scholarly journals A Randomized, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of HFPM-01 in Improving Pain, Stiffness, and Inflammation in Patients Suffering from Knee Osteoarthritis

2021 ◽  
Vol 8 (4) ◽  
pp. 1-11
Author(s):  
Veena Deo ◽  
Bharatbhushan Shrikhande ◽  
Gayatri Ganu

Objective: Osteoarthritis is a common chronic joint condition which causes stiffness and difficulty in moving, loss of muscle tone, strength and stamina. All these difficulties affect daily activities and quality of life and may also have an impact of mental health. Globally over 9.6% men and 18.0% women aged over 60 years has symptomatic osteoarthritis worldwide. It is the second most common rheumatologic problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. Considering the increasing prevalence and limitations of the conventional treatment for the management of Osteoarthritis, the current research aims at systematic clinical validation of the HFPM-01 in subjects primarily suffering from knee osteoarthritis. Materials and Methods: 90 subjects were enrolled in the study and were randomized to one of the three treatment groups. Subjects were undergoing clinical examination. Vitals were recorded. Blood samples were collected for readings of CRP. Subjective questionnaire scores evaluation was performed like SF-36 health survey score, VAS scale, WOMAC questionnaire. Changes in symptoms severity were noted like morning stiffness, tiredness, tenderness, and muscle spasms along with assessment of GI symptoms. Results: The change in WOMAC score, the increase in SF-36 score, the decrease in VAS score, the decrease in CRP levels, and the reduction in GI symptoms were found to be 33%, 308%, 60.44%, 52%, 40% respectively. Swelling, inflammation and pain was reduced from moderated to mild and eventually to no symptoms. Conclusion: This explains that HFPM-01 tablet is significantly effective in improving SF36 score WOMAC and VAS scale score. It is effective in reducing pain, swelling, and stiffness of knee joints, also improves the mobility of knee joints, and provides gastro protection being effective in managing pain and stiffness. HFPM-01tablet is safe and effective in the management of Osteoarthritis. Keywords: Osteoarthritis, WOMAC, VAS, CRP, Gastro protective.

Diseases ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. 26
Author(s):  
Arrigo F. G. Cicero ◽  
Nicolò Girolimetto ◽  
Crescenzio Bentivenga ◽  
Elisa Grandi ◽  
Federica Fogacci ◽  
...  

Objective: the aim of this pilot study was to test the short-term effect of oral supplementation with a sodium hyaluronate with a large spectrum of molecular weights (FS-HA®) on the symptoms and functionality of knee osteoarthritis (OA). Methods: 60 subjects affected by clinical and/or radiological diagnosis of symptomatic knee OA were consecutively enrolled in a randomized, double blind, placebo-controlled, clinical trial. At randomization visit, at day 28 (visit 2), and day 56 (visit 3), the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne Functional Index (LFI) and the Visual Analogue Scale (VAS) for pain (VAS-p) were administered to the enrolled patients. Then, patients were asked how many times they used rescue medications (non-steroidal antinflammatory drugs–NSAIDs and/or anti-pain drugs) during the previous 4 weeks. Finally, the range of knee joint motion (ROM) was also instrumentally measured. Results: In FS-HA® treated subjects, VAS-p, pain and total WOMAC score, LFI and ROM significantly improved compared to the baseline values (p < 0.05). At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA® treatment when compared with placebo as well (p < 0.05). The FS-HA® treated subjects significantly reduced the weekly use of NSAIDs and/or antipain drugs when compared to the placebo-treated ones (p < 0.05). Conclusion: the oral supplementation with a FS-HA® characterized by a large spectrum of molecular weight was associated with a short-term improvement in symptomatology and functionality of osteoarthritis-affected knees, and associated with a reduction in the use of NSAIDS and anti-pain drugs.


2014 ◽  
Vol 2 (11_suppl3) ◽  
pp. 2325967114S0021
Author(s):  
Erick Wonggokusuma ◽  
Bambang Setyohadi ◽  
Carles Siagian ◽  
Andri M.T. Lubis

Objectives: Combination of glucosamine-chondroitin sulfate is often prescribed for patients with first and second grade Kellgren-Lawrence osteoarthritis (OA). Numerous studies have reported significant efficacy of this supplement and also their combinations with methylsulfonylmethane (MSM) for the treatment of OA. However, controversies emerged regarding the effectiveness of these supplements. This current study evaluated the efficacy of glucosamine-chondroitin sulfate and glucosamine-chondroitin sulfate-MSM on improvement of patients with first and second grade knee OA. Methods: This study was a double blind, randomized controlled clinical trial on 147 patients with first and second grade (Kellgren-Lawrence) of knee OA. Subjects were allocated by permuted block randomization to three groups, either glucosamine-chondroitin sulfate (GC) (n=49), or glucosamine-chondroitin sulfate-MSM (GCM) (n=48), or placebo (n=50). The GC group received 1500 mg glucosamine + 1200 mg chondroitin sulfate + 500 mg saccharum lactis; GCM group received 1500 mg glucosamine + 1200 mg chondroitin sulfate + 500 mg MSM; while placebo group received three matching capsules of saccharum lactis. These drugs were administered once a day for three consecutive months. VAS and WOMAC score were measured at the baseline, then at 12th week after treatment. Data was analysed by using t-independent test. Results: At week 12, WOMAC score in placebo group was significantly higher than that in GCM group (mean difference 7.15, CI 12.06-2.23, p=0.005), and it was also higher in GC group compared to GCM group (mean difference 8.17, CI 13.49-2.84, p=0.003). Whereas VAS score at week 12 in placebo group was significantly higher compared to that in GC group (mean difference 0.18, CI 1.18-0.19, p=0.007) and to that in GCM group (mean difference 0.86, CI 1.37-0.35, p=0.001). However, there was no significant difference of WOMAC score at week 12 between placebo and GC groups (p=0.681), and of VAS score between GC and GCM groups (p=0.497). Conclusion: Combinations of glucosamine-chondroitin sulfate and glucosamine-chondroitin sulfate-MSM did not improve WOMAC and VAS scores in patients with grade I and II of knee osteoarthritis, when compared with placebo.


2021 ◽  
Vol 5 (5) ◽  
pp. 301-306
Author(s):  
S.A. Lapshina ◽  
◽  
G.F. Mingaleeva ◽  

Aim: to evaluate the efficacy of two-month therapy with chondroitin sulfate (CS) (Mucosat®) injections in patients with osteoarthritis and the drug potential in terms of structure-modifying action. Patients and Methods: an open prospective study with participation of 30 patients (mean age 52.5±11.7 years) with osteoarthritis, grade 2 gonarthrosis according to the Kellgren-Lawrence classification, and severe pain syndrome (more than 50 points according to VAS) was conducted. 76.7% of subjects had concomitant pathology. The drug was prescribed according to the standard regimen with a course of up to 25–30 injections. The examination included a clinical assessment of indicators of joint syndrome, life quality, joint function using WOMAC, Lekken, KOOS, EQ-5D scales, cartilage oligomeric matrix protein (COMP) and C-reactive protein (CRP), ultrasound of the knee joints. Results: after a two-month treatment course with Mucosat®, there was a significant (p<0.05) decrease in pain intensity by 1.8 times, the number of tender and swollen joints by 2 or more times, an improvement in indicators of functional activity and life quality of patients. Reactive synovitis of the knee joints, which was present at the beginning of the study in 53.3% of cases, was preserved clinically and according to ultrasound data only in 17% of subjects by the end of treatment. There was a tendency to decrease the levels of CRP and COMP. Ultrasound of the knee joints showed a significant (p=0.000) increase in the average thickness of articular cartilage from 1.55±0.26 mm initially to 1.67±0.27 mm after 2 months of treatment. More significant positive dynamics during therapy was observed in patients without arterial hypertension. In general, no adverse events were registered during treatment. Conclusion: in clinical practice, the use of the CS injections in patients with gonarthrosis is safe and effective. The tendency to decrease the cartilage degradation and increase its thickness suggests a positive effect of CS in the form of slowing the disease progression in the long-term period. KEYWORDS: osteoarthritis, cartilage degradation, synovitis, chondroitin sulfate, bioavailability, structure-modifying effect, Mucosat. FOR CITATION: Lapshina S.A., Mingaleeva G.F. Chondroitin sulfate injection efficacy in the treatment of knee osteoarthritis. Russian Medical Inquiry. 2021;5(5):301–306 (in Russ.). DOI: 10.32364/2587-6821-2021-5-5-301-306.


2020 ◽  
Vol 19 (3) ◽  
Author(s):  
S Ab Rahman ◽  
P Narhari ◽  
MA Sharifudin ◽  
AA Shokri

Introduction: The WOMAC questionnaire is used extensively in the assessment of knee osteoarthritis butnot as an indicator of total knee arthroplasty (TKA). We aimed to assess if the WOMAC score can be used asan assessment tool to indicate TKA in primary knee osteoarthritis. Materials and Methods: Patients withprimary knee osteoarthritis Kellgren and Lawrence grades 3 or 4 were assessed separately by either one oftwo arthroplasty surgeons for indications to undergo TKA and evaluated using the WOMAC score. Patients whohad received any form of intra-articular knee injection within six months before assessment were excluded.Patients were divided into two groups; indicated for TKA, and for non-surgical treatment. The mean WOMACscore of patients from both groups was compared using Independent t-test. The accuracy at different cut-offpoints in the score indicated for TKA was determined using the receiver operating characteristic (ROC) curveplotted on sensitivity and 1-specificity graph. Results: The study included 74 patients with a mean age of62.5 years (SD=8.26). There was a significant difference in the total WOMAC score (p<0.001) and itscomponents between patients of the two groups. At the cut-off point of 30, the specificity and sensitivity ofthe score indicated for TKA was 91.18% and 95.00% respectively. The positive predictive value was 93.24%.Conclusion: We recommend all primary knee osteoarthritis Kellgren and Lawrence grades 3 or 4 with ascore of 30 and above should be referred to an arthroplasty surgeon for the possibility of requiring TKA.


2018 ◽  
Vol 2018 ◽  
pp. 1-14 ◽  
Author(s):  
Dong Huang ◽  
Yan-Qing Liu ◽  
Li-Shuang Liang ◽  
Xue-Wu Lin ◽  
Tao Song ◽  
...  

At present, there are many constantly updated guidelines and consensuses on the diagnosis and treatment of osteoarthritis both at home and abroad. The recommendations established using methods of evidence-based medicine has experienced strict research on controlling bias and promoting reproduction rate. As a result, the previous evidence was reevaluated, and a lot of changes were provoked in the diagnosis and treatment concept of osteoarthritis. However, several methods not recommended by foreign guidelines are still in use in the current clinical practice in China. On the one hand, Chinese experts have not reached extensive consensus on whether it is necessary to make changes according to foreign guidelines. On the other hand, almost all the current relevant guidelines are on osteoarthritis, but the lesions around knee joints which, as a whole, bear the largest weight in human body, cannot be ignored. For this purpose, Chinese Association for the Study of Pain (CASP) organized some leading experts to formulate this Chinese Pain Specialist Consensus on the diagnosis and treatment of degenerative knee osteoarthritis (DKOA) in combination with the guidelines in foreign countries and the expert experience of clinical practice in China. The consensus, which includes the definition, pathophysiology, epidemiology, clinical manifestation, diagnostic criteria, and treatments of DKOA, is intended to be used by first-line doctors, including pain physicians to manage patients with DKOA.


Author(s):  
Paulo Fávio Macedo Gouvêa ◽  
Zélia Maria Nogueira Britschka ◽  
Cristina de Oliveira Massoco Salles Gomes ◽  
Nicolle Gilda Teixeira de Queiroz ◽  
Pablo Antonio Vásquez Salvador ◽  
...  

This study aimed to evaluate the effects of treatment with Peruíbe Black Mud (PBM) on the clinical parameters and quality of life of patients with knee osteoarthritis and to compare the effects of PBM samples simply matured in seawater and PBM sterilized by gamma radiation. A controlled, double-blind trial was conducted with 41 patients divided into two treatment groups composed of 20 and 21 patients: one group was treated with matured PBM and the other with sterilized PBM. Evaluations were done using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) questionnaires, the Kellgren and Lawrence (KL) radiographic scale, and the quantification of the serum levels of inflammatory biomarkers. An improvement in pain, physical functions, and quality of life was observed in all of the patients who underwent treatment with both simply matured and sterilized PBM. Nine patients showed remission in the KL radiographic scale, but no statistically significant differences were observed in the serum levels of inflammatory mediators before or after treatment. Peruíbe Black Mud proves to be a useful tool as an adjuvant treatment for knee osteoarthritis (OA), as shown by the results of the WOMAC and SF-36 questionnaires and by the remission of the radiographic grade of some patients on the Kellgren and Lawrence scale.


2021 ◽  
Vol 22 (11) ◽  
pp. 5711
Author(s):  
Julian Zacharjasz ◽  
Anna M. Mleczko ◽  
Paweł Bąkowski ◽  
Tomasz Piontek ◽  
Kamilla Bąkowska-Żywicka

Knee osteoarthritis (OA) is a degenerative knee joint disease that results from the breakdown of joint cartilage and underlying bone, affecting about 3.3% of the world's population. As OA is a multifactorial disease, the underlying pathological process is closely associated with genetic changes in articular cartilage and bone. Many studies have focused on the role of small noncoding RNAs in OA and identified numbers of microRNAs that play important roles in regulating bone and cartilage homeostasis. The connection between other types of small noncoding RNAs, especially tRNA-derived fragments and knee osteoarthritis is still elusive. The observation that there is limited information about small RNAs different than miRNAs in knee OA was very surprising to us, especially given the fact that tRNA fragments are known to participate in a plethora of human diseases and a portion of them are even more abundant than miRNAs. Inspired by these findings, in this review we have summarized the possible involvement of microRNAs and tRNA-derived fragments in the pathology of knee osteoarthritis.


2006 ◽  
Vol 10 (01) ◽  
pp. 47-55 ◽  
Author(s):  
Boonsin Tangtrakulwanich ◽  
Virasakdi Chongsuvivatwong ◽  
Alan F. Geater

Objective: To identify what extent different patterns and severities of involvement affect quality of life of people suffering knee osteoarthritis. Methods: This population-based survey involved 288 women and 288 men aged 40 years or older from Songkhla province, southern Thailand. Quality of life was measured using the Medical Outcome Study Short Form Health sutvery (SF-36) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Radiographic investigation included antero-posterior and skyline view of both knees. Osteoarthritis was categorized into 3 patterns; isolated patellofemoral, isolated tibiofemoral and combined with diagnosis based on Kellgren & Lawrence grade 2 or higher. Results: Quality of life as measured by SF-36 and WOMAC showed poorer score in moderate or severe grade than in mild grade of severity. Isolated patellofemoral and combined patterns demonstrated showed poorer scores on both WOMAC and SF-36 than isolated tibiofemoral pattern. Body mass index, income level and pattern of involvement could independently predict total scores of WOMAC, while age, marital status and pattern of involvement affected total score of SF-36. Conclusion: Pattern of involvement is a better predictor of quality of life than disease severity in patients with knee osteoarthritis.


2021 ◽  
Vol 17 ◽  
Author(s):  
Muhammad Tariq Rafiq ◽  
Mohamad Shariff Abdul Hamid ◽  
Eliza Hafiz ◽  
Khalid Rashid ◽  
Farid Ahmad Chaudhary

Introduction: Knee osteoarthritis (OA) is a weight-bearing joint disease and is more common in overweight and obese persons. The objective of this study was to determine the role of rehabilitation exercises (REs) of lower limbs on weight, functional strength, and exercise adherence in overweight and obese knee OA patients. Materials And Method: The patients were recruited from the Urban community of Lahore, Pakistan. The patients were divided into the rehabilitation group (RG) and control group (CG). The patients in the RG performed the REs of lower limbs and followed the instructions of daily care (IDC), while the patients in the CG only followed the IDC for 12 weeks. Outcome measures were assessed at pre-test before grouping and post-test after 12-weeks of interventions. The measures included: weight, functional strength, and exercise adherence. The Paired Samples t-test (for the normally distributed data) and the Wilcoxon Signed Ranked Test (for the data that was not normally distributed) were used to analyze the differences within groups from pre to post-test measurements. The analysis of variance 2 × 2 factors and the Mann-Whitney U-test were used to analyze the difference of weight and functional strength respectively between the groups. Results: The patients in the RG reported a statistically significant weight reduction (p < 0.001) and improvement in the functional strength (p < 0.001) within the group. Similarly, the patients in the CG also reported a significant improvement in the scores of functional strength (p = 0.004) within the group. The improvement in the scores of functional strength was greater in the patients of RG than the CG (p < 0.001. Similarly, the patients in the RG reported a statistically significant reduction in weight than the CG (p < 0.001). Conclusion: The REs could improve weight, functional strength and exercise adherence.


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