Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis

Background and aim: To our knowledge, the technique of molding orthoses to the non-load-bearing foot is still not widely investigated. The aim of this work is, therefore, first, to describe an off-loading custom-made technique and, second, to explain how it can be specifically adapted to treat Sever’s disease. Techniques: A technique of directly molding orthoses to the non-load-bearing foot by vacuum forming an insole to the foot fabricated with a combination of polyvinyl chloride and polyester resins, 30 Shore A hardness and 148 kg/m3 density polyethylene–ethylene-vinyl-alcohol, and a cushioning heel cup of 22 Shore A polyurethane, using a directly molding orthoses technique to the non-load-bearing foot by vacuum. Discussion: Results show that this new technique could be a good alternative to traditional insoles in the management of Sever’s disease pain. Clinical relevance Manufacturing the insole directly on the patient’s foot could lead to a better individual adaptation in general, and to manage Sever’s pain disease in particular.

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Effectiveness of custom-made foot orthoses vs heel lifts in children with Calcaneal Apophysitis (Sever disease): a CONSORT-compliant randomized trial

10.21203/rs.3.rs-20702/v1 ◽

2020 ◽

Author(s):

Javier Alfaro-Santafé ◽

Antonio Gómez-Bernal ◽

Carla Lanuza-Cerzócimo ◽

José Víctor Alfaro-Santafé ◽

Aitor Pérez-Morcillo ◽

...

Keyword(s):

Pain Perception ◽

Sport Activity ◽

Treatment Strategies ◽

Previous Treatment ◽

Control Group ◽

Foot Orthoses ◽

Custom Made ◽

Experimental Group ◽

Calcaneal Apophysitis

Abstract Background: Calcaneal apophysitis (Sever disease) is a benign ailment which causes heel pain in children. Conservative treatment strategies are widely popular and the prescription of prefabricated orthoses and heel-lifts is very widespread. The aim of the present research was to determine the effectiveness to relieve calcaneal apophysitis pain using “off-the-shelf” heel-lifts and custom-made orthotics. Methods: Two intervention modalities were evaluated and compared in a 12-week follow-up randomized comparative effectiveness trial. Inclusion criteria included 9 to 12 years old boys or girls diagnosed of calcaneal apophysitis, primary exclusion criteria included children who had suffered from foot trauma on the heel or had received previous treatment. Children were stratified randomized into experimental (custom-made polypropylene foot orthoses) and control (“off-the-shelf” heel-lifts) group. The primary outcome was calcaneal apophysitis pain perception, which was assessed by the Visual Analogical Scale (VAS), the algometry threshold and the Sport Activity Pain perception. Points of measure were at baseline and after the follow-up period. Analysis was performed according to the intention-to treat principles.Results: A total of 208 patients were included. Overall, 9 patients were lost to follow-up. Experimental group showed an increase in threshold algometry by 53.4% (95% CI 47.1% to 59.7%), a decrease in VAS by -68.6% (95% CI -74.5% to -62.7%) and a 20.8 times higher probability of improvement of Sport Activity (95% CI 8.9 to 48.6), compared with control group (p <0.001).Conclusions: Calcaneal apophysitis pain perception was improved in both groups custom-made foot orthoses and heel-lifts, but the experimental group revealed significant changes compared with control group. Children who used custom-made foot orthoses had greater probabilities to improve. Physicians should consider these findings in order to prescribe the most effective treatment in the approach of the calcaneal apophysitis. Trial registration: ClinicalTrials.gov Identifier: NCT03960086.

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Effectiveness of Custom-Made Foot Orthoses vs. Heel-Lifts in Children with Calcaneal Apophysitis (Sever’s Disease): A CONSORT-Compliant Randomized Trial

Children ◽

10.3390/children8110963 ◽

2021 ◽

Vol 8 (11) ◽

pp. 963

Author(s):

Javier Alfaro-Santafé ◽

Antonio Gómez-Bernal ◽

Carla Lanuza-Cerzócimo ◽

José-Víctor Alfaro-Santafé ◽

Aitor Pérez-Morcillo ◽

...

Keyword(s):

Randomized Trial ◽

Pain Perception ◽

Treatment Effectiveness ◽

Foot Orthoses ◽

Inclusion Criteria ◽

Visual Analogical Scale ◽

Custom Made ◽

Calcaneal Apophysitis

The aim of the present research was to determine the effectiveness of relieving calcaneal apophysitis pain using “off-the-shelf” heel-lifts and custom-made orthotics. Two intervention modalities were evaluated and compared in a 12-week follow-up trial. Inclusion criteria included 9- to 12-year-old children diagnosed with calcaneal apophysitis. Children were randomly stratified into treatment A (custom-made polypropylene foot orthoses) and treatment B (“off-the-shelf” heel-lifts) groups. Treatment effectiveness was measured by algometry and the visual analogical scale (VAS). A total of 208 patients were included. The treatment A group showed an increase in threshold algometry of 53.4% (95% CI 47.1% to 59.7%) and a decrease in VAS of −68.6% (95% CI −74.5% to −62.7%) compared with the treatment B group (p < 0.001). Calcaneal apophysitis pain perception was improved in both groups, but children who used custom-made foot orthoses showed a greater improvement.

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Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042627 ◽

2021 ◽

Vol 11 (3) ◽

pp. e042627

Author(s):

María Reina-Bueno ◽

María del Carmen Vázquez-Bautista ◽

Inmaculada C Palomo-Toucedo ◽

Gabriel Domínguez-Maldonado ◽

José Manuel Castillo-López ◽

...

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Controlled Trial ◽

Secondary Outcome ◽

Foot Orthoses ◽

Systemic Lupus ◽

Custom Made ◽

Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

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Custom-Made Foot Orthoses as Non-Specific Chronic Low Back Pain and Pronated Foot Treatment

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18136816 ◽

2021 ◽

Vol 18 (13) ◽

pp. 6816

Author(s):

Aurora Castro-Méndez ◽

Inmaculada Concepción Palomo-Toucedo ◽

Manuel Pabón-Carrasco ◽

Javier Ramos-Ortega ◽

Juan Antonio Díaz-Mancha ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Control Group ◽

Foot Orthoses ◽

Low Back ◽

Custom Made ◽

Foot Posture ◽

Foot Pronation ◽

Pain Symptoms

Excessive foot pronation has been reported as being related to chronic low back pain symptoms and risk factors in sports-specific pathologies. Compensating custom-made foot orthotics treatment has not been entirely explored as an effective therapy for chronic low back pain (CLBP). This study aims to observe the effects of custom-made foot orthoses, in subjects with foot pronation suffering from CLBP. A total of 101 patients with nonspecific CLBP and a pronated foot posture index (FPI) were studied. They were randomized in two groups: an experimental one (n = 53) used custom-made foot orthotics, and the control group (n = 48) were treated with non-biomechanical effect orthoses. The CLBP was measured using the Oswestry Disability Index (ODI) Questionnaire and a visual analogue scale (VAS), both for lower back pain. The symptoms were evaluated twice, at first when the subject was included in the study, and later, after 4 weeks of treatment. The analysis of outcomes showed a significant decrease in CLBP in the custom-made foot orthoses participants group (p < 0.001 ODI; p < 0.001 VAS). These findings suggest that controlling excessive foot pronation by using custom-made foot orthoses may significantly contribute to improving CLBP.

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Effectiveness of Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses on Balance, Fear of Falling, and Physical Activity in Older Adults: A Randomized Controlled Trial

Gerontology ◽

10.1159/000494114 ◽

2018 ◽

Vol 65 (3) ◽

pp. 299-307 ◽

Cited By ~ 9

Author(s):

Changhong Wang ◽

Rahul Goel ◽

Hadi Rahemi ◽

Qianzi Zhang ◽

Brian Lepow ◽

...

Keyword(s):

Physical Activity ◽

Older Adults ◽

Fear Of Falling ◽

Controlled Trial ◽

Foot Orthoses ◽

Female Age ◽

Randomized Controlled ◽

Custom Made ◽

Ankle Foot Orthoses

Background: Foot problems are prevalent in older adults, which may increase the risk and concern for falls. Ankle-foot orthoses (AFO) have been shown to be effective in the stabilization of lower extremities, but their long-term effectiveness in improving balance and their potential to encourage older adults to become more physically active are still debated. Objective: This randomized controlled trial investigated the effectiveness of daily use of a custom-made AFO on balance, fear of falling, and physical activity in older adults. Study Design: Forty-four older adults with concern about or at risk for falling were randomly allocated to either the control group (CG; 77.3% female, age 75.6 ± 6.5 years, BMI 29.3 ± 6.4) or the intervention group (IG; 63.6% female, age 73.7 ± 6.3 years, BMI = 27.8 ± 4.8). The IG received walking shoes and bilateral custom-made AFO. The CG received only walking shoes. At the baseline and 6-month follow-ups, balance and physical activity were assessed using validated wearable instrumentation and fear of falling was assessed using the Fall Efficacy Scale-International (FES-I). Adherence and acceptability toward wearing the AFO were assessed using self-reported questionnaires at the 6-month follow-up. Results: No significant between-group difference was observed at baseline (p = 0.144–0.882). Compared to baseline and the CG, hip, ankle, and center-of-mass (COM) sways were significantly reduced at the 6-month follow-up in the IG while standing with the feet together during the eyes-open condition (p = 0.005–0.040). Within the IG, the FES-I was reduced significantly (p = 0.036) and there was an increasing trend in the number of walking bouts with a medium effect size (d = 0.52, p = 0.440) compared to baseline. However, there were no significant changes in FES-I and physical activity measures in the CG (p = 0.122–0.894). The reduction in COM sway in the IG was moderately correlated with adherence (r = –0.484, p = 0.047) and strongly correlated with baseline COM sway (r = –0.903, p < 0.001). Conclusion: Results suggest that bilateral custom-made AFO plus walking shoes is effective in improving balance compared to walking shoes alone, and it significantly reduces the fear of falling, with a nonsignificant but noticeable positive trend in physical activity, compared to baseline. The results also suggest that older adults with poor balance at baseline and higher daily adherence to using the AFO will gain more benefit from the AFO intervention.

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Comparison between customised foot orthoses and insole combined with the use of extracorporeal shock wave therapy in plantar fasciitis, medium-term follow-up results: A randomised controlled trial

Clinical Rehabilitation ◽

10.1177/0269215520976619 ◽

2020 ◽

pp. 026921552097661

Author(s):

Manuel Coheña-Jiménez ◽

Manuel Pabón-Carrasco ◽

Ana Juana Pérez Belloso

Keyword(s):

Shock Wave ◽

Visual Analogue Scale ◽

Plantar Fasciitis ◽

Analogue Scale ◽

Extracorporeal Shock Wave Therapy ◽

Foot Orthoses ◽

Shock Wave Therapy ◽

Extracorporeal Shock Wave ◽

Custom Made

Objective: To determine the clinical results of custom-made foot orthoses versus placebo flat cushioning insoles combined with an extracorporeal shock wave therapy on pain and foot functionality in patients with plantar fasciitis. Design and setting: A randomised controlled clinical trial with follow-up at six months. Faculty of Podiatry and Centre Clinical private of Physiotherapy, Seville, Spain. Subjects and interventions: Patients with plantar fasciitis were randomly assigned to either group A ( n = 42), which received custom-made foot orthoses, or group B ( n = 41), which received placebo insoles. All the participants received active extracorporeal shock wave therapy including stretching exercises. Recruitment period was from Mach 2019 to July 2020. Main measurements: The main outcome was foot pain, measured by visual analogue scale and the secondary outcome measures were recorded by Roles and Maudsley scores respectively, at the beginning and at one week, one month and six months. Results: Eighty-eight patients were assessed for eligibility. Eighty-three patients were recruited and randomised. This study showed significant differences between both groups according to the visual analogue scale. In control group, the difference was at baseline ( P 0.01) and, in the experimental group was at the one- and six-month follow-up ( P 0.001). The mean (SD) visual analogue scale at baseline were Control group 6.31 (1.69) and Experimental group 5.27 (1.64); and at six months were 7.52 (3.40) and 3.29 (4.26), respectively. The custom-made foot orthosis was perceived as ‘good’ (85%) and ‘excellent’ (97.5%) at medium-long term. Conclusion: Wearing a custom-made foot orthosis leads to a improvement in patients with plantar fasciitis; it reduced foot pain and improved foot functionality.

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Effectiveness of footwear and foot orthoses for calcaneal apophysitis: a 12-month factorial randomised trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2015-094986 ◽

2016 ◽

Vol 50 (20) ◽

pp. 1268-1275 ◽

Cited By ~ 13

Author(s):

Alicia M James ◽

Cylie M Williams ◽

Terry P Haines

Keyword(s):

Randomised Trial ◽

Foot Orthoses ◽

Calcaneal Apophysitis

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Are custom-made foot orthoses of any interest on the treatment of foot pain for prolonged standing workers?

Applied Ergonomics ◽

10.1016/j.apergo.2019.05.013 ◽

2019 ◽

Vol 80 ◽

pp. 130-135

Author(s):

Tristan Tarrade ◽

Fabrice Doucet ◽

Nicolas Saint-Lô ◽

Maxime Llari ◽

Michel Behr

Keyword(s):

Foot Orthoses ◽

Foot Pain ◽

Prolonged Standing ◽

Custom Made

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Changes in Plantar Foot Pressure with In-Shoe Varus or Valgus Wedging

Journal of the American Podiatric Medical Association ◽

10.7547/87507315-94-1-1 ◽

2004 ◽

Vol 94 (1) ◽

pp. 1-11 ◽

Cited By ~ 27

Author(s):

Bart Van Gheluwe ◽

Howard J. Dananberg

Keyword(s):

Pressure Distribution ◽

Loading Rate ◽

Peak Pressure ◽

Center Of Pressure ◽

Scientific Evidence ◽

Peak Load ◽

Foot Orthoses ◽

Foot Pressure ◽

Custom Made

Varus and valgus wedging are commonly used by podiatric physicians in therapy with custom-made foot orthoses. This study aimed to provide scientific evidence of the effects on plantar foot pressure of applying in-shoe forefoot or rearfoot wedging. The plantar foot pressure distribution of 23 subjects walking on a treadmill was recorded using a pressure insole system for seven different wedging conditions, ranging from 3° valgus to 6° varus for the forefoot and from 4° valgus to 8° varus for the rearfoot. The results demonstrate that increasing varus wedging magnifies peak pressure and maximal loading rate at the medial forefoot and rearfoot, whereas increasing valgus wedging magnifies peak pressure and maximal loading rate at the lateral forefoot and rearfoot. As expected, the location of the center of pressure shifts medially with varus wedging and laterally with valgus wedging. However, these shifts are less significant than those in peak load and maximal loading rate. Timing variables such as interval from initial impact to peak load do not seem to be affected by forefoot or rearfoot wedging. Finally, rearfoot wedging does not significantly influence pressure variables of the forefoot; similarly, rearfoot pressure remains unaffected by forefoot wedging. (J Am Podiatr Med Assoc 94(1): 1-11, 2004)

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