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Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.

ABSTRACT: Importance:Individually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear. Objective:To assess the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up. Design, Setting, and Participants:Randomized 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. Interventions:Participants 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 Measures:The 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. Results:Among 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?

SUBMITTER: Reichenbach S

PROVIDER: S-EPMC7218497 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.

Reichenbach Stephan S Felson David T DT Hincapié Cesar A CA Heldner Sarah S Bütikofer Lukas L Lenz Armando A da Costa Bruno R BR Bonel Harald M HM Jones Richard K RK Hawker Gillian A GA Jüni Peter P

JAMA 20200501 18

<h4>Importance</h4>Individually calibrated biomechanical footwear therapy may improve pain and physical function in people with symptomatic knee osteoarthritis, but the benefits of this therapy are unclear.<h4>Objective</h4>To assess the effect of a biomechanical footwear therapy vs control footwear over 24 weeks of follow-up.<h4>Design, setting, and participants</h4>Randomized clinical trial conducted at a Swiss university hospital. Participants (N = 220) with symptomatic, radiologically confir ...[more]

PMID: 32396180

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Project description:ImportanceThigh muscle weakness is associated with knee discomfort and osteoarthritis disease progression. Little is known about the efficacy of high-intensity strength training in patients with knee osteoarthritis or whether it may worsen knee symptoms.ObjectiveTo determine whether high-intensity strength training reduces knee pain and knee joint compressive forces more than low-intensity strength training and more than attention control in patients with knee osteoarthritis.Design, setting, and participantsAssessor-blinded randomized clinical trial conducted at a university research center in North Carolina that included 377 community-dwelling adults (≥50 years) with body mass index (BMI) ranging from 20 to 45 and with knee pain and radiographic knee osteoarthritis. Enrollment occurred between July 2012 and February 2016, and follow-up was completed September 2017.InterventionsParticipants were randomized to high-intensity strength training (n = 127), low-intensity strength training (n = 126), or attention control (n = 124).Main outcomes and measuresPrimary outcomes at the 18-month follow-up were Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) knee pain (0 best-20 worst; minimally clinically important difference [MCID, 2]) and knee joint compressive force, defined as the maximal tibiofemoral contact force exerted along the long axis of the tibia during walking (MCID, unknown).ResultsAmong 377 randomized participants (mean age, 65 years; 151 women [40%]), 320 (85%) completed the trial. Mean adjusted (sex, baseline BMI, baseline outcome values) WOMAC pain scores at the 18-month follow-up were not statistically significantly different between the high-intensity group and the control group (5.1 vs 4.9; adjusted difference, 0.2; 95% CI, -0.6 to 1.1; P = .61) or between the high-intensity and low-intensity groups (5.1 vs 4.4; adjusted difference, 0.7; 95% CI, -0.1 to 1.6; P = .08). Mean knee joint compressive forces were not statistically significantly different between the high-intensity group and the control group (2453 N vs 2512 N; adjusted difference, -58; 95% CI, -282 to 165 N; P = .61), or between the high-intensity and low-intensity groups (2453 N vs 2475 N; adjusted difference, -21; 95% CI, -235 to 193 N; P = .85). There were 87 nonserious adverse events (high-intensity, 53; low-intensity, 30; control, 4) and 13 serious adverse events unrelated to the study (high-intensity, 5; low-intensity, 3; control, 5).Conclusions and relevanceAmong patients with knee osteoarthritis, high-intensity strength training compared with low-intensity strength training or an attention control did not significantly reduce knee pain or knee joint compressive forces at 18 months. The findings do not support the use of high-intensity strength training over low-intensity strength training or an attention control in adults with knee osteoarthritis.Trial registrationClinicalTrials.gov Identifier: NCT01489462.

Project description:Importance:Synovitis is common and is associated with progression of structural characteristics of knee osteoarthritis. Intra-articular corticosteroids could reduce cartilage damage associated with synovitis but might have adverse effects on cartilage and periarticular bone. Objective:To determine the effects of intra-articular injection of 40 mg of triamcinolone acetonide every 3 months on progression of cartilage loss and knee pain. Design, Setting, and Participants:Two-year, randomized, placebo-controlled, double-blind trial of intra-articular triamcinolone vs saline for symptomatic knee osteoarthritis with ultrasonic features of synovitis in 140 patients. Mixed-effects regression models with a random intercept were used to analyze the longitudinal repeated outcome measures. Patients fulfilling the American College of Rheumatology criteria for symptomatic knee osteoarthritis, Kellgren-Lawrence grades 2 or 3, were enrolled at Tufts Medical Center beginning February 11, 2013; all patients completed the study by January 1, 2015. Interventions:Intra-articular triamcinolone (n?=?70) or saline (n?=?70) every 12 weeks for 2 years. Main Outcomes and Measures:Annual knee magnetic resonance imaging for quantitative evaluation of cartilage volume (minimal clinically important difference not yet defined), and Western Ontario and McMaster Universities Osteoarthritis index collected every 3 months (Likert pain subscale range, 0 [no pain] to 20 [extreme pain]; minimal clinically important improvement, 3.94). Results:Among 140 randomized patients (mean age, 58 [SD, 8] years, 75 women [54%]), 119 (85%) completed the study. Intra-articular triamcinolone resulted in significantly greater cartilage volume loss than did saline for a mean change in index compartment cartilage thickness of -0.21 mm vs -0.10 mm (between-group difference, -0.11 mm; 95% CI, -0.20 to -0.03 mm); and no significant difference in pain (-1.2 vs -1.9; between-group difference, -0.6; 95% CI, -1.6 to 0.3). The saline group had 3 treatment-related adverse events compared with 5 in the triamcinolone group and had a small increase in hemoglobin A1c levels (between-group difference, -0.2%; 95% CI, -0.5% to -0.007%). Conclusions and Relevance:Among patients with symptomatic knee osteoarthritis, 2 years of intra-articular triamcinolone, compared with intra-articular saline, resulted in significantly greater cartilage volume loss and no significant difference in knee pain. These findings do not support this treatment for patients with symptomatic knee osteoarthritis. Trial Registration:ClinicalTrials.gov Identifier: NCT01230424.

Project description:BackgroundTranscutaneous electrical nerve stimulation (TENS) is commonly used for the management of pain; however, its effects on several pain and function measures are unclear.ObjectiveThe purpose of this study was to determine the effects of high-frequency TENS (HF-TENS) and low-frequency TENS (LF-TENS) on several outcome measures (pain at rest, movement-evoked pain, and pain sensitivity) in people with knee osteoarthritis.DesignThe study was a double-blind, randomized clinical trial.SettingThe setting was a tertiary care center.ParticipantsSeventy-five participants with knee osteoarthritis (29 men and 46 women; 31-94 years of age) were assessed.InterventionParticipants were randomly assigned to receive HF-TENS (100 Hz) (n=25), LF-TENS (4 Hz) (n=25), or placebo TENS (n=25) (pulse duration=100 microseconds; intensity=10% below motor threshold).MeasurementsThe following measures were assessed before and after a single TENS treatment: cutaneous mechanical pain threshold, pressure pain threshold (PPT), heat pain threshold, heat temporal summation, Timed "Up & Go" Test (TUG), and pain intensity at rest and during the TUG. A linear mixed-model analysis of variance was used to compare differences before and after TENS and among groups (HF-TENS, LF-TENS, and placebo TENS).ResultsCompared with placebo TENS, HF-TENS and LF-TENS increased PPT at the knee; HF-TENS also increased PPT over the tibialis anterior muscle. There was no effect on the cutaneous mechanical pain threshold, heat pain threshold, or heat temporal summation. Pain at rest and during the TUG was significantly reduced by HF-TENS, LF-TENS, and placebo TENS.LimitationsThis study tested only a single TENS treatment.ConclusionsBoth HF-TENS and LF-TENS increased PPT in people with knee osteoarthritis; placebo TENS had no significant effect on PPT. Cutaneous pain measures were unaffected by TENS. Subjective pain ratings at rest and during movement were similarly reduced by active TENS and placebo TENS, suggesting a strong placebo component of the effect of TENS.

Project description:Impairment-based exercise programs have yielded only small to moderate benefits in reducing pain and improving function in people with knee osteoarthritis (OA). It has previously been proposed that adding agility and perturbation training to exercise programs for people with knee OA may improve treatment effects for pain and function.The purpose of this study was to examine the effectiveness of adding agility and perturbation techniques to standard exercise therapy compared with the standard exercise program alone for people with knee OA.This was a single-blinded randomized controlled trial.The study was conducted in the outpatient physical therapy clinic of a large, university-based health center.One hundred eighty-three people with knee OA (122 women, 61 men) participated.Participants were randomly assigned to either a group that received agility and perturbation training with standard exercise therapy or a group that received only the standard exercise program.The outcome measures were self-reported knee pain and function, self-reported knee instability, a performance-based measure of function, and global rating of change.Although both groups exhibited improvement in self-reported function and in the global rating of change at the 2-, 6-, and 12-month follow-up periods, there were no differences between groups on these outcomes. There was no reduction in knee pain or improvement in performance-based function in either group.It is possible that more-intense application of the interventions or application of the interventions to participants with knee OA who were at greater risk for falling may have yielded additive effects of the agility and perturbation training approach.Both intervention groups exhibited improvement in self-reported function and the global rating of change. Our results, however, did not support an additive effect of agility and perturbation training with standard exercise therapy in our sample of individuals with knee OA. Further study is needed to determine whether there are subgroups of individuals who might achieve an added benefit with this approach.

Project description:Importance: Limited evidence is available regarding long-term outcomes of opioids compared with nonopioid medications for chronic pain.Objective: To compare opioid vs nonopioid medications over 12 months on pain-related function, pain intensity, and adverse effects.Design, setting, and participants: Pragmatic, 12-month, randomized trial with masked outcome assessment. Patients were recruited from Veterans Affairs primary care clinics from June 2013 through December 2015; follow-up was completed December 2016. Eligible patients had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite analgesic use. Of 265 patients enrolled, 25 withdrew prior to randomization and 240 were randomized.Interventions: Both interventions (opioid and nonopioid medication therapy) followed a treat-to-target strategy aiming for improved pain and function. Each intervention had its own prescribing strategy that included multiple medication options in 3 steps. In the opioid group, the first step was immediate-release morphine, oxycodone, or hydrocodone/acetaminophen. For the nonopioid group, the first step was acetaminophen (paracetamol) or a nonsteroidal anti-inflammatory drug. Medications were changed, added, or adjusted within the assigned treatment group according to individual patient response.Main outcomes and measures: The primary outcome was pain-related function (Brief Pain Inventory [BPI] interference scale) over 12 months and the main secondary outcome was pain intensity (BPI severity scale). For both BPI scales (range, 0-10; higher scores = worse function or pain intensity), a 1-point improvement was clinically important. The primary adverse outcome was medication-related symptoms (patient-reported checklist; range, 0-19).Results: Among 240 randomized patients (mean age, 58.3 years; women, 32 [13.0%]), 234 (97.5%) completed the trial. Groups did not significantly differ on pain-related function over 12 months (overall P = .58); mean 12-month BPI interference was 3.4 for the opioid group and 3.3 for the nonopioid group (difference, 0.1 [95% CI, -0.5 to 0.7]). Pain intensity was significantly better in the nonopioid group over 12 months (overall P = .03); mean 12-month BPI severity was 4.0 for the opioid group and 3.5 for the nonopioid group (difference, 0.5 [95% CI, 0.0 to 1.0]). Adverse medication-related symptoms were significantly more common in the opioid group over 12 months (overall P = .03); mean medication-related symptoms at 12 months were 1.8 in the opioid group and 0.9 in the nonopioid group (difference, 0.9 [95% CI, 0.3 to 1.5]).Conclusions and relevance: Treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months. Results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.Trial registration: clinicaltrials.gov Identifier: NCT01583985.

Project description:ImportancePatients with osteoarthritis (OA) may remain symptomatic with traditional OA treatments.ObjectiveTo assess 2 subcutaneous tanezumab dosing regimens for OA.Design, setting, and participantsA randomized, double-blind, multicenter trial from January 2016 to May 14, 2018 (last patient visit). Patients enrolled were 18 years or older with hip or knee OA, inadequate response to OA analgesics, and no radiographic evidence of prespecified joint safety conditions.InterventionsPatients received by subcutaneous administration either tanezumab, 2.5 mg, at day 1 and week 8 (n = 231); tanezumab, 2.5 mg at day 1 and 5 mg at week 8 (ie, tanezumab, 2.5/5 mg; n = 233); or placebo at day 1 and week 8 (n = 232).Main outcomes and measuresCo-primary end points were change from baseline to week 16 in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain (0-10, no to extreme pain), WOMAC Physical Function (0-10, no to extreme difficulty), and patient global assessment of osteoarthritis (PGA-OA) (1-5, very good to very poor) scores.ResultsAmong 698 patients randomized, 696 received 1 or more treatment doses (mean [SD] age, 60.8 [9.6] years; 65.1% women), and 582 (83.6%) completed the trial. From baseline to 16 weeks, mean WOMAC Pain scores decreased from 7.1 to 3.6 in the tanezumab, 2.5 mg, group; 7.3 to 3.6 in the tanezumab, 2.5/5 mg, group; and 7.3 to 4.4 in the placebo group (least squares mean differences [95% CI] vs placebo were -0.60 [-1.07 to -0.13; P = .01] for tanezumab, 2.5 mg, and -0.73 [-1.20 to -0.26; P = .002] for tanezumab, 2.5/5 mg). Mean WOMAC Physical Function scores decreased from 7.2 to 3.7 in the 2.5-mg group, 7.4 to 3.6 in the 2.5/5-mg group, and 7.4 to 4.5 with placebo (differences vs placebo, -0.66 [-1.14 to -0.19; P = .007] for tanezumab, 2.5 mg, and -0.89 [-1.37 to -0.42; P < .001] for tanezumab, 2.5/5 mg). Mean PGA-OA scores decreased from 3.4 to 2.4 in the 2.5-mg group, 3.5 to 2.4 in the 2.5/5-mg group, and 3.5 to 2.7 with placebo (differences vs placebo, -0.22 [-0.39 to -0.05; P = .01] for tanezumab, 2.5 mg, and -0.25 [-0.41 to -0.08; P = .004] for tanezumab, 2.5/5 mg). Rapidly progressive OA occurred only in tanezumab-treated patients (2.5 mg: n = 5, 2.2%; 2.5/5 mg: n = 1, 0.4%). The incidence of total joint replacements was 8 (3.5%), 16 (6.9%), and 4 (1.7%) in the tanezumab, 2.5 mg; tanezumab, 2.5/5 mg; and placebo groups, respectively.Conclusions and relevanceAmong patients with moderate to severe OA of the knee or hip and inadequate response to standard analgesics, tanezumab, compared with placebo, resulted in statistically significant improvements in scores assessing pain and physical function, and in PGA-OA, although the improvements were modest and tanezumab-treated patients had more joint safety events and total joint replacements. Further research is needed to determine the clinical importance of these efficacy and adverse event findings.Trial registrationClinicalTrials.gov Identifier: NCT02697773.

Project description:Integrating physical therapy sessions and an online application (e-Exercise) might support people with hip osteoarthritis (OA), knee OA, or both (hip/knee OA) in taking an active role in the management of their chronic condition and may reduce the number of physical therapy sessions.The objective of this study was to investigate the short- and long-term effectiveness of e-Exercise compared to usual physical therapy in people with hip/knee OA.The design was a prospective, single-blind, multicenter, superiority, cluster- randomized controlled trial.The setting included 143 primary care physical therapist practices.The participants were 208 people who had hip/knee OA and were 40 to 80 years of age.e-Exercise is a 3-month intervention in which about 5 face-to-face physical therapy sessions were integrated with an online application consisting of graded activity, exercise, and information modules. Usual physical therapy was conducted according to the Dutch physical therapy guidelines on hip and knee OA.Primary outcomes, measured at baseline after 3 and 12 months, were physical functioning and free-living physical activity. Secondary outcome measures were pain, tiredness, quality of life, self-efficacy, and the number of physical therapy sessions.The e-Exercise group (n = 109) received, on average, 5 face-to-face sessions; the usual physical therapy group (n = 99) received 12. No significant differences in primary outcomes between the e-Exercise group and the usual physical therapy group were found. Within-group analyses for both groups showed a significant improvement in physical functioning. After 3 months, participants in the e-Exercise group reported an increase in physical activity; however, no objectively measured differences in physical activity were found. With respect to secondary outcomes, after 12 months, sedentary behavior significantly increased in the e-Exercise group compared with the usual physical therapy group. In both groups, there were significant improvements for pain, tiredness, quality of life, and self-efficacy.The response rate at 12 months was 65%.The blended intervention, e-Exercise, was not more effective than usual physical therapy in people with hip/knee OA.

Project description:BackgroundKinesio Taping® method is a nonpharmacological alternative for pain management in musculoskeletal disorders. However, the existing evidence is insufficient to assess its full effectiveness for pain management in knee osteoarthritis (KO). Our aim was to evaluate the effectiveness of the Kinesio Taping method in reducing knee pain for KO patients.MethodsIn this randomized, double blind, controlled trial, we recruited 187 patients with grade I-III KO who were allocated to either the Kinesio Taping or control group. The study was carried out in outpatient facility. Either Kinesio Taping or nonspecific taping was applied on the affected knee area for 4 weeks. Pain evaluation was performed at baseline, after 1 month of taping and after 1 further month without taping. The data on usage of painkillers were collected; Numeric Pain Rating Scale; an algometer, and Knee injury and Osteoarthritis Outcome Scores (KOOS) pain subscale were used to assess pain. Tolerance and subjective opinions toward the effectiveness of taping were evaluated. The chosen level of significance was p < 0.05, ß ⩽ 0.2.ResultsThe majority (>70%) of both groups' patients indicated that tapes reduced the knee pain. The reported use of painkillers decreased, in addition to self-reported increase in the KOOS subscale, thereby indicating pain alleviation. All self-reported improvement remained at the 1-month follow up (p < 0.05). Significantly higher and clinically meaningful reduction of pain intensity was found in the Kinesio Taping group after the treatment month, in comparison with the control group (p < 0.05). More pain reduction was reported in the daytime for participants in the Kinesio Taping group at the follow up (p = 0.022). No changes in algometry results were observed.ConclusionsElastic taping can safely relieve knee pain and reduce the need for pharmacological management in KO. A specific Kinesio Taping technique is clinically more beneficial for knee-pain alleviation in comparison with nonspecific taping.[ClinicalTrials.gov identifier: NCT03076177.].

Dataset Information

Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.

Publications

Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial.

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