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

NCT ID: NCT05657535

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2022-12-06

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: OTHER

Low-intensity continuous ultrasound stimulator

Intervention Type: DEVICE

Stimulation 5 minutes, 3 times a day for 4 weeks on the knee

Interventions

Low-intensity continuous ultrasound stimulator

Stimulation 5 minutes, 3 times a day for 4 weeks on the knee

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyu Jae Lee

OTHER

Sponsor Role: lead

Responsible Party

Kyu Jae Lee

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kyu-Jae Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Convergence Medicine, Wonju College of Medicine, Yonsei University

Locations

Wonju College of Medicine

Wŏnju, Ganwon-do, South Korea

Countries

South Korea

Other Identifiers

2019-51-0458

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EMB-2022-7

Identifier Type: -

Identifier Source: org_study_id