A Comparative Study on the Effectiveness and Safety of Thread Embedding Acupuncture(TEA) and Acupuncture in Patients with Knee Osteoarthritis : A Pilot, Assessor-blinded, Randomized, Controlled Trial
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0008979
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
?Those who meet the clinical criteria for primary knee osteoarthritis according to the American College of Rheumatology criteria 3 months prior to screening
a. Currently experiencing pain in one or both knees
b. and at least three of the following
age >50 years, stiffness <30 min, crepitus, bony tenderness, bony enlargement , no palpable warmth
?Knee pain during daily activities VAS=40mm
?Kellgren-Lawrence Grading Scale Grade 2 or higher according to knee X-ray examination
?After receiving a sufficient explanation of the research purpose and implementation process, voluntarily decide to participate and agree in writing.
?Anyone who can complete the case report form for the participant on their own or with the assistance
?Age 40 to 85 years old (if 75 years old or older, participant judged to have the capacity to consent through consent competency evaluation form)
?History of severe trauma to the knee, such as cartilage damage and cruciate ligament rupture.
?History of infectious or inflammatory diseases of the knee, such as bacterial arthritis, tuberculous arthritis, or gout
?Congenital deformity of the knee joint
?Those who have a history of invasive procedures such as knee replacement surgery or proximal tibial osteotomy (excluding knee arthroscopy) or who have a plan within the study period
?Received intra-articular injection treatment of steroids, hyaluronic acid, prolotherapy, PRP (Platelet-Rich Plasma), etc. within the past 6 months.
?Received TEA or other invasive treatment for the knee joint within the past 6 months, or received acupuncture or other oriental medicine treatment within the past 2 weeks.
?Screening clinical examination ESR>40mm/h, RA Factor>20U/mL
?Aspartate aminotransferase (8-40IU/L) and alanine aminotransferase (5-43IU/L) are more than three times higher than normal levels.
?Blood urea nitrogen (BUN, 5-23mg/dL) and creatinine (0.6-1.3mg/dL) are more than three times higher than normal levels.
?musculoskeletal problem that causes more pain in another part of the body than in the knee
?Taking narcotic analgesics, anticonvulsants, or corticosteroids for pain control within the past week
?Acupuncture hypersensitivity, metal allergy, severe atopy, keloid skin, other skin sensitivities, etc.
?Factors that can affect hemostasis, such as taking anticoagulants and antiplatelet drugs, and bleeding disorders
?Pregnant, lactating, or planning to become pregnant within the clinical trial period
?Uncontrolled diabetes, serious cardiovascular disease (myocardial infarction, congestive heart failure, etc.), etc.
?Are receiving or need active treatment due to significant neuropsychiatric medical history, history of alcohol or drug abuse, or serious underlying disease.
?Less than 1 month has passed since the end of participation in another interventional clinical study (including human trials), or the person was selected for this clinical study and plans to participate in other interventional clinical studies (including human trials) while participating.
?Clinical research staff determines it is inappropriate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method knee pain VAS
- Secondary Outcome Measures
Name Time Method Korean Western Ontario and McMaster Universities Osteoarthritis Index(;EQ-5D(EuroQol)3;Active Range of knee Motion ;Dosage of rescue medication; Adverse reaction evaluation