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

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 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

Case Medical Research ◽

10.31525/ct1-nct03960086 ◽

2019 ◽

Author(s):

Keyword(s):

Foot Orthoses ◽

Custom Made ◽

Calcaneal Apophysitis

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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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Foot orthoses custom-made by vacuum forming on the non-load-bearing foot: Preliminary results in male children with calcaneal apophysitis (Sever’s disease)

Prosthetics and Orthotics International ◽

10.1177/0309364613482844 ◽

2013 ◽

Vol 37 (6) ◽

pp. 495-498 ◽

Cited By ~ 8

Author(s):

Gabriel Gijon-Nogueron ◽

Encarnacion Cortes-Jeronimo ◽

Jose Antonio Cervera-Marin ◽

Raquel García-de-la-Peña ◽

Salomon Benhamu-Benhamu ◽

...

Keyword(s):

Vinyl Alcohol ◽

Clinical Relevance ◽

Good Alternative ◽

Foot Orthoses ◽

Polyester Resins ◽

Load Bearing ◽

Ethylene Vinyl Alcohol ◽

Vacuum Forming ◽

Custom Made ◽

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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Benefits of custom-made foot orthoses in treating patellofemoral pain

Prosthetics and Orthotics International ◽

10.1177/0309364611420201 ◽

2011 ◽

Vol 35 (4) ◽

pp. 342-349 ◽

Cited By ~ 7

Author(s):

Pedro V Munuera ◽

Rocio Mazoteras-Pardo

Keyword(s):

Clinical Trial ◽

Visual Analogue Scale ◽

Conservative Treatment ◽

Analogue Scale ◽

Patellofemoral Pain ◽

Control Group ◽

Foot Orthoses ◽

Custom Made ◽

Forefoot Varus

Background: Patellofemoral pain is one of the most common disorders affecting the knee. Forefoot varus and excessive subtalar pronation can be associated with patellofemoral pain. Foot orthotics may produce an improvement in symptoms. Objectives: The aim of this study was to test whether patellofemoral pain is improved after four weeks of using custom-made foot orthoses. Study Design: Clinical trial without control group. Methods: Twenty-one subjects with patellofemoral pain were given custom-made foot orthoses (2-mm thick polypropylene and 4-mm thick polyethylene foam liner of 45 shore A hardness). Patellofemoral pain was evaluated with a visual analogue scale before applying the treatment, and at two weeks and four weeks follow-up. At the two-week check-up, a forefoot varus posting was added to the orthoses. Results: Improvements in patellofemoral pain was significant in all comparisons: initial pain with pain at the two-week check-up ( P<0.001), initial pain with pain at four weeks ( P<0.001), and pain at two weeks with pain at four weeks ( P<0.001). The effect size was large in all comparisons. Conclusion: For the participants in this study, the custom-made foot orthoses were found to be an effective conservative treatment to reduce the symptoms of patellofemoral pain.

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Effect of custom-made foot orthoses in female hallux valgus after one-year follow up

Prosthetics and Orthotics International ◽

10.1177/0309364612447097 ◽

2012 ◽

Vol 37 (2) ◽

pp. 113-119 ◽

Cited By ~ 11

Author(s):

María Reina ◽

Guillermo Lafuente ◽

Pedro V Munuera

Keyword(s):

Hallux Valgus ◽

Subtalar Joint ◽

Prospective Trial ◽

Control Group ◽

Foot Orthoses ◽

Repeated Measures Design ◽

Custom Made ◽

Experimental Group ◽

Group Comparisons

Background: Subtalar joint hyperpronation plays a fundamental role in the development of hallux valgus (HV). Foot orthotics have used to treat this condition and are aimed at preventing progression of the deformity. Objectives: The aim of this study was to determine if the use of custom-made foot orthotics for 12 months prevented the advancement of HV in women. Study Design: Prospective trial, using a repeated-measures design. Methods: Fifty-four women with mild to moderate HV were divided into two groups: the experimental group used custom-made foot orthoses, and the control group used no treatment. First intermetatarsal (IMA) and hallux abductus (HAA) angles were measured at the beginning of the study and after 12-months follow up. Inter-group comparisons were made of these angles at both times of measurement, and intra-group comparisons between the two times of measurement. Results: The initial HAA was similar in both groups (19.92 ± 4.25 degrees for the control group, 20.55 ± 5.10 degrees for the experimental group; p = 0.392), and also the IMA (10.56 ± 2.45 degrees for the control group, 10.86 ± 2.33 for the experimental group; p = 0.618) There were no significant differences in the follow-up values of these angles ( p = 0.395 and p = 0.288, respectively). There were no significant intra-group differences in the comparisons of the initial and follow-up angles. Conclusions: HV did not have a significantly slower evolution in participants of the experimental group compared with controls. Custom-made orthoses appear to have no effect in the evolution of mild and moderate HV during a 12 month period. Clinical relevance Subtalar joint hyperpronation plays a fundamental role in the development of hallux valgus. Conservative management typically involves the use of foot orthotics which is aimed at preventing the progress of the condition. The use of foot orthotics however should be used as a long term management strategy (beyond 12 months).

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