Mindfulness Is Associated With Treatment Response From Nonpharmacologic Exercise Interventions in Knee Osteoarthritis.

OBJECTIVE: To examine the association between baseline mindfulness and response from exercise interventions in knee osteoarthritis (OA). DESIGN: Cohort study; responder analysis of a clinical trial subset. SETTING: Urban tertiary care academic hospital. PARTICIPANTS: Participants with symptomatic, radiographic knee OA (N=86; mean age, 60y; 74% female; 48% white). INTERVENTIONS: Twelve weeks (twice per week) of Tai Chi or physical therapy exercise. MAIN OUTCOME MEASURES: Treatment response was defined using Osteoarthritis Research Society International criteria indicating meaningful improvements in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, WOMAC function, or Patient Global Assessment scores. At baseline, participants completed the Five Facet Mindfulness Questionnaire (mean total score, 142±17) and were grouped into 3 categories of total mindfulness: higher, medium, or lower. Relative risk (RR) ratios were used to compare treatment response across groups. RESULTS: Participants with higher total mindfulness were 38% (95% confidence interval [CI], 1.05-1.83) more likely to meet responder criteria than those with lower mindfulness. We found no significant difference between medium and lower mindfulness groups (RR=1.0; 95% CI, 0.69-1.44). Among the 5 mindfulness facets, medium acting-with-awareness was 46% (95% CI, 1.09-1.96) more likely to respond than lower acting-with-awareness, and higher acting-with-awareness was 34% more likely to respond, but this did not reach significance (95% CI, 0.97-1.86). CONCLUSIONS: In this study, higher mindfulness, primarily driven by its acting-with-awareness facet, was significantly associated with a greater likelihood of response to nonpharmacologic exercise interventions in knee OA. This suggests that mindfulness-cultivating interventions may increase the likelihood of response from exercise.

Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial.

BACKGROUND: Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. OBJECTIVE: To compare Tai Chi with standard physical therapy for patients with knee osteoarthritis. DESIGN: Randomized, 52-week, single-blind comparative effectiveness trial. (ClinicalTrials.gov: NCT01258985). SETTING: An urban tertiary care academic hospital. PATIENTS: 204 participants with symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white). INTERVENTION: Tai Chi (2 times per week for 12 weeks) or standard physical therapy (2 times per week for 6 weeks, followed by 6 weeks of monitored home exercise). MEASUREMENTS: The primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 weeks. Secondary outcomes included physical function, depression, medication use, and quality of life. RESULTS: At 12 weeks, the WOMAC score was substantially reduced in both groups (Tai Chi, 167 points [95% CI, 145 to 190 points]; physical therapy, 143 points [CI, 119 to 167 points]). The between-group difference was not significant (24 points [CI, -10 to 58 points]). Both groups also showed similar clinically significant improvement in most secondary outcomes, and the benefits were maintained up to 52 weeks. Of note, the Tai Chi group had significantly greater improvements in depression and the physical component of quality of life. The benefit of Tai Chi was consistent across instructors. No serious adverse events occurred. LIMITATION: Patients were aware of their treatment group assignment, and the generalizability of the findings to other settings remains undetermined. CONCLUSION: Tai Chi produced beneficial effects similar to those of a standard course of physical therapy in the treatment of knee osteoarthritis. PRIMARY FUNDING SOURCE: National Center for Complementary and Integrative Health of the National Institutes of Health.

Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial.

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.

Physical examination findings and their relationship with performance-based function in adults with knee osteoarthritis.

BACKGROUND: Many physical examination (PE) maneuvers exist to assess knee function, none of which are specific to knee osteoarthritis (KOA). The Osteoarthritis Research Society International also recommends the use of six functional performance measures to assess function in adults with KOA. While earlier studies have examined the relationship between PE findings and self-reported function or PE findings and select performance tests in adults with knee pain and KOA, few have examined the all three types of measures. This cross-sectional study specifically examines the relationships between results of PE findings, functional performance tests and self-reported function in adults with symptomatic KOA. METHODS: We used baseline PE data from a prospective randomized controlled trial in 87 participants aged ≥40 years with symptomatic and radiographic KOA. The PE performed by three experienced physical therapists included: muscle assessment, function and special tests. Participants also completed functional performance tests and the Western Ontario and McMaster Osteoarthritis Index (WOMAC). Multivariate linear regression identified contributions of PE findings towards functional performance and WOMAC scores, adjusting for age and gender. RESULTS: Participants' mean age was 60.4 years (SD = 10.5), mean disease duration was 8.4 years (SD = 10.1) and 27 participants had varus knee alignment. Mean WOMAC pain and function scores were 211 (SD = 113) and 709 (SD = 394), respectively. Weakness was present in major hip and knee muscles. Seventy-nine participants had a positive Ely's, 65 a positive Waldron and 49 a positive Grind. Mean 6-min walk was 404 m (SD = 83) and mean Berg Balance was 53 (SD = 4). Regression analysis identified positive findings on 5 special tests (P < 0.05) as indicative of poorer 6 min walk. Positive Apley's was associated (P < 0.05) with slower 20 m walk and a positive Ober with poorer balance scores (P < 0.05). CONCLUSIONS: Diminished hip muscle strength and flexibility, and patella dysfunction were prevalent in these adults with symptomatic KOA. Results of functional performance tests suggest balance and walking ability are impaired and are associated with PE findings of muscle length imbalance, hip muscle weakness and patella dysfunction. None of the PE measures were associated with self-reported function. Therefore, performance-based test results may be more useful in informing rehabilitation interventions.

Coronal tibial slope is associated with accelerated knee osteoarthritis: data from the Osteoarthritis Initiative.

BACKGROUND: Accelerated knee osteoarthritis may be a unique subset of knee osteoarthritis, which is associated with greater knee pain and disability. Identifying risk factors for accelerated knee osteoarthritis is vital to recognizing people who will develop accelerated knee osteoarthritis and initiating early interventions. The geometry of an articular surface (e.g., coronal tibial slope), which is a determinant of altered joint biomechanics, may be an important risk factor for incident accelerated knee osteoarthritis. We aimed to determine if baseline coronal tibial slope is associated with incident accelerated knee osteoarthritis or common knee osteoarthritis. METHODS: We conducted a case-control study using data and images from baseline and the first 4 years of follow-up in the Osteoarthritis Initiative. We included three groups: 1) individuals with incident accelerated knee osteoarthritis, 2) individuals with common knee osteoarthritis progression, and 3) a control group with no knee osteoarthritis at any time. We did 1:1:1 matching for the 3 groups based on sex. Weight-bearing, fixed flexion posterior-anterior knee radiographs were obtained at each visit. One reader manually measured baseline coronal tibial slope on the radiographs. Baseline femorotibial angle was measured on the radiographs using a semi-automated program. To assess the relationship between slope (predictor) and incident accelerated knee osteoarthritis or common knee osteoarthritis (outcomes) compared with no knee osteoarthritis (reference outcome), we performed multinomial logistic regression analyses adjusted for sex. RESULTS: The mean baseline slope for incident accelerated knee osteoarthritis, common knee osteoarthritis, and no knee osteoarthritis were 3.1(2.0), 2.7(2.1), and 2.6(1.9); respectively. A greater slope was associated with an increased risk of incident accelerated knee osteoarthritis (OR = 1.15 per degree, 95 % CI = 1.01 to 1.32) but not common knee osteoarthritis (OR = 1.04, 95 % CI = 0.91 to 1.19). These findings were similar when adjusted for recent injury. Among knees with varus malalignment a greater slope increases the odds of incident accelerated knee osteoarthritis; there is no significant relationship between slope and incident accelerated knee osteoarthritis among knees with normal alignment. CONCLUSIONS: Coronal tibial slope, particularly among knees with malalignment, may be an important risk factor for incident accelerated knee osteoarthritis.

Relationship of bone mineral density to progression of knee osteoarthritis.

OBJECTIVE: To evaluate the longitudinal relationship between bone mineral density (BMD) and BMD changes and the progression of knee osteoarthritis (OA), as measured by cartilage outcomes. METHODS: We used observational cohort data from the Vitamin D for Knee Osteoarthritis trial. Bilateral femoral neck BMD values as well as knee magnetic resonance imaging (MRI) scans in each subject were obtained at baseline and subsequently at 12 months and 24 months. The change in total cartilage volume and tibial and femoral cartilage thickness was measured by manual cartilage segmentation of 2 sequential knee MRI scans in each subject. Multivariable linear regression models were used to examine the associations of baseline BMD and BMD change with the cartilage outcomes, adjusting for baseline age, sex, body mass index, malalignment, and vitamin D treatment. Model fit and assumptions were validated. RESULTS: A total of 127 subjects were eligible for analysis. Longitudinal BMD loss was associated with loss of cartilage volume (ß = 1.25 per 0.1 gm/cm(2) , P = 0.02) and loss of tibial cartilage thickness (ß = 0.028, P = 0.03). BMD loss of a magnitude greater than the least significant change (<-4.7%) was associated with 1.02% cartilage volume loss per year (P = 0.005), 0.014 mm femoral cartilage thickness loss (P = 0.04), and 0.021 mm tibial cartilage thickness loss per year (P = 0.009). There were no significant associations between baseline BMD and any of the cartilage outcomes. CONCLUSION: Longitudinal BMD loss is associated with progressive cartilage loss in knees with OA. Further work to clarify the basis of this relationship could reveal novel therapeutic targets for knee OA.

Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial.

BACKGROUND: Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. METHODS/DESIGN: A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. DISCUSSION: This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind-body effect for a major disabling disease with substantial health burdens and economic costs. Results of this study are expected to have important public health implications for the large and growing population with knee OA. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01258985.

Pharmacologic risk factors for post-operative delirium in total joint arthroplasty patients: a case-control study.

Total joint arthroplasty (TJA) patients are at increased risk of post-operative delirium (POD) given their demographics and functional impairment. Certain pharmacologic agents are known to cause delirium, but those that cause delirium following TJA are unknown. Our aim was to explore if specific anesthetic agents, opiate pain medications, or benzodiazepines are associated with POD following TJA. A matched case (n=98)-control (n=365) design and conditional logistic regression model were used to examine risk factors for POD among TJA patients at our institution from 2006 to 2010. The model was adjusted for gender, pre-operative alcohol use, and pre-operative depression. Our data suggest that isoflurane and benzodiazepines are associated with an increased risk of delirium in TJA patients and should be used with caution. Hydromorphone and morphine did not increase the risk of delirium in TJA patients and may be considered for post-operative pain control.

Associations of varus thrust and alignment with pain in knee osteoarthritis.

OBJECTIVE: To investigate associations of varus thrust and varus static alignment with pain in patients with knee osteoarthritis (OA). METHODS: This was a cross-sectional study of participants from a randomized controlled trial of vitamin D treatment for knee OA. Participants were video recorded while walking and scored for presence of varus thrust. Static alignment was measured on standard posteroanterior knee radiographs. Pain questions from the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire were used to assess symptoms. We calculated means for total WOMAC pain in relation to varus thrust and static varus alignment (i.e., corrected anatomic alignment<178 degrees). Ordinal logistic regressions were performed, with responses on individual WOMAC pain questions as the outcomes and varus thrust and varus alignment as the predictors. RESULTS: There were 82 participants, 60% of whom were female. The mean±SD age was 65.1±8.5 years, and the mean±SD body mass index was 30.2±5.4 kg/m2. The mean total WOMAC pain score was 6.3 versus 3.9, respectively, in those with versus without definite varus thrust (P=0.007) and 5.0 versus 4.2 in those with versus without varus alignment (P=0.36). Odds ratios for pain with walking and standing were 4.7 (95% confidence interval 1.8-11.9) and 5.5 (95% confidence interval 2.2-14.2), respectively, in those with and those without definite varus thrust. There were no significant associations between varus alignment and responses to individual WOMAC pain questions. Sensitivity analyses suggested that varus classified using a more stringent definition might have been associated with pain on walking and standing. CONCLUSION: In patients with knee OA, varus thrust, and possibly varus static alignment, were associated with pain, specifically during weight-bearing activities. Treatment of varus thrust (e.g., via bracing or gait modification) may lead to improvement of symptoms.

Preventing lost-to-follow up diagnostic imaging in ambulatory care: evaluation of an electronic notification tool.

OBJECTIVE: Missed or cancelled imaging tests may be invisible to the ordering clinician and result in diagnostic delay. We developed an outpatient results notification tool (ORNT) to alert physicians of patients' missed radiology studies. DESIGN: Randomised controlled evaluation of a quality improvement intervention. SETTING: 23 primary care and subspecialty ambulatory clinics at an urban academic medical centre. PARTICIPANTS: 276 physicians randomised to intervention or usual care. MAIN OUTCOME MEASURE: 90-day test completion of missed imaging tests. RESULTS: We included 3675 radiology tests in our analysis: 1769 ordered in the intervention group and 1906 in the usual care group. A higher per cent of studies were completed for intervention compared with usual care groups in CT (20.7% vs 15.3%, p=0.06), general radiology (19.6% vs 12.0%, p=0.02) and, in aggregate, across all modalities (18.1% vs 16.1%, p=0.03). In the multivariable regression model adjusting for sex, age and insurance type and accounting for clustering with random effects at the level of the physician, the intervention group had a 36% greater odds of test completion than the usual care group (OR: 1.36 (1.097-1.682), p=0.005). In the Cox regression model, patients in the intervention group were 1.32 times more likely to complete their test in a timely fashion (HR: 1.32 (1.10-1.58), p=0.003). CONCLUSIONS: An electronic alert that notified the responsible clinician of a missed imaging test ordered in an ambulatory clinic reduced the number of incomplete tests at 90 days. Further study of the obstacles to completing recommended diagnostic testing may allow for the development of better tools to support busy clinicians and their patients and reduce the risk of diagnostic delays.

Realignment treatment for medial tibiofemoral osteoarthritis: randomised trial.

OBJECTIVES: The objective of this 30-week randomised crossover trial was to determine whether a multi-modal realignment treatmentwould be successful in relieving pain and improving function among persons with medial tibiofemoral osteoarthritis (OA). METHODS: The authors conducted a double-blind randomised crossover trial of a multi-modal realignment treatment for medial tibiofemoral OA. Trial participants met American College of Rheumatology criteria for OA, with knee pain, aching or stiffness on most days of the past month and radiographic evidence of a definite osteophyte with predominant medial tibiofemoral OA. The authors tested two different treatments: (A) control treatment consisting of a neutral knee brace (no valgus angulation), flat unsupportive foot orthoses and shoes with a flexible mid-sole; and (B) active treatment consisting of a valgus knee brace, customised neutral foot orthoses and shoes designed for motion control. For each subject, the trial lasted 30 weeks, including 12 weeks each of active treatment and control treatment separated by a 6-week washout period. The primary outcome of the linear regression model was change in knee pain and function, as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). RESULTS: 80 participants with medial tibiofemoral OA were randomised. Their mean age was 62 years, their mean body mass index was 34 kg/m(2) and their mean WOMAC Pain score was 9.2 (0-20 scale). There was no evidence of a carryover effect. The regression model demonstrated that the mean difference in pain between the active treatment and the control treatment was -1.82 units (95% CI -3.05 to -0.60; p=0.004) on the WOMAC Pain scale, indicating a small but statistically significant decrease in pain with the multi-modal active treatment. For WOMAC Function, the realignment intervention had a non-significant effect on function, with a -2.90 unit decrease (95% CI -6.60 to 0.79) compared with the control condition (p=0.12). CONCLUSION: Multi-modal realignment treatment decreases pain in persons with medial tibiofemoral OA.

Association of leg-length inequality with knee osteoarthritis: a cohort study.

BACKGROUND: Leg-length inequality is common in the general population and may accelerate development of knee osteoarthritis. OBJECTIVE: To determine whether leg-length inequality is associated with prevalent, incident, and progressive knee osteoarthritis. DESIGN: Prospective observational cohort study. SETTING: Population samples from Birmingham, Alabama, and Iowa City, Iowa. PATIENTS: 3026 participants aged 50 to 79 years with or at high risk for knee osteoarthritis. MEASUREMENTS: The exposure was leg-length inequality, measured by full-limb radiography. The outcomes were prevalent, incident, and progressive knee osteoarthritis. Radiographic osteoarthritis was defined as Kellgren and Lawrence grade 2 or greater, and symptomatic osteoarthritis was defined as radiographic disease in a consistently painful knee. RESULTS: Compared with leg-length inequality less than 1 cm, leg-length inequality of 1 cm or more was associated with prevalent radiographic (53% vs. 36%; odds ratio [OR], 1.9 [95% CI, 1.5 to 2.4]) and symptomatic (30% vs. 17%; OR, 2.0 [CI, 1.6 to 2.6]) osteoarthritis in the shorter leg, incident symptomatic osteoarthritis in the shorter leg (15% vs. 9%; OR, 1.7 [CI, 1.2 to 2.4]) and the longer leg (13% vs. 9%; OR, 1.5 [CI, 1.0 to 2.1]), and increased odds of progressive osteoarthritis in the shorter leg (29% vs. 24%; OR, 1.3 [CI, 1.0 to 1.7]). LIMITATIONS: Duration of follow-up may not be long enough to adequately identify cases of incidence and progression. Measurements of leg length, including radiography, are subject to measurement error, which could result in misclassification. CONCLUSION: Radiographic leg-length inequality was associated with prevalent, incident symptomatic, and progressive knee osteoarthritis. Leg-length inequality is a potentially modifiable risk factor for knee osteoarthritis. PRIMARY FUNDING SOURCE: National Institute on Aging.

Altered functional connectivity between hypothalamus and limbic system in fibromyalgia.

The hypothalamus links the nervous system to the endocrine system and plays a crucial role in maintaining the human body's homeostasis. This study aims to investigate the resting state functional connectivity (rsFC) changes of the hypothalamus in fibromyalgia patients. 24 Fibromyalgia patients and 24 matched healthy controls (HCs) were recruited. Resting state fMRI data were collected from the fibromyalgia patients and HC's. Fibromyalgia patients went through a second scan after 12 weeks of Tai Chi mind-body intervention. Data analysis showed that fibromyalgia patients displayed less medial hypothalamus (MH) rsFC with the thalamus and amygdala when compared to the functional connectivity in the HCs. After the Tai Chi mind-body intervention, fibromyalgia patients showed increased MH rsFC with the thalamus and amygdala accompanied by clinical improvement. Effective connectivity analysis showed disrupted MH and thalamus interaction in the fibromyalgia patients, which was altered by mind-body exercise. Our findings suggest that fibromyalgia is associated with altered functional connectivity within the diencephalon and limbic system. Elucidating the roles of the diencephalon and limbic system in the pathophysiology and development of fibromyalgia may facilitate the development of a new biomarker and effective treatment methods for this prevalent disorder.Trial Registration ClinicalTrials.gov, NCT02407665. Registered: 3 April 2015, https://clinicaltrials.gov/ct2/show/NCT02407665?term=NCT02407665&draw=2&rank=1.

Effective recruitment strategies in an exercise trial for patients with fibromyalgia.

BACKGROUND: Recruitment of fibromyalgia populations into long-term clinical trials involving exercise interventions is a challenge. We evaluated the cost and randomization yields of various recruitment methods used for a fibromyalgia trial in an urban setting. We also investigated differences in participant characteristics and exercise intervention adherence based on recruitment source. METHODS: We recruited individuals with fibromyalgia in the greater Boston area to a randomized controlled trial (RCT) using six recruitment strategies: newspaper advertisements, web advertisements, flyers, clinic referrals, direct mailing to patients in a clinic database, and word of mouth. We used the American College of Rheumatology 1990 and 2010 diagnostic criteria to screen and enroll participants. During an initial phone call to an interested participant, the study staff asked how they heard about the study. In this study, we compared the cost and yield of the six recruitment strategies as well as baseline characteristics, adherence, and attendance rates of participants across strategies. RESULTS: Our recruitment resulted in 651 prescreens, 272 screening visits, and 226 randomized participants. Advertisements in a local commuter newspaper were most effective, providing 113 of 226 randomizations, albeit high cost ($212 per randomized participant). Low-cost recruitment strategies included clinical referrals and web advertisements, but they only provided 32 and 16 randomizations. Community-based strategies including advertisement and flyers recruited a more racially diverse participant sample than clinic referrals and mailing or calling patients. There was no evidence of difference in adherence among participants recruited from various strategies. CONCLUSIONS: Newspaper advertisement was the most effective and most expensive method per randomized participant for recruiting large numbers of individuals with fibromyalgia in an urban setting. Community-based strategies recruited a more racially diverse cohort than clinic-based strategies. TRIAL REGISTRATION: ClinicalTrials.gov NCT01420640 . Registered on 19 August 2011.

2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee.

OBJECTIVE: To develop an evidence-based guideline for the comprehensive management of osteoarthritis (OA) as a collaboration between the American College of Rheumatology (ACR) and the Arthritis Foundation, updating the 2012 ACR recommendations for the management of hand, hip, and knee OA. METHODS: We identified clinically relevant population, intervention, comparator, outcomes questions and critical outcomes in OA. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benefits and harms of available educational, behavioral, psychosocial, physical, mind-body, and pharmacologic therapies for OA. Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of the evidence. A Voting Panel, including rheumatologists, an internist, physical and occupational therapists, and patients, achieved consensus on the recommendations. RESULTS: Based on the available evidence, either strong or conditional recommendations were made for or against the approaches evaluated. Strong recommendations were made for exercise, weight loss in patients with knee and/or hip OA who are overweight or obese, self-efficacy and self-management programs, tai chi, cane use, hand orthoses for first carpometacarpal (CMC) joint OA, tibiofemoral bracing for tibiofemoral knee OA, topical nonsteroidal antiinflammatory drugs (NSAIDs) for knee OA, oral NSAIDs, and intraarticular glucocorticoid injections for knee OA. Conditional recommendations were made for balance exercises, yoga, cognitive behavioral therapy, kinesiotaping for first CMC OA, orthoses for hand joints other than the first CMC joint, patellofemoral bracing for patellofemoral knee OA, acupuncture, thermal modalities, radiofrequency ablation for knee OA, topical NSAIDs, intraarticular steroid injections and chondroitin sulfate for hand OA, topical capsaicin for knee OA, acetaminophen, duloxetine, and tramadol. CONCLUSION: This guideline provides direction for clinicians and patients making treatment decisions for the management of OA. Clinicians and patients should engage in shared decision-making that accounts for patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee.

OBJECTIVE: To develop an evidence-based guideline for the comprehensive management of osteoarthritis (OA) as a collaboration between the American College of Rheumatology (ACR) and the Arthritis Foundation, updating the 2012 ACR recommendations for the management of hand, hip, and knee OA. METHODS: We identified clinically relevant population, intervention, comparator, outcomes questions and critical outcomes in OA. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benefits and harms of available educational, behavioral, psychosocial, physical, mind-body, and pharmacologic therapies for OA. Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of the evidence. A Voting Panel, including rheumatologists, an internist, physical and occupational therapists, and patients, achieved consensus on the recommendations. RESULTS: Based on the available evidence, either strong or conditional recommendations were made for or against the approaches evaluated. Strong recommendations were made for exercise, weight loss in patients with knee and/or hip OA who are overweight or obese, self-efficacy and self-management programs, tai chi, cane use, hand orthoses for first carpometacarpal (CMC) joint OA, tibiofemoral bracing for tibiofemoral knee OA, topical nonsteroidal antiinflammatory drugs (NSAIDs) for knee OA, oral NSAIDs, and intraarticular glucocorticoid injections for knee OA. Conditional recommendations were made for balance exercises, yoga, cognitive behavioral therapy, kinesiotaping for first CMC OA, orthoses for hand joints other than the first CMC joint, patellofemoral bracing for patellofemoral knee OA, acupuncture, thermal modalities, radiofrequency ablation for knee OA, topical NSAIDs, intraarticular steroid injections and chondroitin sulfate for hand OA, topical capsaicin for knee OA, acetaminophen, duloxetine, and tramadol. CONCLUSION: This guideline provides direction for clinicians and patients making treatment decisions for the management of OA. Clinicians and patients should engage in shared decision-making that accounts for patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

The role of analgesics and intra-articular injections in disease management.

The most important goals of therapy in patients with osteoarthritis are pain management, improvement in function and disability, and, ultimately, disease modification. This review discusses the current pharmacologic regimen available to address these goals. Specific attention is paid to current trends and controversies related to pharmacologic management, including the use of oral, topical, and injectable agents.

Altered resting state functional connectivity of the cognitive control network in fibromyalgia and the modulation effect of mind-body intervention.

This study examines altered resting state functional connectivity (rsFC) of the cognitive control network (CCN) in fibromyalgia patients as compared to healthy controls, as well as how an effective mind-body intervention, Tai Chi, can modulate the altered rsFC of the CCN. Patients with fibromyalgia and matched healthy subjects were recruited in this study. Fibromyalgia patients were scanned 12 weeks before and after intervention. The bilateral dorsolateral prefrontal cortex (DLPFC) was used as a seed to explore the rsFC of the CCN. Data analysis was conducted with 21 patients and 20 healthy subjects. Compared to healthy subjects, fibromyalgia patients exhibited increased rsFC between the DLPFC and the bilateral rostral anterior cingulate cortex (rACC) and medial prefrontal cortex (MPFC) at baseline. The rsFC between the CCN and rACC/MPFC further increased after Tai Chi intervention, and this increase was accompanied by clinical improvements. This rsFC change was also significantly associated with corresponding changes in the Overall Impact domain of the Revised Fibromyalgia Impact Questionnaire (FIQR). Further analysis showed that the rACC/MPFC rsFC with both the PAG and hippocampus significantly decreased following Tai Chi intervention. Our study suggests that fibromyalgia is associated with altered CCN rsFC and that effective mind-body treatment may elicit clinical improvements by further increasing this altered rsFC. Elucidating this mechanism of enhancing the allostasis process will deepen our understanding of the mechanisms underlying mind-body interventions in fibromyalgia patients and facilitate the development of new pain management methods.

Mindfulness is associated with psychological health and moderates the impact of fibromyalgia.

OBJECTIVE: Previous studies suggest mindfulness is associated with pain and depression. However, its impact in individuals with fibromyalgia remains unclear. We examined associations between mindfulness and physical and psychological symptoms, pain interference, and quality of life in fibromyalgia patients. METHODS: We performed a cross-sectional analysis on baseline data from a fibromyalgia clinical trial. Mindfulness was assessed using the Five Facet Mindfulness Questionnaire (FFMQ). Pearson's correlations and multivariable linear regression models were used to evaluate associations between mindfulness and fibromyalgia impact, pain interference, physical function, depression, anxiety, stress, self-efficacy, and health-related quality of life. We also examined whether mindfulness moderated associations between fibromyalgia impact and psychological outcomes. RESULTS: A total of 177 participants (age 52.0 ± 12.2 (SD) years; 93.2% women; 58.8% white; body mass index 30.1 ± 6.7 kg/m2; FFMQ score 131.3 ± 20.7; Revised Fibromyalgia Impact Questionnaire score 57.0 ± 19.4) were included. Higher total mindfulness was significantly associated with lower fibromyalgia impact (r = - 0.25), pain interference (r = - 0.31), stress (r = - 0.56), anxiety (r = - 0.58), depression (r = - 0.54), and better mental health-related quality of life (r = 0.57). Describing, Acting-with-awareness, and Non-judging facets of mindfulness were also associated with these outcomes. Mindfulness moderated the effect of fibromyalgia impact on anxiety (interaction P = 0.01). CONCLUSION: Higher mindfulness is associated with less pain interference, lower impact of fibromyalgia, and better psychological health and quality of life in people with fibromyalgia. Mindfulness moderates the influence of fibromyalgia impact on anxiety, suggesting mindfulness may alter how patients cope with fibromyalgia. Future studies should assess how mind-body therapies aiming to cultivate mindfulness may impact the well-being of patients with fibromyalgia. KEY POINTS: • Higher mindfulness was associated with better psychological health and lower overall impact of fibromyalgia. • Mindfulness moderated the relationship between overall fibromyalgia impact and anxiety.

The role of personality in patients with fibromyalgia.

Previous studies suggest personality, the multifaceted characteristics underlying a person's affect, cognition, and behavior, may influence fibromyalgia. We examined associations among personality, fibromyalgia impact, and health-related outcomes in patients with fibromyalgia. We further tested whether anxiety and depression mediated the effect of personality on fibromyalgia impact. We performed a secondary analysis using baseline data from a randomized trial on fibromyalgia. Personality was assessed using the NEO-Five Factor Inventory 3. Fibromyalgia impact was evaluated using the revised Fibromyalgia Impact Questionnaire (FIQR). We also measured symptom severity, anxiety, depression, stress, quality of life, social support, self-efficacy, outcome expectations, and mindfulness. Multivariable linear regression was performed to evaluate each association. Mediation analysis assessed whether anxiety and depression mediated the relationship between personality and FIQR. There were 92 participants, 95% female, mean age 52 years, body mass index (BMI) 30 kg/m2, 52% white, and mean duration of body pain 14 years. Higher neuroticism was significantly associated with higher FIQR (P = 0.002) and symptom severity (P = 0.008), as well as higher levels of anxiety, depression and stress, worse mental component quality of life, and lower self-efficacy, mindfulness, and social support. Higher conscientiousness and extraversion were associated with better psychological health and health-related outcomes. The effect of neuroticism on fibromyalgia impact was mediated by anxiety and depression. Personality was associated with fibromyalgia impact and a variety of health outcomes. Identifying the factors that influence fibromyalgia will help us better understand the condition and provide insight for more effective treatment.