scholarly journals Bioavailable turmeric extract for knee osteoarthritis: a randomized, non-inferiority trial versus paracetamol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shubha Singhal ◽  
Nazer Hasan ◽  
Kirti Nirmal ◽  
Rohit Chawla ◽  
Shalini Chawla ◽  
...  
Keyword(s):  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Womac Score ◽  
Secondary Outcome ◽  
Womac Pain ◽  
Knee Oa ◽  
Turmeric Extract ◽  
Tnf Α ◽  
Pain Subscale ◽  
And Function

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

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 Profiling of inflammatory mediators in the synovial fluid related to pain in knee osteoarthritis

2019 ◽  
Author(s):  
Li Li ◽  
Zhenxing Li ◽  
Yuyan Li ◽  
Xi Hu ◽  
Yu Zhang ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Synovial Fluid ◽  
Knee Osteoarthritis ◽  
Inflammatory Mediators ◽  
Early Stage ◽  
Womac Score ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Pain Scores ◽  
Tnf Α

Abstract Background: Inflammatory mediators in the synovial fluid (SF) play critical roles in the initiation and development of pain in knee osteoarthritis (KOA). However, the expression of inflammatory mediators is controversial and the role of SF inflammatory mediators in neuropathic pain is not clear. Therefore, the aim of this study is to identify the SF inflammatory mediators associated with nociceptive and neuropathic pain in KOA. Methods: The levels of IL-1β, IL-6, TNF-α, macrophage colony-stimulating factor, MMP-3, MMP-13, metalloproteinase with thrombospondin motifs 5, calcitonin gene-related peptide, neuropeptide Y, substance P and bradykinin were measured in 86 patients using enzyme-linked immunosorbent assays. Nociceptive pain was measured using the numeric rating scale (NRS), visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Neuropathic pain was measured using the PainDETECT questionnaire. Moreover, knee function was evaluated by the WOMAC score and range of motion (ROM) assessments. Radiological grade was defined using the Kellgren-Lawrence (K-L) grading scale. Results: Pain scores measured using different methods were highly correlated to each other. The worse the pain, the worse the K-L grade and knee function were. The expression of IL-1β and IL-6 was increased in the early stage compared with the late stage. The NRS was positively correlated to age, K-L grade, and the WOMAC score and negatively correlated to ROM and TNF-α expression. The VAS was positively correlated to age, K-L grade, and the WOMAC score but negatively correlated to ROM and the levels of IL-1β, IL-6 and TNF-α. The WOMAC pain score was not correlated to any of the measured inflammatory mediators; it correlated to only ROM. The PainDETECT score correlated to only the WOMAC score. The expression of other inflammatory mediators was not correlated to any of the pain scores. Conclusions: IL-1β, IL-6 and TNF-α play critical roles in pain in the early stage of KOA and correlated to pain. The measured catabolic enzymes and neuropeptides are not correlated to nociceptive and neuropathic pain. New biomarkers related to pain in the late stage need to be further investigated.

scholarly journals Profiling of inflammatory mediators in the synovial fluid related to pain in knee osteoarthritis

2020 ◽  
Author(s):  
Li Li ◽  
Zhenxing Li ◽  
Yuyan Li ◽  
Xi Hu ◽  
Yu Zhang ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Synovial Fluid ◽  
Knee Osteoarthritis ◽  
Inflammatory Mediators ◽  
Early Stage ◽  
Womac Score ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Pain Scores ◽  
Tnf Α

Abstract Background: Inflammatory mediators in the synovial fluid (SF) play critical roles in the initiation and development of pain in knee osteoarthritis (KOA). However, data for inflammatory marker expression are conflicting, and the role of SF inflammatory mediators in neuropathic pain is not clear. Therefore, the aim of this study was to identify SF inflammatory mediators associated with nociceptive and neuropathic pain in KOA. Methods: Levels of IL-1β, IL-6, TNF-α, macrophage colony-stimulating factor, MMP-3, MMP-13, metalloproteinase with thrombospondin motifs 5, calcitonin gene-related peptide, neuropeptide Y, substance P and bradykinin were measured using enzyme-linked immunosorbent assays in 86 patients. Nociceptive pain was assessed using the numeric rating scale (NRS), visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Neuropathic pain was determined using the PainDETECT questionnaire. Moreover, knee function was evaluated by the WOMAC score and range of motion (ROM) assessments. Radiological grade was defined using the Kellgren-Lawrence (K-L) grading scale. Results: Pain scores measured using different methods correlated highly with each other. A worse K-L grade and knee function were associated with worse pain. Expression of IL-1β and IL-6 was increased in the early stage compared with the late stage. The NRS score correlated positively with age, K-L grade, and the WOMAC score and negatively with ROM and TNF-α expression. The VAS correlated positively with age, K-L grade, and the WOMAC score but negatively with ROM and levels of IL-1β, IL-6 and TNF-α. The WOMAC pain score did not correlate with any of the inflammatory mediators measured; it correlated only with ROM. The PainDETECT score correlated only with the WOMAC score. Expression of other inflammatory mediators did not correlate with any of the pain scores. Conclusions: IL-1β, IL-6 and TNF-α play critical roles in pain in the early stage of KOA and correlate with pain. The catabolic enzymes and neuropeptides measured do not correlate with nociceptive and neuropathic pain. New biomarkers related to pain in the late stage need to be further investigated.

scholarly journals Intra Articular Ozone Modulates Inflammation and Has Anabolic Effect on Knee Osteoarthritis: IL-6 and IGF-1 as Pro-Inflammatory and Anabolic Biomarkers

Processes ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 138
Author(s):  
Marcos E. Fernández-Cuadros ◽  
Olga S. Pérez-Moro ◽  
María J. Albaladejo-Florín ◽  
María M. Tobar-Izquierdo ◽  
Amelia Magaña-Sánchez ◽  
...  
Keyword(s):  
Uric Acid ◽  
Knee Osteoarthritis ◽  
Real World ◽  
Secondary Outcome ◽  
Womac Pain ◽  
Anabolic Effect ◽  
Obese Patients ◽  
Knee Oa ◽  
Before And After ◽  
Anti Inflammatory

Objectives: (1) to demonstrate the anti-inflammatory and anabolic effect of Ozone by determining in serum samples the biochemical levels of IL-6 and IGF-1 in knee osteoarthritis (OA) patients in a real world rehabilitation setting; (2) to differentiate Ozone effect in diabetic (DM)/obese and non-DM/non-obese patients; (3) to evaluate clinical effectiveness by visual analog scale (VAS) and WOMAC scale, and biochemical effect by C-reactive protein (CRP), uric acid and erythrocyte sedimentation rate (ESR). Material and methods: 65 patients with knee OA Kellgren Lawrence (KL) grade 2 or more were analyzed in a retrospective observational study. The study ran from January 2018 to September 2021. Inclusion criteria: (a) patients 18 years or older; (b) with knee OA KL 2° or more; (c) biochemical analysis before-and-after treatment; (d) pain more than 3 on VAS. Exclusion Criteria: (a) previous knee surgery; (b) favism; (c) pregnancy; (d) any other disease that originates lack of collaboration for infiltration. Primary Outcome variables: (a) IL-6; (b) IGF-1 in diabetes mellitus (DM)/obese and non-DM/non-obese patients; both before-and-after Ozone treatment. Secondary Outcome variables: (a) CRP, (b) ESR, (c) uric acid, (d) VAS pain, (e) WOMAC pain, function and stiffness. Ozone protocol consisted of four sessions (once a week) of an intra-articular infiltration of 20 mL (20 µg/mL concentration) of a gas mixture of Oxygen-Ozone 95-5% (produced by Ozone generator Ozonosan-α Plus®). For biochemical evaluation, SNIBE MAGLUMI ™ IL-6 (CLIA) and SNIBE MAGLUMI ™ IGF-1 (CLIA) kits were used. CRP and uric acid were analyzed by a Abbott Alinity c kit; and ESR was evaluated by DIESSE VES MATIC CUBE 30. Results: There is a linear correlation between age and OA severity. IL-6 decreased both in DM and non-DM patients and in all OA KL grades (from 2.70 to 1.59 pg/mL). IGF-1 decreased in total group (OA + DM + obesity) from 112.09 to 107.19 ng/mL. When only non-DM/non-obese knee OA patients were analyzed, Ozone improved IGF-1 levels (from 100.17 to 102.03 ng/mL). Ozone decreased CRP, ESR, uric acid, and improved VAS pain, WOMAC pain, function and stiffness (p < 0.05). Conclusions: Ozone is a valid option for the management of knee osteoarthritis in a real world rehabilitation setting, because of its anti-inflammatory, metabolic and anabolic properties. Ozone tends to downregulate pro-inflammatory IL-6 cytokine. Ozone has a metabolic/hypoglycemic effect on obese/diabetic knee osteoarthritis patients by reducing IGF-1. Ozone has an anabolic effect on non-diabetic/non-obese patients by improving IGF-1. Ozone reduces other biomarkers of inflammation (CRP, ESR and uric acid) and improves, pain, function and quality of life.

scholarly journals Profiling of inflammatory mediators in the synovial fluid related to pain in knee osteoarthritis

2019 ◽  
Author(s):  
Li Li ◽  
Zhenxing Li ◽  
Yuyan Li ◽  
Xi Hu ◽  
Yu Zhang ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Synovial Fluid ◽  
Knee Osteoarthritis ◽  
Inflammatory Mediators ◽  
Early Stage ◽  
Womac Score ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Pain Scores ◽  
Tnf Α

Abstract Background: Inflammatory mediators in the synovial fluid (SF) play critical roles in the initiation and development of pain in knee osteoarthritis (KOA). However, data for inflammatory marker expression are conflicting, and the role of SF inflammatory mediators in neuropathic pain is not clear. Therefore, the aim of this study was to identify SF inflammatory mediators associated with nociceptive and neuropathic pain in KOA. Methods: Levels of IL-1β, IL-6, TNF-α, macrophage colony-stimulating factor, MMP-3, MMP-13, metalloproteinase with thrombospondin motifs 5, calcitonin gene-related peptide, neuropeptide Y, substance P and bradykinin were measured using enzyme-linked immunosorbent assays in 86 patients. Nociceptive pain was assessed using the numeric rating scale (NRS), visual analog scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. Neuropathic pain was determined using the PainDETECT questionnaire. Moreover, knee function was evaluated by the WOMAC score and range of motion (ROM) assessments. Radiological grade was defined using the Kellgren-Lawrence (K-L) grading scale. Results: Pain scores measured using different methods correlated highly with each other. A worse K-L grade and knee function were associated with worse pain. Expression of IL-1β and IL-6 was increased in the early stage compared with the late stage. The NRS score correlated positively with age, K-L grade, and the WOMAC score and negatively with ROM and TNF-α expression. The VAS correlated positively with age, K-L grade, and the WOMAC score but negatively with ROM and levels of IL-1β, IL-6 and TNF-α. The WOMAC pain score did not correlate with any of the inflammatory mediators measured; it correlated only with ROM. The PainDETECT score correlated only with the WOMAC score. Expression of other inflammatory mediators did not correlate with any of the pain scores. Conclusions: IL-1β, IL-6 and TNF-α play critical roles in pain in the early stage of KOA and correlate with pain. The catabolic enzymes and neuropeptides measured do not correlate with nociceptive and neuropathic pain. New biomarkers related to pain in the late stage need to be further investigated.

scholarly journals The Role of PRP and Its Platelet Concentration in Improving WOMAC Score on Early-Stage Knee Osteoarthritis (OA) Patients

2020 ◽  
Vol 8 (5_suppl5) ◽  
pp. 2325967120S0010
Author(s):  
Basuki Supartono ◽  
Salma Rahmadati ◽  
Diana Agustini
Keyword(s):  
Early Stage ◽  
Platelet Rich Plasma ◽  
Womac Score ◽  
Bivariate Analysis ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Significant Difference ◽  
Platelet Concentration ◽  
And Function

Platelet concentration is one of the important factors in OA treatment with platelet-rich plasma (PRP). The purpose of this study was to determine the effect of PRP quality, which was determined by its platelet concentration, on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores in early-stage knee OA patients. This study involved 50 patients diagnosed with early-stage knee OA (stage I to III). Twenty-five patients received PRP with moderate platelet concentration (1× to 4×), another twenty-five patients received PRP with high platelet concentration (>4× to 6×). Patients were evaluated using WOMAC questionnaire before and three months after injection with PRP. Bivariate analysis showed that there was a significant improvement of three WOMAC score subscales (pain, stiffness, and function) in both group (p<0.05) and a significant difference in the differences between WOMAC pain scores between the two groups (p<0.05), meanwhile, significant differences in the differences between WOMAC stiffness and function scores between the two groups weren’t found (p>0.05). The conclusions of this study was, PRP with moderate and high platelet concentration had been shown to improve the three WOMAC score subscales of early-stage knee OA patients, but the effect of PRP’s platelet concentration was only significant in the improvement of WOMAC pain score.

scholarly journals Effect of Dextrose Prolotherapy, Platelet Rich Plasma and Autologous Conditioned Serum on Knee Osteoarthritis: A Randomized Clinical Trial

2020 ◽  
Author(s):  
Alireza Pishgahi ◽  
Rozita Abolhasan ◽  
Seyed Kazem Shakouri ◽  
Mohammad Sadegh Soltani-Zangbar ◽  
Shahla Dareshiri ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Randomized Clinical Trial ◽  
Platelet Rich Plasma ◽  
Womac Score ◽  
Knee Function ◽  
Post Intervention ◽  
Knee Oa ◽  
Autologous Conditioned Serum ◽  
And Function

Knee osteoarthritis (OA) is one of the common degenerative articular disorders that are related to decreased quality of life. Currently, novel biologic therapeutic approaches are introduced in the literature for OA management. In this study, the clinical efficiency of Dextrose prolotherapy, platelet-rich plasma (PRP) and autologous conditioned serum (ACS) injection on the level of pain and function in Knee OA were compared. A randomized clinical trial was directed on 92 knee OA patients. Patients were randomly divided into three groups: 30 were received dextrose prolotherapy once in a week for three weeks, 30 received autologous PRP for two times with seven days interval, and in the remaining 32 patients 2ml of ACS were injected two times every seven days. Study participants were measured through the Western Ontario and McMaster Universities (WOMAC) score, the visual analogue scale (VAS), at baseline, 1 and 6 months post-intervention. Both ACS and PRP treated patients showed improvement in pain intensity and knee function during 1 and 6 months pursue; however, this progress was more significant in the ACS group. Dextrose prolotherapy showed no substantial changes in pain and function of the affected knee in treated patients. Treatment of Knee OA with ACS and PRP injections are associated with pain reduction and knee function improvement. Not only, ACS therapy is more effective than that of PRP, but also due to its less variability in processing and less reported side effects, it could be considered as a safe and effective non-surgical alternative for OA management.  

Exercise and education versus saline injections for knee osteoarthritis: a randomised controlled equivalence trial

2021 ◽  
pp. annrheumdis-2021-221129
Author(s):  
Elisabeth Bandak ◽  
Robin Christensen ◽  
Anders Overgaard ◽  
Lars Erik Kristensen ◽  
Karen Ellegaard ◽  
...  
Keyword(s):  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Primary Outcome ◽  
Education Programme ◽  
Comparable Efficacy ◽  
Open Label ◽  
Knee Oa ◽  
Pain Subscale ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo compare the efficacy of an exercise and education programme with open-label placebo given as intra-articular injections of inert saline on pain and function in individuals with knee osteoarthritis (OA).MethodsIn this open-label, randomised controlled trial, we recruited adults aged ≥50 years with symptomatic and radiographically confirmed knee OA in Denmark. Participants were randomised 1:1 to undergo an 8-week exercise and education programme or four intra-articular saline injections over 8 weeks. Primary outcome was change from baseline to week 9 in the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire pain subscale (range 0 (worst)–100 (best)). Prespecified equivalence margins of ±8 KOOS pain points were chosen for the demonstration of comparable efficacy. Key secondary outcomes were the KOOS function and quality of life subscales, and patients’ global assessment of disease impact.Results206 adults were randomly assigned: 102 to exercise and education and 104 to intra-articular saline injections. For the primary outcome, the least squares mean changes in KOOS pain were 10.0 for exercise and education and 7.3 for saline injections (difference 2.7 points, 95% CI −0.6 to 6.0; test for equivalence p=0.0008). All group differences in the key secondary outcomes respected the predefined equivalence margins. Adverse events and serious adverse events were similar in the two groups.ConclusionIn individuals with knee OA, an 8-week exercise and education programme provided efficacy for symptomatic and functional improvements equivalent to that of four open-label intra-articular saline injections over 8 weeks.Trial registration numberNCT03843931.

Inflammatory Characteristics on Ultrasound Predict Poorer Longterm Response to Intraarticular Corticosteroid Injections in Knee Osteoarthritis

2010 ◽  
Vol 37 (3) ◽  
pp. 650-655 ◽  
Author(s):  
JEANNIE CHAO ◽  
CHRISTOPHER WU ◽  
BOB SUN ◽  
MICHAL KALLI HOSE ◽  
ANNA QUAN ◽  
...  
Keyword(s):  
Treatment Group ◽  
Knee Osteoarthritis ◽  
Clinical Response ◽  
Subscale Score ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Symptomatic Knee ◽  
Pain Subscale ◽  
Corticosteroid Injections

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.

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.

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