scholarly journals Efficacy and Safety of Tongning Gel for Knee Osteoarthritis: A Multicentre, Randomized, Double-Blinded, Parallel, Placebo-Controlled, Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Ye Zhao ◽  
Zhi Bi Shen ◽  
Ji Rong Ge ◽  
Wen Gang Liu ◽  
Jun Xing Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Physical Function ◽  
Pain Score ◽  
Adverse Reactions ◽  
Control Group ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Experimental Group

Objective. To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA). Methods. A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276). Results. Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups (P<0.05), and the decreased value of WOMAC pain score in the TNG group were better than those in the PC group (P<0.05). Secondary efficiency outcome: the WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes of the two groups of patients after treatment were statistically significant (P<0.05), and the improvement of the above indexes in the TNG group was better than that of the PC group (P<0.05). Safety Evaluation. A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group. And 8 adverse reactions were reported by 6 patients including 2 adverse reactions by 2 patients (0.46%) in the experimental group and 6 adverse reactions by 4 patients (2.78%) in the control group. Two cases of significant adverse events occurred in the experimental group. Both groups had one serious adverse event, respectively, which were not relevant to the intervention. Conclusion. These results of the trial demonstrate that TNG is superior to placebo in the treatment of patients with KOA, and TNG can improve other symptoms of KOA, such as stiffness and physical function. TNG is safe for the treatment of knee osteoarthritis as a whole.

scholarly journals Treatment of knee osteoarthritis with intra-articular injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE®: a phase I/II, randomized, active-control, single-blind, multiple-center clinical trial

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Cheng-Fong Chen ◽  
Chih-Chien Hu ◽  
Chen-Te Wu ◽  
Hung-Ta H. Wu ◽  
Chun-Shin Chang ◽  
...  
Keyword(s):  
Stem Cells ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Pain Score ◽  
Active Control ◽  
Womac Pain ◽  
Adipose Derived Stem Cells ◽  
Serious Adverse Events ◽  
Treatment Visit ◽  
Womac Pain Score

Abstract Objective To evaluate the safety and efficacy of intra-articular (IA) injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE® for knee osteoarthritis. Methods This was a patient-blind, randomized, active-control trial consisted of 4 arms including hyaluronic acid (HA) control and 3 ELIXCYTE® doses. A total of 64 subjects were screened, and 57 subjects were randomized. The primary endpoints included the changes from baseline to post-treatment visit of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at Week 24 and the incidence of adverse events (AEs) and serious adverse events (SAEs). Results No ELIXCYTE®-related serious adverse events were reported during 96 weeks of follow-up and no suspected unexpected serious adverse reaction (SUSAR) or death was reported. The changes of the primary endpoint, WOMAC pain score at Week 24, showed significant differences in all ELIXCYTE® groups, as well as in HA groups between post-treatment visit and baseline. The ELIXCYTE® groups revealed significant decreases at Week 4 compared to HA group in WOMAC total scores, stiffness scores, functional limitation scores suggested the potential of ELIXCYTE® in earlier onset compared to those from HA. The significant differences of visual analog scale (VAS) pain score and Knee Society Clinical Rating System (KSCRS) functional activities score at Week 48 after ELIXCYTE® administration suggested the potential of ELIXCYTE® in the longer duration of the effectiveness compared to HA group. Conclusions ELIXCYTE® for knee osteoarthritis treatment was effective, safe, and well-tolerated. The efficacy results were showed that ELIXCYTE® conferred the earlier onset of reductions in pain scores and improvements in functional scores than HA group. Trial registration: ClinicalTrials.gov Identifier: NCT02784964. Registered 16 May, 2016—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02784964

scholarly journals T2 mapping evaluation of changes in cartilage matrix after PRP and HA injection therapy in knee osteoarthritis: a prospective, randomized, double blind, placebo controlled study

2020 ◽  
Author(s):  
Matjaz Vogrin ◽  
Jakob Naranda ◽  
Mario Gorenjak ◽  
Tomaz Bajec ◽  
Domen Mongus ◽  
...  
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Pain Score ◽  
T2 Mapping ◽  
Womac Score ◽  
Controlled Study ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Knee Oa

Abstract BackgroundIn this study we focused on evaluating the effect of intra-articular platelet-rich plasma (PRP) and hyaluronic acid (HA) on the qualitative and quantitative properties of the articular cartilage in patients with knee osteoarthritis (OA).MethodsWe evaluated 264 patients undergoing treatment of moderate knee OA. Patients aged between 40 and 70 years were included with articular K-L stage ≤ 2. Patients were randomized into three groups and treated with three doses of intra-articular PRP, HA, or placebo injection. Patients were evaluated clinically and by using T2 mapping.ResultsBoth PRP (619.05 ± 243 ms; p = 2.7 × 10− 5) and HA (637.12 ± 273 ms; p = 1.×10− 4) group showed statistically significant lower post-application T2 relaxation times in comparison to the placebo group (859.80 ± 406 ms).Cartilage thickness increased significantly after PRP (2.41±0.87 vs. 2.58±0.97 mm, p=0.033) and HA (2.28±0.81 vs. 2.80±1.00 mm, p=1.8×10) applications. There was a significant decrease in WOMAC pain score by 30% (p=0,001) and the overall WOMAC score by 27 p=1.9×10-4%) in PRP group. The decrease in WOMAC pain score and the overall WOMAC score in the placebo group was similar to the results observed in the PRP group. In the HA group a significant decrease in WOMAC pain score by 14% (p=0,005) was observed only at the first follow-up, whereas no difference was observed at the second follow-up. ConclusionsT2 mapping of cartilage tissue may aid to monitor its properties after the intra-articular therapies in knee OA. However, there is a discrepancy between clinical findings and the results of T2 mapping, suggesting questionable grounds for applying intra-articular therapy.

scholarly journals Efficacy of Balneotherapy and Mud Therapy in Patients with Knee Osteoarthritis: A Systematic Literature Review

2020 ◽  
Author(s):  
Hafiz Muhammad Asim Raza ◽  
Grazina Krutulyte ◽  
Inesa Rimdeikiene ◽  
Raimondas Savickas
Keyword(s):  
Knee Osteoarthritis ◽  
Pain Score ◽  
Clinical Studies ◽  
Meta Analysis ◽  
Womac Pain ◽  
Function Score ◽  
Womac Pain Score ◽  
Womac Function ◽  
Significant Difference ◽  
Mud Therapy

Abstract Objectives To identify literature reporting on thermal mineral water and mud therapy effectiveness on pain, stiffness and knee function in patients with knee osteoarthritis. Design Systematic evidence scan of MEDLINE and PubMed was performed to identify the randomized controlled trial studies published from 2004 to December 2018. Study selection Papers reporting the effect of balneotherapy and mud therapy for treating knee OA, a duration of ≥2 weeks and in which Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were used as an outcome measure. Data extraction Not RCT, Studies not in English. Results A quantitative meta-analysis of ten studies (831 patients) was performed. Five clinical studies (407 patients) measured effectiveness of balneotherapy and there was significant difference between the groups in WOMAC pain score, WOMAC stiffness score and WOMAC function score, with the differences in favour of balneotherapy. Six clinical studies (500 patients) measured effectiveness of mud therapy and there was significant difference between the groups in WOMAC pain score, WOMAC stiffness score and WOMAC function score, with the differences in favour of mud therapy. Conclusion This meta-analysis indicates that balneotherapy and mud therapy were clinically effective in relieving pain, stiffness, and improving function, as assessed by WOMAC score.

Effect of laser moxibustion for knee osteoarthritis: a multi-site double-blind randomized controlled trial

2020 ◽  
pp. jrheum.200217
Author(s):  
Ling Zhao ◽  
Ke Cheng ◽  
Fan Wu ◽  
Jiong Du ◽  
Yue Chen ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Pain Score ◽  
Laser Treatment ◽  
Pain Reduction ◽  
Active Group ◽  
Womac Pain ◽  
Double Blind ◽  
Womac Pain Score ◽  
Clinically Significant ◽  
And Function

Objective To examine the effects of laser moxibustion on pain and function in patients with knee osteoarthritis. Methods A double-blind randomized clinical trial (4-week treatment, 20-week follow-up) was conducted. A total of 392 symptomatic knee osteoarthritis patients with moderate or greater clinically significant knee pain were randomly assigned to laser treatment or sham laser control group (1:1). Twelve sessions of laser moxibustion treatments or sham on the acupuncture points at the affected knee(s) were performed three times a week for 4 weeks. The primary outcome measurement was change in WOMAC pain score from baseline to week 4. Results Among the 392 randomized participants, 364 (92.86%) completed the trial. The median WOMAC pain score significantly decreased at week 4 in the active group than in the sham group (2.1; 95% CI, 1.6 to 2.6; P < .01). At week 24, compared to the sham laser, active laser treatment resulted in significant pain reduction and function improvement (3.0; 95% CI, 2.5 to 3.6; P < 0.01, and 14.8; 95% CI, 11.9 to 17.6; P < .01, respectively). The physical component of the quality of life significantly improved in the active group than in the sham control at week 4 (3.2; 95% CI, 1.3 to 5.0; P = 0.001) up to week 24 (5.1; 95% CI, 3.3 to 7.0; P < .001). No serious adverse effects were reported. Conclusion Laser moxibustion resulted in statistically and clinically significant pain reduction and function improvement following a 4-week treatment in patients with knee osteoarthritis. Keywords: 10.6μm laser moxibustion, knee osteoarthritis, pain, traditional Chinese medicine, phototherapy

scholarly journals Comparison of Two Different Ozone Injection Sites for Knee Osteoarthritis, Tibio-femoral Joint versus Supra-patellar Recess: An Open Randomized Clinical Trial

2020 ◽  
pp. 37-49
Author(s):  
Masoud Hashemi ◽  
Mehrdad Taheri ◽  
Payman Dadkhah ◽  
Hasti Hassani ◽  
Mohammadhossein Ataie ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Pain Score ◽  
Outcome Measures ◽  
Secondary Outcome ◽  
Womac Pain ◽  
Joint Injection ◽  
Knee Oa ◽  
Ozone Injection

Background: The aim of this study was to compare the efficacy of ozone injection at Tibio-femoral joint with Supra-patellar recess on knee osteoarthritis (OA). Methods: In this randomized, controlled clinical trial, 99 patients with symptomatic knee OA were randomized into two groups. 47 patients selected to receive 7-8 ml ozone (20 µg/ml) through Tibio-femoral joint injection, and 49 patients received 10 ml ozone (20 µg/ml) through supra-patellar recess injection by using in-plane ultrasound-guided. The primary outcome was the change from baseline in the visual analogue scale (VAS) (0-100 mm) pain score during 3 months after injection. Secondary outcome measures included the Western Ontario and McMaster universities OA Index (WOMAC), Lequesne index, time “Up and Go” (TUG) test, single-limb stance (SLS) tests, patient satisfaction, and adverse effects. All of these measurements were evaluated at the base time, 48 hours, 2 weeks, 1 month, 2 months, and 3 months after injection. Results: Both groups had significantly improvement in the primary and secondary outcome measures. VAS pain score except at the 3–month follow-up (16.8±13.3 versus 18.1±16.6, 95% CI, -7.33 to 4.73, p =0.6), WOMAC pain score, WOMAC stiffness score at all evaluated times, and WOMAC total score at 48 hours after injection (95% CI, -19.4 to -4.9) were significantly better among Tibio-femoral ozone injection compare to Supra-patellar recess injection (95% CI, -20.68 to -6.51, p<0.001)). In both groups satisfaction, TUG and SLS times were improved, but no significant difference was seen between groups (p>0.05). At the 3-month follow-up, WOMAC pain and total scores for only Tibio-femoral joint injection group as well as WOMAC function, TUG and SLS times for both groups were gradually coming back to the baseline. Conclusion: Ozone injection in both groups was associated with pain relief, functional improvement, and quality of life in patient with knee OA. Pain and stiffness of joint were improved better in Supra-patellar recess ozone injection.

scholarly journals A Preliminary Study on the Safety, Efficacy and Acceptability of the Community Preparation of Siling Labuyo (Capsicum frutescens) Liniment in the Management of Knee Osteoarthritis in a Six-Week, Active-Controlled Community-Based Clinical Trial

2019 ◽  
Vol 53 (4) ◽  
Author(s):  
Elizabeth R. Paterno ◽  
Clarisse A. Pangilinan ◽  
Erna C. Arollado ◽  
Rachael Marie B. Rosario
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Control Agent ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Control Groups ◽  
Double Blind ◽  
The Difference ◽  
And Control ◽  
Experimental Group

Objective. The study determined the safety, efficacy and acceptability of a Philippine community preparation of Siling Labuyo liniment in the management of knee osteoarthritis. Methods. A 6-week randomized, double-blind, active-controlled clinical trial was conducted in three municipalities of Cavite from 2017-2018. The municipalities were randomly assigned to either the control or experimental group, using a commercially available Diclofenac 1% gel as the control agent. Knee Injury and Osteoarthritis Outcome Score (KOOS) and Pain Visual Analogue Scale (VAS) were used to measure the outcomes. Results. Forty-seven participants completed the study. Statistically significant improvement (p<0.05) in pain relief, reduction of symptoms and increase in knee functionality was reported by participants in both the experimental and control groups. Across the dimensions measured, at least 30% improvement in scores was reported by the experimental group, and at least 40% by the control group. The difference was statistically not significant (p>0.05). Itching (13%), burning sensation (11%) and reddening of the skin (15%) were experienced in both the experimental and the active control groups. Conclusion. Use of the liniment led to a modest therapeutic effect and was well-tolerated by the participants.

scholarly journals Acupotomy Therapy for Knee Osteoarthritis Pain: Systematic Review and Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-17
Author(s):  
Jigao Sun ◽  
Yan Zhao ◽  
Ruizheng Zhu ◽  
Qianglong Chen ◽  
Mengge Song ◽  
...  
Keyword(s):  
Systematic Review ◽  
Knee Osteoarthritis ◽  
Pain Score ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Effectiveness Rate ◽  
And Function

Background and Purpose. Knee osteoarthritis (OA) is a major public health problem, and currently, few effective medical treatments exist. Chinese acupotomy therapy has been widely used for the treatment of knee OA in China. We conducted this systematic review and meta-analysis to evaluate the efficacy of Chinese acupotomy in treating knee OA to inform clinical practice. Methods. We performed a comprehensive search on PubMed, the Cochrane Library, EMBASE, and four Chinese databases for articles published prior to June 2020. We included only randomized controlled trials (RCTs) that used acupotomy therapy as the major intervention in adults with knee OA, were published in either Chinese and English, included more than 20 subjects in each group, and included pain and function in the outcome measures. Knee OA was defined by the American College of Rheumatology or Chinese Orthopedic Association criteria in all studies. We extracted the visual analogue scale (VAS) pain score, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, the total effectiveness rate, the modified Japanese Orthopedic Association (JOA) activities of daily living score, and Lysholm’s score. We calculated the mean difference (MD) or risk ratio (RR) for all relevant outcomes. Meta-analyses were conducted using random-effects models when appropriate. Results. We identified 1317 potentially relevant studies, thirty-two of which met the eligibility criteria and were conducted in China between 2007 and 2020. A total of 3021 knee OA patients (62.96% female, median age: 57 years, and median disease duration: 33 months) were included. The treatment duration ranged from 1 week to 5 weeks (median: 3 weeks). The typical acupotomy treatment involved releasing soft tissue adhesions and was performed once a week for 1–5 weeks until the pain was relieved. The control group treatments included acupuncture (8 studies), electroacupuncture (10 studies), sodium hyaluronate (8 studies), radiofrequency electrotherapy (1 study), and nonsteroidal anti-inflammatory drugs (NSAIDs, 5 studies). The results from the meta-analysis showed that acupotomy led to superior improvements in the VAS pain score (MD = −1.11; 95% confidence interval (CI), −1.51 to −0.71; p  < 0.00001) and WOMAC pain score (MD = −2.32; 95% CI, −2.94 to −1.69; p  < 0.00001), a higher total effectiveness rate (RR = 1.15; 95% CI, 1.09–1.21; p  < 0.00001), and superior improvements in the JOA score (MD = 6.39; 95% CI, 4.11–9.76; p  < 0.00001) and Lysholm’s score (MD = 12.75; 95% CI, 2.61–22.89; p  = 0.01) for overall pain and function. No serious adverse events were reported. Conclusion. Chinese acupotomy therapy may relieve pain and improve function in patients with knee OA. Furthermore, rigorously designed and well-controlled RCTs are warranted.

scholarly journals Mindful Exercise (Baduanjin) as an Adjuvant Treatment for Older Adults (60 Years Old and Over) of Knee Osteoarthritis: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
JiaJia Ye ◽  
Qikai Zheng ◽  
Liye Zou ◽  
Qian Yu ◽  
Nicola Veronese ◽  
...  
Keyword(s):  
Older Adults ◽  
Postural Control ◽  
Knee Osteoarthritis ◽  
Physical Function ◽  
Center Of Pressure ◽  
Control Group ◽  
Movement Trajectory ◽  
Womac Function ◽  
Ellipse Area ◽  
Experimental Group

Background. The postural stability is a major factor that helps prevent developing knee osteoarthritis with aging. The aim of this study was to investigate the effects of Baduanjin qigong on postural control and physical function in older adults with knee osteoarthritis. Methods. Fifty-six individuals over 60 years of age with knee osteoarthritis were randomly assigned to either an experimental group (n = 28) or a control group (n = 28). Participants in the experimental group received a 12-week Baduanjin training, while those in the control group did not receive any additional physical exercise during the study period. The postural control was quantified by perimeter and ellipse area of center of pressure movement trajectory. The assessments were conducted three times (baseline, week 8, and week 12). Results. The perimeter and ellipse area with both open- and closed-eyes conditions and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function were significantly improved at week eight in the experimental group (p<0.005). The ellipse area with open-eyes condition, WOMAC index, and stiffness and physical function domains were significantly decreased after the 12 weeks of Baduanjin training compared to the control group (p<0.005). Only the perimeter area with both open- and closed-eyes conditions was not statistically significant at week 12 in the intervention group (p>0.005). Conclusions. Baduanjin is an effective and adjuvant therapy for older adults with knee osteoarthritis. Regular Baduanjin training can improve postural control and WOMAC function of old individuals with knee osteoarthritis. More advanced techniques and biopsychological measurements are required for further understanding of Baduanjin exercise in this population. The trial was registered in Chinese Clinical Trial Registry (ChiCTR-IOR-16010042).

scholarly journals Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomised, double-blind, parallel positive control, multi-center clinical trial

2019 ◽  
Author(s):  
Bao-ping Xu ◽  
Min Yao ◽  
Zi-rui Tian ◽  
Long-yun Zhou ◽  
Long Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Clinical Symptoms ◽  
Positive Control ◽  
Control Group ◽  
Efficacy And Safety ◽  
Adhesive Plaster ◽  
Double Blind ◽  
Experimental Group

Abstract Background: Knee osteoarthritis (KOA) is a common chronic musculoskeletal disorder that seriously affect quality of life. Patients with KOA frequently develop one or more of the typically following symptoms: joint pain, stiffness, joint friction noise, impaired functionality. Traditional Chinese medicines (TCM) have showed a superior effect and peculiar advantage on the treatment of KOA, among TCMs, the Tong-luo Qu-tong plaster is the convenient and most commonly used method in China to improve symptoms including pain, stiffness and limited mobility in patients with KOA, as it causes few adverse effects. But there is a lack of high quality of clinical evidences to support the therapeutic effect that Chinese adhesive plaster can relieve pain and stiffness. The purpose of this study will be to evaluate the efficacy and safety of Tong-luo Qu-tong plaster in patients with KOA. Methods/Design: This study will be a randomised, double-blind, parallel positive control, multi-center clinical trial, a non-inferiority trial design was adopted. A total of 2000 participants older than 40 years with KOA, will be randomly allocated into a experimental group (n=1500) and a control group (n=500). All participants will receive a conventional conservative treatment lasted for 14 days as two courses, daily 1 time. Tong-luo Qu-tong plaster will be administered externally to participants in the experimental group, while the control group will receive a Qi-zheng Xiao-tong plaster. The outcome of the total Western Ontario and McMaster Universities Arthritis Index scores, TCM syndrome quantitative score, visual analog scale scores will be measured during the assessment visits (baseline and 1-, 2-week follow-up). In addition, adverse events concerning clinical symptoms and signs as well as laboratory tests will be documented during clinical trials. Discussion: This study will be a randomized, double-blind, parallel positive control trial to further evaluate the effectiveness and safety of Tong-luo Qu-tong plaster for patients with KOA in nine medical centers compared with control group, it is expected that the patients with KOA will benefit from this study.

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