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Introduction and Background

Osteoarthritis is a general form of arthritis. In pathology, it is identified by “whole joint” of articular cartilage and marginal, central bone function. Cartilage degradation, synovitis, remodelling of sub-chondral bone, degeneration of ligaments and menisci as well as hyporetrophy of joint capsule participate in the pathogenesis. The attributed risk of disability to joint arthritis may cause due to severe pain and due to intra-articular disorders permanently.

Intra-articular issues are well established as a medication of joint osteoarthritis. For the knee osteoarthritis, intra-articular injection such as corticosteroids, visco-supplements, blood-derived products is accepted as the final modality of non-operative. However, the osteoarthritis does not depend up on randomised controlled trials (Ayhan, Kesmezacar, and Akgun, 2014). There is a requirement for higher rigorously designed studies on treatment of osteoarthritis as a subject.

Does intra-articular injection of Hyaluronic acid give more clinical efficacy than standard corticosteroid injection in managing patients with major joint osteoarthritis?

Ayhan, E., Kesmezacar, H., & Akgun, I. (2014). Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World journal of orthopedics, 5(3), 351.

The aetiology of Osteoarthritis is multi-factorial and involves both generalised factors such as aging, sex, obesity, heredity and adverse mechanical factors such as trauma, recreational usage and alignment. IA corticosteroid injections give temporary reduction in OA pain and could be regarded as a conjunct to major treatment for the “moderate relief” to “severe pain” in people with OA. It is to observe whether intra-articular injection of Hyaluronic acid is sufficient for the disease or standard corticosteroid injection could perform better with efficiency (Zhang et al., 2007). The case study incorporates the comparison of standard Corticosteroid for the treatment of Osteoarthritis of the joint with intra-articular injections of Hyaluronic and (Pham et al., 2004). Blinding of the patients and outcome assessors handled design of prospective randomized and the controlled study.

This article must be included for future analysis in Capstone project, as it describes the influence of a single dosage of hyaluronic acid for treatment of joint osteoarthritis. The outcomes appear to be stable after 24 weeks of administration and continuous enhancement is detected.

The current study satisfied all inclusion criteria. The study was executed by intervention trials. IA CS injections are utilised to inhale acute and chronic inflammatory circumstances. In Accordance to the evidences related to inflammation and joint effusion, CS injections reduce acute episodes of pain and improve joint mobility. While the correlation of chondrolysis and flare of OA is regarded, the IA CS injection for temporary treatment is recommended. Randomized control trials in OA patients are the evidence of effectiveness of IA corticosteroids in this report.

The clinical outcomes of these actions are reduced in erythema of the inflamed joints and an enhancement in relative viscosity with an improvement of physical quality by hyaluronic acid (HA).  

The research design is a randomized control trial comparing the mechanism of action as well as effectivity of two treatment methods (McArthur et al., 2012). The major question is to determine the safety and efficiency of intra-articular injection of a high molecular weight hyaluronic acid with respect to corticosteroid injection to treat joint osteoarthritis.

PICO question

The research does not appropriately compare the efficacy of intra-articular injections of corticosteroid and hyaluronic acid.

Randomized assignment of patients to treatments

Centralized computer randomization is ideal. The methods section indicates that the patients were allocated to groups based on the presence of joint disease, affected by joint injury disease for three months and those with joint mobility. However, the researchers carried out an unblended study that is not favourable for randomized clinical trials.

Detection of similarity of groups at the start of the trial

A table is not provided that compares the variable outcomes associated with age of patients and risk factors. Patients meeting all eligibility criteria and consenting to participate were randomly assigned to Standard corticosteroid injection group wise. It was formed by BMI and OA pain indexes.

Whether group were treated equally aside from the allocated treatment

Yes, there are groups treated equally apart from the allocated treatment. It is a three-armed and parallel-group design. Patients complying with the inclusion and exclusion criterion would be randomized into the following treatment group: infiltration of the joint with hyaluronic acid with a corticosteroid.

Beneficial sampling was used for participant recruitment due to the specificity of the research question. With the random assignment, initial random selection of subjects was performed. We collected the cross-sectional data due to long follow up. Patients within treatment facilities were extensively evaluated for inclusion and clinical trial eligibility. Conditional and stratified randomization was used with the help of blinding technique in forming the two intervention groups with regard to proportional representation of study centre and access site.

Blinding is a process by which one or more than one parties in a trial are remained unaware of which patients of the treatment have been implicated to. Blinding is a important part of any trial done for avoiding and preventing conscious or unconscious bias in the design and executed in a clinical trial.

Blinding is a randomized, masked-observer, controlled trial that has three-armed parallel-group design. Patients fulfilling the inclusion or exclusion criteria would be randomized to one of the following treatment groups:

  1. Hyaluronic Acid infiltrates of joint
  2. Corticosteroids infiltration of joint

A randomization scheme would be utilised for the randomization. The researcher considers to ignor random imbalances in group-size (Chang et al., 2013). The randomization does not consider stratification variables. After the injection, efficacy parameters would be examined at baseline and the constructed follow-up visits by four weeks.

Among the treated patients, to identify in both the groups in comparison to placebo, it was found clinically meaningful variability in change of IA CS and OA. IA injection of HA has safety for using in patients with knee osteoarthritis (OA). The only affect of significance are transient local reactions in the injected joint noticed at a rate of 2% to 4%.

The study was executed in clinical centres and included the patients suffering from joint osteoarthritis. Prescribed both types of doses were used with each patient and consistent protocol for medication management was implemented. The following result measuring instruments would be evaluated at baseline before the intra-articular injection of the study (Lin et al., 2004). Prior to discharge, participants underwent the follow-up assessments that were also performed at 26 weeks post-intervention. The following factors were enrolled as the measure: Pain (100 mm VAS), BMI and OA level. Inflammatory mediators have a pivotal role in OA process initiation and continuation.

Journal article

The subject mortality is very insignificant. This percentage of patients entered the clinical trial but could not attribute the conclusion. This is further variability in case of meta-analysis of seven randomized controlled trials to the patients with joint osteoarthritis (OA) in which IA HA dose was compared with IA CS. The exploited cases could be occurred due to subchondral bone vasculture and less flow of blood in adipose tissues. The lack plasma level in platelets may cause mortality (Chang et al., 2014).

A sterile, transparent, homogenous and viscoelastic preparation consist of a pure form of hyaluronic acid was used. It was not crosslinked to a chemical agent, which reduces the risk of allergy and other cortisocoid reactions (Bellamy et al., 1988). IA corticosteroids had no significant differences after 4 weeks of dose applied. In the first two weeks, for relieving pain corticosteroids had more efficacy after 4 weeks. However, after week 8, both seemed equally effective. Analysis of the outcomes for other results such as rigid decrement and functional enhancement following IA HA and IA CS are equal. We observed the Relative Risk Reduction (RRR) that shows us the decrement in the result rate in the treatment group with tespect to the control group.

Relative Risk <1: Treatment decreases the risk of outcome

Relative Risk >1: Treatment enhanced the risk of the outcome

Relative Risk =1: No effect.

Patients were divided into those who have acute and chronic inflammatory situations, prevailing joint pain for at least 24 weeks. BMI and OA index were used determined. A single high molecular weight hyaluronic acid dosage was found to be safe. It was found to be effective to control pain in patients suffering from joint arthritis.

Categorical variables (ex: age) were evaluated by t-test or chi-square, and continuous variables (e.g., BMI, OA, burden of illness, quality of life, pain of arthritis) were measured through means and standard deviations and t-tests.  Analysis was performed using the SAS software package.

This randomized and controlled study would give robust information on intra-articular (IA) treatments applied in osteoarthritis compared to cortisocoid. PRP for patients who are younger than 60 years, along with light OA and BMI (body mass index) less than 30 do not have vividly mal-alignment. In case of the patients are older than 60 years along with BMI less than 30 and moderate OA, would apply PRP in injection that is preceded by a supplementary single dose of HA injection after two to four years.

Testing samples were not randomly selected, but any bias appeared to be well controlled. Closely observed protocols may have mitigated any potential issue there. The study’s power and effect size were noted, which provide greater meaning to clinical significance as well as meeting the threshold for statistical significance (Arroll and Goodyear-Smith, 2004).

Statistically significant scores were obtained in case of hyaluronic acid and cortisocoid injection in following treatment. The results were also clinically significant as a single hyaluronic acid dosage (IA) was found to be effective for treatment in the aspect of the worst-case scenario (Leblan, Chantre and Fournie, 2000). Rates of patient at follow-up were comparable between groups that contribute to this group’s PICO question. While the hazy etipathegenesis and OA heterogeneity are regarded, it is critical to group the patients and their disease level of IA injection.

References:-

Arroll, B., & Goodyear-Smith, F. (2004). Corticosteroid injections for osteoarthritis of the knee: meta-analysis. Bmj, 328(7444), 869.

Ayhan, E., Kesmezacar, H., & Akgun, I. (2014). Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World journal of orthopedics, 5(3), 351.

Bellamy, N., Buchanan, W. W., Goldsmith, C. H., Campbell, J., & Stitt, L. W. (1988). Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. The Journal of rheumatology, 15(12), 1833-1840.

Chang, K. V., Hung, C. Y., Aliwarga, F., Wang, T. G., Han, D. S., & Chen, W. S. (2014). Comparative effectiveness of platelet-rich plasma injections for treating knee joint cartilage degenerative pathology: a systematic review and meta-analysis. Archives of physical medicine and rehabilitation, 95(3), 562-575.

Chang, K. V., Hsiao, M. Y., Chen, W. S., Wang, T. G., & Chien, K. L. (2013). Effectiveness of intra-articular hyaluronic acid for ankle osteoarthritis treatment: a systematic review and meta-analysis. Archives of physical medicine and rehabilitation, 94(5), 951-960.

Lin, J., Zhang, W., Jones, A., & Doherty, M. (2004). Efficacy of topical non-steroidal anti-inflammatory drugs in the treatment of osteoarthritis: meta-analysis of randomised controlled trials. Bmj, 329(7461), 324.

McArthur, B. A., Dy, C. J., Fabricant, P. D., & Della Valle, A. G. (2012). Long term safety, efficacy, and patient acceptability of hyaluronic acid injection in patients with painful osteoarthritis of the knee. Patient preference and adherence, 6, 905.

Pham, T., van der Heijde, D. M. F. M., Altman, R. D., Anderson, J. J., Bellamy, N., Hochberg, M., ... & Dougados, M. (2004). OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis and Cartilage, 12(5), 389-399.

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My Assignment Help. 'Comparison Of The Efficacy Of Intra-Articular Hyaluronic Acid And Corticosteroid Injections For Joint Osteoarthritis: An Essay.' (My Assignment Help, 2022) <https://myassignmenthelp.com/free-samples/busn652-operational-quality-in-healthcare/statistical-analysis-on-clinical-trial-file-KA1959.html> accessed 22 December 2024.

My Assignment Help. Comparison Of The Efficacy Of Intra-Articular Hyaluronic Acid And Corticosteroid Injections For Joint Osteoarthritis: An Essay. [Internet]. My Assignment Help. 2022 [cited 22 December 2024]. Available from: https://myassignmenthelp.com/free-samples/busn652-operational-quality-in-healthcare/statistical-analysis-on-clinical-trial-file-KA1959.html.

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