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Foot Orthoses in Plantar Fasciitis Treatment Report


Title (Cover) Page

Article reference (APA style):
Baldassin, V., Gomes, C. R., & Beraldo, P. S. (2009). Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for non-complicated plantar fasciitis: A randomized controlled trial. Archives of physical medicine and rehabilitation, 90(4), 701-706.
Weisberg, H. I. (2013). Bias and Causation: Models and judgment for valid comparisons. Hoboken, N.J: Wiley.

Introduction

Précis (or summary) of the article, including the study research question, the study design, the participants and the sampling or selection strategy, the data collection procedure, and the results (study findings).
The research article focuses on evaluating the effectiveness of customized and prefabricated foot orthoses produced from low-cost foam (EVA) in the treatment of patients with plantar fasciitis. The design the study used was a double-blinded randomized control trial. This research design includes interventions to remove the influence of immeasurable or unidentified confound variables that are likely to lead to a biased and inaccurate estimate of the treatment impact.

The research included one hundred and forty-two adults who had plantar fasciitis but had no anatomical operations of the feet. Of the participants, seventy-five percent were women. Seventeen members who accounted for twelve percent of the research did not return for the follow-ups. The data collection technique involved analyzing the flow of participants and recruiting patients who showed symptoms of plantar fasciitis spon admission to the Orthotics and Prosthetics Department of the SARAH Network of Rehabilitation Hospitals from May 2004 to July 2005.

Eligible subjects had to be over eighteen years of age and diagnosed with plantar fasciitis. The complaints of the subjects had to include first-step pain and significant tenderness in the area of the medial calcaneal tuberosity. The research found that low-cost prefabricated and customized insoles had the same effect in the treatment of plantar fasciitis, suggesting that EVA prefabricated orthoses are an excellent option for the treatment of this condition.

Study Quality

Evaluation of the methodological quality of the study, using specified criteria

Assessment of the methodological quality of the study is to be done with the aid of The PEDro appraisal tool (you may want to set this up as a table).
PEDro scale is used to assess the quality of the study based on 11 separate criteria. The first point of PEDro evaluation addresses the eligibility criteria as outlined by the authors. Baldassin, Gomes, and Beraldo (2009) clearly describe the eligibility criteria they had applied to determine the subjects eligible for participation. The researchers only admitted participants over 18 years of age who showed strong signs of plantar fasciitis, with a focus on patients who had experienced the first-step pains and great tenderness at the heels.

Secondly, the PEDro scale assesses the grouping of the subjects. Here, the subjects were randomly allocated to groups, which satisfies the second criterion of the scale. The allocation of the subjects was concealed, and the results of allocation were distributed in opaque sealed envelopes, which satisfies the next criterion of the PEDro scale. Criterion 4 emphasizes the importance of the groups having similar baseline characteristics.

Given that the initial eligibility criteria used by the researchers during the recruitment process applied to all of the participants, it can be assumed that this criterion was also met in the study. Criteria 5 to 7 assess the blindfolding of all the participants, therapists, and assessors. The authors mention the blindfolding practices applied to the participants and their physiotherapists. For instance, all insoles were made to look the same so that the participants would not know which ones they received (Baldassin et al., 2009). The therapists were unable to see the patients’ orthoses and had no access to their previous medical records (Baldassin et al., 2009).

Overall, the precautions applied in the studies satisfy criteria 5 and 6 of the PEDro scale. However, the study does not mention whether or not the blinding practices were applied to assessors, too, which is the next criterion. For instance, the researchers mention that as soon as the randomization procedure was complete, the authors were not blinded to their allocation groups for the rest of the study (Baldassin et al., 2009). This does not comply with blinding standards as outlined in PEDro scale.

The next criteria of the assessment concern the results obtained and their presentations. The results of the study were obtained from 88% of the participants that were initially selected for the study, which satisfies Criterion 8 of the scale. The authors explain that 12% of the participants did not return for the follow-ups, and thus did not participate in the subsequent questionnaires (Baldassin et al., 2009). The majority of the remaining subjects, however, attended all follow-ups and thus received the treatment as planned, by their allocation group (Baldassin et al., 2009). For those who have missed some of the appointments, the authors performed a sensitivity analysis and, if no information was available, used the score from the previous evaluation. Overall, the conditions of Criterion 9 of the scale are also satisfied in the study.

The analysis of results provided by the authors is relatively short; however, the authors draw a statistical comparison between the two groups in terms of the improvement of pain and tenderness in the affected area, including both point measures and measures of variability in the comparison. The analysis of results satisfies the last two criteria of the scale. All in all, the study scores 10 out of 11 points on the PEDro scale, which shows that this is a high-quality study with reliable results.

The bias that can potentially impact the RCT. Discuss the most important types of bias that may have affected the study you have chosen. Please refer to recognized biases from high-quality references. [Use single line spacing when completing this table.]

Type of bias Definition Has this type of bias affected the study and, if so, how?
Has this type of bias been avoided in this study and, if so, how?
Belief Bias An effect in which a person evaluates logic strength depending on the believability of the concept (Weisberg, 2013). The researchers believed that the use of prefabricated inserts is cost-efficient and requires little resources, and thus did not examine other alternatives for treating plantar fasciitis.
Expectation Bias The likelihood of researchers to certify, believe, and publish data that meets their expectations, and not paying attention to data that conflicts the expectations (Weisberg, 2013). The researchers expected to obtain similar results from the two groups, which means that they were subject to expectation bias. However, the bias did not affect the outcomes of the study, as the results were statistically analyzed and compared before publication.

With these biases in mind, is the quality of the study so poor that any observed effect(s) can be explained by the biases?

  • Yes.
  • No.

All things considered, is the study of sufficient quality (i.e. sufficiently valid) to warrant its use to inform practice?

  • Yes.
  • No.

Study Results

Articulate the main results of the study (i.e. the primary analysis). Identify the main statistically significant effects and, for each of these effects, identify the values of the associated statistics (e.g. the population effect size estimate/or mean the difference between groups and the 95% confidence limits for this estimate, and the values of the inferential statistics, e.g. the tor Fvalue and the P-value associated with it).
As a result of the study, the two groups exhibited similar improvement of modified FFI and pain fondle (P<.05, F=5.18) without any significant difference between them. In both cases, the prefabricated group showed higher tendencies for modified FFI pain, but after adjusting the baseline values, the variation in the groups’ results between the fourth and eight weeks was negligible (4.0 points [95%CI, -4.2 to 12.3; P=.337] and 3.9 points [95% CI, -4.6 to 12.5; P=.363]). 13 points was the lowest clinically relevant difference used for the evaluation. In the follow-ups, the higher limits of the CI excluded this lowest clinically relevant difference (Baldassin et al., 2009).

The clinical or practical importance of the study findings

Concerning the trial’s main statistically significant finding, do you think the difference between groups is clinically worthwhileto patients? When answering this question, please consider previously calculated estimates of what is considered clinically worthwhile (i.e. the minimum clinically important difference or clinically worthwhile effect for the outcome measure used), which will help you with your answer. If previously calculated minimum clinically important difference or clinically worthwhile effect are not available (i.e. have not been previously calculated), you will need to justify your answer.
The trial’s main statistically significant finding was that both the prefabricated and customized foot orthoses were effective in improving the symptoms of plantar fasciitis (Baldassin et al., 2009). The difference between the groups was not clinically worthwhile to patients, which means that people suffering from the condition will benefit from using both options. The results of the orthoses use were measured in comparison to the baseline, and the result was at P<.05, which proves that the insoles promote positive development, and are thus recommendable for prescribing to a patient. Previous trials did not analyze the use of orthoses made from EVA, which makes this study an important evaluation of this cost-effective treatment method.

References

Add your references below
Baldassin, V., Gomes, C. R., & Beraldo, P. S. (2009). Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for non-complicated plantar fasciitis: A randomized controlled trial. Archives of physical medicine and rehabilitation, 90(4), 701-706.
Weisberg, H. I. (2013). Bias and causation: Models and judgment for valid comparisons. Hoboken, N.J: Wiley.
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IvyPanda. (2020, November 20). Foot Orthoses in Plantar Fasciitis Treatment. Retrieved from https://ivypanda.com/essays/foot-orthoses-in-plantar-fasciitis-treatment/

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"Foot Orthoses in Plantar Fasciitis Treatment." IvyPanda, 20 Nov. 2020, ivypanda.com/essays/foot-orthoses-in-plantar-fasciitis-treatment/.

1. IvyPanda. "Foot Orthoses in Plantar Fasciitis Treatment." November 20, 2020. https://ivypanda.com/essays/foot-orthoses-in-plantar-fasciitis-treatment/.


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IvyPanda. "Foot Orthoses in Plantar Fasciitis Treatment." November 20, 2020. https://ivypanda.com/essays/foot-orthoses-in-plantar-fasciitis-treatment/.

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IvyPanda. 2020. "Foot Orthoses in Plantar Fasciitis Treatment." November 20, 2020. https://ivypanda.com/essays/foot-orthoses-in-plantar-fasciitis-treatment/.

References

IvyPanda. (2020) 'Foot Orthoses in Plantar Fasciitis Treatment'. 20 November.

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