None listed
Conditions
Interventions
Medical Device : - Control group: sham invasive laser acupuncture(ILA) at EX-LE4, ST35, SP10, ST34, SP9, GB34, EX-LE2 for 10 minutes once daily, twice a week for 6 weeks
- 650 group: 650nm wavelength
Sponsors
WONTECH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale(VAS) of pain | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactJae-Hong Kim
Dongshin University
Outcome results
None listed