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Klinik Çalışmalar

(Research)

BMJ Randomised Clinical Trial:

Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome

Abstract
Objective:
To compare the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy, and to investigate the effectiveness of foot orthoses plus physiotherapy.

Participants:
179 participants (100 women) aged 18 to 40 years, with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks’ duration, who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months.

Interventions:
Six weeks of physiotherapist intervention with off the shelf foot orthoses, flat inserts, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or foot orthoses plus physiotherapy.

Main outcome measures:
Global improvement, severity of usual and worst pain over the preceding week, anterior knee pain scale, and functional index questionnaire measured at 6, 12, and 52 weeks.

Results:Foot orthoses produced improvementbeyond that of flat inserts in the short term, notably at six weeks (relative risk reduction 0.66,99%confidence interval 0.05 to 1.17; NNT 4 (99% confidence interval 2 to 51). No significant differences were found between foot orthoses and physiotherapy, or between physiotherapy and physiotherapy plus orthoses. All groups showed clinically meaningful improvements in primary outcomes over 52 weeks.

Conclusions:While foot orthoses are superior to flat inserts according to participants’ overall perception, they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain. Given the long term improvement observed in all treatment groups, general practitioners may seek to hasten recovery by prescribing prefabricated orthoses.

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GlideSoft Scientific Trial Report:

Wear and Biomechanical Characteristics of a Novel Shear-Reducing Insole with Implications for High-Risk Persons with Diabetes

Abstract
Objective
:

This study was designed to measure pressure and shear reduction of a novel insole design.

Methods:
We compared three multilayer viscoelastic insoles to a novel insole design (GlideSoft®, Xilas Medical, Inc., San Antonio, TX). The bottom pad of each insole was fabricated from firm-density Plastazote® [Apex Foot Products (now Aetrex), South Hackensack, NJ] with an upper of Plastazote, ethyl vinyl acetate, or PORON® (Langer Biomechanics Group, Inc., Deer Park, NY). The GlideSoft design used the same materials with two intervening thin sheets of a low friction material. We measured foot pressures, shear, and material stiffness prospectively as the insoles aged during daily usage in 30 healthy adults. We used the F-Scan® (Tekscan, Inc., Boston, MA) to determine in-shoe foot pressures and the Automated Stress-relaxation Creep Indenter System (Xilas Medical) to measure material stiffness. To evaluate shear force, the insole was placed on the slide assembly of a custom-designed shear tester equipped with a reciprocating mechanism and force transducers.

Results:
The GlideSoft exhibited 57% less peak shear force than the standard insole (P < 0.05) in laboratory testing under simulated conditions. Ethyl vinyl acetate had higher compressive stiffness values than Plastazote and PORON at all test intervals (P < 0.05). There were no statistical differences between any of the insoles for peak in-shoe pressure measurements (P > 0.05).

Conclusions:
The GlideSoft design demonstrated a significant reduction in shear while maintaining equivalent pressure reduction compared with standard insole designs with three different material combinations for up to 320,000 steps.

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GlideSoft Clinical Trial:

Evaluation of the effectiveness of a shear reducing insole compared to a standard insole design to prevent foot ulceration in high risk patients with Diabetes

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The Short Term Treatment of Plantar Fasciitis Using Simple "off the shelf" Foot Orthoses

Abstract
Objective:
To determine the effect of off the self foot orthoses in the treatment of idiopathic plantar fasciitis.

Methods:
Thirty-four subjects with a clinical diagnosis of plantar fasciitis were evaluated using isotopic bone scan, ultrasound and physical examination as a baseline measure. A Foot Function Index (FFI), standardized orthopedic foot and ankle joint measures plus a navicular drop test were used to evaluate each patient's physical baseline parameters at the being of the study. FFI and ultrasound were then repeated at 12 weeks post treatment. Plantar fascia thickness of less than 3mm was used as a definition of normal. Body mass index was also calculated for all subjects.

After diagnosis of plantar Fasciitis with the above techniques the subjects were issued with a pair of "off the shelf" arch supports (VASYLI devices). The subjects were asked to wear the orthoses for a three-month period (12 week period) and were then re-evaluated.

Results:
A significant (p < 0.05) reduction in all FFI scores was observed with over 90% of patients showing significant or total relief of plantar fasciitis symptoms. A direct correlation (p < 0.001) was found between increased thickness of the plantar fasciae in the right foot only with increased BMI and body weight. However, no correlation was seen between increased foot flattening and plantar fascia thickness or level of pain, disability or disability as defined by the FFI.

This paper represents one part of a larger study entitled: "Local corticosteriod injection therapy in plantar fasciitis: a randomized controlled trial"

Key Words:
Ultrasonography, Plantar Fasciitis, Orthoses.

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A Randomised Control Trial for evaluating over-the-counter golf orthoses in alleviating pain in amateur golfers

Abstract
Background:
There are few studies to evaluate the effectiveness of orthoses on foot function and pain whilst playing golf.

Objectives:
The study aimed to evaluate the capacity of three different types of orthoses to alleviate levels of pain, whilst playing golf.

Method:
Over a period of 3 months, 32 amateur golfers took part in a Randomised Control Trial which looked at a prefabricated over-thecounter golf orthosis against a placebo and a cushioning Poron insole using two validated tools-the Foot Health Status Questionnaire and the Foot Posture Index.

Results:
Of the 27 golfers that completed the trial, the results showed that the use of orthoses whilst playing golf reduced the levels of pain experienced, with equally positive responses in the placebo group. Of statistical significance (where p > 0.05) was the improvement in foot posture of the right foot (p=0.053), for those using the Golf Orthaheel. A visual analogue scale showed statistically significant pain reduction (p=0.007) when using the Poron insole.

The results from this trial suggest that orthoses may have an effect in reducing pain and improving foot posture by controlling pronatory movements in golfers.

© 2006 Elsevier Ltd. All rights

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