None listed
Conditions
Interventions
Medical Device : Participants who met the inclusion criteria are randomised to experimental group(gold mae-sun therapy group) or control group(sham group).
- Experimental group
1) Treatment method:
Sponsors
Wonkwang University, Gwangju Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 50 to 80 years old 2. A person who diagnosed primary osteoarthritis on American college of rheumatology criteria a. A person who currently has pain in on or both knees b. Person who over at least three of the following sis criteria 1) Age: 50 to 80 years old 2) A person who knee joints are not more than 30 minutes stiffness in the morning 3) Crepitus of knee joint 4) Bony tenderness 5) Bony enlargement 6) No palpable warmth 3. A person who 100mm VAS(visual analogue scale) pain is more than average 40 points per day (for a week) 4. Those who have heard the full explanation of this human application test, fully understand it, and have voluntarily decided to participate and have agreed in writing to comply with the precautions.
Exclusion criteria
Exclusion criteria: 1. A person who had a steriod injecionin the joint cavity(within the last 3 months). 2. A person who received an viscosupplement(hylan, sodium hyaluronate, hyalulonan etc.) injection in the joint cavity(within the last 6 months). 3. A person who eliminated to expel joint fluid from joint cavity(within the last 6 months). 4. Those with past history or current history such as inflammoatory disease, tumor, rheumarthritis, autoimmune dieases and degeneratio of knee(serious valgus, varus ets.) 5. those who particiapate in other osteoarthritis clinical studies(3 months before screening) 6. Subjects with connective tissue(collagen) disease 7. Subjects with multiple sclerosis disease 8. A person taking immunosuppressant, corticosteroid, cyclosporin 9. A person who experienced to antisychotics treatment(within 3 months before screening test) 10. those who have a history of drug or alcohol abuse 11. Female patients who are pregnant or breastfeeding 12. Diagnostic test A person who is determined by the Principal inspector to be ineligible for research due to medical examination results or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of 100mm VAS(visual analog scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of 100mm VAS(visual analog scale);Changes of K-WOMAC(Korean version-Western Ontario and McMaster Universities Questionnaire) total score and subscores;Changes of SF-36(Short-Foam 36 health survey) subscores;Change of physical function test;Adverse events;laboratory test vlaue;Vital sign | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Kwon
Wonkwang University, Gwangju Medical Center
Outcome results
None listed