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

NCT05657535 | Completed

• 2 other identifiers: EMB-2022-72019-51-0458
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale(VAS)

  Evaluation of pain on movement assessed by the VAS index

  4 weeks

Secondary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  4 weeks

Study Arms (1)

Treatment group

OTHER

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

Device: Low-intensity continuous ultrasound stimulator

Interventions

Low-intensity continuous ultrasound stimulator DEVICE

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

Treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyu Jae Lee: lead

Study Sites (1)

Wonju College of Medicine

Wŏnju, Ganwon-do, 26426, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kyu-Jae Lee, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No need of blinding
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Before and after of treatment in single group

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 20, 2022
• Study Start: October 11, 2022
• Primary Completion: November 23, 2022
• Study Completion: December 6, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)