Effect of unloading brace treatment on pain and function in patients with symptomatic knee osteoarthritis: the ROTOR randomized clinical trial.
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ABSTRACT:
SUBMITTER: Thoumie P
PROVIDER: S-EPMC6043544 | biostudies-literature | 2018 Jul
REPOSITORIES: biostudies-literature
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Effect of unloading brace treatment on pain and function in patients with symptomatic knee osteoarthritis: the ROTOR randomized clinical trial.
Thoumie Philippe P Marty Marc M Avouac Bernard B Pallez Adeline A Vaumousse Arnaud A Pipet Linh Pham Thi LPT Monroche André A Graveleau Nicolas N Bonnin Armand A Amor Cyrine Ben CB Coudeyre Emmanuel E
Scientific reports 20180712 1
Evidence is still inconclusive for the benefits of bracing in patients with knee osteoarthritis. To assess the effect of REBEL RELIEVER unloading knee brace in conservative treatment of knee osteoarthritis, a randomized controlled trial was conducted in 67 patients with symptomatic medial knee osteoarthritis, who randomly received 6-week treatment with either REBEL RELIVER unloading knee brace + usual care (Brace group, N = 32) or usual care alone (Control group, N = 35). Primary outcome was the ...[more]
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Project description:Pain in knee osteoarthritis (OA) has historically been attributed to peripheral pathophysiology; however, the poor correspondence between objective measures of disease severity and clinical symptoms suggests that non-local factors, such as altered central processing of painful stimuli, also contribute to clinical pain in knee OA. Consistent with this notion, recent evidence demonstrates that patients with knee OA exhibit increased sensitivity to painful stimuli at body sites unaffected by clinical pain.In order to further investigate the contribution of altered pain processing to knee OA pain, the current study tested the hypothesis that symptomatic knee OA is associated with enhanced sensitivity to experimental pain stimuli at the knee and at remote body sites unaffected by clinical pain. We further anticipated that pain sensitivity would differ as a function of the OA symptom severity. Older adults with and without symptomatic knee OA completed a series of experimental pain assessments. A median split of the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) was used to stratify participants into low vs high OA symptom severity.Compared to controls and the low symptom group, individuals in the high symptom group were more sensitive to suprathreshold heat stimuli, blunt pressure, punctuate mechanical, and cold stimuli. Individuals in the low symptomatic OA group subgroup exhibited experimental pain responses similar to the pain-free group on most measures. No group differences in endogenous pain inhibition emerged.These findings suggest that altered central processing of pain is particularly characteristic of individuals with moderate to severe symptomatic knee OA.
| S-EPMC3831366 | biostudies-literature
Project description:ObjectiveTo evaluate whether improvement of proprioception, pain, or dynamic knee instability mediates the effect of wearing a soft knee brace on activity limitations in patients with knee osteoarthritis (OA).MethodsWe conducted an analysis of data for 44 patients with knee OA who were enrolled in a laboratory-based trial evaluating the effect of wearing a commercially available soft knee brace. Activity limitations were assessed with the 10-meter walk test and the Get Up and Go test. Knee joint proprioception was assessed by an active joint position sense test; pain was assessed on a numeric rating scale (NRS) (range 0-10); pressure pain threshold (PPT) was assessed with a hand-held pressure algometer; dynamic knee instability was expressed by the perturbation response, i.e., a measure reflecting a deviation in mean knee varus-valgus angle after a controlled mechanical perturbation on a treadmill, with respect to level walking. Mediation analysis was conducted using the product of coefficients approach. Confidence intervals were calculated with a bootstrap procedure.ResultsA decrease in pain (scored on an NRS) and a decrease in dynamic knee instability mediated the effect of wearing a soft knee brace on the reduction of activity limitations (P < 0.05), while changes in proprioception and PPT did not mediate this effect (P > 0.05).ConclusionThis study shows that decreased pain and reduced dynamic knee instability are pathways by which wearing a soft knee brace decreases activity limitations in patients with knee OA.
| S-EPMC6771793 | biostudies-literature
Project description:BackgroundRecent studies indicate that the administration of open-label placebos (OLP) can improve symptoms in various medical conditions. The primary aim of this 3-week randomized controlled trial was to examine the effects of OLP treatments on pain, functional disability, and mobility in patients with arthritic knee pain.MethodsSixty patients (55% females; mean age, 66.9 ± 9.7 SD years) were randomized to one of two OLP treatments (n = 41) or no treatment (NT; n = 19). OLP treatments were accompanied by the verbal suggestion "to decrease pain" (OLP-pain, n = 20) or "to improve mood" (OLP-mood, n = 21). Pain and mood levels were monitored on 11-point Numeric Rating Scales (NRSs) in a patient diary, and global clinical improvement (CGI-I) was assessed at the end of the study. At baseline and after 21 days, patients filled in validated questionnaires to assess symptoms and functional disability of the knee (WOMAC), mental and physical quality of life (SF-36), state anxiety (STAI-state), perceived stress (PSQ-20), and self-efficacy (GSE). In addition, knee mobility (neutral zero-method), heart rate variability (HRV), and diurnal cortisol levels were evaluated before and after treatment.ResultsEvaluation of daily pain ratings indicated significant pain decrease in the OLP groups compared to NT (p = 0.013, d = 0.64), with no difference between the OLP-pain and the OLP-mood groups (p = 0.856, d = 0.05). OLP treatment also improved WOMAC pain (p = 0.036, d = 0.55), again with no difference between the two OLP groups (p = 0.65, d = 0.17). WOMAC function and stiffness, knee mobility, stress, state anxiety, quality of life, and self-efficacy did not change differently between groups.ConclusionOLP treatment improved knee pain in elderly patients with symptomatic knee osteoarthritis (OA), while functional disability and mobility of the knee did not change. The content of the verbal suggestion was of minor importance. OLP administration may be considered as supportive analgesic treatment in elderly patients with symptomatic knee OA.Trial registrationGerman Clinical Trials Register (https://www.drks.de/), DRKS00015191 (retrospectively registered).
| S-EPMC9122028 | biostudies-literature
Project description:ImportanceKnee osteoarthritis (OA), a disorder of cartilage and periarticular bone, is a public health problem without effective medical treatments. Some studies have suggested that vitamin D may protect against structural progression.ObjectiveTo determine whether vitamin D supplementation reduces symptom and structural progression of knee OA.Design, setting, and patientsA 2-year randomized, placebo-controlled, double-blind, clinical trial involving 146 participants with symptomatic knee OA (mean age, 62.4 years [SD, 8.5]; 57 women [61%], 115 white race [79%]). Patients were enrolled at Tufts Medical Center in Boston between March 2006 and June 2009.InterventionParticipants were randomized to receive either placebo or oral cholecalciferol, 2000 IU/d, with dose escalation to elevate serum levels to more than 36 ng/mL.Main outcome measuresPrimary outcomes were knee pain severity (Western Ontario and McMaster Universities [WOMAC] pain scale, 0-20: 0, no pain; 20, extreme pain), and cartilage volume loss measured by magnetic resonance imaging. Secondary end points included physical function, knee function (WOMAC function scale, 0-68: 0, no difficulty; 68, extreme difficulty), cartilage thickness, bone marrow lesions, and radiographic joint space width.ResultsEighty-five percent of the participants completed the study. Serum 25-hydroxyvitamin D levels increased by a mean 16.1 ng/mL (95% CI, 13.7 to 18.6) in the treatment group and by a mean 2.1 mg/mL (95% CI, 0.5 to 3.7) (P < .001) in the placebo group. Baseline knee pain was slightly worse in the treatment group (mean, 6.9; 95% CI, 6.0 to 7.7) than in the placebo group (mean, 5.8; 95% CI, 5.0 to 6.6) (P = .08). Baseline knee function was significantly worse in the treatment group (mean, 22.7; 95% CI, 19.8 to 25.6) than in the placebo group (mean, 18.5; 95% CI, 15.8 to 21.2) (P = .04). Knee pain decreased in both groups by a mean -2.31 (95% CI, -3.24 to -1.38) in the treatment group and -1.46 (95% CI, -2.33 to -0.60) in the placebo group, with no significant differences at any time. The percentage of cartilage volume decreased by the same extent in both groups (mean, -4.30; 95% CI, -5.48 to -3.12 vs mean, -4.25; 95% CI, -6.12 to -2.39) (P = .96). There were no differences in any of the secondary clinical end points.Conclusion and relevanceVitamin D supplementation for 2 years at a dose sufficient to elevate 25-hydroxyvitamin D plasma levels to higher than 36 ng/mL, when compared with placebo, did not reduce knee pain or cartilage volume loss in patients with symptomatic knee OA.Trial registrationclinicaltrials.gov Identifier: NCT00306774.
| S-EPMC3984919 | biostudies-literature
Project description:Although several factors are known to contribute to ethnic differences in pain, relatively little attention has been devoted to physiological factors. Our first aim was to examine the relationship between cortisol and pain responses during a cold-pressor task (CPT) among African American (AA) and non-Hispanic White (NHW) adults with knee osteoarthritis (OA). Our second aim was to assess the relationship between perceived racial discrimination and cortisol among AA participants.Participants were 91 (56 AA; 35 NHW) community-dwelling adults between the ages of 45 to 85 with knee OA based upon the American College of Rheumatology clinical criteria. Plasma cortisol was measured at 3 timepoints: (1) baseline, (2) before the CPT, and (3) 20 minutes following the CPT. Perceived racial discrimination was measured by the Experiences of Discrimination scale.Using linear regression, we found a significant interaction between ethnicity and cortisol before the CPT with pain intensity ratings (?=-0.26; P=0.02). Analysis of simple slopes revealed that cortisol concentrations were negatively associated with pain intensity ratings in NHW participants (?=-0.54; P=0.001), but not in AA participants (?=-0.15; P=0.26). Perceived racial discrimination was not related to cortisol concentrations or pain ratings.Consistent with previous findings in young healthy adults, cold-pressor pain responses are related to pre-CPT cortisol concentrations in NHW persons with knee OA but not in their AA counterparts. Additional studies are required to better understand this finding.
| S-EPMC5446937 | biostudies-literature
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.
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Project description:ObjectiveTo estimate the lifetime risk of symptomatic knee osteoarthritis (OA), overall and stratified by sex, race, education, history of knee injury, and body mass index (BMI).MethodsThe lifetime risk of symptomatic OA in at least 1 knee was estimated from logistic regression models with generalized estimating equations among 3,068 participants of the Johnston County Osteoarthritis Project, a longitudinal study of black and white women and men age >or=45 years living in rural North Carolina. Radiographic, sociodemographic, and symptomatic knee data measured at baseline (1990-1997) and first followup (1999-2003) were analyzed.ResultsThe lifetime risk of symptomatic knee OA was 44.7% (95% confidence interval [95% CI] 40.0-49.3%). Cohort members with history of a knee injury had a lifetime risk of 56.8% (95% CI 48.4-65.2%). Lifetime risk rose with increasing BMI, with a risk of 2 in 3 among those who were obese.ConclusionNearly half of the adults in Johnston County will develop symptomatic knee OA by age 85 years, with lifetime risk highest among obese persons. These current high risks in Johnston County may suggest similar risks in the general US population, especially given the increase in 2 major risk factors for knee OA, aging, and obesity. This underscores the immediate need for greater use of clinical and public health interventions, especially those that address weight loss and self-management, to reduce the impact of having knee OA.
| S-EPMC4516049 | biostudies-literature
Project description:BACKGROUND:Few studies have investigated the effects of mobilization with movement (MWM) in patients with knee osteoarthritis (OA) compared to other procedures. Sham procedures are generally more appropriate control than using no or usual treatments. Moreover, studies investigating the widespread hypoalgesic effects of MWM in patients with knee OA are lacking. The aim was to investigate the effect of MWM on function and pain in patients with knee OA compared to sham MWM. METHODS:This is a randomized double-blind (patients and assessor) controlled trial. Forty adult patients with knee OA of grade II and above were recruited to receive either MWM treatment or sham MWM for the knee. The outcome measures included the following: a visual analogue scale (VAS) for pain, the pressure pain threshold (PPT) test, the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the timed up and go (TUG) test, knee strength and knee range of motion (ROM). The measurements were taken at baseline, immediately after intervention and 2?days later. RESULTS:Compared with sham MWM, MWM resulted in greater immediate improvement in pain [mean difference (95% CI): -?2.2 (-?2.8, -?1.6)], PPT at both the knee [176 (97, 254)] and shoulder [212 (136, 288)], TUG time [-?1.6 (-?2.1, -?1.1)], knee flexor strength [2.0 (1.3, 2.7)] and extensor strength [5.7 (4.1, 7.2)] and knee flexion ROM [12.8 (9.6, 15.9)] (all, p?<?0.001) but not knee extension ROM [-?0.8 (-?1.6, 0.1)] (p?=?0.067). After 2?days of intervention, patients who received MWM also demonstrated a greater improvement in pain [-?1.0 (-?1.8, -?0.1)], PPT at the shoulder [107 (40, 175)], TUG time [-?0.9 (-?1.4, -?0.4)], knee flexor strength [0.9 (0.2, 1.7)] and extensor strength [2.9 (2.1, 3.9)] and knee flexion ROM [8.3 (4.7, 11.9)] (all, p???0.026). However, WOMAC scores and knee extension ROM showed no evidence of change at any stage after intervention (p???0.067). CONCLUSIONS:MWM provided superior benefits over sham MWM in terms of local and widespread pain, physical function (walking), knee flexion and extension muscle strength and knee flexion ROM for at least 2?days in patients with knee OA. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT02865252 ), registered on August 12, 2016.
| S-EPMC6800493 | biostudies-literature
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.
| S-EPMC5885909 | biostudies-literature
Project description:The objective of this study was to describe the rate of change in knee cartilage volume over 4.5 years in subjects with symptomatic knee osteoarthritis (OA) and to determine factors associated with cartilage loss. One hundred and five subjects were eligible for this longitudinal study. Subjects' tibial cartilage volume was assessed by magnetic resonance imaging (MRI) at baseline, at 2 years and at 4.5 years. Of 105 subjects, 78 (74%) completed the study. The annual percentage losses of medial and lateral tibial cartilage over 4.5 years were 3.7 +/- 4.7% (mean +/- SD; 95% confidence interval 2.7 to 4.8%) and 4.4 +/- 4.7% (mean +/- SD; 95% confidence interval 3.4 to 5.5%), respectively. Cartilage volume in each individual seemed to track over the study period, relative to other study participants. After multivariate adjustment, annual medial tibial cartilage loss was predicted by lesser severity of baseline knee pain but was independent of age, body mass index and structural factors. No factors specified a priori were associated with lateral cartilage volume rates of change. Tibial cartilage declines at an average rate of 4% per year in subjects with symptomatic knee OA. There was evidence to support the concept that tracking occurs in OA. This may enable the prediction of cartilage change in an individual. The only significant factor affecting the loss of medial tibial cartilage was baseline knee pain, possibly through altered joint loading.
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