Effects of Golden Plaster on Knee Osteoarthritis: A Multicenter Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Golden plaster is the preferred and most commonly used in China for pain reduction in patients with knee osteoarthritis (OA). However, there was no evidence-based medical evidence about its effect in relieving pain of knee OA patients. Here, a multicenter randomized, double-blind, placebo-controlled trial was performed to evaluate the efficacy and safety of golden plaster for the improvement of pain relief and function's obstacle in patients with knee OA. METHODS: 320 patients with knee OA were enrolled at four hospitals and randomly divided into the treatment group and the control group with 160 subjects in each group. Patients in treatment group were treated with golden plaster, and those in control group with placebo plaster. The study cycle in both groups was 21 days. Patient visits were documented before treatment and 7-, 14-, and 21-day follow-ups after treatment. The outcomes included VAS score, WOMAC score, and adverse events. RESULTS: Compared to the control group, the VAS score in the treatment group was significantly decreased after treatment with golden plaster for 7 days, 14 days, and 21 days. Compared to the control group, the WOMAC score in the treatment group was significantly decreased 14 days and 21 days. The incidence rate of adverse events had no statistical difference between both the groups. CONCLUSIONS: In conclusion, our study, for the first time by carrying on the double-blind and placebo-controlled randomized trial, showed that golden plaster can effectively alleviate the pain of knee and improve the physical function in the patients with knee OA. This trial is registered with ChiCTR-TRC-13003418.

Activation of the extracellular-signal-regulated kinase (ERK)/c-Jun N-terminal kinase (JNK) signal pathway and osteogenic factors in subchondral bone of patients with knee osteoarthritis.

BACKGROUND: The objectives of this study was to explore the activation of the extracellular-signal-regulated kinase (ERK) and c-Jun N-terminal kinase (JNK) signaling pathway and osteogenesis-related factors in the subchondral bone of patients with knee osteoarthritis (OA). METHODS: Ten patients with primary OA who underwent total knee arthroplasty in the Department of Arthritis Surgery of our hospital were enrolled, and subchondral bone tissue samples were obtained during the operation. He staining and saffron staining were used to observe the arrangement of chondrocytes in the patient tissues. The protein expression levels of JNK, p-JNK, ERK, p-ERK, Runx2 and OMD in subchondral bone were detected by Western Blot. Knee osteoarthritis mice were established. He staining was used to observe the arrangement of subchondral bone cells in the knee joint of mice. Cellular mineralized nodules were determined by alizarin red staining. RESULTS: Firstly, in general and staining, it was observed that the subchondral bone lesions of knee OA participants were obvious. Compared with normal knee joints, the levels of phosphorylation-c-Jun N-terminal kinase (P-JNK) and phosphorylation-extracellular-signal-regulated kinase (P-ERK) in the subchondral bone of knee arthritis participants were significantly increased (P<0.05). The level of osteomodulin (OMD) was significantly reduced (P<0.05). Secondly, compared with normal mice, the levels of JNK, P-JNK, OMD, ERK, and P-ERK in the model group were significantly different (P<0.05). At 2-8 weeks, the JNK and P-JNK levels in the mice model group increased significantly over time (P<0.05), and the OMD level decreased significantly over time (P<0.05). The levels of ERK and P-ERK fluctuated over time. Thirdly, osteoblasts were treated with different concentrations of anisomycin, and stained with alizarin red after continuous culture for 24 and 48 h, respectively. It was found that all the cells were stained with orange-red mineralized nodules. As the concentration of anisomycin was increased, the number of cell mineralization nodules was significantly larger, and the positive rate of chemical nodules increased. Different concentrations of anisomycin were given to interfere with the osteoblasts of mice. When anisomycin was administered at a dose of 25 ng, the OMD level reached the highest level. When the concentration of anisomycin was increased, the osteocalcin (OCN) level also showed an upward trend. CONCLUSIONS: The process by which the JNK signaling pathway regulates OMD may be closely related to the pathological changes of subchondral bone in patients with knee OA, and is involved in the occurrence and development of knee arthritis.

Case Report: Bosworth Fracture-Dislocation managed by Closed Reduction and Conservative Treatment.

Bosworth fracture-dislocation is a rare type of ankle injury, which in the typical radiologic are overlap of distal tibia and fibula in the anteroposterior view, posterior subluxation of the talus and syndesmosis dissociation in the lateral view, while in the CT scan, the fibula was displaced behind the posterior edge of the fibular notch (incisura tibiae), locked between the distal tibia and the displaced posterior malleolus fragment. Treatment can be challenging owing to the ignorance or failure of the initial reduction, resulting in an irreducible tibiotalar joint and tibiofibular syndesmosis reduction. To treat this complicated injury, emergent open surgery is always recommended for the first stage reduction to prevent adverse events. Successful closed reduction and conservative treatment of Bosworth fracture-dislocation is rare. This unique case presents a 25-year-old male with a Bosworth fracture-dislocation cured with closed reduction and U-shaped plaster splint. The patient was fully weight bearing and had no pain, and there were no limitations in the range of motion of the ankle and subtalar joints at 30 months of follow-up.

[Analysis of related factors and evaluation of quality of life of osteonecrosis of femoral head after internal fixation of femoral neck fracture].

OBJECTIVE: To explore the risk factors of osteonecrosis of femoral head after internal fixation of femoral neck fracture in young patients, to describe the quality of life of patients with surviving femoral head, and to quantify the predictive factors. METHODS: From January 2013 to December 2016, 172 patients (174 hips) with femoral neck fracture treated by closed reduction and cannulated screw internal fixation were selected for retrospective analysis. The general data of the patients were summarized, including age, gender, body mass index, trauma mechanism, trauma operation interval, trauma season and whether the internal fixation was removed. The imaging data included the Garden classification and Pauwel classification of fractures, femoral head retroversion angle, postoperative fracture reduction, screw distribution. Single factor analysis and multi-factor Logistic regression analysis were carried out to explore the risk factors of femoral head necrosis and internal fixation failure. The patients who survived the internal fixation were followed up. The quality of life of the patients was evaluated by the health survey of SF-36. The Harris score of hip joint function was used to evaluate the hip joint function. The predictors of the quality of life of the patients after the operation of femoral neck fracture were analyzed by multiple linear regression analysis. RESULTS: Total 172 patients(174 hips) were included in the study, 29 patients(16.67%) had necrosis of the femoral head. In multivariate Logistic regression analysis, the significant differences were reduction quality (OR=0.126, P=0.027) and posterior inclination angle (OR=4.380, P=0.010). One hundred and thirty six patients (137 hips) who survived the femoral head were included in the quality of life survey. Harris score was 90.14±7.92, including excellent 96 hips (70.07%), good 28 hips (20.44%), medium 13 hips (9.49%) and poor 0 hip. In SF-36 score, physical health summary (PCS) was 46.12±9.12, mental health summary(MCS) was 50.21±3.97, there was no linear correlation between them (P>0.05). In multiple linear regression analysis, the variables with significant difference in PCS were reduction quality and retroversion angle, and the variables with significant difference in MCS were fracture displacement and trauma mechanism. CONCLUSION: Poor reduction quality and posterior inclination angle>15° are the risk factors of femoral head necrosis. The function of hip joint and MCS of patients with femoral neck fracture recovered well, but PCS could not recover to the average level of normal people. The reduction quality and retroversion angle could be used as the predictors of PCS, and the displacement and trauma mechanism of fracture could be used as the predictors of MCS.

[Clinical observation of Yishen Huoxue decoction(YSHXD) for the treatment of non-traumatic osteonecrosis of femoral head at early and middle stage].

OBJECTIVE: To observe clinical efficacy of Yishen Huoxue decoction(YSHXD) for the treatment of non-traumatic osteonecrosis of femoral head at early and middle stage. METHODS: From January to June 2016, 69 patients (72 hips) with non-traumatic osteonecrosis of femoral head at early and middle stage were divided into treatment group and control group according to therapeutic methods. In treatment group, there were 35 patients 43 hips, including 15 males and 20 females, aged from 28 to 62 years old with an average of(41.80±11.03) years old, 6 hips were at the stage I, 27 hips were at the stageII, 10 hips were at the stage IIIa according to ARCO classification; and treated by using YSHXD, one dose a day for 12 months. In control group, there were 34 patients 39 hips, including 16 males and 18 females, aged from 31 to 61 years old with an average of (43.35±13.52) years old, 5 hips were at the stage I, 26 hips were at the stageII, 8 hips were at the stage IIIa according to ARCO classification; and treated by using alendronate sodium tablets 70 mg every week for 12 months. Preoperative and postoperative HSS score at 2 weeks were observed and compared, EQ-5D index was used to compare clinical effects. ARCO classification was applied to imaging evaluation, the stage of ARCO over IIIa was considered as end point of observation. The final following-up time and ARCO classification were recorded and performed Kaplan-Meier survival analysis. RESULTS: All patients were followed-up from 26 to 76 months with an average of(43.50±13.26) months. Postoperative Harris score at 2 years in treatment group (84.92±7.56) was higher than that of before treatment (73.58±10.02) (P<0.05), and higher than that of control group(79.61±10.92)(P<0.05), especially the scores of joint function and activity were higher than those of control group(P<0.05). EQ-5D index in treatment group 0.66±0.12 was higher than that of control group 0.59±0.12(P<0.05). Nine hips were collapsed in treatment group at final follow-up, and 10 hips were collapsed in control group, and had no statistical difference between two groups (P>0.05). There was no statistical difference in kaplan-meier survival analysis curves between two groups (P>0.05). There were statistical difference in survival rate between the early, middle ARCO stage and different Harris evaluation. CONCLUSIONS: YSHXD for the treatment of non-traumatic osteonecrosis of femoral head at early and middle stage has obviously clinical effects, could improve hip joint function, and quality of life, and delay the process of femoral head necrosis collapse.

[Limited external fixation of plastic cardboard for the treatment of senile comminuted humeral fracture].

OBJECTIVE: To explore clinical efficacy of limited external fixation with plastic paperboard in treating senile proximal comminuted humeral fracture. METHODS: From June 2015 to December 2017, 32 senile patients with proximal comminuted fracture of humerus were treated with plasticized cardboard after manual external fixation. Among them, including 13 males and 19 females aged from 55 to 85 years old with an average of(68.22±8.36) years old; 18 patients on the left side and 14 patients on the right side; all patients were regularly review shoulder X-rays and performed appropriate functional exercises. Constant-Murley shoulder joint scoring was used to evaluate clinical effects. RESULTS: Thirty-two patients were followed up for 3 to 12 months with an average of (4.97±2.39) months. All patients were underwent functional exercise under guidance of physicians. Nine patients were treated with topical Chinese herbal moist heat compresses to promote shoulder function recovery. Thirty-one patients were obtained fracture healing, the time ranged from 5 to 12 weeks with an average of(7.44±1.72)weeks. One patient was not healed due to comminuted fracture of fracture end and the separation was large, the blood supply to humeral head was insufficient for necrosis absorption. Postoperative Constant-Murley shoulder score at 3 months was 87.56±6.93; 15 patients got excellent results, 14 good, 2 fair and 1 poor. CONCLUSIONS: Limited external fixation with plastic paperboard for the treatment of senile proximal comminuted humeral fracture could ensure biomechanical stability of fracture, promote early recovery of shoulder joint function and shorten recovery time.

Golden plaster for pain therapy in patients with knee osteoarthritis: study protocol for a multicenter randomized, double-blind, placebo-controlled trial.

BACKGROUND: Osteoarthritis is a relatively common musculoskeletal disorder that increases in prevalence with age. Worldwide, knee osteoarthritis is one of the leading causes of disability, particularly in the elderly. In numerous trials of agents for long-term pain therapy, no well-established and replicable results have been achieved. Complementary and alternative medical approaches have been employed for thousands of years to relieve knee osteoarthritis pain. Among herbal medicines, the golden plaster is the preferred and most commonlyused method in China to reduce pain in patients with knee osteoarthritis, as it causes few adverse effects. The purpose of this study will be to evaluate the efficacy and safety of golden plaster on pain in patients with knee osteoarthritis. METHODS/DESIGN: This study will be a multicenter randomized, double-blind, placebo-controlled trial. A total of 320 participants aged 45 to 79 years with knee osteoarthritis, whose scores on a visual analog scale (VAS) are more than 20 mm,will be randomly allocated into a treatment group and a control group. A golden plaster will be administered externally to participants in the treatment group for 2 weeks, while the control group will receive a placebo plaster externally for 2 weeks. Follow-up will be at regular intervals during a 4-week period with a VAS score for pain, quality of life, and complications. DISCUSSION: This study will be a methodologically sound randomized controlled trial to assess pain relief after the intervention of golden plaster, compared to a placebo intervention in patients with knee osteoarthritis. TRIAL REGISTRATION: ClinicalTrials.gov identifier: ChiCTR-TRC-13003418.