Change In Knee Pain Research Articles

An unsupervised online Tai Chi program for people with knee osteoarthritis (“My Joint Tai Chi”): study protocol for the RETREAT randomised controlled trial

BackgroundKnee osteoarthritis (OA) is a leading contributor to global disability, with exercise proven to be an effective treatment. Tai Chi is a recommended type of exercise, but it is primarily done in person which imposes an accessibility issue. This study aims to evaluate the effects of an online unsupervised program, when provided with online educational information and exercise adherence support, on changes in knee pain and physical function, when compared to online education control for people with knee OA. MethodsA two-arm, superiority parallel-design, pragmatic randomised controlled trial will be conducted involving 178 people with a clinical diagnosis of knee OA. After completing baseline assessment, participants will be randomly assigned to either: i) “My Joint Education”, an education control website containing OA information only; or ii) “My Joint Tai Chi”, an intervention website containing the same information as the control, a 12-week unsupervised online Tai Chi program to be undertaken at home 3 times a week, and information about an exercise adherence support app. All participants will be reassessed at 12 weeks after randomisation. Primary outcomes are overall knee pain during walking and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index subscale. DiscussionThis randomised controlled trial will provide evidence about the effectiveness of the “My Joint Tai Chi” website compared to “My Joint Education” website on self-reported knee pain and physical function for people with knee OA. Trial RegistrationProspectively registered with the Australia New Zealand Clinical Trials Registry (ID: ACTRN12623000780651) on 18th July 2023.

Exercise and footwear in medial knee osteoarthritis: a randomized controlled trial comparing flat flexible footwear to stable supportive shoes

Abstract Objective This randomized controlled trial (RCT) investigated whether adding daily use of flat flexible footwear (FFF) to a strengthening and aerobic exercise programme improved short- and longer-term outcomes compared to adding stable supportive shoes (SSS) in people with medial tibiofemoral osteoarthritis (OA). Methods Participants (n = 97) with medial tibiofemoral OA were randomly assigned (1:1) to FFF (n = 50) or SSS (n = 47) group. Participants in both group received a 9-month intervention (3 months supervised followed by 6 months unsupervised exercise). The primary outcome was change in knee pain on walking at 3 months measured using a 11-point numeric rating scale (NRS). Secondary outcomes included change from baseline to 3 and 9 months in severity of knee pain overall (NRS), physical function (WOMAC subscale), habitual physical activity level (PASE), quality of life (QoL) (EQ-5D-5L), and markers of inflammation (Effusion- and Hoffa-synovitis) and structural disease progression (bone marrow lesions (BMLs)). Results There were no significant differences between the groups in the change in pain on walking (between-group difference, -0.67 [95% CI, -1.62 to 0.29]) at 3 months. Knee pain on walking and overall knee pain significantly decreased in both groups at 3 months and 9 months. Physical function and QoL improved in both groups at 3 months and at 9 months. We found no between-group differences in any secondary outcome at any time. Conclusions FFF added to exercise therapy did not provide additional better symptom- nor structure-modification benefit compared to conventional SSS and exercise in people with medial tibiofemoral OA. Clinical trial registration number ClinicalTrials.gov (NCT03796832)

Impact of prior knee surgery on change in knee pain, quality of life, and walking speed following supervised education and exercise therapy: an analysis of 30,545 people with knee osteoarthritis.

To investigate the impact of prior knee surgery on changes in outcomes following an 8-week supervised patient education and exercise therapy program in patients with knee osteoarthritis. Patients were classified according to knee surgery in the most affected knee joint (yes/no) prior to enrolment in the Good Life with osteoArthritis in Denmark (GLA:D®) program. Between-group differences in outcome changes from baseline to 3 months follow-up were evaluated using linear regression stratified by sex. Outcomes were knee pain intensity (VAS, 0-100 mm), joint related quality of life (Knee Injury and Osteoarthritis Outcome Score Quality of Life subscale score (KOOS QOL, 0-100)) and walking speed (40-m fast-paced walk test). To evaluate clinically relevant between-group differences, proportions of patients reaching a threshold of minimal important change in the surgery and non-surgery groups were compared. Among 30,545 patients, 27% (n, 8254) had prior surgery in the most affected knee. The prior surgery and the non-surgery group experienced improvements in all outcomes with minor between-group differences in change in pain intensity (males, 0.03 95% CI - 0.9 to 1.0; females, 1.3 95% CI 0.6 to 2.1); KOOS QOL (males, 0.3 95% CI - 0.4 to 0.9; females 0.02 95% CI - 0.5 to 0.5); and walking speed (males, 0.01 95% CI - 0.01 to 0.02; females 0.01 95% CI 0.003 to 0.02). The responder analysis showed no clinically relevant between-group differences in improvements. Previous knee surgery does not seem to modify the clinical outcome following exercise therapy and patient education in patients with knee osteoarthritis.

Usefulness and Safety of a Wearable Transcutaneous Electrical Nerve Stimulation Device for Promoting Exercise Therapy in Patients With Chronic Knee Pain: A Randomized Controlled Trial

ObjectiveTo investigate the effect of transcutaneous electrical nerve stimulation (TENS) in reducing barriers to the implementation of exercise therapy and promoting exercise therapy, focusing on physical activity (PA). DesignA single-center, participant-blinded, randomized controlled trial with a pre-post design. SettingOrthopedic clinic at a single institution,. ParticipantsParticipants (N=63, aged ≥50y) who had knee pain for ≥3 months were randomly assigned to the TENS (N=21), exercise (N=23), or combined (N=19) groups. InterventionsParticipants were provided with 4 weeks of intervention: the TENS group using a wearable TENS device, exercise group performing designated exercises, and combined group performing activities from the TENS and exercise groups. Main Outcome MeasuresThe primary outcome measure was PA. The secondary outcome measures were 6-minute walk test (6MWT); timed Up and Go (TUG) test; stair climbing; knee pain using the visual analog scale at 6MWT, TUG test, and stair climbing; and patient-reported changes in knee pain over time. ResultsAt pre- and postintervention, light-intensity PA time (minutes per day) in the TENS, exercise, and combined groups was 735.62±68.82 vs 714.21±73.06 (P=.061), 733.05±103.90 vs 700.31±90.33 (P=.057), and 710.09±62.98 vs 685.22±58.35 (P=.049), respectively, with a significant decrease in the combined group. Significant improvement in knee pain and stair climbing was observed in all groups pre- and postintervention. ConclusionsThe group using TENS showed improved effects of early reduction in knee pain and when combined with exercise therapy, a reduction in time spent in light-intensity activities such as sedentary behavior. Thus, the use of TENS in combination with conventional exercise therapy has the potential to reduce psychological barriers to the introduction of exercise therapy. It also promotes and ensures the safe implementation and continuation of exercise therapy.

Efficacy and safety of an oral complementary medicine combination in people with symptomatic knee osteoarthritis: Protocol for the double-blind, randomized, placebo-controlled ATLAS trial

ObjectiveTo investigate the efficacy and safety of an oral complementary medicine combination formulation relative to placebo, on changes in pain intensity from baseline to week 12, in people with knee osteoarthritis (OA). DesignA placebo-controlled, double-blind, two-arm, superiority, phase II, Randomized Controlled Trial (RCT) (ACTRN12623000380695). We will recruit 82 participants (∼41 per arm), aged ≥40 years, with a clinical diagnosis of symptomatic knee OA and radiographic change on x-ray (Kellgren-Lawrence Grade ≥2). Participants will be randomly allocated to receive either a complementary medicine formulation containing a daily dose of Boswellia serrata extract (Boswellin® Super, 250 ​mg/day), pine bark extract (Fenoprolic™ 70 Organic 100 ​mg/day), curcumin (500 ​mg/day), piperine (5 ​mg/day), and methylsulfonylmethane (MSM, 1500 ​mg/day), or placebo, for 12-weeks. The primary endpoint will be change from baseline in average knee pain intensity at 12-weeks (visual analogue scale). Secondary endpoints will include change in knee pain from baseline to 12-weeks in the Knee Injury and Osteoarthritis Outcome Score (KOOS), global assessment of disease activity, global rating of change, and health-related quality of life (AQoL-8D). Ethics and disseminationThis protocol has been approved by the University of Sydney Human Research Ethics Committee (#2021/877). Dissemination will occur through lay summaries, infographics, conference abstracts, oral presentations, theses, and scientific publications. ConclusionThis RCT will provide credible evidence about the efficacy and safety of this complementary medicine combination and inform updates to international clinical practice standards on the use of complementary medicines in the management of symptomatic knee OA.

The impact of an illness perception conversation on open-label placebo response in knee osteoarthritis: A randomised controlled trial

ObjectiveTo compare the effect of an illness perception conversation (IPC), relative to a research participation conversation (RPC), on 2-week changes in knee pain in patients with knee osteoarthritis. MethodThis was a randomised single-blind trial. Patients were randomised to two matched conversations. An Illness Perception (IP) conversation concerning the participant’s knee pain-related IP or a research participation conversation, concerning the participant’s motivation for participating in research. Both conversations were followed by an open-label intraarticular saline injection in the most symptomatic knee. The primary outcome was change in knee pain from baseline to 2 weeks follow-up on a 100 mm Visual Analogue Scale (VAS). Key secondary outcomes included the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: Activities of daily living (ADL) and Quality of life (QoL). Main analyses were based on the intention-to-treat population using repeated measures mixed effects linear models. Results103 patients were randomised to the IPC group (n = 52) and the RPC group (n = 51). VAS knee pain scores changed statistically significantly from baseline to end of treatment in both groups, -13.7 (SE: 3.2) in the IPC group and -13.0 (SE: 3.1) in the RPC group with an adjusted between-group difference of -0.7 (95% CI: -8.3 to 6.9; P= 0.85). Likewise, no group differences were seen in KOOS ADL and KOOS QoL. ConclusionA conversation concerning knee pain-related IP did not augment the pain-relieving effect of an open-label placebo injection, when compared to a similar control conversation concerning motivations for participating in research. TRIAL REGISTRATIONNCT05225480

Krill Oil for Knee Osteoarthritis

Knee osteoarthritis is disabling, with few effective treatments. Preliminary evidence suggested that krill oil supplementation improved knee pain, but effects on knee osteoarthritis remain unclear. To evaluate efficacy of krill oil supplementation, compared with placebo, on knee pain in people with knee osteoarthritis who have significant knee pain and effusion-synovitis. Multicenter, randomized, double-blind, placebo-controlled clinical trial in 5 Australian cities. Participants with clinical knee osteoarthritis, significant knee pain, and effusion-synovitis on magnetic resonance imaging were enrolled from December 2016 to June 2019; final follow-up occurred on February 7, 2020. Participants were randomized to 2 g/d of krill oil (n = 130) or matching placebo (n = 132) for 24 weeks. The primary outcome was change in knee pain as assessed by visual analog scale (range, 0-100; 0 indicating least pain; minimum clinically important improvement = 15) over 24 weeks. Of 262 participants randomized (mean age, 61.6 [SD, 9.6] years; 53% women), 222 (85%) completed the trial. Krill oil did not improve knee pain compared with placebo (mean change in VAS score, -19.9 [krill oil] vs -20.2 [placebo]; between-group mean difference, -0.3; 95% CI, -6.9 to 6.4) over 24 weeks. One or more adverse events was reported by 51% in the krill oil group (67/130) and by 54% in the placebo group (71/132). The most common adverse events were musculoskeletal and connective tissue disorders, which occurred 32 times in the krill oil group and 42 times in the placebo group, including knee pain (n = 10 with krill oil; n = 9 with placebo), lower extremity pain (n = 1 with krill oil; n = 5 with placebo), and hip pain (n = 3 with krill oil; n = 2 with placebo). Among people with knee osteoarthritis who have significant knee pain and effusion-synovitis on magnetic resonance imaging, 2 g/d of daily krill oil supplementation did not improve knee pain over 24 weeks compared with placebo. These findings do not support krill oil for treating knee pain in this population. Australian New Zealand Clinical Trials Registry Identifier: ACTRN12616000726459; Universal Trial Number: U1111-1181-7087.

Efficacy and safety of pentosan polysulfate sodium in people with symptomatic knee osteoarthritis and dyslipidaemia: protocol of the MaRVeL trial

IntroductionKnee osteoarthritis (OA) is the most prevalent arthritis type and a leading cause of chronic mobility disability. While pain medications provide only symptomatic pain relief; growing evidence suggests pentosan polysulfate...

Efficacy of diadynamic currents as an adjunct to exercise to manage symptoms of knee osteoarthritis in adults: A randomized controlled clinical trial

Objective To investigate the effect of diadynamic currents administered prior to exercises on pain and disability in patients with osteoarthritis of the knee. Design A randomized-controlled trial. Setting Special Rehabilitation Services in Taboão da Serra. Participants Patients with bilateral knee osteoarthritis. Intervention Participants were randomly allocated to Group I (diadynamic currents and exercises; n = 30, 60 knees) or Group II (exercises alone; n = 30, 60 knees) and were treated three times a week for 8 weeks. Main outcome measures The primary outcome measures were change in knee pain evaluated by visual analog scale and disability Index Score (Lequesne). Secondary outcomes included change in mobility (Timed Up and Go test), range of motion (goniometer), muscle strength (dynamometer), a composite score for pain and disability (Western Ontario and McMaster Universities Osteoarthritis questionnaire), and a drug diary to measure consumption of rescue pain medication (paracetamol). All measurements were collected at baseline, 8 weeks, and 6 months from baseline (follow-up). Results There were 60 participants with a mean (SD) age of 63.40 (8.20) years. Between-group differences in the follow-up (8 weeks and 6 months) were observed for pain at rest, pain during activities of daily living and disability. There was improvement in Group I that was maintained for the three variables 6 months after treatment. Mean difference for pain at rest was −3.08 points (95% confidence interval −4.13; −2.02), p < 0.01 with an effect size of 1.4; mean difference for pain during activities of daily living was −2.40 points (95% confidence interval −3.34; −1.45), p < 0.01 with an effect size of 1.24; and mean difference for disability was −4.08 points (95% confidence interval −5.89; −2.26), p < 0.01 with an effect size of 1.04. Conclusion Patients with symptomatic knee osteoarthritis receiving 8 weeks of treatment with diadynamic currents as an adjunct to a program of exercises had significantly greater improvements in pain and disability than those receiving exercises alone. Beneficial effects were sustained for 6 months.

Protocol of a Randomised Controlled Trial to Assess the Efficacy and Safety of a Oral Complementary Medicine Combination in People with Knee Osteoarthritis

Background Osteoarthritis (OA) is a leading cause of pain and disability in middle-aged or older adults worldwide. The prevalence of symptomatic knee OA has been increasing over the past several decades, indicating the need for the deployment of innovative prevention and treatment strategies for knee OA. The aim of this study is to investigate the efficacy and safety of an oral complementary medicine formulation in people with symptomatic knee OA. Methods This is a randomised, placebo-controlled, double-blinded (participants and investigators), two-arm, superiority, parallel, phase II trial. The study will recruit 82 ([Formula: see text]41 per arm) community-based participants with knee OA living in Australia. Participants aged [Formula: see text] 40 years with a clinical diagnosis of symptomatic knee OA and radiographic change on X-ray (Kellgren-Lawrence Grade [Formula: see text] 2) will be recruited. Participants will be randomly allocated to receive either a complementary medicine formulation containing a daily dose of Boswellia serrata extract (Boswellin[Formula: see text]Super, 250 mg/day), pine bark extract (Fenoprolic™70 Organic 100mg/day), curcumin (500mg/day), piperine (5mg/day), and methylsulfonylmethane (MSM, 1500mg/day), or placebo, for 12 weeks. The primary endpoint is change from baseline in average index knee pain at 12 weeks (visual analogue scale). Secondary endpoints include change in knee pain at other timepoints, the Knee Injury and Osteoarthritis Outcome Score (KOOS), global assessment of disease activity, global rating of change, health-related quality of life (AQoL-8D), and adverse events. Ethics, trial registration and dissemination: The study protocol has been approved by the University of Sydney Human Research Ethics Committee (#2021/877). The trial has been prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12623000380695, 14/04/2023). Dissemination will occur through lay summaries, scientific publications, conference abstracts, poster or oral presentations, infographics, and theses. Conclusion The outcomes of this study will provide high-quality evidence guiding the clinical use of the complementary medicine combination and will inform updates on international OA clinical practice standards on the use of complementary medicines.

Metformin for knee osteoarthritis with obesity: study protocol for a randomised, double-blind, placebo-controlled trial

IntroductionOver half of the populations with knee osteoarthritis (OA) have obesity. These individuals have many other shared metabolic risk factors. Metformin is a safe, inexpensive, well-tolerated drug that has pleiotropic...

Prognostic value of illness perception on changes in knee pain among elderly individuals: Two-year results from the Frederiksberg Cohort study

ObjectiveTo investigate the prognostic value of illness perception (IP) on knee pain, quality of life (QoL) and functional level in elderly individuals reporting knee pain. DesignA prospective cohort study of 1552 elderly with knee pain comparing two previously established clusters based on the Brief Illness Perception questionnaire. Cluster 1 (“Concerned optimists” [hypothesized unfavorable profile]; n ​= ​642) perceived their knee pain as a greater threat to them than Cluster 2 (“Unconcerned confident” [hypothesized favorable profile]; n ​= ​910). Primary outcome was the change from baseline to year 2 in the KOOS Pain subscale. Secondary outcomes were changes from baseline in quality of life (EuroQol-5 Domain and EQ VAS) and in the KOOS subscales Symptom, Activities of Daily Living, Knee-related QoL and Sports and recreation. Analyses were done on the original Intention-To-Survey (ITS) population, using repeated measures mixed linear models. ResultsAmong the ITS population, 841 (54%) responded to the 2-year survey. There was a statistically significant but clinically irrelevant cluster difference in the 2-year change from baseline in KOOS pain (mean difference: 6.0 KOOS points [95% CI: 7.3 to −4.7]) explained by a minor improvement in Cluster 1: (6.2 points) and no changes in Cluster 2: (0.2 points). Comparable results were found across the secondary outcomes. Clinically irrelevant cluster changes in IP were seen. ConclusionIn a cohort of people with knee pain, IP phenotype (i.e., Clusters) were of no prognostic value for the 2-year changes in pain, function, and QoL. Targeting IP may not be relevant in this patient population. Trial registration number and date of registrationThe Frederiksberg Cohort study was pre-registered at clinicaltrials.gov (NCT03472300) on March 21, 2018.

Influence of Self-Reported Knee Instability on Outcomes Following Education and Exercise: A Cohort Study of 2,466 Patients With Knee Osteoarthritis.

To study the influence of self-reported knee instability on changes in knee pain and gait speed following patient education and supervised exercise therapy in patients with knee osteoarthritis (OA). We included patients enrolled in the Good Life With Osteoarthritis in Denmark (GLA:D) program, an 8-week education and supervised neuromuscular exercise program. Patients were classified into 4 groups according to their level of self-reported knee instability (never; rarely; sometimes; most of the time or all the time). Knee pain intensity was evaluated on a 0-100 mm scale and gait speed from the 4 × 10 meters fast-paced walk test at baseline and after the program. Using linear regression, we examined the association between knee instability and the change in pain and gait speed, respectively. Sex, age, body mass index, physical activity level, and previous knee surgery were covariates in adjusted models. Among 2,466 patients with knee OA, mean baseline pain and gait speed varied between 38-59 mm and 1.39-1.56 meters/second in patients experiencing no instability and patients experiencing instability most or all the time, respectively. All instability groups improved in pain and gait speed. Compared to the no instability group, patients reporting instability most or all the time experienced larger improvements in pain (4.3 mm [95% confidence interval 1.2, 7.5]), while no difference between instability groups was found for gait speed. Knee OA patients with self-reported instability seem to benefit even more from a patient education and supervised exercise therapy program than OA patients without instability.

The effect of interactions between BMI and sustained depressive symptoms on knee osteoarthritis over 4 years: data from the osteoarthritis initiative

BackgroundTo assess the compound effects of BMI and sustained depressive symptoms on changes in knee structure, cartilage composition, and knee pain over 4 years using statistical interaction analyses.MethodsOne thousand eight hundred forty-four individuals from the Osteoarthritis Initiative Database were analyzed at baseline and 4-year follow-up. Individuals were categorized according to their BMI and presence of depressive symptoms (based on the Center for Epidemiological Studies Depression Scale (threshold≥16)) at baseline and 4-year follow-up. 3 T MRI was used to quantify knee cartilage T2 over 4 years, while radiographs were used to assess joint space narrowing (JSN). Mixed effects models examined the effect of BMI-depressive symptoms interactions on outcomes of cartilage T2, JSN, and knee pain over 4-years.ResultsThe BMI-depressive symptoms interaction was significantly associated with knee pain (p < 0.001) changes over 4 years, but not with changes in cartilage T2 (p = 0.27). In women, the BMI-depressive symptoms interaction was significantly associated with JSN (p = 0.01). In a group-based analysis, participants with obesity and depression had significantly greater 4-year changes in knee pain (coeff.(obesity + depression vs. no_obesity + no_depression) = 4.09, 95%CI = 3.60–4.58, p < 0.001), JSN (coeff. = 0.60, 95%CI = 0.44–0.77, p < 0.001), and cartilage T2 (coeff. = 1.09, 95%CI = 0.68–1.49, p < 0.001) than participants without depression and normal BMI.ConclusionsThe compound effects of obesity and depression have greater impact on knee pain and JSN progression compared to what would be expected based on their individual effects.

Efficacy and safety of GLucocorticoid injections into InfrapaTellar faT pad in patients with knee ostEoarthRitiS: protocol for the GLITTERS randomized controlled trial

BackgroundKnee osteoarthritis (OA) is a prevalent disabling disorder that involves changes in articular cartilage damage, subchondral bone remodeling, synovitis, and abnormal infrapatellar fat pad (IPFP). Due to the complicated etiology and numerous phenotypes of knee OA, limited improvement is achieved for treatments among knee OA patients with different phenotypes. Inflammatory OA phenotype is a typical knee OA phenotype, and individualized treatment targeting inflammation is a promising way to obtain an optimal therapeutic effect for people with inflammatory knee OA phenotype. Glucocorticoid is a traditional anti-inflammatory drug for knee OA, and intra-articular glucocorticoid injections are recommended clinically. However, emerging evidence has shown that repeated intra-articular glucocorticoid injections in the long term would induce cartilage loss. IPFP and its adjacent synovium are considered as the main source of inflammation in knee OA. This GLITTERS trial aims to investigate if a glucocorticoid injection into the IPFP is effective and safe over 12 weeks among knee OA patients with an inflammatory phenotype.MethodsGLITTERS is a multicenter, double-blinded, randomized, and placebo-controlled clinical trial among knee OA patients with both Hoffa-synovitis and effusion-synovitis. Sixty participants will be allocated randomly and equally to either the glucocorticoid group or the control group. Each group will receive an injection of glucocorticoid or saline into the IPFP with an intra-articular hyaluronic acid injection as a background treatment at baseline and be followed at 4, 8, and 12 weeks. The primary outcomes will be changes in knee pain on a visual analog scale and effusion-synovitis volume measured on magnetic resonance imaging (MRI). The secondary outcomes will be changes in the total score of Western Ontario and McMaster Universities Osteoarthritis Index score, MRI-detected Hoffa-synovitis score, quality of life, pain medication use, IPFP volume, and the incidence of adverse reactions. Data analyses based on the intention-to-treat principle will include mixed-effects regressions, Wilcoxon rank-sum tests, and chi-square tests (or Fisher’s exact test).DiscussionGLITTERS may provide high-quality evidence for the efficacy and safety of ultrasound-guided glucocorticoid injections into IPFP among people with inflammatory knee OA in a short term. The results of this trial are expected to provide a reliable reference for a longer-term risk–benefit profile of this treatment in the future.Trial registrationClinicalTrials.gov NCT05291650. Registered on 23 March 2022.

Automated machine learning-based prediction of the progression of knee pain, functional decline, and incidence of knee osteoarthritis in individuals at high risk of knee osteoarthritis: Data from the osteoarthritis initiative study.

This study aimed to examine the performance of machine learning models in predicting the progression of knee pain, functional decline, and incidence of knee osteoarthritis (OA) in high-risk individuals, with automated machine learning (AutoML) being used to automate the prediction process. There were four stages in the process of our AutoML-integrated prediction. Stage 1-Data preparation: The data of 3200 eligible individuals in the Osteoarthritis Initiative (OAI) study who were considered at high risk of knee OA at the baseline visit were extracted and used. Specifically, 1094 variables from the OAI study were used to predict the changes in knee pain, physical function, and incidence of knee OA (i.e. the first occurrence of frequent knee symptoms and definite tibial osteophytes (Kellgren and Lawrence grade ≥2)) over a 9-year period. Stage 2-Model training: The AutoML approach was used to automatically train nine widely used machine learning (ML) models. Stage 3-Model testing: The AutoML approach was used to automatically test the performance of the ML models. Stage 4-Selection of important input variables: The AutoML approach automated the process of computing the importance scores of all input variables and identifying the most important ones, using the technique of permutation feature importance. Using the AutoML approach, the weighted ensemble model and the CatBoost model showed the best performance among all nine ML models. For the prediction of each outcome in each year, the five most important input variables were identified, most of which were obtained from self-reported questionnaire surveys and radiographic imaging reports. The AutoML approach has shown potential in automating the process of using ML models to predict long-term changes in knee OA-related outcomes. Its use could support the deployment of ML solutions, facilitating the provision of personalized interventions to prevent the deterioration of knee health and incident knee OA.

A Randomised Controlled Trial of YOGa and Strengthening Exercise for Knee OsteoArthritis: Protocol for a Comparative Effectiveness Trial (YOGA Trial).

Osteoarthritis (OA) is a common joint disorder for which there is no cure. Current treatments are suboptimal. Exercise is a core treatment for knee OA, with muscle strengthening exercise commonly recommended. Yoga is a mind-body exercise intervention that can improve flexibility, muscle strength, balance, and fitness and potentially reduce symptoms of OA. However, there is a scarcity of robust, high-quality conclusive evidence on the efficacy of yoga in knee OA. We are currently conducting the first randomised comparative effectiveness and cost-effectiveness trial of a yoga program compared with a strengthening exercise program in patients with symptomatic knee OA. This study protocol describes the design and conduct of this trial. The YOGA study is a phase III, single-centre, parallel, superiority, randomised, active-controlled trial which will be conducted in Hobart, Australia. One hundred and twenty-six participants (63 in each arm) aged over 40 years with symptomatic knee OA will be recruited from the community and randomly allocated to receive either a 24-week yoga program (3×/week) or a strengthening exercise program (3×/week). The primary outcome will be change in knee pain over 12 weeks, assessed using a 100 mm visual analogue scale (VAS). The secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life, gait speed, biomarkers, and others over 12 and 24 weeks. We will also assess whether the presence of neuropathic pain moderates the effects of yoga compared to strengthening exercise. Additional data, such as cost and resource utilization, will be collected for the cost-effectiveness analysis. The primary analysis will be conducted using an intention-to-treat approach. Adverse events will be monitored throughout the study. Once completed, this trial will contribute to the knowledge of whether yoga can be used as a simple, effective, low-cost option for the management of knee OA, thus saving economic costs in the healthcare system.

Effectiveness of an Unsupervised Online Yoga Program on Pain and Function in People With Knee Osteoarthritis : A Randomized Clinical Trial.

Yoga is a mind-body exercise typically done in groups in person, but this delivery method can be inconvenient, inaccessible, and costly. Effective online programs may increase access to exercise for knee osteoarthritis. To evaluate the effectiveness of an unsupervised 12-week online yoga program. Two-group superiority randomized trial. (Australian New Zealand Clinical Trials Registry: ACTRN12620000012976). Community. 212 adults with symptomatic knee osteoarthritis. Both groups received online osteoarthritis information (control). The yoga group also received access to an unsupervised online yoga program delivered via prerecorded videos over 12 weeks (1 video per week, with each session to be performed 3 times per week), with optional continuation thereafter. Primary outcomes were changes in knee pain during walking (0 to 10 on a numerical rating scale) and physical function (0 to 68 on the Western Ontario and McMaster Universities Osteoarthritis Index) at 12 weeks (primary time point) and 24 weeks, analyzed using mixed-effects linear regression models. Secondary outcomes were self-reported overall knee pain, stiffness, depression, anxiety, stress, global change, quality of life, self-efficacy, fear of movement, and balance confidence. Adverse events were also collected. A total of 195 (92%) and 189 (89%) participants provided 12- and 24-week primary outcomes, respectively. Compared with control at 12 weeks, yoga improved function (between-group mean difference in change, -4.0 [95% CI, -6.8 to -1.3]) but not knee pain during walking (between-group mean difference in change, -0.6 [CI, -1.2 to 0.1]), with more yoga participants than control participants achieving the minimal clinically important difference (MCID) for both outcomes. At 12 weeks, knee stiffness, quality of life, and arthritis self-efficacy improved more with yoga than the control intervention. Benefits were not maintained at 24 weeks. Adverse events were minor. Participants were unblinded. Compared with online education, an unsupervised online yoga program improved physical function but not knee pain at 12 weeks in people with knee osteoarthritis, although the improvement did not reach the MCID and was not sustained at 24 weeks. National Health and Medical Research Council and Centres of Research Excellence.

Study protocol for a randomised controlled trial of diacerein versus placebo to treat knee osteoarthritis with effusion-synovitis (DICKENS)

BackgroundThere is an unmet need for treatments for knee osteoarthritis (OA). Effusion-synovitis is a common inflammatory phenotype of knee OA and predicts knee pain and structural degradation. Anti-inflammatory therapies, such as diacerein, may be effective for this phenotype. While diacerein is recommended for alleviating pain in OA patients, evidence for its effectiveness is inconsistent, possibly because studies have not targeted patients with an inflammatory phenotype. Therefore, we will conduct a multi-centre, randomised, placebo-controlled double-blind trial to determine the effect of diacerein on changes in knee pain and effusion-synovitis over 24 weeks in patients with knee OA and magnetic resonance imaging (MRI)-defined effusion-synovitis.MethodsWe will recruit 260 patients with clinical knee OA, significant knee pain, and MRI-detected effusion-synovitis in Hobart, Melbourne, Adelaide, and Perth, Australia. They will be randomly allocated to receive either diacerein (50mg twice daily) or identical placebo for 24 weeks. MRI of the study knee will be performed at screening and after 24 weeks of intervention. The primary outcome is improvement in knee pain at 24 weeks as assessed by a 100-mm visual analogue scale (VAS). Secondary outcomes include improvement in volumetric (ml) and semi-quantitative (Whole-Organ Magnetic Resonance Imaging Score, 0–3) measurements of effusion-synovitis using MRI over 24 weeks, and improvement in knee pain (VAS) at 4, 8, 12, 16, and 20 weeks. Intention-to-treat analyses of primary and secondary outcomes will be performed as the primary analyses. Per protocol analyses will be performed as the secondary analyses.DiscussionThis study will provide high-quality evidence to determine whether diacerein improves pain, changes disease trajectory, and slows disease progression in OA patients with effusion-synovitis. If diacerein proves effective, this has the potential to significantly benefit the substantial proportion (up to 60%) of knee OA patients with an inflammatory phenotype.Trial registrationAustralian and New Zealand Clinical Trial Registry ACTRN12618001656224. Registered on 08 October 2018.

Efficacy of prolonged application of low-level laser therapy combined with exercise in knee osteoarthritis: A randomized controlled double-blind study

Objectives To investigate the effect of prolonged low-level laser therapy application combined with exercise on pain and disability in patients with osteoarthritis of the knee. Design A randomized controlled trial. Setting Special rehabilitation services. Subjects Forty-three participants with knee osteoarthritis. Intervention Following initial assessment, participants were randomly allocated to the Laser group (n = 22, 44 knees) and received low-level laser therapy while the Placebo group (n = 21, 42 knees) received placebo therapy three times a week for 3 weeks. Both groups then received low-level laser therapy combined with exercise three times a week for the following 8 weeks. Main outcome measures The primary outcome was change in knee pain and disability (Lequesne). Secondary outcomes included change in mobility (Timed Up and Go test), range of motion (goniometer), muscular strength (dynamometer), activity (Western Ontario and McMaster Universities Osteoarthritis questionnaire), and medication intake and relief. Results Mean (SD) age of participants was 63.02 (9.9) years. Pain scores at baseline, 3 weeks, 11 weeks, and 6 months follow-up were 9.1 (1.3), 2.6 (2.3), 0.2 (0.9), and 0.2 (0.8) for the Laser group and 9.5 (8.0), 7.7 (5.3), 5.6 (2.4), and 7.4 (5.0) for the Placebo group, respectively. Disability scores at baseline, 3 weeks, 11 weeks, and 6 months follow-up were 14.9 (4.7), 7.6 (4.8), 3.9 (4.2), and 3.5 (4.1) for the Laser group and 17.8 (14.7), 15.2 (11.5), 11.6 (6.4), and 15.8 (11.9) for the Placebo Group, respectively. Conclusion In participants with osteoarthritis of the knee, the isolated application of low-level laser therapy in the initial 3 weeks and combined with exercises in the final 8 weeks reduced pain, disability, and intake of medication over a 6-month period.