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Search / Trial NCT05657535

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

Launched by KYU JAE LEE · Dec 15, 2022

Trial Information

Current as of January 16, 2025

Completed

Keywords

ClinConnect Summary

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.

Gender

ALL

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

Trial Officials

Kyu-Jae Lee, Ph.D.

Principal Investigator

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

About Kyu Jae Lee

Kyu Jae Lee is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative trial designs and rigorous methodologies. With a focus on developing effective therapeutic solutions, Kyu Jae Lee collaborates with healthcare professionals, regulatory bodies, and research institutions to ensure the highest standards of ethical conduct and scientific integrity in clinical investigations. By leveraging a wealth of expertise and a patient-centered approach, Kyu Jae Lee aims to contribute significantly to the field of medicine and enhance the quality of life for individuals globally.

Locations

Wonju, Ganwon Do, Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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