Clinical trials to investigate the safety and short-term pain relief effects of different wavelength(650nm, 830nm) of invasive laser medical device (Ellise) for knee osteoarthritis
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0008860
- Lead Sponsor
- WONTECH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 45
1) an elderly aged between 50 and 85 years
2) diagnosed with KOA according to the American College of Rheumatology diagnostic criteria.
3) has knee pain lasting for at least the preceding three months, knee pain that occurred more than 14 days a month, and moderate knee pain ( a mean 100mm VAS score for pain had a range of 35-74 at rest and moving during a week prior to screening)
4) patients with stage 2 or stage 3 KOA according to Kellgren-Lawrence(KL) criteria
5) voluntary provision of informed consent.
1) A person who has undergone total knee replacement due to KOA
2) posttraumatic KOA patient
3) has a serious diseases (cancer, severe kidney disease, severe liver disease, severe cardiovascular disease, severe central nervous system disease, diabetic neuropathy)
4) has a knee pain caused by inflammatory disease, tumor, trauma, rheumatoid arthritis, autoimmune disease, severe Genu varum or Genu valgum, severe hip joint disease, or gout
5) has a history of treatment for mental illness (dementia, schizophrenia, or epilepsy) or drug/alcohol dependency in the 6 months preceding screening
6) has been injected with Intraarticular mucus supplement (hylan, sodium hyaluronate, and hyalulonan) for the purpose of treating KOA in the 6 months preceding screening
7) has drained knee joint fluid in the 3 months preceding screening
8) has received prolotherapy or steroid injections into the knee joint in the 3 months preceding screening
9) current treatment for KOA, such as Korean medicine treatment, physical therapy, medication, or health functional food in the 4 weeks preceding screening
10) has other diseases that require treatment for pain control, such as steroids or NSAIDs
11) has contraindications for ILA, such as presence of electronic medical devices, severe skin disease in the knee region, blood clotting abnormalities, or presence of metallic devices in the knee
12) has a history of knee surgery within one year or scheduled procedures during the trial
13) pregnancy, breastfeeding, or having a plan for pregnancy.
14) A people who is participating in other trials or has participated in other trials within 8 weeks prior to screening
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Analogue Scale(VAS) of pain
- Secondary Outcome Measures
Name Time Method Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC);European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L);Patient’s Global Assessment (PGA);OMERACT-OARSI set responder rate;WOMAC pain subscale;WOMAC function subscale;dose of rescue medication