Clinical trial NCT05657535: Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Knee Arthritis
Official title: Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Patients Suffering From Knee Arthritis; A Single-arm Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after of treatment in single group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual analogue scale(VAS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju College of Medicine
state: Ganwon-do
Study officials:
affiliation: Department of Convergence Medicine, Wonju College of Medicine, Yonsei University
name: Kyu-Jae Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: