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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05657535
• Other study ID #: EMB-2022-7
• Secondary ID: 2019-51-0458
• Status: Completed
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: December 6, 2022

Study information

• Verified date: December 2022
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 6, 2022
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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 grades?,?)

• 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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• Low-intensity continuous ultrasound stimulator
Stimulation 5 minutes, 3 times a day for 4 weeks on the knee

Locations

Country	Name	City	State
Korea, Republic of	Wonju College of Medicine	Wonju	Ganwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Kyu Jae Lee

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale(VAS)	Evaluation of pain on movement assessed by the VAS index	4 weeks
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Evaluation of pain on movement assessed by the WOMAC	4 weeks