.D., Department of Convergence Medicine, Wonju College of Medicine, Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 25, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: EMB-2022-7; 2019-51-0458 (Other Grant/Funding Number: Mailtech Co.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No