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

Effectiveness and Safety of Polydioxanone Thread-Embedding Acupuncture (TEA) and Electroacupuncture (EA) Treatment for Knee Osteoarthritis (KOA) Patients with Postoperative Pain: An Assessor-blinded, Randomized, Controlled Pilot Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004804
Enrollment
36
Registered
2020-03-06
Start date
2020-05-22
Completion date
Unknown
Last updated
2020-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Subjects eligible for this study are randomized(1: 1) in two groups: Usual care+TEA+EA group or Usual care only group. Usual care+TEA+EA group conducts 4 times of TEA once a week f

Sponsors

Korea Institute of Oriental Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Pain(Visual Analogue Scale; VAS)

Secondary

MeasureTime frame
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)

Countries

Korea, Republic of

Contacts

Public ContactJu Hyun Jeon

Daejeon University

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 18, 2026