JMIR Publications

ABSTRACT

Background:

The treatment options for knee osteoarthritis (KOA) remain limited. While previous studies suggest that acupuncture can alleviate pain and functional impairment associated with KOA, there is significant variation in acupoint selection across studies, and a lack of objective criteria to guide this choice. Infrared thermography (IRT) is recognized as a reliable method for identifying inflammatory regions in KOA. Our prior research has revealed abnormal skin temperature in specific acupoints and surrounding areas in the lower limbs of KOA patients, indicating potential treatment targets. However, there is still insufficient evidence to support their clinical use.

Objective:

This pilot trial aims to assess the feasibility of conducting large-scale studies in the future and to provide preliminary evidence of the effect of acupuncture applied on IRT-guided thermal sensitized acupoints for the treatment of KOA.

Methods:

This will be a randomized, controlled pilot trial with participant blinding. A total of 60 KOA patients will be randomly assigned in a 1:1 ratio to either the thermal sensitized acupoint (TA) group or the conventional acupoint (CA) group. Both groups will receive three acupuncture sessions per week for 4 weeks. In the TA group, acupoint selection will be based on points with abnormal skin temperature identified by IRT using real-time surface projection technology. In the CA group, acupoint selection will follow the established prescription validated in previous study. The primary outcome will be the feasibility, assessed using the traffic light system to evaluate recruitment, retention, intervention completion, and the completion of other outcomes. Secondary outcomes include Visual Analog Scale for pain, the Western Ontario and McMaster Universities Osteoarthritis Index function subscale, Credibility/Expectancy Questionnaire, skin temperature, and safety.

Results:

The study has been approved by the ethics committee of the Third Affiliated Hospital of Beijing University of Chinese Medicine (BZYSY-2024KYKTPJ-44, date: 2024/11/15) and registered in the International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn, registration number: ITMCTR2025000019, date: 2025/01/06). Since the first participant was enrolled on February 25, 2025, a total of 20 participants has been enrolled (as of August 4, 2025). All enrollment and follow-up are expected to be completed by June 2026.

Conclusions:

The findings of this study will provide feasibility and preliminary evidence of clinical effect for the future clinical adoption of acupuncture prescription based on thermal sensitized acupoints for the treatment of KOA.