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We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.
Participants who fulfilled the combine...
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Context 1
... vinyl acetate (ICB Medical, Australia), and the subtalar joint was maintained in a neutral position (Fig. 2). The procedure was detailed in a previous study. [28] Each participant in the soft LWAS insole group received a pair of ready-made insoles consisting of a soft 5° lateral wedge and an arch support composed of polyurethane (Lanew, Taiwan) (Fig. ...
Citations
... The use of validated outcome measures (VAS and WOMAC) ensured robust assessment of pain and function. Moreover, the single-blinded approach reduced the risk of performance bias, further strengthening the study's validity (18). In conclusion, the study provided evidence supporting the effectiveness of exercise combined with Kinesio tape in reducing pain and improving physical function in patients with grade 3 knee osteoarthritis. ...
Background: Knee osteoarthritis (OA) is a common degenerative joint disease, often resulting from wear-and-tear and articular cartilage loss. This condition frequently leads to significant pain and physical limitations, affecting the quality of life, particularly in older adults. Objective: To determine the effectiveness of exercise combined with Kinesio tape (KT) and wedge insoles on pain and physical limitations in patients with grade 3 knee osteoarthritis. Methods: A randomized clinical trial was conducted on a sample of 60 participants diagnosed with grade 3 knee OA. Participants were randomly divided into two groups of 30 each using a sealed envelope method. Group A received exercise, KT, and wedge insoles, while Group B received exercise and KT only. Both groups underwent 24 sessions over eight weeks, with three sessions per week. The interventions included electrotherapeutic modalities, strengthening exercises for the quadriceps and hamstrings, and KT application. Pain and physical function were measured using the Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, the fourth week, and the eighth week. Data were analyzed using SPSS version 25, with the Friedman test assessing within-group effects and the Mann-Whitney U test evaluating between-group differences. Statistical significance was set at p < 0.05. Results: Group A consisted of 12 males (40%) and 18 females (60%), with a mean age of 52.33 ± 6.34 years. Group B had 10 males (33.3%) and 20 females (66.7%), with a mean age of 52.94 ± 5.75 years. Significant improvements were observed within both groups in VAS and WOMAC scores (p < 0.05). Post-treatment, Group A demonstrated greater improvements in VAS (mean difference = 2.5, p = 0.000) and WOMAC (mean difference = 15.3, p = 0.000) compared to Group B. Conclusion: Both exercise combined with KT and exercise combined with KT and wedge insoles were effective in reducing pain and improving physical function in patients with grade 3 knee osteoarthritis. However, the combination of exercise and KT without wedge insoles produced superior effects. These findings suggest that KT, as an adjunct to exercise therapy, may provide additional benefits for managing knee OA. Keywords: Knee Osteoarthritis, Kinesio Tape, Wedge Insole, Pain Management, Physical Function, Randomized Clinical Trial, Non-Surgical Treatment, Electrotherapeutic Modalities, Strengthening Exercises, Visual Analogue Scale, WOMAC
... Many studies have attempted to improve knee kinematics with the use of foot orthoses. For medial osteoarthritis, the use of a lateral (valgus) wedge orthosis has been reported to reduce the load on the medial compartment and help reduce pain in the medial knee joint [38][39][40]. Similarly, the use of a medial wedge orthosis can improve symptoms for cases with lateral osteoarthritis [41]. ...
Background
The effect of medial arch support foot orthoses on kinematics and kinetics of the knee joint has remained unknown.
Methods
Sixteen female collegiate-level athletes volunteered to participate. Participants were asked to perform a 30° sidestep cut using orthoses of 3 different medial arch heights, comprising of the following: (1) “low,” a full flat foot orthosis without arch support, (2) “mid,” a commercially available foot orthosis with general height arch support, and (3) “high,” a foot orthosis with double the commercially available height for arch support to observe the effect on the knee when overcorrected. Kinematics and kinetics of the knee joint were collected by a markerless motion capture system with 2 force plates and compared between orthosis types using linear regression analysis, assuming a correlation between the measurements of the same cases in the error term.
Results
The knee valgus angle at initial contact was 2.3 ± 5.2 degrees for “low” medial arch support height, 2.1 ± 5.8 degrees for “mid,” and 0.4 ± 6.6 degrees for “high”. Increased arch support height significantly decreased the knee valgus angle at initial contact ( p = 0.002). Other kinematic and kinetic measurements did not differ between groups.
Conclusions
The valgus angle of the knee at initial contact was decreased by the height of the medial arch support provided by foot orthosis during cutting manoeuvres. Increasing the arch support height may decrease knee valgus angle at initial contact. Medial arch support of foot orthosis may be effective in risk reduction of ACL injury.
Clinical trial registration numbers and date of registration : UMIN000046071, 15/11/2021.
... In some previous studies, it has been concluded that lateral wedge insoles reduces the moment arm by shifting the ground reaction force on lateral foot during walking. Therefore, the load on knee is redistributed, which reduces the medial knee adduction moment, so that load on the medial knee is reduced 22,24,26 . However, in recent literature, it has been discussed that lateral wedge insoles are effective for only 20% of osteoarthritic patients because of very small reductions in knee adduction angular impulse and medial knee adduction moment, thus, is not significantly affected for medial knee osteoarthritis 27 . ...
Background: Osteoarthritis (OA) is a persistent joint disorder, which normally affects the weight bearing joints especially knee joint. Lateral wedge insole is one such approach suggested by professionals to manage the knee osteoarthritis. Objective: To determine the effectiveness of lateral wedge insoles on knee osteoarthritis outcomes in Pakistani population Design: A single-blinded, pretest-posttest comparison. Setting: District Headquarter (DHQ) Hospital, Bahawalnagar and National Institute of Rehabilitation Medicine (NIRM), for a time period of one month. Population: Patients with the age criteria of 40-70 years, and who had knee OA were included in the study. Methods: Participants were randomly divided in two groups; lateral wedge insoles (LWI) group (n=20), and conventional physical therapy (CPT) group (n=20). Pain, stiffness, activities of daily living, sports and recreational activities, and quality of life was assessed on Urdu version of Knee Injury and Osteoarthritis Outcome Score scale (KOOS) on every week till 4th week of intervention. Mixed ANOVA was used for interaction effect of between-subject factor (group) and within-subject factor (time) with-in group analysis and one way ANOVA for between group comparisons with their effect size (ɳp2). Results: Significant improvement with large effect size was observed in Symptoms and stiffness (p<0.001, ɳp2=.329} , pain (p<0.001, ɳp2=.559), functional activities (p<0.001, ɳp2=.394), recreational activities (p<0.001, ɳp2=.369) and quality of life (p<0.001, ɳp2=.280). The CPT group showed more significant improvement (p<0.001) in all domains of KOOS as compared to LWI group. Conclusion: Lateral wedge insoles (LWI) and conventional physical therapy (CPT) both have positive impact on knee osteoarthritis outcomes. But conventional physical therapy was more effective in improving functional independence. Clinical rehabilitation impact: This study provides the evidence on the use of LWI and CPT as alternative strategies to improving Knee OA outcome measures. Keywords: Knee osteoarthritis, functional independence, geriatric population, musculoskeletal physiotherapy, orthotics, quality of life, rehabilitation
... Many studies have attempted to improve knee kinematics with the use of foot orthoses. For medial osteoarthritis, the use of a lateral (valgus) wedge orthosis has been reported to reduce the load on the medial compartment and help reduce pain in the medial knee joint [37][38][39]. Similarly, the use of a medial wedge orthosis can improve symptoms for cases with lateral osteoarthritis [40]. ...
Background
We aimed to clarify the effect of medially posted foot orthoses on kinematics and kinetics of the knee joint in female athletes.
Methods
Sixteen female collegiate-level athletes who played basketball or volleyball volunteered to participate in this study. Participants were asked to perform a 30° sidestep cut with their dominant leg using orthoses of 3 different medial arch heights, comprising of the following: 1) “low,” a full flat foot orthosis without medial arch support 2) “mid,” a commercially available foot orthosis with general height arch support, and 3) “high,” a foot orthosis with double the commercially available height for arch support to observe the effect on the knee when overcorrected. Kinematics and kinetics of the knee joint were collected by a markerless motion capture system with 2 force plates and compared between orthosis types using linear regression analysis.
Results
The knee valgus angle at initial contact was 2.3 ± 5.2 degrees for “low” medial arch support height, 2.1 ± 5.8 degrees for “mid,” and 0.4 ± 6.6 degrees for “high.” Increased arch support height significantly decreased the knee valgus angle at initial contact. Other kinematic and kinetic measurements did not differ between groups.
Conclusions
The valgus angle of the knee at initial contact was decreased by the height of the medial arch support provided by foot orthosis during cutting manoeuvres. Increasing the arch support height may decrease knee valgus angle at initial contact. Medial arch support of foot orthosis may be effective in risk reduction of ACL injury.
... The insoles were remolded or modi ed as necessary. The details of this procedure were described in our previous studies [9,19,20]. The treatment group participants each received a pair of highdensity ethyl vinyl acetate thermoplastic foot insoles with medial arch support. ...
The effectiveness of arch-support insoles on children remains controversial. We evaluated the short-term therapeutic effects of arch-support insoles on the physical functional performance, physical function, and psychological well-being of healthy children under the International Classification of Functioning, Disability, and Health (ICF) framework. It was a prospective double-blind randomized controlled study. The participants were randomized into 2 groups, the treatment group (with customized arch-support insoles) and the control group (without insoles) for a 12-week intervention period. The walking speed test, stairs ascent and descent tests, the Five Times Sit-to-Stand test, and the Timed Up and Go test for physical functional performance, and the Pediatric Outcome Data Collection Instrument-Parent (PODCI) and the Child Health Questionnaire-Parent Form (CHQ-PF28) for the physical function and psychological well-being of children were assessed. Forty-five children completed the study. Compared with the control group, after 12 weeks of wearing customized insoles, the treatment group exhibited significant improvement in physical functional performance in terms of fastest walking speed (effect size: .515, P = .046), stairs ascent time (effect size: .658, P = .023), and stairs descent time (effect size: .718, P = .012). No significant difference was found between PODCI and CHQ-PF28 scores.
Conclusions: Children wearing customized arch-support insoles for 12 weeks improved their physical functional performance which belonged to the domain of activity in the ICF. However, using insoles did not affect the physical function and psychological well-being of children.
ClinicalTrials.gov (NCT03198299), date of registration: June 2017, retrospectively registered.
... How ever, limited by few included studies, the previous study could not perform more stratified analyses and draw strong conclusions. Several recent randomized controll ed trials (RCTs) (11,12) have focused on this topic and provided new evidence. The current metaanalysis and systematic review investigated the potential benefits of orthopaedic insoles in subjects with knee OA. ...
... Of these, 830 were excluded after title or abstract screening. Finally, 15 studies from 13 RCTs (11,12,(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) were eligible for data extraction and metaanalysis after retrieving 101 fulllength manus cripts. A schematic illustration of the selection criteria for the included studies is shown in Fig. 1. www.medicaljournals.se/jrm ...
... The mean age of subjects was > 60 years except for one study (28); the majority of studies included more females than males. Two RCTs were performed in Chinese Taipei (12,25), 2 in Japan (30,31), 3 in USA (20,21,24), 2 in Brazil (23,27), and 1 in each of Australia (22), Iran (28), France (26), and Canada (11). Most studies investigated differences between the effects of lateral wedge and flat control insoles, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were documented in 11 studies. ...
Objective:
Recent clinical evidence supports that orthopaedic insoles, especially lateral-wedge insoles, can significantly benefit patients with knee osteoarthritis. The aim of this study is to explore the effects of orthopaedic insoles in patients with knee osteoarthritis.
Methods:
Randomized controlled trials evaluating the effects of orthopaedic insoles on patients with knee osteoarthritis, published up to 16 February 2021, were reviewed and outcomes quantitatively summarized.
Results:
A total of 15 studies from 13 randomized controlled trials that involved 1,086 participants were included in this study. All the included studies exhibited a moderate bias risk and were of acceptable quality. The pooled mean difference of pain determined by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was -1.05 (p < 0.01, 95% confidence interval (95% CI) -2.31-0.20) with a high heterogeneity (I2 = 73%). In the sensitivity analysis, the overall incidence was -0.19 (p= 0.73, 95% CI= -0.83-0.44) with an accepted heterogeneity (I2 = 0%). No difference was observed between the Asian and Caucasian groups (p= 0.26). No significant difference was found in the pain score, Lequesne index or functional improvements.
Conclusion:
Meta-analysis revealed that orthopaedic insoles do not provide relief of pain or improve functionality in patients with knee osteoarthritis.
... Effect of insoles: Eight studies found out that pain significantly decreases after wearing a lateral wedge insole (Barrios et al., 2009;De Campos et al., 2015;Esfandiari et al., 2018;Felson et al., 2019;Hatef et al., 2014;Hsieh & Lee, 2016;Hsu et al., 2015;Rubin & Menz, 2005). Four others found no significant pain reduction after wearing a lateral wedge insole (Baker et al., 2007;Dessery et al., 2017;Lewinson et al., 2016;Maillefert et al., 2001). ...
... However, EKFS improved significantly in the lateral wedge insole group after 2 months. A study that compared soft and rigid insoles with 5° arch support reported significant improvements in stair ascent time, daily life activities, sport and leisure, function and quality of life in the soft insole group (Hsieh & Lee, 2016). ...
... Six studies investigated patient satisfaction and compliance after wearing the knee braces (Brand et al., 2017;Hsieh & Lee, 2016;Laroche et al., 2014;Madara et al., 2019;Ornetti et al., 2015;Robert-Lachaine et al., 2020). A study reported that most patients were satisfied with wearing braces since it resulted in decreasing knee osteoarthritis symptoms in their daily activities (Laroche et al., 2014). ...
Background and objective: Knee osteoarthritis is a disabling disease, causing pain and reduced function. Orthoses are used to manage this problem, including knee braces and lateral wedge insoles. However, there is still controversy on which type of intervention is more effective. This systematic review aimed to evaluate the effect of knee braces and lateral wedge insoles and compare their clinical outcomes on individuals with medial knee osteoarthritis.
Methods: We conducted the search strategy based on the population, intervention, comparison, and outcome (PICO) method. We searched with PubMed, EMBASE, Web of Science, and Scopus databases for the related studies. The articles’ quality assessment was done based on the modified Downs and Black checklist.
Results: Totally, we chose 32 controlled trials, including 1.849 participants, for the final evaluation. Almost two-thirds of the studies had a moderate quality. The overall outcome suggested that both interventions had improved pain and function. The difference between both interventions on pain reduction was not significant (standardized mean difference= -0.12, 95% confidence interval= -0.34 to 0.1) based on meta-analysis.
Conclusion: Both knee brace and lateral wedge insole can improve pain and function in people with knee osteoarthritis. Using either separately or both of them together are effective.
... Fourteen papers were randomised control trials, 18 had a pre-post intervention study design, 1 was a cross-sectional observational study and there was also a single prospective case-control study. Regarding interventions used by the studies, 22 papers looked at LWIs; 12 looking specifically at the effectiveness of LWIs compared to a control (either no insole or a neutral one) [40,49,[54][55][56][57][58][59][60][61][62][63], 2 looked at the effect of insole rigidity [64,65], 2 at insole customisation [66,67], 1 at the effect of insole length [68], 2 at the effect of different elevations of LWIs [69,70], 1 at the correlation between disease severity and LWIs' effectiveness [71], and finally 2 papers investigated the effectiveness of arch support [72,73]. Eleven papers looked at footwear's effect on knee OA: 1 at the effect of different footwear of knee OA [74], 5 at barefoot mimicking shoes [75][76][77][78][79], 3 at variable sole height shoes [80][81][82], and 2 at variable stiffness shoes [83,84]. ...
... Turpin et al. saw an improvement in the WOMAC pain subscale scores for shock absorbing insoles compared to no wedge (P < 0.05) [64]. Hseih et al. found significant time × group effect improvements in pain (P = 0.008 for the KOOS) for soft LWIs compared to rigid LWIs [65]. Gait analyses for shock absorbing insoles revealed a significant reduction in the late stance peak KAM (P = 0.03) during follow-up compared with the baseline test session [64]. ...
... Gait analyses for shock absorbing insoles revealed a significant reduction in the late stance peak KAM (P = 0.03) during follow-up compared with the baseline test session [64]. Functionally, shock absorbing insoles reduced the timed stair climb (P < 0.05) [64], and soft LWIs saw improvements in stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for KOOS) [65]. ...
Background
Knee osteoarthritis is a disease of the joint causing decreased function and pain. Currently, treatments range from medication to surgery, with the use of different insoles and footwear recommended. These methods are effective by either correcting the position of the knee or providing shock absorption. However, there is little understanding of the effective characteristics of these devices.
Research question
This paper aims to investigate this question and provide future areas of research to help better define treatment guidelines. Foot orthoses are an example of non-pharmacological conservative treatments mentioned in National Institute for Health and Care Excellence (NICE) guidelines to treat knee osteoarthritis (OA). These include lateral wedge insoles (LWI), developed with the intention of load reduction of the knee. Different footwear has also been shown to affect pain, biomechanical and functional outcomes in knee OA patients.
Methods
To address what features of LWIs and footwear make them effective in the treatment of knee OA, scientific databases were used to search for papers on this topic and then selected to be included based on pre-defined criteria. Data were extracted and analysed from these studies to provide a basis for possible areas for future development of these foot orthoses, and research required to improve clinical treatment guidelines. Databases used were PubMed, Scopus and Web of Science.
Results and Significance
Thirty-four out of 226 papers were included after application of inclusion and exclusion criteria. Regarding LWIs, the characteristics showing the most beneficial effect on either biomechanical, functional or pain outcomes were customisation, full-length, 5° elevation, shock absorption and arch support. For footwear, barefoot mimicking soles produced the most favourable biomechanics. Results also showed that insoles work in correcting the position of the knee, but it may or may not affect patients’ pain and function.
... Knee osteoarthritis (KOA), as the most common musculoskeletal disorders, is a degenerative articular joint disease which leads to erosion and degradation of the articular cartilage, formation of extended bone, and narrowing of the joint space [1,2]. In general, KOA is associated with symptoms such as knee stiffness, pain around knee, and restricted movement range of knee joint [3]. ...
Background
Using the lateral wedge insole is a conservative management strategy for knee osteoarthritis. The theoretical basis for this intervention is to correct femorotibial angle, thereby reducing pain and optimising function.
Objective
This systematic review evaluates the evidence on the effectiveness of wedge insole compared with flat insole for the treatment of knee osteoarthritis.
Methods
A systematic review was performed, searching published (MEDLINE, EMBASE, CNKI, Cochrane Library, and Web of Science) and unpublished literature from their inception to April 2018. Randomized controlled trials (RCTs) that compared the use of wedge insole with a flat insole were included. Risk of bias and clinical relevance were assessed, and outcomes were analysed through meta-analysis.
Result
From a total of 413 citations, 8 studies adhered to the a priori eligibility criteria. The WOMAC pain was shown to be statistically nonsignificant change with the use of wedge insole (SMD=0.07), and low heterogeneity (I²=22%) and a 95% CI that crossed zero (95% CI: −0.09 to 0.24). The 5 independent trials were not significant in improving pain score (SMD = −0.02, 95% CI: −0.19 to 0.16). This review also revealed no significance in improving Lequesne index (SMD = −0.27, 95% CI: −0.72 to 0.19). The meta-analysis from the 2 independent trials was significant in improving femorotibial angle (SMD = −0.41, 95% CI: −0.73 to -0.09). In conclusion, this meta-analysis suggested that lateral wedge insoles can improve femorotibial angle but are of no benefit with pain and functions in knee osteoarthritis.
... As with the stimulation insoles, the conflicting results may be attributable to differences between the lateral wedge insoles in each study. Paradoxically, if the optimum structure can be identified, lateral wedges appear to have potential as a knee OA treatment [81]. Sawada et al. [82] reported that an individual's foot alignment also determines the effectiveness of a lateral wedge insole in reducing peak knee adduction moment. ...
... An additional modification that may enhance the lateral wedge insole is arch-support [84]. Based on data from 90 participants [81], soft, rather than hard, lateral wedge insoles have also been found to be more effective. ...
Impaired walking increases injury risk during locomotion, including falls-related acute injuries and overuse damage to lower limb joints. Gait impairments seriously restrict voluntary, habitual engagement in injury prevention activities, such as recreational walking and exercise. There is, therefore, an urgent need for technology-based interventions for gait disorders that are cost effective, willingly taken-up, and provide immediate positive effects on walking. Gait control using shoe-insoles has potential as an effective population-based intervention, and new sensor technologies will enhance the effectiveness of these devices. Shoe-insole modifications include: (i) ankle joint support for falls prevention; (ii) shock absorption by utilising lower-resilience materials at the heel; (iii) improving reaction speed by stimulating cutaneous receptors; and (iv) preserving dynamic balance via foot centre of pressure control. Using sensor technology, such as in-shoe pressure measurement and motion capture systems, gait can be precisely monitored, allowing us to visualise how shoe-insoles change walking patterns. In addition, in-shoe systems, such as pressure monitoring and inertial sensors, can be incorporated into the insole to monitor gait in real-time. Inertial sensors coupled with in-shoe foot pressure sensors and global positioning systems (GPS) could be used to monitor spatiotemporal parameters in real-time. Real-time, online data management will enable ‘big-data’ applications to everyday gait control characteristics.
