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Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: a randomised clinical trial.

Vicenzino B, Collins N, Crossley K, Beller E, Darnell R, McPoil T - BMC Musculoskelet Disord (2008)

Bottom Line: Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale.Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests.Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Physiotherapy, School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia. b.vicenzino@uq.edu.au

ABSTRACT

Background: Patellofemoral pain syndrome is a highly prevalent musculoskeletal overuse condition that has a significant impact on participation in daily and physical activities. A recent systematic review highlighted the lack of high quality evidence from randomised controlled trials for the conservative management of patellofemoral pain syndrome. Although foot orthoses are a commonly used intervention for patellofemoral pain syndrome, only two pilot studies with short term follow up have been conducted into their clinical efficacy.

Methods/design: A randomised single-blinded clinical trial will be conducted to investigate the clinical efficacy and cost effectiveness of foot orthoses in the management of patellofemoral pain syndrome. One hundred and seventy-six participants aged 18-40 with anterior or retropatellar knee pain of non-traumatic origin and at least six weeks duration will be recruited from the greater Brisbane area in Queensland, Australia through print, radio and television advertising. Suitable participants will be randomly allocated to receive either foot orthoses, flat insoles, physiotherapy or a combined intervention of foot orthoses and physiotherapy, and will attend six visits with a physiotherapist over a 6 week period. Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale. Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests. Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries.

Discussion: The randomised clinical trial will utilise high-quality methodologies in accordance with CONSORT guidelines, in order to contribute to the limited knowledge base regarding the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome, and provide practitioners with high-quality evidence upon which to base clinical decisions.

Trial registration: Australian Clinical Trials Registry ACTRN012605000463673ClinicalTrials.gov NCT00118521.

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Related in: MedlinePlus

Sequential procedure for fitting of foot orthoses.
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Figure 2: Sequential procedure for fitting of foot orthoses.

Mentions: Participants assigned to this group will be provided with prefabricated foot orthoses from a commercially available range (Vasyli International). The orthoses are made of ethylene-vinyl acetate (EVA) of high (Shore A 75°), medium (Shore A 60°) or low (Shore A 52°) density, and have an inbuilt arch support and 6° varus wedge as specified by the manufacturer. The range includes four types of orthoses to suit a variety of footwear: full length and three-quarter length (general use); easy fit (a three-quarter length with lateral cut-away for narrower footwear e.g. men's dress shoes); and slim fit (a thin minimally arched orthosis designed for women's dress/court shoes). In order to maximise compliance, orthoses will be fitted to up to four pairs of the participants' shoes, using a standardised iterative procedure based primarily on perceived comfort (Figure 2). The first stage will involve selection of an appropriate device based on the amount of space available in the shoe (Step 1a) and the length of the participant's foot (Step 1b). In the first instance, an orthosis made from the highest density EVA will be used (Step 2). Following this process, if the orthoses are uncomfortable when worn in the shoe, the therapist will review the type, size and density, and then choose an alternative orthosis that does fit comfortably. If the participant is not satisfied with the comfort level of the orthoses, the orthoses will be customised. This will first involve heat moulding as per the manufacturer's instructions (Step 3a). This process involves mildly heating the underside of the orthosis, placing it in the intended shoe and then having the participant stand on it with the foot positioned in its neutral zone for approximately 60 seconds. If the heat moulding process alone fails to optimise comfort, the therapist will sequentially trial the addition of medial wedges of the rear and forefoot and/or a heel raise to the orthoses (Step 3b). The medial rearfoot wedges have a manufacturer specified 2° or 4° of inclination, the forefoot wedges 4° or 6° and the heel raises are 4, 6 or 8 mm thick. The forgoing underscores the primary goal of fitting of the orthoses to achieve a comfortable fit. Once comfort has been achieved, the effect of the orthoses on performance of a functional task will be evaluated. This will involve quantification of the effect of the orthoses on pain-free performance of an activity identified as pain provocative immediately prior to orthosis fitting, such as, step ups, step downs or squats. A substantial increase in the number of pain-free repetitions that can be performed will be regarded as a success. The therapist will modify the orthoses in order to improve the performance of the functional task, but with the fundamental aim of ensuring the orthoses are comfortable. This process of fitting, reviewing and adjusting the orthoses will continue over the six visits. Participants will also be given a home exercise program of foot arch-forming exercises and weight-bearing calf stretches to be performed bilaterally twice daily.


Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: a randomised clinical trial.

Vicenzino B, Collins N, Crossley K, Beller E, Darnell R, McPoil T - BMC Musculoskelet Disord (2008)

Sequential procedure for fitting of foot orthoses.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2279129&req=5

Figure 2: Sequential procedure for fitting of foot orthoses.
Mentions: Participants assigned to this group will be provided with prefabricated foot orthoses from a commercially available range (Vasyli International). The orthoses are made of ethylene-vinyl acetate (EVA) of high (Shore A 75°), medium (Shore A 60°) or low (Shore A 52°) density, and have an inbuilt arch support and 6° varus wedge as specified by the manufacturer. The range includes four types of orthoses to suit a variety of footwear: full length and three-quarter length (general use); easy fit (a three-quarter length with lateral cut-away for narrower footwear e.g. men's dress shoes); and slim fit (a thin minimally arched orthosis designed for women's dress/court shoes). In order to maximise compliance, orthoses will be fitted to up to four pairs of the participants' shoes, using a standardised iterative procedure based primarily on perceived comfort (Figure 2). The first stage will involve selection of an appropriate device based on the amount of space available in the shoe (Step 1a) and the length of the participant's foot (Step 1b). In the first instance, an orthosis made from the highest density EVA will be used (Step 2). Following this process, if the orthoses are uncomfortable when worn in the shoe, the therapist will review the type, size and density, and then choose an alternative orthosis that does fit comfortably. If the participant is not satisfied with the comfort level of the orthoses, the orthoses will be customised. This will first involve heat moulding as per the manufacturer's instructions (Step 3a). This process involves mildly heating the underside of the orthosis, placing it in the intended shoe and then having the participant stand on it with the foot positioned in its neutral zone for approximately 60 seconds. If the heat moulding process alone fails to optimise comfort, the therapist will sequentially trial the addition of medial wedges of the rear and forefoot and/or a heel raise to the orthoses (Step 3b). The medial rearfoot wedges have a manufacturer specified 2° or 4° of inclination, the forefoot wedges 4° or 6° and the heel raises are 4, 6 or 8 mm thick. The forgoing underscores the primary goal of fitting of the orthoses to achieve a comfortable fit. Once comfort has been achieved, the effect of the orthoses on performance of a functional task will be evaluated. This will involve quantification of the effect of the orthoses on pain-free performance of an activity identified as pain provocative immediately prior to orthosis fitting, such as, step ups, step downs or squats. A substantial increase in the number of pain-free repetitions that can be performed will be regarded as a success. The therapist will modify the orthoses in order to improve the performance of the functional task, but with the fundamental aim of ensuring the orthoses are comfortable. This process of fitting, reviewing and adjusting the orthoses will continue over the six visits. Participants will also be given a home exercise program of foot arch-forming exercises and weight-bearing calf stretches to be performed bilaterally twice daily.

Bottom Line: Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale.Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests.Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Physiotherapy, School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, Australia. b.vicenzino@uq.edu.au

ABSTRACT

Background: Patellofemoral pain syndrome is a highly prevalent musculoskeletal overuse condition that has a significant impact on participation in daily and physical activities. A recent systematic review highlighted the lack of high quality evidence from randomised controlled trials for the conservative management of patellofemoral pain syndrome. Although foot orthoses are a commonly used intervention for patellofemoral pain syndrome, only two pilot studies with short term follow up have been conducted into their clinical efficacy.

Methods/design: A randomised single-blinded clinical trial will be conducted to investigate the clinical efficacy and cost effectiveness of foot orthoses in the management of patellofemoral pain syndrome. One hundred and seventy-six participants aged 18-40 with anterior or retropatellar knee pain of non-traumatic origin and at least six weeks duration will be recruited from the greater Brisbane area in Queensland, Australia through print, radio and television advertising. Suitable participants will be randomly allocated to receive either foot orthoses, flat insoles, physiotherapy or a combined intervention of foot orthoses and physiotherapy, and will attend six visits with a physiotherapist over a 6 week period. Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale. Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests. Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries.

Discussion: The randomised clinical trial will utilise high-quality methodologies in accordance with CONSORT guidelines, in order to contribute to the limited knowledge base regarding the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome, and provide practitioners with high-quality evidence upon which to base clinical decisions.

Trial registration: Australian Clinical Trials Registry ACTRN012605000463673ClinicalTrials.gov NCT00118521.

Show MeSH
Related in: MedlinePlus