Osteoarthritis, KneeNCT05657535
Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Knee Arthritis
A study testing Low-intensity continuous ultrasound stimulator in people with Osteoarthritis, Knee, run by Kyu Jae Lee at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Low-intensity continuous ultrasound stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2022to 6 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Patients Suffering From Knee Arthritis; A Single-arm Pilot Clinical Trial
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Low-intensity continuous ultrasound stimulator
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity continuous ultrasound stimulatorDevice
Stimulation 5 minutes, 3 times a day for 4 weeks on the knee
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Other | Single treatment group for evaluation pain relief before and after LICUS treatment Receives: Device: Low-intensity continuous ultrasound stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale(VAS)
Evaluation of pain on movement assessed by the VAS index
Measured: 4 weeks
Secondary outcomes (1)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Evaluation of pain on movement assessed by the WOMAC
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start11 Oct 2022
- Primary completion23 Nov 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after of treatment in single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyu Jae Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyu Jae Lee, Wonju Severance Christian Hospital
- Investigators
- Kyu-Jae Lee, Ph.D., Principal investigator, Department of Convergence Medicine, Wonju College of Medicine, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657535
- Sponsor's protocol ID
- EMB-2022-7
- Other IDs
- 2019-51-0458
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief Effect of Low-intensity Continuous Ultrasound Stimulator for Patients Suffering From Knee Arthritis; A Single-arm Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT05657535
- Acronym / sponsor ID
- EMB-2022-7
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kyu Jae LeeUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after of treatment in single group
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Device: Low-intensity continuous ultrasound stimulatorSingle treatment group for evaluation pain relief before and after LICUS treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity continuous ultrasound stimulatorStimulation 5 minutes, 3 times a day for 4 weeks on the knee | Device | Treatment group |
Primary outcome
Visual analogue scale(VAS)
Time frame: 4 weeks
Evaluation of pain on movement assessed by the VAS index
1 secondary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Jae Lee, Ph.D. principal investigator
Department of Convergence Medicine, Wonju College of Medicine, Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity continuous ultrasound stimulator in people with Osteoarthritis, Knee, run by Kyu Jae Lee at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale(VAS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.