Clinical trial to evaluate the efficacy and safety of Gold Mae-sun therapy on degenerative knee osteoarthritis

INTERVENTION: 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: Gold mae‐sun therapy (Put a gold in acupuncture point of affected part.) 2) Regions of treatment: acupuncture point of affected knee joint / Acupuncture point select is according to patient symptoms ‐ acupuncture points: ST35, EX‐LE5, EX‐LE2, Ashipoint, BL18, BL23, BL60, GB39, SP6, LR2, ST41, KI3 3) Number of treatments: 4 treatments for 6 weeks 4) Acupuncture usage: 2 5 per 1 treatment ‐ Control group 1) Treatment method: Applied a normal acupuncture(Acupuncture is applied to level of tingling sensation) 2) Regions of treatment: Around of affected knee joint 3) Number of treatments: 4 treatments for 6 weeks 4) Acupuncture usage: 3 per 1 treatment CONDITION: Diseases of the musculo‐skeletal system and connective tissue PRIMARY OUTCOME: Change of 100mm VAS(visual analog scale) SECONDARY OUTCOME: Adverse events Change of 100mm VAS(visual analog scale) Change of physical function test 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 Vital sign laboratory test vlaue 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.