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Abstract Background Both massage and topically administered NSAIDs are safe and effective treatments for knee osteoarthritis (KOA); however, different massage technique sects in China caused assessment difficulties for the treatment of KOA. In order to standardize the massage techniques and procedures, we organized multi-disciplinary experts in China to acquire an evidence-based traditional Chinese medicine massage treatment of knee osteoarthritis. The purposes of this study will be to provide clinicians a complementary and alternative therapy for patients and to evaluate the efficacy and safety of evidence-based traditional Chinese medicine massage treatment of KOA compared to External Diclofenac Diethylamine Emulgel. Methods and design A randomized controlled trial in which 300 participants diagnosed with KOA will be recruited and randomly allocated to either the experimental group or the control group in a ratio of 2:1. Two hundred participants will receive evidence-based traditional Chinese medicine massage 2 sessions per week for 10 weeks as the experimental group, and 100 participants will receive External Diclofenac Diethylamine Emulgel 3–4 times per day for 10 weeks as the control group. The patients in the two groups will receive follow-up at two time points at 5 weeks and 10 weeks from the beginning of treatment, respectively. The MRI scans and X-ray will be performed at baseline and at the end of the intervention. The primary outcome will be the changes in the Western Ontario and McMaster Osteoarthritis Index (WOMAC). Secondary outcomes will be measured by the PRO scale for knee osteoarthritis based on the concept of traditional Chinese medicine (Chinese scale for knee osteoarthritis (CSKO)), X-ray evaluation, and MRI scan evaluation. The data of WOMAC and CSKO will be analyzed at the baseline, 5 weeks, and 10 weeks from the beginning of treatment. The data from MRI scans and X-rays will be analyzed at baseline and at the end of the intervention. The significance level sets as 5%. The safety of interventions will be evaluated after each treatment session. Discussion This study will provide clinicians with much-needed knowledge for the treatment of KOA through a controlled trial. Trial registration Chinese Clinical Trial Registry ChiCTR1800014400 . Registered on 10 January 2018

Objective: To analysis and determine MR signs of Harris score ARCO stages 2-4 in osteonecrosis of femoral head (ONFH)., Methods: Thirty-four patients with ONFH of ARCO stages 2 to 4 who underwent routine MR, T2 mapping, 3D-SPACE sequence examination and Harris score were retrospectively collected from January 2019 to June 2020, and 3 patients were excluded, and 31 patients were finally included, including 23 males and 8 females, aged from 18 to 62 years old with an average of(40.0±10.8) years old. Among them 21 patients with bilateral femoral head necrosis, totally 52 cases, including 17 with ARCO stage 2 patients, 24 ARCO stage 3, and 11 ARCO stage 4. MR imaging signs (femoral head collapse depth, ONFH index, bone marrow edema, hyperplasia, grade and T2 value of cartilage injury, and joint effusion) were scored and measured on the picture archiving and communication system (PACS) workstation, and the cartilage quantitative parameter T2 value was calculated and measured on Siemens postprocessing workstation. Pearson correlation analysis was used to evaluate the correlation between various MR signs and Harris score, and then multiple linear regression analysis was used to examine impact of MR signs on Harris hip score., Results: Femoral head collapse depth( r =-0.563, P =0.000), grade of cartilage injury( r =-0.500, P =0.000), and joint effusion ( r =-0.535, P =0.000) were negatively correlated with Harris score by Pearson correlation analysis. Multiple linear regression analysis showed that joint effusion( β =-6.198, P =0.001) and femoral head collapse depth( β =-4.085, P =0.014) had a significant negative impact on Harris hip score., Conclusion: Femoral head collapse depth and joint effusion both had significant negative relationship with Harris hip score. It is recommended to routinely evaluate femoral head collapse depth and joint effusion quantitatively and gradedly, so as to efficiently and accurately assist clinical diagnosis and treatment.

Objective: To establish a risk assessment and prediction system for early osteonecrosis of the femoral head (ONFH) in order to predict the collapse risk., Methods: The risk assessment system for early necrosis and collapse of femoral head was established based on the combination of Steinberg stage, ABC typing and the proportion of the proximal sclerotic rim. Firstly, Steinberg stage system was applied. ABC typing was applied to predict risk in stage I, type C was risk free, type B was low risk, type A and type BC were medium risk, type A-C and type AB were high risk. The classification of proximal sclerotic rim was first applied when the Steinberg stage was Ⅱ-Ⅲ, and type 2 was expected to be low risk. If the classification of proximal sclerotic rimwas type 1, then the ABC typing was applied, type C was risk-free, type B was low risk, type A and type BC were medium risk, type A-C and type AB were high risk. According to this prediction system, the collapse risk of femoral head in 188 cases(301 hips) were predicted by retrospective analysis. All the hips were enrolled at the out-patient department of orthopedic in Guang'anmen Hospital attached to China Academy of Chinese Medical Science. The consistency of the prediction results of three doctors and one doctor at different times were evaluated., Results: Among them, 136 cases were male, 52 were female. 75 cases were single hip, 113 were double hip. The age of the patients wa 19 to 64(42.61±12.07) years. The natural course of disease was 0.33 to 5.00(3.62±1.93) years. 206 hips in 301 hips had collapsed, with a collapse rate of 68.44%. In the risk-free group, none hip had collapsed, with a collapse rate of 0%. In the low-risk group, 9 hip in 91 hips had collapsed, with a collapse rate of 9.89%. In the medium-risk group, 12 hip in 19 hips had collapsed, with a collapse rate of 63.16%. And in the high risk group, 185 hips in 190 hips had collapsed, with a collapse rate of 97.37%. They were significantly differences in their collapse rate ( P =0.00) in the following order:high-risk group> medium-risk > low-risk group > risk-free group. The prediction value of the system was high (AUC=0.95, P =0.00). The results predicted by different doctors were consistent (ICC=0.94, P =0.00), and the results predicted by the same doctor at two different times were consistent (Kappa coefficient =0.90, P =0.00)., Conclusion: The risk assessment and prediction system for early ONFH selects different methods to predict the risk of collapse according to the imaging characteristics of different stages, which is combines with the comprehensive assessment of multiple risk factors. The system is applicable to a wide range, simple operation and convenient for clinical application.

In this study, we used Ultra Performance Liquid Chromatography-Time-of-Flight Mass Spectrometry(UPLC-TOF-MS)to identify the chemical constituents in both ethanol and water extract of Polygonum capitatum. A Waters ACQUITY UPLC BEH C₁₈ column(2.1 mm×100 mm,1.7 μm) was used for separation. The mobile phase was consisted of(A) 0.10% formic acid in water and(B)0.10% formic acid in acetonitrile, and the flow rate was 0.35 mL•min⁻¹. ESI source in negative ion mode was used for MS detection. Structural identification was carried out according to the accurate mass and matching with database. The results showed that flavonoids, polyphenols and lignans were the main components in both extracts. However, the chemical compositions of both extracts were different, e.g. there are less hydrolyzable tannins, loss of ellagic acid and more anthocyanins in ethanol extract. In a conclusion, this study provides an important scientific basis for identifying the active ingredients in P. capitatum, which also help to reveal the pharmacological effect of P. capitatum., Competing Interests: The authors of this article and the planning committee members and staff have no relevant financial relationships with commercial interests to disclose., (Copyright© by the Chinese Pharmaceutical Association.)

Objective: To observe the distribution of constitution types of Chinese medicine (CM) in patients with osteonecrosis of femoral head (ONFH)., Methods: Totally 130 ONFH patients were recruited. Constitution types of CM were identified in all patients. Distribution features of constitution types of CM in ONFH patients were observed. The differences of distribution in gender, age, single or bilateral hips, course of disease, staging, cause, and region were also analyzed., Results: Seventy patients were of complicated constitutions, while 60 patients were of single constitution. Among the 60 single constitution cases, yang-deficiency constitution [18 (13.9%)], damp-heat constitution [10 (7.7%)], blood-stasis constitution [7 (5.4%)], and qi-deficiency constitution [7 (5.4%)] were mainly distributed. Of the complicated constitutions, yang-deficiency dominated constitution occupied the top ratio [30 (23.1%)], followed by blood-stasis dominated constitution [15 (11.5%)], damp-heat dominated constitution [9 (6.9%)]. By putting them together, yang-deficiency constitution occupied the top constitution of CM [48 (36.9%)], followed by blood-stasis constitution [ 22 (16.9%)] and damp-heat constitution [19 (14.6%)]. The aforesaid three constitutions accounted for 68.5% of the total. There were no statistical distribution differences in gender, age, single or bilateral hips, course of disease, staging, or cause., Conclusion: Yang-deficiency constitution, damp-heat constitution, and blood-stasis constitution were liable constitutions of CM in ONFH patients.