Protocol to establish auxiliary diagnostic model for knee osteoarthritis functional testing equipment

doi:10.19852/j.cnki.jtcm.20230105.001

Abstract

Abstract:

In China, 50% of Knee Osteoarthritis (KOA) patients will be treated with Traditional Chinese Medicine or a combination of Traditional Chinese and Western Medicine, which call for objective efficacy evaluation methods. The collection, processing and fusion of multi-source data were taken as the main methods, with 150 KOA patients and 100 healthy people as an example to design prospective clinical tests. Data were collected with tongue inspection APP, infrared instrument and channel instrument, etc. And the analysis, screening, fusion and modelling of multi-source data were conducted. The traditional clinical tests have been combined with the customized information platform in this study, which is convenient for clinical tests, medical follow-ups and timely feedback to statistical analysis of data.

Key words: osteoarthritis, knee, multi-source data, efficacy evaluation, prospective clinical test, diagnostic tests, routine, protocol

GUO Zhuang, WANG Junwen, LI Zhonglong, CHEN Zhongjie, CHEN Li, YAN Shiyan, LU Hongrong, LI Zhigeng, LI Guanying. Protocol to establish auxiliary diagnostic model for knee osteoarthritis functional testing equipment[J]. Journal of Traditional Chinese Medicine, 2023, 43(2): 379-385.

Figures/Tables 6

References 12.

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Information sources	Collecting equipment (Manufacturer)	Collection site	Observation and analysis of indexes
Tongue inspection	Tongue inspection APP (Shanghai Daosh Medical Technology Co., Ltd.)	Frontal tongue picture	Tongue color, red edge, ecchymosis, coating color, thickness of coating, grimy coating of the tongue, bean curd tongue fur, peeling tongue fur, fat and thin tongue, tooth marks, prickles, cracks, etc.
Infrared	Portable infrared detector (Beijing KongSun TCM Image Technology Corp. Ltd.)	Face, hands and legs	Holographic partition temperature of face and hands: heart, liver, spleen, lung and kidney; The legs could be divided according to channels and acupoints;
Channel	JK-02A channel detector (Tonghua Haienda Hi-Tech Co., Ltd.)	Whole body channels	Electrical impedance of 12 channels and acupoints
Pain and Dysfunction	Subjective score	-	VAS/WOMAC osteoarthritis index
Routine Medical Record Information	Traditional Chinese medicine data collection APP (Self-research)	Whole body	Subjective four diagnostic information, syndrome differentiation type, Western Medicine diagnosis, imaging examination, treatment, and prescription and medicine

Information sources	Collecting equipment (Manufacturer)	Collection site	Observation and analysis of indexes
Tongue inspection	Tongue inspection APP (Shanghai Daosh Medical Technology Co., Ltd.)	Frontal tongue picture	Tongue color, red edge, ecchymosis, coating color, thickness of coating, grimy coating of the tongue, bean curd tongue fur, peeling tongue fur, fat and thin tongue, tooth marks, prickles, cracks, etc.
Infrared	Portable infrared detector (Beijing KongSun TCM Image Technology Corp. Ltd.)	Face, hands and legs	Holographic partition temperature of face and hands: heart, liver, spleen, lung and kidney; The legs could be divided according to channels and acupoints;
Channel	JK-02A channel detector (Tonghua Haienda Hi-Tech Co., Ltd.)	Whole body channels	Electrical impedance of 12 channels and acupoints
Pain and Dysfunction	Subjective score	-	VAS/WOMAC osteoarthritis index
Routine Medical Record Information	Traditional Chinese medicine data collection APP (Self-research)	Whole body	Subjective four diagnostic information, syndrome differentiation type, Western Medicine diagnosis, imaging examination, treatment, and prescription and medicine

Pain	Stiffness	Difficulty of daily activities		Scoring rule
1.When walking on flat ground	1.Morning stiffness	1.When coming down stairs	10.When getting up
2.When going up and down stairs	2.After sitting, lying or resting	2.When coming up stairs	11.When taking off socks
3.When sleeping at night		3.When standing up from seats	12.When lying in bed	None (0)
4.When sitting up or lying down		4.When standing	13.When going in and out of the bathtub	Mild (1)
5.When standing		5.When bending forward	14.When sitting	Moderate (2)
		6.When walking on flat ground	15.When sitting on the toilet or standing up	Very (3)
		7.When getting on and off the car	16.When doing heavy housework	Extreme (4)
		8.When shopping	17.When doing light housework
		9.When wearing socks
Total score of pain	Total score of stiffness	Total score of difficulty of daily activities

Pain	Stiffness	Difficulty of daily activities		Scoring rule
1.When walking on flat ground	1.Morning stiffness	1.When coming down stairs	10.When getting up
2.When going up and down stairs	2.After sitting, lying or resting	2.When coming up stairs	11.When taking off socks
3.When sleeping at night		3.When standing up from seats	12.When lying in bed	None (0)
4.When sitting up or lying down		4.When standing	13.When going in and out of the bathtub	Mild (1)
5.When standing		5.When bending forward	14.When sitting	Moderate (2)
		6.When walking on flat ground	15.When sitting on the toilet or standing up	Very (3)
		7.When getting on and off the car	16.When doing heavy housework	Extreme (4)
		8.When shopping	17.When doing light housework
		9.When wearing socks
Total score of pain	Total score of stiffness	Total score of difficulty of daily activities

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