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Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial.

ABSTRACT: Knee osteoarthritis (OA) progression has been linked to increased peak external knee adduction moments (KAMs). Although some trials have attempted to reduce pain and improve function in OA by reducing KAMs with a wedged footwear insole intervention, KAM reduction has not been specifically controlled for in trial designs, potentially explaining the mixed results seen in the literature. Therefore, the primary purpose of this trial is to identify the effects of reduced KAMs on knee OA pain and function.Forty-six patients with radiographically confirmed diagnosis medial knee OA will be recruited for this 3 month randomized controlled trial. Recruitment will be from Alberta and surrounding areas. Eligibility criteria include being between the ages of 40 and 85 years, have knee OA primarily localized to the medial tibiofemoral compartment, based on the American College of Rheumatology diagnostic criteria and be classified as having a Kellgren-Lawrence grade of 1 to 3. Patients will visit the laboratory at baseline for testing that includes dual x-ray absorptiometry, biomechanical testing, and surveys (KOOS, PASE activity scale, UCLA activity scale, comfort visual analog scale). At baseline, patients will be randomized to either a wedged insole group to reduce KAMs, or a waitlist control group where no intervention is provided. The survey tests will be repeated at 3 months, and response to wedged insoles over 3 months will be evaluated.This study represents the first step in systematically evaluating the effects of reduced KAMs on knee OA management by using a patient-specific wedged insole prescription procedure rather than providing the same insole to all patients. The results of this trial will provide indications as to whether reduced KAMs are an effective strategy for knee OA management, and whether a personalized approach to footwear insole prescription is warranted.NCT02067208.

SUBMITTER: Lewinson RT

PROVIDER: S-EPMC4265477 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

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Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial.

Lewinson Ryan T RT Collins Kelsey H KH Vallerand Isabelle A IA Wiley J Preston JP Woodhouse Linda J LJ Reimer Raylene A RA Worobets Jay T JT Herzog Walter W Stefanyshyn Darren J DJ

BMC musculoskeletal disorders 20141203

<h4>Background</h4>Knee osteoarthritis (OA) progression has been linked to increased peak external knee adduction moments (KAMs). Although some trials have attempted to reduce pain and improve function in OA by reducing KAMs with a wedged footwear insole intervention, KAM reduction has not been specifically controlled for in trial designs, potentially explaining the mixed results seen in the literature. Therefore, the primary purpose of this trial is to identify the effects of reduced KAMs on kn ...[more]

PMID: 25467955

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Project description:ObjectiveThe aim of this study was to evaluate the immediate effects of lateral wedge arch support insoles (LWAS) on reducing the knee joint load in patients with medial knee osteoarthritis (OA) compared with an appropriate control.MethodsDatabases including Medline, EMBASE, Web of Science, Wiley Online Library, Cochrane library, and Google Scholar were searched with no limits on study date or language, from the earliest available date to October 31, 2016. The included studies had to have the aim of reducing knee load and have an appropriate control. The main measured values were the first and second peak external knee adduction moments (EKAM) and the knee adduction angular impulse (KAAI). The random-effects model was used for analyzing the eligible studies.ResultsNine studies met the inclusion criteria with a total of 356 participants of whom 337 received LWAS treatment. The risk of methodological bias scores (quality index) ranged from 21 to 27 of 32. Treatment with LWAS resulted in statistically significant reductions in the first peak EKAM (P?=?.005), the second peak EKAM (P?=?.01), and the KAAI (P?=?.03). However, among trials in which the control treatment was control shoes, the LWAS showed no associations on the first peak EKAM (P?=?.10) or the KAAI (P?=? .06); among trials in which the control treatment was neutral insoles, the LWAS showed no associations on the second peak EKAM (P?=?.21) or the KAAI (P?=?.23). At the same time, the LWAS showed no statistically significant reduction on the first peak EKAM (P?=?.39) when compared with flat insoles.ConclusionAlthough meta-analysis outcomes of all studies indicated statistically significant associations between LWAS and reductions of the first peak EKAM, second peak EKAM and KAAI in people with medial knee OA while walking, different results existed in subgroups using various control conditions for comparison. These findings do not support the use of LWAS insoles for reducing knee load. An optimal LWAS treatment should provide the appropriate height of arch support and amount of lateral wedging. Further research should investigate the best combination of these 2 parameters to achieve efficacy without altered comfort.

Project description:ImportanceThere is no consensus regarding the efficacy of lateral wedge insoles as a treatment for pain in medial knee osteoarthritis.ObjectiveTo evaluate whether lateral wedge insoles reduce pain in patients with medial knee osteoarthritis compared with an appropriate control.Data sourcesDatabases searched include the Cochrane Central Register of Controlled Trials, EMBASE, AMED, MEDLINE, CINAHL Plus, ScienceDirect, SCOPUS, Web of Science, and BIOSIS from inception to May 2013, with no limits on study date or language. The metaRegister of Controlled Trials and the NHS Evidence website were also searched.Study selectionIncluded were randomized trials comparing shoe-based treatments (lateral heel wedge insoles or shoes with variable stiffness soles) aimed at reducing medial knee load, with a neutral or no wedge control condition in patients with painful medial knee osteoarthritis. Studies must have included patient-reported pain as an outcome.Data extraction and synthesisTrial data were extracted independently by 2 researchers using a standardized form. Risk of bias was assessed using the Cochrane Risk of Bias tool by 2 observers. Eligible studies were pooled using a random-effects approach.Main outcome and measuresChange in self-reported knee pain at follow-up.ResultsTwelve trials met inclusion criteria with a total of 885 participants of whom 502 received lateral wedge treatment. The pooled standardized mean difference (SMD) suggested a favorable association with lateral wedges compared with control (SMD, -0.47; 95% CI, -0.80 to -0.14); however, substantial heterogeneity was present (I2 = 82.7%). This effect size represents an effect of -2.12 points on the 20-point Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale. Larger trials with a lower risk of bias suggested a null association. Meta-regression analyses showed that higher effect sizes (unstandardized β, 1.07 [95% CI, 0.28 to 1.87] for trials using a no treatment control) were seen in trials using a no wedge treatment control group (n = 4 trials; SMD, -1.20 [95% CI, -2.09 to -0.30]) and lower effect sizes (unstandardized β, 0.26 [95% CI, 0.002 to 0.52] for each bias category deemed low risk) when the study method was deemed at low risk of bias. Among trials in which the control treatment was a neutral insole (n = 7), lateral wedges showed no association (SMD, -0.03 [95% CI, -0.18 to 0.12] on WOMAC; this represents an effect of -0.12 points), and results showed little heterogeneity (I2 = 7.1%).Conclusions and relevanceAlthough meta-analytic pooling of all studies showed a statistically significant association between use of lateral wedges and lower pain in medial knee osteoarthritis, restriction of studies to those using a neutral insole comparator did not show a significant or clinically important association. These findings do not support the use of lateral wedges for this indication.

Project description: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 combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6?±?10.8 and 63.1?±?10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time?×?group effect improvements in pain (P = 0.008 for the KOOS), 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 the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function, and quality of life, which belong to the body functions and structures and the activities and participation components in the ICF scheme.

Project description:BackgroundLateral wedge insoles are traditionally used to reduce the adduction moment that crosses the knee during walking in people with medial knee osteoarthritis. However, the best degree to reduce knee joint load is not yet well established.MethodsElectronic databases were searched from their inception until May 2017. Included studies reported on the immediate biomechanical effects of different degrees of lateral wedge insoles during walking in people with knee osteoarthritis. The main measures of interest relating to the biomechanics were the first and second peak of external knee adduction moment and knee adduction angular impulse. For the comparison of the biomechanical effects of different degrees of insoles, the studies were divided in three subgroups: insoles with a degree higher than 0° and equal to or lower than 5°; insoles higher than 5° and equal to or lower than 9°; and insoles higher than 9°. Eligible studies were pooled using random-effects meta-analysis.ResultsFifteen studies with a total of 415 participants met all eligibility criteria and were included in the final review and meta-analysis. The overall effect suggests that lateral wedge insoles resulted in a statistically significant reduction in the first peak (standardized mean difference [SMD] -0.25; 95% confidence interval [CI] -0.36, - 0.13; P < 0.001), second peak (SMD -0.26 [95% CI -0.48, - 0.04]; P = 0.02) and knee adduction angular impulse (SMD -0.17 [95% CI -0.31, - 0.03]; P = 0.02). The test of subgroups found no statistically significant differences.ConclusionSystematic review and meta-analysis suggests that lateral wedge insoles cause an overall slight reduction in the biomechanical parameters. Higher degrees do not show higher reductions than lower degrees. Prior analysis of biomechanical parameters may be a valid option for selecting the optimal angle of wedge that best fits in knee osteoarthritis patients with the lowest possible degree.

Project description:Anterior cruciate ligament (ACL) injury predisposes individuals to early-onset knee joint osteoarthritis (OA). Abnormal joint loading is apparent after ACL injury and reconstruction. The relationship between altered joint biomechanics and the development of knee OA is unknown.Altered knee joint kinetics and medial compartment contact forces initially after injury and reconstruction are associated with radiographic knee OA 5 years after reconstruction.Case-control study; Level of evidence, 3.Individuals with acute, unilateral ACL injury completed gait analysis before (baseline) and after (posttraining) preoperative rehabilitation and at 6 months, 1 year, and 2 years after reconstruction. Surface electromyographic and knee biomechanical data served as inputs to an electromyographically driven musculoskeletal model to estimate knee joint contact forces. Patients completed radiographic testing 5 years after reconstruction. Differences in knee joint kinetics and contact forces were compared between patients with and those without radiographic knee OA.Patients with OA walked with greater frontal plane interlimb differences than those without OA (nonOA) at baseline (peak knee adduction moment difference: 0.00 ± 0.08 N·m/kg·m [nonOA] vs -0.15 ± 0.09 N·m/kg·m [OA], P = .014; peak knee adduction moment impulse difference: -0.001 ± 0.032 N·m·s/kg·m [nonOA] vs -0.048 ± 0.031 N·m·s/kg·m [OA], P = .042). The involved limb knee adduction moment impulse of the group with osteoarthritis was also lower than that of the group without osteoarthritis at baseline (0.087 ± 0.023 N·m·s/kg·m [nonOA] vs 0.049 ± 0.018 N·m·s/kg·m [OA], P = .023). Significant group differences were absent at posttraining but reemerged 6 months after reconstruction (peak knee adduction moment difference: 0.02 ± 0.04 N·m/kg·m [nonOA] vs -0.06 ± 0.11 N·m/kg·m [OA], P = .043). In addition, the OA group walked with lower peak medial compartment contact forces of the involved limb than did the group without OA at 6 months (2.89 ± 0.52 body weight [nonOA] vs 2.10 ± 0.69 body weight [OA], P = .036).Patients who had radiographic knee OA 5 years after ACL reconstruction walked with lower knee adduction moments and medial compartment joint contact forces than did those patients without OA early after injury and reconstruction.

Dataset Information

Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial.

Publications

Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial.

Similar Datasets

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