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Completed

NCT Number: NCT05657535

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonju College of Medicine

Wŏnju, Ganwon-do, 26426, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-intensity continuous ultrasound stimulator

Device

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

Primary outcomes

  1. Visual analogue scale(VAS)

    Time frame: 4 weeks

    Evaluation of pain on movement assessed by the VAS index

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 4 weeks

    Evaluation of pain on movement assessed by the WOMAC

Sponsors and collaborators

Lead sponsor

Kyu Jae Lee

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2022
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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