None listed
Conditions
Interventions
Medical Device : Forty patients with degenerative knee osteoarthritis will be randomly assigned to the biodegradable microneedle acupuncture (BMA) treatment group or the sham device treatment group. I
Sponsors
Naju Dongshin University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged 50 years or older at the time of screening. 2) Those who meet the clinical criteria for primary knee osteoarthritis according to the American College of Rheumatology criteria at the time of screening: a) Those who currently have pain in one or both knees b) Those who meet at least three of the following six criteria: - 50 years of age or older. - Morning stiffness in the knee joint lasting less than 30 minutes. - Crepitus in the knee joint. - Bony tenderness. - Bony enlargement of the knee joint. - No palpable warmth. 3) The degree of joint space stenosis graded 1-3 according to the Kellgren & Lawrence scale on radiography (X-ray). 4) In a 100 mm pain visual analog scale (VAS) during activity, those who marked in the range of 40-80 mm in at least one knee joint. 5) Those who had no problem reading and writing in Korean, who have voluntarily submitted written consent, and who signed the consent.
Exclusion criteria
Exclusion criteria: 1) Those with history of knee injury within six months of the screening. 2) Those with history of knee surgery with loss of connective tissue around the knee within six months of the screening. 3) Those who received intraarticular viscosupplementation Injections, including hylan, sodium hyaluronate, hyalulonan, within six months of the screening. 4) Those who received injections, including corticosteroids and prolotherapy, into the joint cavity or around the knee within three months of the screening. 5) Those who drained joint fluid by intraarticular injection within three months of the screening. 6) Those with current or past history of inflammatory diseases, tumors, trauma, severe valgus and varus degeneration of the knee joint, secondary arthritis, hip joint diseases, or other inflammatory arthritis. 7) Those with severe cardiovascular diseases, hepaticpathy, nephropathy, immunodeficiency, diabetes, or hemopathy. 8) Those taking immunosuppressants, corticosteroids, cyclosporine, or osteoarthritis medications. 9) Those with psychiatric or immunological diseases, or taking medications for these diseases. 10) Those with skin allergies, glue allergies, or skin infections on the treated acupoints. 11) Pregnant or lactating women. 12) Those who have participated in other clinical trials within one month of the screening or who plan to participate in other clinical trials during the study period (however, those who have participated in a non-interventional observational study may participate in this trial if the principal investigator has determined that the prior trial does not affect the efficacy and safety of the investigational medical device). 13) Others whom the principal investigator deemed to be ineligible for participating in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in 100 mm pain visual analog scale (VAS) during activity between the baseline and week 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in 100 mm pain visual analog scale (VAS) at rest between the baseline and week 5;Changes in the Knee Injury and Osteoarthritis Outcome Score (KOOS) between the baseline and week 5;Changes in the 5-level EQ-5D version (EQ-5D-5L) score between the baseline and week 5;Changes in the patient's global assessment (PGA) score between the baseline and week 5 | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Hoon Song
Dongshin University
Outcome results
None listed