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A treatment applying a biomechanical device to the feet of patients with knee osteoarthritis results in reduced pain and improved function: a prospective controlled study.

ABSTRACT: This study examined the effect of treatment with a novel biomechanical device on the level of pain and function in patients with knee OA.Patients with bilateral knee OA were enrolled to active and control groups. Patients were evaluated at baseline, at 4 weeks and at the 8-week endpoint. A novel biomechanical device was individually calibrated to patients from the active group. Patients from the control group received an identical foot-worn platform without the biomechanical elements. Primary outcomes were the WOMAC Index and ALF assessments.There were no baseline differences between the groups. At 8 weeks, the active group showed a mean improvement of 64.8% on the WOMAC pain scale, a mean improvement of 62.7% on the WOMAC function scale, and a mean improvement of 31.4% on the ALF scale. The control group demonstrated no improvement in the above parameters. Significant differences were found between the active and control groups in all the parameters of assessment.The biomechanical device and treatment methodology is effective in significantly reducing pain and improving function in knee OA patients.The study is registered at clinicaltrials.gov, identifier NCT00457132, http://www.clinicaltrials.gov/ct/show/NCT00457132?order=1.

SUBMITTER: Bar-Ziv Y

PROVIDER: S-EPMC2928172 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature

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A treatment applying a biomechanical device to the feet of patients with knee osteoarthritis results in reduced pain and improved function: a prospective controlled study.

Bar-Ziv Yaron Y Beer Yiftah Y Ran Yuval Y Benedict Shaike S Halperin Nahum N

BMC musculoskeletal disorders 20100810

<h4>Background</h4>This study examined the effect of treatment with a novel biomechanical device on the level of pain and function in patients with knee OA.<h4>Methods</h4>Patients with bilateral knee OA were enrolled to active and control groups. Patients were evaluated at baseline, at 4 weeks and at the 8-week endpoint. A novel biomechanical device was individually calibrated to patients from the active group. Patients from the control group received an identical foot-worn platform without the ...[more]

PMID: 20698991

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Project description:ImportanceIndividually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear.ObjectiveTo assess the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up.Design, setting, and participantsRandomized clinical trial conducted at a Swiss university hospital. Participants (N = 220) with symptomatic, radiologically confirmed knee osteoarthritis were recruited between April 20, 2015, and January 10, 2017. The last participant visit occurred on August 15, 2017.InterventionsParticipants were randomized to biomechanical footwear involving shoes with individually adjustable external convex pods attached to the outsole (n = 111) or to control footwear (n = 109) that had visible outsole pods that were not adjustable and did not create a convex walking surface.Main outcomes and measuresThe primary outcome was knee pain at 24 weeks of follow-up assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscore standardized to range from 0 (no symptoms) to 10 (extreme symptoms). The secondary outcomes included WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms) at 24 weeks of follow-up, and serious adverse events.ResultsAmong the 220 randomized participants (mean age, 65.2 years [SD, 9.3 years]; 104 women [47.3%]), 219 received the allocated treatment and 213 (96.8%) completed follow-up. At 24 weeks of follow-up, the mean standardized WOMAC pain subscore improved from 4.3 to 1.3 in the biomechanical footwear group and from 4.0 to 2.6 in the control footwear group (between-group difference in scores at 24 weeks of follow-up, -1.3 [95% CI, -1.8 to -0.9]; P < .001). The results were consistent for WOMAC physical function subscore (between-group difference, -1.1 [95% CI, -1.5 to -0.7]), WOMAC stiffness subscore (between-group difference, -1.4 [95% CI, -1.9 to -0.9]), and WOMAC global score (between-group difference, -1.2 [95% CI, -1.6 to -0.8]) at 24 weeks of follow-up. Three serious adverse events occurred in the biomechanical footwear group compared with 9 in the control footwear group (2.7% vs 8.3%, respectively); none were related to treatment.Conclusions and relevanceAmong participants with knee pain from osteoarthritis, use of biomechanical footwear compared with control footwear resulted in an improvement in pain at 24 weeks of follow-up that was statistically significant but of uncertain clinical importance. Further research would be needed to assess long-term efficacy and safety, as well as replication, before reaching conclusions about the clinical value of this device.Trial registrationClinicalTrials.gov Identifier: NCT02363712.

Project description:BackgroundOsteoarthritis (OA) and lower back pain (LBP) are most common health problems which lead to pain and disability. This study aimed to systematically review the evidence to find any relationship between knee osteoarthritis (KOA) and LBP or any potential causation.MethodsThe databases of Scopus, MEDLINE, and Embase were searched from inception to 01 October 2022. Any study published in English assessing live humans over 18 years with KOA and LBP was eligible to be included. Studies were independently screened by two researchers. Data of the included studies were extracted based on the participants, outcomes related to knee and lumbar spine, reported association or causation between LBP and KOA, and study design. Data were narratively analyzed and presented as graphs and table. Methodology quality was assessed.ResultsOf 9953 titles and abstracts, duplicates were removed, and 7552 were screened. Altogether, 88 full texts were screened, and 13 were eligible for the final inclusion. There were some biomechanical and clinical causations were observed for the concurrent presence of LBP and KOA. Biomechanically, high pelvic incidence is a risk factor for development of spondylolisthesis and KOA. Clinically, knee pain intensity was higher in KOA when presents with LBP. Less than 20% of studies have justified their sample size during the quality assessment.DiscussionDevelopment and progression of KOA in patients with degenerative spondylolisthesis may be induced by significantly greater mismatches of lumbo-pelvic sagittal alignment. Elderly patients with degenerative lumbar spondylolisthesis and severe KOA reported a different pelvic morphology, increased sagittal malalignment with a lack of lumbar lordosis due to double-level listhesis, and greater knee flexion contracture than in patients with no to mild and moderate KOA. People with concurrent LBP and KOA have reported poor function with more disability. Both LBP and lumbar kyphosis indicate functional disability and knee symptoms in patients with KOA.ConclusionsDifferent biomechanical and clinical causations were revealed for the concurrent existence of KOA and LBP. Therefore, careful assessment of both back and knee joints should be considered when treating KOA and vice versa.Systematic review registrationPROSPERO CRD42022238571.

Dataset Information

A treatment applying a biomechanical device to the feet of patients with knee osteoarthritis results in reduced pain and improved function: a prospective controlled study.

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A treatment applying a biomechanical device to the feet of patients with knee osteoarthritis results in reduced pain and improved function: a prospective controlled study.

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