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

Kyu Jae Lee

Status

Completed

Conditions

Osteoarthritis, Knee

Treatments

Device: Low-intensity continuous ultrasound stimulator

Study type

Interventional

Funder types

Other

Identifiers

NCT05657535

EMB-2022-7

2019-51-0458 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Volunteers

Accepts 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