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critically appraised the paper Baldassin V, Gomes CR, Beraldo PS: Effectiveness of Prefabricated and Customized Foot Orthoses Made From Low-Cost Foam for Noncomplicated Plantar Fasciitis: A Randomized Controlled Trial. Archives of Physical Medicine and Re

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journal article as well called: Baldassin V, Gomes CR, Beraldo PS: Effectiveness of Prefabricated and Customized Foot Orthoses Made From Low-Cost Foam for Noncomplicated Plantar Fasciitis: A Randomized Controlled Trial. Archives of Physical Medicine and Rehabilitation 2009, 90(4):701-706.
Use this article to answer the questions on the template. Also Please write it well. the first bit is to reference the journal article, the summary of the article as stated in the word doc, then using the PEDro appraisal tool do the Evaluation of the methodological quality of the study, also the PEDro appraisal tool document is included. after that do the biases, then answer the two questions and explain briefly. after that Study Results, then the Clinical or practical importance of the study findings and lastly the References. please use at least 3 references, journal articles. once doen please read it and then send it to me.

Article reference (APA style):

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*Note: do not change font or spacing throughout this template. You can bold, italicise or underline text as necessary (e.g. to provide an appropriate reference style). Otherwise, just click inside a text box and begin typing you answer. If you prepare your answers in another document, then please make sure you paste your answer into this template using the ‘Paste Special’ ? ‘Unformatted Text’ function in Word – this will remove rogue (or different) font styles from the document you have copied the information from.

2. Introduction (~150-200 words)

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).

3. Study Quality (~200 words)

(a) 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).

1.    eligibility criteria were specified no 0 yes 0 where:

2.     subjects were randomly allocated to groups (in a crossover study, subjects were randomly allocated an order in which treatments were received) no 0 yes 0 where:

3.     allocation was concealed  no 0 yes 0 where:

4.     the groups were similar at baseline regarding the most important prognostic indicators no 0 yes  where:

5.     there was blinding of all subjects no 0 yes 0 where:

6.    there was blinding of all therapists who administered the therapy no 0 yes 0
where:

7.    there was blinding of all assessors who measured at least one key outcome no 0 yes 0  where:

8.    measures of at least one key outcome were obtained from more than 85% of the subjects initially allocated to groups no 0 yes 0  where:

9.    all subjects for whom outcome measures were available received the treatment or control condition as allocated or, where this was not the case, data for at least one key outcome was analysed by “intention to treat” no 0 yes 0  where:

10.    the results of between-group statistical comparisons are reported for at least one key outcome no 0 yes 0 where:

11. the study provides both point measures and measures of variability for at least one key outcome  no 0 yes 0  where

(b) Bias that can potentially impact upon the RCT. Discuss the most important types of bias that may have affected the study you have chosen. [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?

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 0     No 0

(c) All things considered, is the study of sufficient quality (i.e. sufficiently valid) to warrant its use to inform practice?
Yes 0     No 0

4. Study Results (~100-150 words)

Articulate the results of the study. Identify 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 difference between groups and the 95% confidence limits for this estimate; or the values of the inferential statistics, e.g. the t or F value and the P value associated with it).

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5. Clinical or practical importance of the study findings (~150-200 words)

With reference to one of the study’s statistically significant effects, estimate the minimum clinically important difference or clinically worthwhile effect and provide a rationale for this estimate (i.e. do you think the difference between groups is clinically worthwhile to patients). Decide if the effect found in the study is clinically or practically important and provide a rationale for this judgement.

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6. References (you do not need to include these in your word count)

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PROSTHETICS, ORTHOTICS, DEVICES
Effectiveness of Prefabricated and Customized Foot Orthoses
Made From Low-Cost Foam for Noncomplicated Plantar
Fasciitis: A Randomized Controlled Trial
Valéria Baldassin, PT, Cícero R. Gomes, MD, Paulo S. Beraldo, PhD
ABSTRACT. Baldassin V, Gomes CR, Beraldo PS. Effectiveness
of prefabricated and customized foot orthoses made
from low-cost foam for noncomplicated plantar fasciitis: a
randomized controlled trial. Arch Phys Med Rehabil 2009;90:
701-6.
Objectives: To evaluate the effectiveness of prefabricated
and customized foot orthoses made from low-cost foam (ethylene
vinyl acetate [EVA]) in plantar fasciitis.
Design: Double-blinded randomized controlled trial.
Setting: Public rehabilitation referral medical center.
Participants: One hundred forty-two adults (75% women)
with plantar fasciitis, without anatomical alterations in the feet.
Seventeen subjects (12%) were lost during the follow-up.
Interventions: Prefabricated and customized foot orthoses,
both made from EVA, used for 8 weeks.
Main Outcome Measures: The primary outcome was pain
(modified subscale of the Foot Function Index, [FFI] pain). The
secondary outcomes were pain elicited by palpation in the
medial calcaneal tuberosity and modified FFI total. Each participant
was reviewed in the 4th and 8th weeks of follow-up.
Results: One hundred twenty-five participants returned to at
least 1 of the follow-up evaluations (63 in the prefabricated and
62 in the customized groups). There was a significant improvement
in both groups (P.05), but there was no difference of
modified FFI pain between intragroup differences at 4 (4.03
points; 95% confidence interval [CI], 4.2 to 12.3) and 8
weeks (3.93 points; 95% CI, 4.6 to 12.5).
Conclusions: The low-cost prefabricated and customized
foot orthoses, as used in this trial, had similar effectiveness in
the treatment of noncomplicated plantar fasciitis after 8 weeks
of use. Our results were similar to other trials, although those
trials did not use orthoses made from EVA. Thus, EVA prefabricated
inserts may be the best choice for the treatment of
plantar fasciitis without complication.
Key Words: Fasciitis, plantar; Foot; Orthotic devices; Pain;
Podiatry; Rehabilitation.
© 2009 by the American Congress of Rehabilitation
Medicine
PLANTAR FASCIITIS IS A SYNDROME caused by repetitive
traumas at the origin of the plantar fascia.1 In more
than 80% of patients, pain on the foot will disappear within a
year, regardless of therapy.1 Because limited progress has been
made toward preventing the disease, the management of symptoms
is the mainstay of treatment.1,2 Conservative treatment,
such as stretching, icing, anti-inflammatory use, and short-term
use of foot orthoses, is successful in improving function and
reducing pain.1,2 Foot orthoses reduce strain in the fascia
during standing and ambulation by providing medial arch support.
1,3,4
Most of the orthoses described in the literature are made
from rubber.1 There are many densities and thicknesses of
rubber, features that are pertinent in this issue and have not
been properly addressed. EVA is a low-cost foam with similar
properties of rubber, which is rarely cited in the studies. EVA
combines the mechanical properties required for orthoses and a
low price.5 Furthermore, foot orthoses for the treatment of
plantar fasciitis can be prefabricated or custom-made. In our
facility, the former is based on a mold of average feet, whereas
the latter is made specifically for the patient’s feet. The use of
either type of orthosis can be suggested unless there is an
important anatomic change in the feet. Other differences between
the insoles are their flexibility, thickness, and cost,
which can vary according to the construction process. A prefabricated
foot orthosis costs much less than a customized
orthosis.2,6,7
Three out of the 5 previous randomized controlled trials did
not show any difference between prefabricated and customized
foot orthoses for plantar fasciitis.2,6,8-10 The foot orthoses used
in these trials were made in different ways and from different
materials, although none of them were made from EVA. Furthermore,
2 of the 5 trials were underpowered, only 1 assessed
function (disability), 3 had losses to follow-up of at least 15%,
and only 2 explicitly analyzed by intention to treat. Considering
the mechanical properties of each material and the methodologic
flaws of these studies, their results cannot be generalized.
3,11 Thus, we conducted a randomized trial to compare
prefabricated and customized foot orthoses made from EVA to
treat noncomplicated plantar fasciitis. We hypothesized that
both types of orthoses made from EVA would present similar
results in terms of pain relief.
METHODS
Participant Flow and Follow-Up
Patients with plantar fasciitis consecutively admitted from
May 2004 to July 2005 in the Orthotics and Prosthetics De-
From the Postgraduate Rehabilitation Sciences/SARAH Rehabilitation Hospital
Network, Sarah, Brazil (Baldassin, Gomes, Beraldo).
Trial registration: Australian New Zealand Clinical Trials Registry,
ACTRN012607000319471 (www.anzctr.org.au).
No commercial party having a direct financial interest in the results of the research
supporting this article has or will confer a benefit on the authors or on any organization
with which the authors are associated.
Correspondence to Paulo S. Beraldo, SMPW Q 18 Conj 5 lote 3 casa H, Park-Way,
71741-805 Núcleo Bandeirante, DF, Brazil, e-mail: [email protected] Reprints
are not available from the author.
0003-9993/09/9004-00081$36.00/0
doi:10.1016/j.apmr.2008.11.002
List of Abbreviations
CI confidence interval
EVA ethylene vinyl acetate
FFI Foot Function Index
701
Arch Phys Med Rehabil Vol 90, April 2009

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