scholarly journals Effect of a Single-Shot of a High-Density Viscoelastic Solution of Hyaluronic Acid in Patients with Symptomatic Primary Knee Osteoarthritis: The No-Dolor Study

Author(s):  
Joan Calvet ◽  
Danial Khorsandi ◽  
Laura Tío ◽  
Jordi Monfort

Abstract Background Pronolis®HD mono 2.5% is a novel, one-shot, high-density sterile viscoelastic solution, recently available in Spain, which contains a high amount of intermediate molecular weight hyaluronic acid (HA), highly concentrated (120 mg in 4.8 mL solution: 2.5%). The objective of the study was to analyze the efficacy and safety of this treatment in symptomatic primary knee osteoarthritis (OA). Methods This observational, prospective, multicenter, single-cohort study involved 166 patients with knee OA treated with a single-shot of Pronolis®HD mono 2.5% and followed up as many as 24 weeks. Results Compared with baseline, the score of the Western Ontario and McMaster Universities Arthritis Osteoarthritis Index (WOMAC) pain subscale significantly reduced at the 12-week visit (primary endpoint, median: 9 interquartile range [IQR]: 7-11 versus median: 4; IQR: 2-6). The percentage of patients achieving >50% improvement in the pain subscale increased progressively from 37.9% (at 2 weeks) to 66.0% (at 24 weeks). Similarly, WOMAC scores for pain on movement, stiffness subscale, and functional capacity subscale showed significant reductions at the 12-week visit which were maintained up to the 24-week visit. The EuroQol visual analog scale score significantly increased after 12 weeks (median: 60 versus 70). The need for rescue medication (analgesics/nonsteroidal anti-inflammatory drugs) also significantly decreased in all post-injection visits. Three patients (1.6%) reported local adverse events (joint swelling) of mild intensity. Conclusions In conclusion, a single intra-articular injection of the high-density viscoelastic gel of HA is effective and safe for the relief of symptoms in patients with knee OA. Trial registration: ClinicalTrial# NCT04196764

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Charles D. Hummer ◽  
Felix Angst ◽  
Wilson Ngai ◽  
Craig Whittington ◽  
Sophie S. Yoon ◽  
...  

Abstract Background The 2013 American Academy of Orthopaedic Surgeons (AAOS) guidelines made strong recommendations against intraarticular hyaluronic acid (IAHA) for patients with knee osteoarthritis (OA), as evidence supporting improvements in pain did not meet the minimal clinically important improvement (MCII) threshold. However, there may be important distinctions based on IAHA molecular weight (MW). Hence our objective was to evaluate the efficacy of IAHAs in knee OA based on molecular weight. Methods Randomized controlled trials were searched within MEDLINE, Embase, and CENTRAL and selected based on AAOS criteria. A pain measure hierarchy and longest follow-up were used to select one effect size from each trial. Mean differences between interventions were converted to standardized mean differences (SMDs) and incorporated into a random-effects Bayesian network meta-analysis. High MW (HMW) was defined as ≥6000 kDa, and low MW (LMW) as < 750 kDa. Results HMW IAHA was associated with a statistically significant and possibly clinically significant improvement in pain (SMD − 0.57 (95% credible interval [Crl]: − 1.04, − 0.11), exceeding the − 0.50 MCII threshold. LMW IAHA had a lesser, non-significant improvement (− 0.23, 95% Crl: − 0.67, 0.20). Back-transforming SMDs to the WOMAC pain scale indicated a 14.65 (95% CI: 13.93, 15.62) point improvement over IA placebo, substantially better than the 8.3 AAOS MCII threshold. Conclusions Unlike LMW IAHA, HMW IAHA exceeded the MCII threshold for pain relief, suggesting that improvements can be subjectively perceived by the treated patient. Amalgamation of LMW and HMW may have blurred the benefits of IAHA in the past, leading to negative recommendations. Differentiation according to MW offers refined insight for treatment with IAHA.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1337.3-1338
Author(s):  
E. Sharapova ◽  
N. Kashevarova ◽  
E. Taskina ◽  
D. Kusevich ◽  
L. Alekseeva ◽  
...  

Background:Administration of Chondroitin Sulfate for treatment of osteoarthritis included treatment types include systemic and parenteral therapies. The benefits of local therapies between difference route is ambivalent.Objectives:To evaluate effectiveness and safety of Chondroitin Sulfate (CS) by intramuscular and concomitant (intramuscular and intraarticular) route of administration in patients with knee osteoarthritis (OA).Methods:In total 150 patients with knee OA according by ACR criteria and with radiological stages 2 and 3 according to Kellgren-Lawrence were enrolled. Patients were divided by 2 groups: 75 patients (R) received course of 25 intramuscular injection every other day: at the first 3 injection’s in dose 100 mg, and in continue in dose 200 mg, 75 patients in 2nd group (N) received 5 intra-articular injections in target knee in dose 200 mg once per 3 days, in continue 16 intramuscular injections every other day in dose 200 mg. All patients received NSAID - meloxicam in stable dose 15 mg per day. All patients were checked by WOMAC, pain by visual analog scale (VAS), McGiIl Pain Questionnaire (MPQ). At the baseline, standard clinical examination for all patients were blood tests, urine test, coagulation panel and ECG.Results:After comparing of two groups by the end of course the intensity of pain by VAS was significantly greater in R group (21,88±13,24 vs 16,81±13,49; р<0,0001). There were no significant differences between groups in improvement of WOMAC, WOMAC subscales and MPQ from baseline. Serious adverse events (AE) were absent. 11 AE’s were detected 3,3% (5/150), but in 100% of cases AE’s were resolved by the end of course.Conclusion:CS is effective decreased intensity of pain and stiffness, improved functional ability of joints both intramuscular and concomitant route of administration. However, significantly greater results at pain intensity by VAS shows combination: pain intensity by the end of course was significantly lower in group with concomitant intramuscular and intra-articular injections. Probably, it was associated with faster resolution of synovitis by intraarticular route of administration, that leads to choose this route for patients with comorbidity.Disclosure of Interests:None declared.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shubha Singhal ◽  
Nazer Hasan ◽  
Kirti Nirmal ◽  
Rohit Chawla ◽  
Shalini Chawla ◽  
...  

Abstract Background To compare the efficacy and safety of bioavailable turmeric extract versus paracetamol in patients with knee osteoarthritis (OA). Methods In this randomized, non-inferiority, controlled clinical study, patients of knee OA were randomized to receive bioavailable turmeric extract (BCM-95®) 500 mg capsule two times daily or paracetamol 650 mg tablet three times daily for 6 weeks. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The secondary outcome measures were WOMAC total, WOMAC stiffness, and WOMAC physical function scores. Responder analysis of individual patients at different levels (≥ 20%, ≥ 50%, and ≥ 70%) for WOMAC score was calculated. TNF alpha and CRP levels were evaluated and adverse events (AE) were also recorded. Results Seventy-one and seventy-three knee OA patients, respectively in bioavailable turmeric extract and paracetamol groups, completed the study. Non-inferiority (equivalence) test showed that WOMAC scores were equivalent in both the groups (p value < 0.05) in all the domains within the equivalence limit defined by effect size (Cohen’s d) of 0.5 whereas CRP and TNF-α were better reduced with turmeric extract than paracetamol. After 6 weeks of treatment, WOMAC total score, pain, stiffness, and function scores got a significant improvement of 23.59, 32.09, 28.5, and 20.25% respectively with turmeric extract. In the turmeric extract group, 18% of patients got more than 50% improvement and 3% of patients got more than 70% improvement in WOMAC pain and function/stiffness score and none of the patients in the paracetamol group met the criteria. CRP and TNF-α got significantly reduced (37.21 and 74.81% respectively) in the turmeric extract group. Adverse events reported were mild and comparatively less in the turmeric extract group (5.48%) than in the paracetamol group (12.68%). Conclusion The results of the study suggest that bioavailable turmeric extract is as effective as paracetamol in reducing pain and other symptoms of knee osteoarthritis and found to be safe and more effective in reducing CRP and TNF-α. Trial registration Clinical Trials Registry – India CTRI/2017/02/007962. Registered on 27 February 2017


2010 ◽  
Vol 37 (3) ◽  
pp. 650-655 ◽  
Author(s):  
JEANNIE CHAO ◽  
CHRISTOPHER WU ◽  
BOB SUN ◽  
MICHAL KALLI HOSE ◽  
ANNA QUAN ◽  
...  

Objective.To assess whether inflammation on ultrasound is predictive of clinical response to intraarticular (IA) corticosteroid injections in patients with knee osteoarthritis (OA).Methods.Patients with symptomatic knee OA were randomized to receive either an IA injection of 40 mg triamcinolone acetonide in the treatment group or 1 cc 0.9% saline in the placebo group. Clinical response was assessed by changes in baseline Western Ontario and McMaster Universities (WOMAC) index scores and physician global assessment at 4 and 12 weeks. Ultrasounds were performed at each visit. Patients and assessors were blinded to treatment status.Results.Seventy-nine patients were enrolled into the study. Four-week data were available for 67 patients in the primary analysis comparing change in WOMAC pain score from baseline to 4 weeks. There was almost no change in the WOMAC pain subscale score from baseline to 4 weeks in the control group, but there was a significant improvement in WOMAC pain subscale score from 10.8 (SD ± 3.2) at baseline to 8.75 (SD ± 4.0) at 4 weeks in the treatment group (adjusted p = 0.001). Of the 34 patients in the treatment group; 16 (47%) had inflammatory disease and 18 (53%) had noninflammatory disease as determined by ultrasound. There was no difference in the change in WOMAC pain score between the inflammatory and noninflammatory patients in the treatment group at 4 weeks. There was a statistically significant greater improvement in pain subscale scores among noninflammatory patients than among inflammatory patients at 12 weeks.Conclusion.Intraarticular corticosteroid injections are an effective short-term treatment for symptomatic knee OA compared to placebo. Patients with noninflammatory characteristics on ultrasound had a more prolonged benefit from IA corticosteroids compared to inflammatory patients.


2012 ◽  
Vol 37 (1) ◽  
pp. 50-57 ◽  
Author(s):  
Mokhtar Arazpour ◽  
Monireh Ahmadi Bani ◽  
Maryam Maleki ◽  
Farhad Tabatabai Ghomshe ◽  
Reza Vahab Kashani ◽  
...  

Background: Patients suffering from medial compartment knee osteoarthritis (OA) may be treated with unloader knee orthoses or laterally wedged insoles. Objectives: The aim of this study was to identify and compare the effects of them on the gait parameters and pain in these patients. Study Design: Quasi-experimental. Methods: Volunteer subjects with medial compartment knee OA ( n = 24, mean age 59.29 ± 2.23 years) were randomly assigned to two separate groups and evaluated when wearing an unloader knee orthosis or insoles incorporating a 6° lateral wedge. Testing was performed at baseline and after six weeks of each orthosis use. A visual analog scale score was used to assess pain and gait analysis was utilized to determine gait parameters. Results: Both orthoses improved all parameters compared to the baseline condition ( p = 0.000). However, no significant differences in pain ( p = 0.649), adduction moment ( p = 0.205), speed of walking ( p = 0. 056) or step length ( p = 0.687) were demonstrated between them. The knee range of motion ( p = 0.000) were significantly different between the two interventions. Conclusion: Both orthoses reduced knee pain. Maximum knee range of motion was increased by both interventions although it was 3 degrees less when wearing the knee orthosis. Clinical relevance Both orthoses reduce pain and improve gait anomalies in medial compartment knee OA. Our results suggest a laterally wedged insole can be an alternative conservative approach to unloader knee orthosis for treating symptoms of medial compartment knee OA.


Cartilage ◽  
2016 ◽  
Vol 8 (4) ◽  
pp. 384-390 ◽  
Author(s):  
Mustafa Ozcamdalli ◽  
Abdulhamit Misir ◽  
Turan Bilge Kizkapan ◽  
Erdal Uzun ◽  
Fuat Duygulu ◽  
...  

Objective To compare the relative effectiveness of intra-articular N-acetyl cysteine (NAC) and hyaluronic acid (HA) on pain, function and cartilage degradation markers in patients with mild to moderate knee osteoarthritis (OA). Design We prospectively conducted a clinical trial with 20 patients having a diagnosis of Kellgren-Lawrence grade 2-3 knee OA, and randomly allocated to the HA or NAC groups. Groups were matched on age, sex, and body mass index. Injections of 3-mL HA (Hylan G-F 20) or 3-mL NAC (Asist ampoule) were administered as a single shot. Functional status and pain were evaluated before and after injection, using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the visual analogue scale (VAS) scores. Pre- and posttreatment concentrations of serum C-reactive protein (CRP), synovial fluid chondroitin-6-sulfate (C-6S), matrix metalloproteinase-3 (MMP-3), cross-linked C-terminal telopeptide of type 2 collagen (CTX-II), total oxidant status (TOS), and total antioxidant concentration (TAC) were obtained. Results WOMAC, VAS scores, and CRP levels were comparable between groups prior to treatment. Both HA and NAC produced comparable reductions in TOS and MMP-3. NAC was more effective in reducing C-6S and CTX-II ( P < 0.05). No effects on TAC were noted. Conclusions NAC is effective in lowering some cartilage degradation markers, with comparable outcomes to HA for pain and function. NAC could provide a cheaper alternative to HA for intra-articular injection treatment of mild to moderate knee OA. Future placebo controlled trials are warranted to evaluate effectiveness in a larger patient population with a wider range of age and OA severity.


2021 ◽  
Author(s):  
Jih-Hsi Yeh ◽  
Po-Yen Ko ◽  
Chung-Jung Shao ◽  
Kuo-Chen Wu ◽  
Tai-Chang Chern ◽  
...  

Abstract Background: Hyaluronic acid (HA) is the most common intra-articular therapy used to treat mild to moderate osteoarthritis (OA). However, the mechanism involved in this treatment is still not fully understood. The aim of the present study was to examine the effect and the possible mechanism of intra-articular HA (IAHA) injection in patients with knee osteoarthritis (OA).Methods: Twenty-eight patients with Kellgren–Lawrence scale II to III were enrolled in this study. All patients underwent ultrasound-guided injection using three consecutive weekly IAHA. Functional ability and pain were determined by the Western Ontario and McMaster University Index (WOMAC) questionnaire and visual analog scale (VAS). Further, the levels of HA, metalloproteinase (MMP)-1, MMP-3, MMP-13, interleukin (IL)-1β and IL-6 in synovial fluid were determined weekly before HA injection. Results: Functional improvement and pain relief were observed 4 weeks after treatment. At week 4, a significant increase of HA concentration was found, and the concentration of inflammatory cytokines including IL-1β, and IL-6, as well as matrix MMP-3 and MMP-13 significantly decreased. However, no significant difference was observed in MMP-1 level. Conclusion: These results suggest that increasing HA accumulation in synovial fluid may be associated with disease relief after weekly IAHA injection in patients with knee OA.


2020 ◽  
Vol 8 (1) ◽  
pp. 232596711989790 ◽  
Author(s):  
Larry E. Miller ◽  
Michael Fredericson ◽  
Roy D. Altman

Background: Intra-articular hyaluronic acid (HA) injections and oral nonsteroidal anti-inflammatory drugs (NSAIDs) are common treatments for symptomatic knee osteoarthritis (OA). However, the comparative effects of these treatments are unclear. Purpose: To compare the efficacy and safety of intra-articular HA injections compared with oral NSAIDs for the treatment of knee OA. Study Design: Systematic review; Level of evidence, 1. Methods: We systematically searched Medline, Embase, and the Cochrane Central Register of Controlled Trials for randomized trials of knee OA treatment with HA injections compared with oral NSAIDs. The main outcomes were knee pain, knee function, adverse events (AEs), serious AEs, study withdrawals, and study withdrawals because of AEs. Pooled effect sizes were reported at the final follow-up with standardized mean difference (SMD) for efficacy outcomes and risk ratio (RR) for safety outcomes. Results: In 6 randomized trials of 831 patients (414 HA, 417 NSAIDs), with follow-up ranging from 5 to 26 weeks, HA injections were associated with small, statistically significant improvements in knee pain (SMD, 0.15; P = .04) and knee function (SMD, 0.23; P = .01) compared with oral NSAIDs. The risk of AEs was lower with HA compared with NSAIDs (19.8% vs 29.0%; RR, 0.74; P = .01). The risk of a serious AE (RR, 1.37; P = .71), study withdrawal (RR, 1.05; P = .68), or study withdrawal because of an AE (RR, 0.65; P = .22) was comparable between groups. Gastrointestinal concerns were the most frequent AE reported, occurring more often with NSAIDs (23.4% vs 14.1%; P = .001). AEs reported more frequently with HA injections were injection site pain (11.7% vs 4.7%; P < .001), headache (8.4% vs 4.4%; P = .03), and arthralgia (8.1% vs 2.9%; P = .001). Significant heterogeneity or publication bias was not observed for any outcome. Conclusion: Comparing short-term outcomes of HA injections with oral NSAIDs for treatment of knee OA, HA injections provided statistically significant but not clinically important improvements in knee pain and function, along with a lower overall risk of AEs.


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