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Effectiveness and Safety of Electric Warm-needling Therapy for Knee Osteoarthritis: a randomized controlled trial

Effectiveness and Safety of Electric Warm-needling Therapy used Cettum-Core(CT3) for Knee Osteoarthritis: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010600
Enrollment
40
Registered
2025-06-09
Start date
2025-06-11
Completion date
Unknown
Last updated
2025-06-24

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 : [Intervention Group] Electric Warm-Needling Therapy Group Electric warm-needling therapy will be applied for 13 minutes per session using the Cettum-Core device (Dongje Medical Co.

Sponsors

Dongguk University Bundang Oriental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Adults aged between 40 and 75 years (inclusive). 2.Individuals who meet the American College of Rheumatology classification criteria for osteoarthritis of the knee and satisfy both of the following conditions: ? Report unilateral or bilateral knee joint pain during weight-bearing activities within the past 6 months. ? Report a pain score of 40 mm or higher on a 100 mm Visual Analog Scale (VAS) due to knee joint pain. 3.Individuals with intact thermal sensation and the ability to distinguish differences in temperature. 4.Individuals who voluntarily decide to participate in this clinical trial and provide written informed consent. 5.Individuals who are reliable, willing to cooperate for the duration of the 3-month study period, and able to comply with the study requirements.

Exclusion criteria

Exclusion criteria: 1.History of knee joint trauma within the past 6 months. 2.History of knee joint surgery within the past 6 months. 3.Received intra-articular injection therapy (e.g., steroids, hyaluronic acid, prolotherapy, PRP [Platelet-Rich Plasma], etc.) within the past 3 months. 4.Use of medications such as opioid analgesics, anticonvulsants, or corticosteroids for pain control within the past 1 week. 5.Suspected inflammatory arthritis such as rheumatoid arthritis, infectious diseases, or autoimmune diseases based on physical examination or diagnostic medical tests. 6.Presence of physical or mental illness that may interfere with electrothermal acupuncture or device-based stimulation (e.g., severe cardiovascular or respiratory diseases, peripheral neuropathy due to diabetes). 7.Presence of neurological disorders such as local or generalized sensory paralysis. 8.Pregnant or breastfeeding women. 9.Individuals who have a fear of, adverse reactions to, or are expected to have adverse reactions to Electric Warm-Needling Therapy or Moxibustion Therapy 10.Any other case deemed unsuitable forElectric Warm-Needling Therapy or Moxibustion Therapy by the investigator.

Design outcomes

Primary

MeasureTime frame
Pain NRS

Secondary

MeasureTime frame
K-WOMAC score;100mm Pain VAS ;PGIC score;EQ-5D score; Adverse reaction evaluation

Countries

Korea, Republic of

Contacts

Public ContactEUNJIN KIM

Dongguk University Bundang Oriental Hospital

utopialimpid@naver.com+82-31-710-3724

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026