BackgroundKnee osteoarthritis (KOA) is a highly prevalent joint disease among the middle-aged and elderly population that can lead to pain, functional impairment, decreased quality of life, and a large number of medical expenses. Physical therapy is one of the main treatment methods for KOA. In China, Tuina has been widely used in the treatment of KOA, but up to now, there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to objectively evaluate the efficacy and safety of Tuina in the treatment of KOA.MethodsA crossover design clinical trial was performed on 96 patients. The test group and the control group in the trial were allocated randomly in a ratio of 1:1. The test group received Tuina treatment for 4 weeks first and then received health education intervention for another 4 weeks. The control group received health education intervention for 4 weeks first and then received Tuina treatment for another 4 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score was chosen as the primary outcome. The WOMAC pain score, WOMAC stiffness, WOMAC daily activity score, and visual analog scale (VAS) score were the secondary outcomes. Adverse events during the intervention were collected in both groups.ResultsCompared with the baseline, the WOMAC total score, WOMAC pain score, WOMAC stiffness, WOMAC daily activity, and VAS score of patients in both groups were improved significantly at weeks 4 and 8 (p < 0.001). All patients who received Tuina treatment were significantly superior to those who received health education intervention in the WOMAC total score (194.96, 95% CI = 164.94–224.97, P < 0.001), WOMAC pain score (45.96, 95% CI = 35.82–56.09, P < 0.001), WOMAC stiffness (31.42, 95% CI = 26.37–36.46, P < 0.001), WOMAC daily activity (117.58, 95% CI = 97.56–137.61, P < 0.001), and VAS score (1.07, 95% CI = 0.83–1.32, P < 0.001). Both groups had no serious adverse events during the treatment.ConclusionThis trial demonstrated that Tuina can reduce joint pain in patients with KOA and improve the physical functions of the knee joint effectively and safely.Clinical trial registrationThis trial was registered in the Chinese Clinical Trial Registry (No. ChiCTR-TTRCC-13003157). http://www.chictr.org.cn/showproj.aspx?proj=6402.
IntroductionThe Western Ontario and McMaster University osteoarthritis index (WOMAC) is the most commonly used indicator of disease-specific outcome in knee osteoarthritis for its convenience and reliability. It has two formats the paper-based WOMAC (p-WOMAC) and the electronic WOMAC (e-WOMAC). In China, the p-WOMAC has been widely used though e-WOMAC is yet untested. This study aims to test whether e-WOMAC is consistent with the p-WOMAC before and after the intervention.Methods and analysisA total of 70 patients from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine will be randomly assigned in two groups, named, group A and group B. This study is divided into three stages. In the first stage, patients in group A will be evaluated first by p-WOMAC and then by e-WOMAC. Patients in group B will be evaluated by e-WOMAC and then by p-WOMAC. In the second stage of the study, drug interventions will be implemented. 200 mg celecoxib will be administered orally once a day starting from the second day of enrolment for a period of 21 days. In the third stage, postintervention evaluation will be conducted after administration. Patients in group A will be evaluated first by e-WOMAC and then by p-WOMAC. Patients in group B will be evaluated first by p-WOMAC and then by e-WOMAC. In order to avoid the possible bias because of patients’ potential memory, e-WOMAC and p-WOMAC will be taken for each patient at 15 min apart. The primary outcome of the study is the mean score difference in WOMAC, and the secondary outcomes are the score differences in WOMAC subscales: pain, stiffness and physical function.Ethics and disseminationThe protocol has been approved by the Independent Review Board of SGH (approval number: 2020-814-21-01). The results of the trial will be submitted for publication in a peer-reviewed journal.Trial registration numberChiCTR2100050914.
Diedaqili tablet has been found effective for fracture healing in previous clinical studies. In a recent study, we investigated the effects of diedaqili tablet (DDQL) on bone fracture repair in mice. Adult C57BL/6 mice were subjected to transverse femoral fractures and administrated orally with a low dose (40.55mg/ ml), a high dose (162.18mg/ml) DDQL suspension and normal saline daily from day 1 after operation. The femur and blood of mice was analyzed by plain radiography, micro-computed tomography (Micro-CT), histology, biomechanical analysis, and serum Ca, P, and ALP test. The results demonstrated that DDQL can effectively improve the porosis of fracture end and bony union in the course of healing via Micro-CT and hematoxylin-eosin staining (HE staining) analysis. Consistent with morphological findings, biomechanical properties of fracture healing have also been demonstrated. And Diedaqili tablet has a dose-dependent effect. DDQL augmented the release of alkaline phosphatase (ALP) and phosphorus (P) into blood, indicating that it promoted mineralization of hypertrophic cartilage and woven bone growth simultaneously during bone healing. In summary, the preliminary experiment revealed that DDQL can improve bone formation via promoting osteogenic capability, calcium (Ca) and P metabolism, and subsequently accelerates fracture repair and bony fusion.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.