Effectiveness and Safety of Polydioxanone Thread Embedding Acupuncture(TEA) and Electroacupuncture(EA) Treatment for Knee Osteoarthritis(KOA) Patients with Postoperative Pai

Not Applicable

Recruiting

Conditions: Diseases of the musculo-skeletal system and connective tissue

Registration Number: KCT0004804

Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 36

Inclusion Criteria

1. Age over 40 years
2. Diagnosed with degenerative arthritis who have passed 6 months after surgery(arthroscope, autologous chondrocyte transplantation, or autologous osteochondral transplantation)
3. Knee pain more than VAS(Visual Analogue Scale) 40mm at screening
4. Subjects who voluntarily decides to participate and agrees to the written agreement after having received a full explanation of the research objectives and processes
5. Subjects who can write patient preparation data on their own or with the support of a guardian or researcher.

Exclusion Criteria

1. History of arthroplasty on the knee
2. Severe knee trauma in the last 6 months
3. Subjects who received TEA within 6 months and EA within 2 weeks
4. Subjects who received injection treatment such as steroids or hyaluronic acid within 3 months and prolotherapy or platelet-rich plasma(PRP) within 6 months
5. ESR>40 mmhr, RA Factor>20IU/mL in screening clinical eamination
6. Subjects with musculoskeletal problems that cause more pain than knee pain in other body parts
7. Hypersensitive reaction to previous acupuncture treatment, metal allergy, severe atopy, keloid, and other skin hypersensitivities
8. Subjects who have hemorrhagic disease, cardiovascular disease or with factors that may affect hemostasis, such as taking anti-coagulants or anti-platelets
9. Pregnancy, nursing or diagnosed with malignant tumors
10. Subjects who have severe diabetes or cardiovascular disease such as angina pectoris or congestive heart failure
11. Subjects with senile dementia, severe mental or psychological disorders
12. Subjects who has inserted pacemaker
13. Subjects who are considered to be inappropriate for the study by the researcher

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain(Visual Analogue Scale; VAS)

Secondary Outcome Measures

Name	Time	Method
Disability(Korean Western Ontario and McMaster Universities Osteoarthritis Index; K-WOMAC);Quality of life(EuroQol five dimensions questionnaire; EQ-5D);Rescue medication taking;Safety assessment(Adverse event)