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.

Association between Pre-Intervention Physical Activity Level and Treatment Response to Exercise Therapy in Persons with Knee Osteoarthritis - An Exploratory Study.

OBJECTIVE: Examine whether pre-intervention physical activity (PA) level is associated with achieving a positive treatment response of pain and/or function improvement after a 12-week exercise intervention in participants with knee osteoarthritis (OA). METHODS: We performed a secondary analysis of a randomized, single-blind comparative effectiveness trial showing similar treatment effects between Tai Chi mind-body exercise and standard physical therapy intervention for knee OA. Baseline PA was assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire and, in a subsample, by tri-axial accelerometers. OMERACT-OARSI dichotomous responder criteria was used for clinically meaningful improvement at follow-up. Associations between baseline self-reported PA by CHAMPS and outcomes of responders vs. non-responders (reference group) were assessed using logistic regressions, adjusting for demographic covariates. We compared objectively-measured PA by accelerometry between responders vs. non-responders using Wilcoxon tests. RESULTS: Our sample consisted of 166 participants with knee OA who completed both baseline and 12-week post-intervention evaluations: mean age 60.7 year (SD 10.5), BMI 32.4 kg/m2 (6.9), 119 (72%) women, and 138 (83%) OMERACT-OARSI responders. Neither time spent in total PA (OR 1.00; 95% CI 0.96, 1.03) nor time in moderate-to-vigorous (MV) PA (OR 1.01; 95% CI 0.93, 1.09) at pre-intervention were associated with being a responder. Similar findings were observed in 42 accelerometry sub-cohort participants. CONCLUSION: Pre-intervention PA level (subjective report or objective measurement) was not associated with whether an individual will achieve favorable treatment outcomes after a 12-week exercise intervention, suggesting that regardless of pre-intervention PA level, individuals will likely benefit from structured exercise interventions.

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.

Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial.

OBJECTIVES: To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. DESIGN: Prospective, randomized, 52 week, single blind comparative effectiveness trial. SETTING: Urban tertiary care academic hospital in the United States between March 2012 and September 2016. PARTICIPANTS: 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. INTERVENTIONS: Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. MAIN OUTCOME MEASURES: The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. RESULTS: FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group difference in FIQR scores=16.2 points, 8.7 to 23.6, P<0.001). The groups who received tai chi for 24 weeks showed greater improvements than those who received it for 12 weeks (difference in FIQR scores=9.6 points, 2.6 to 16.6, P=0.007). There was no significant increase in benefit for groups who received tai chi twice weekly compared with once weekly. Participants attended the tai chi training sessions more often than participants attended aerobic exercise. The effects of tai chi were consistent across all instructors. No serious adverse events related to the interventions were reported. CONCLUSION: Tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise, the current most commonly prescribed non-drug treatment, for a variety of outcomes for patients with fibromyalgia. Longer duration of tai chi showed greater improvement. This mind-body approach may be considered a therapeutic option in the multidisciplinary management of fibromyalgia. TRIAL REGISTRATION: ClinicalTrials.gov NCT01420640.

Dose-Response Effects of Tai Chi and Physical Therapy Exercise Interventions in Symptomatic Knee Osteoarthritis.

BACKGROUND: Therapeutic exercise is a currently recommended nonpharmacological treatment for knee osteoarthritis (KOA). The optimal treatment dose (frequency or duration) has not been determined. OBJECTIVE: To examine dose-response relationships, minimal effective dose, and baseline factors associated with the timing of response from 2 exercise interventions in KOA. DESIGN: Secondary analysis of a single-blind, randomized trial comparing 12-week Tai Chi and physical therapy exercise programs (Trial Registry #NCT01258985). SETTING: Urban tertiary care academic hospital PARTICIPANTS: A total of 182 participants with symptomatic KOA (mean age 61 years; BMI 32 kg/m2, 70% female; 55% white). METHODS: We defined dose as cumulative attendance-weeks of intervention, and treatment response as ≥20% and ≥50% improvement in pain and function. Using log-rank tests, we compared time-to-response between interventions, and used Cox regression to examine baseline factors associated with timing of response, including physical and psychosocial health, physical performance, outcome expectations, self-efficacy, and biomechanical factors. MAIN OUTCOME MEASURES: Weekly Western Ontario and McMasters Osteoarthritis Index (WOMAC) pain (0-500) and function (0-1700) scores. RESULTS: Both interventions had an approximately linear dose-response effect resulting in a 9- to 11-point reduction in WOMAC pain and a 32- to 41-point improvement in function per attendance-week. There was no significant difference in overall time-to-response for pain and function between treatment groups. Median time-to-response for ≥20% improvement in pain and function was 2 attendance-weeks and for ≥50% improvement was 4-5 attendance-weeks. On multivariable models, outcome expectations were independently associated with incident function response (hazard ratio = 1.47, 95% confidence interval 1.004-2.14). CONCLUSIONS: Both interventions have approximately linear dose-dependent effects on pain and function; their minimum effective doses range from 2-5 weeks; and patient perceived benefits of exercise influence the timing of response in KOA. These results may help clinicians to optimize patient-centered exercise treatments and better manage patient expectations. LEVEL OF EVIDENCE: II.

Could Activity Modifications Indicate Physical Decline Among Adults With Symptomatic Knee Osteoarthritis?

OBJECTIVES: Mobility activity modifications indicate early functional losses that act as precursors to future declines among community-dwelling older adults. However, there is scarce evidence on whether activity modifications indicate poorer physical health among adults with symptomatic osteoarthritis, a major cause of disability. Our purpose was to investigate whether patient-reported mobility activity modifications indicated poorer physical health among adults with symptomatic knee osteoarthritis. DESIGN: Secondary cross-sectional analysis of randomized trial data was performed. Preclinical Disability Questionnaire was used to group participants into the following three categories: difficulty, modified, and no difficulty walking/stair climbing. Kruskal Wallis and χ tests were used to compare clinical factors across groups. RESULTS: Among 121 participants (median age = 60 yrs; 73% female; 60% white), less than 10% had modified walking/stair climbing. Compared with those with no walking difficulty, participants with modified walking had significantly less balance (P = 0.01) and global health (P = 0.01) as well as greater knee pain (P = 0.05) and physical disability (P = 0.04). Those with modified stair climbing had significantly smaller walking distances (P = 0.03) compared with those with no difficulty stair climbing. CONCLUSIONS: Activity modifications may signal early impairments in physical health among people with symptomatic knee osteoarthritis. If confirmed, patient-reported activity modifications may enhance symptom evaluation in osteoarthritis and enable a better understanding of the disablement process.

Effects of Tai Chi versus Physical Therapy on Mindfulness in Knee Osteoarthritis.

Tai Chi mind-body exercise is widely believed to improve mindfulness through incorporating meditative states into physical movements. A growing number of studies indicate that Tai Chi may improve health in knee osteoarthritis (OA), a chronic pain disease and a primary cause of global disability. However, little is known about the contribution of mindfulness to treatment effect of Tai Chi practice. Therefore, our purpose was to investigate the effect of Tai Chi mind-body practice compared to physical therapy (PT) on mindfulness in knee OA. Adults with radiographic-confirmed, symptomatic knee OA were randomized to either 12 weeks (twice weekly) of Tai Chi or PT. Participants completed the Five Facet Mindfulness Questionnaire (FFMQ) before and after intervention along with commonly-used patient-reported outcomes for pain, physical function, and other health-related outcomes. Among 86 participants (74% female, 48% white, mean age 60 years, 85% at least college educated), mean total FFMQ was 142±17. Despite substantial improvements in pain, function, and other health-related outcomes, each treatment group's total FFMQ did not significantly change from baseline (Tai Chi= 0.76, 95% CI: -2.93, 4.45; PT= 1.80, 95% CI: -2.33, 5.93). The difference in total FFMQ between Tai Chi and PT was not significant (-1.04 points, 95% CI: -6.48, 4.39). Mindfulness did not change after Tai Chi or PT intervention in knee OA, which suggests that Tai Chi may not improve health in knee OA through cultivating mindfulness. Further study is needed to identify underlying mechanisms of effective mind-body interventions among people with knee OA.

Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis.

Patient-Reported Outcomes Measurement Information System (PROMIS) instruments can provide valid, interpretable measures of health status among adults with osteoarthritis (OA). However, their ability to detect meaningful change over time is unknown. We evaluated the responsiveness and minimally important differences (MIDs) for 4 PROMIS Short Forms: Physical Function, Pain Interference, Depression, and Anxiety. We analyzed adults with symptomatic knee OA from our randomized trial comparing Tai Chi and physical therapy. Using baseline and 12-week scores, responsiveness was evaluated according to consensus standards by testing 6 a priori hypotheses of the correlations between PROMIS and legacy change scores. Responsiveness was considered high if ≥5 hypotheses were confirmed, and moderate if 3 or 4 were confirmed. MIDs were evaluated according to prospective change for people achieving previously-established MID on legacy comparators. The lowest and highest MIDs meeting a priori quality criteria formed a MID range for each PROMIS Short Form. Among 165 predominantly female (70%) and white (57%) participants, mean age was 61 years and body mass index was 33. PROMIS Physical Function had 5 confirmed hypotheses and Pain Interference, Depression, and Anxiety had 3 or 4. MID ranges were: Depression = 3.0 to 3.1; Anxiety = 2.3 to 3.4; Physical Function = 1.9 to 2.2; and Pain Interference = 2.35 to 2.4. PROMIS Physical Function has high responsiveness, and Depression, Anxiety, and Pain Interference have moderate responsiveness among adults with knee OA. We established the first MIDs for PROMIS in this population, and provided an important standard of reference to better apply or interpret PROMIS in future trials or clinical practice. PERSPECTIVE: This study examined whether PROMIS Short Form instruments (Physical Function, Pain Interference, Depression, and Anxiety) were able to detect change over time among adults with knee OA, and provided minimally important change estimates for each measure. This standard of reference can help apply or interpret these instruments in the future.

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.

Development of a clinical prediction algorithm for knee osteoarthritis structural progression in a cohort study: value of adding measurement of subchondral bone density.

BACKGROUND: Risk prediction algorithms increase understanding of which patients are at greatest risk of a harmful outcome. Our goal was to create a clinically useful prediction algorithm for structural progression of knee osteoarthritis (OA), using medial joint space loss as a proxy; and to quantify the benefit of including periarticular bone mineral density (BMD) in the algorithm. METHODS: Participants were from the Osteoarthritis Initiative (OAI) Progression Cohort, with X-ray readings of medial joint space at 36- and 48-month visits, and a 30- or 36-month medial-to-lateral tibial BMD ratio (M:L BMD ratio) value. Loss of medial joint space was the outcome and clinically available factors associated with OA progression were employed in the base prediction algorithm, with M:L BMD ratio added to an enhanced prediction algorithm. The benefit of adding M:L BMD ratio was evaluated by change in area under the ROC curve (AUC), net reclassification improvement (NRI), and integrated discrimination improvement (IDI). RESULTS: Five hundred thirty-three participants were included; 51 (14%) had medial joint space loss; 47% were female; the mean (SD) age was 64.6 (9.2) years and BMI was 29.6 (4.8) kg/m2. The base algorithm model included age, BMI, gender, recent injury, knee pain, and hand OA as predictors and had an AUC value of 0.65. The algorithm adding M:L BMD ratio had an AUC value of 0.73, and the AUC, NRI and IDI were all significantly improved (p ≤ 0.002). CONCLUSIONS: This clinical prediction algorithm predicts structural progression in individuals with OA using only clinically available predictors supplemented by the M:L BMD ratio, a biomarker that could be made available at clinical sites.

Outcome Expectations and Osteoarthritis: Association of Perceived Benefits of Exercise With Self-Efficacy and Depression.

OBJECTIVE: Outcome expectancy is recognized as a determinant of exercise engagement and adherence. However, little is known about which factors influence outcome expectations for exercise among people with knee osteoarthritis (OA). This is the first study to examine the association of outcome expectations for exercise with demographic, physical, and psychosocial outcomes in individuals with knee OA. METHODS: We performed a cross-sectional analysis of the baseline data from a randomized trial of tai chi versus physical therapy in participants with symptomatic knee OA. Knee pain was evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Outcome expectations for exercise, self-efficacy, depression, anxiety, stress, and social support were measured using standard instruments. Logistic regression models were utilized to determine associations with outcome expectations. RESULTS: There were 262 participants, with a mean age of 59.8 years and a mean body mass index of 32.1 kg/m2 ; 69.1% of the participants were female, 51.5% were white, the mean disease duration was 8.6 years, and the mean WOMAC knee pain and function scores were 260.8 and 906.8, respectively. Higher outcome expectations for exercise were associated with greater self-efficacy (odds ratio [OR] 1.25 [95% confidence interval (95% CI) 1.11-1.41]; P = 0.0004), as well as with fewer depressive symptoms (OR 0.84 for each 5-point increase [95% CI 0.73-0.97]; P = 0.01). Outcome expectancy was not significantly associated with sex, race, education, pain, function, radiographic severity, social support, anxiety, or stress. CONCLUSION: Our results suggest significant associations between outcome expectations for exercise and self-efficacy and depression. Future studies should examine how these relationships longitudinally affect long-term clinical outcomes of exercise-based treatment for knee OA.

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.

Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity.

BACKGROUND: The psychometric properties of Patient Reported Outcomes Measurement Information System (PROMIS) instruments have been explored in a number of general and clinical samples. No study, however, has evaluated the psychometric function of these measures in individuals with symptomatic knee osteoarthritis (KOA). The aim of this project was to evaluate the construct (structural) validity and floor/ceiling effects of four PROMIS measures in this population. METHODS: We conducted a secondary analysis of baseline data from a randomized trial comparing Tai Chi and physical therapy. Participants completed four PROMIS static short-form instruments (i.e., Anxiety, Depression, Physical Function, and Pain Interference) as well as six well-validated (legacy) measures that assess pain, function, and psychological health. We calculated descriptive statistics and percentages of participants scoring the minimum (floor) and maximum (ceiling) possible scores for PROMIS and legacy measures. We also estimated the association between PROMIS scores and scores on legacy measures using Spearman's rank correlations coefficients. RESULTS: Data from 204 participants were analyzed. Mean age of the sample was 60 years; 70% were female. The PROMIS Anxiety and Depression had floor effects with 17 and 24% of participants scoring the minimum, respectively. PROMIS Anxiety and Depression scores had strongest associations with general mental health, including stress (Perceived Stress Scale, r ≥ 0.65) and depression (Beck Depression Index-II, r = 0.70). PROMIS Pain Interference scores correlated most strongly with measures of whole body pain (Short-Form 36 Bodily Pain, r = -0.73) and physical health (Short-Form 36 Physical-Component Summary, r = -0.73); their correlations were lower with other legacy measures, including with the WOMAC knee-specific pain (r = 0.47). PROMIS Physical Function scores had stronger associations with scores on the Short-Form 36 Physical Function (r = 0.79) than with scores on other legacy measures. CONCLUSION: The four PROMIS static-short forms performed well among individuals with symptomatic knee osteoarthritis as evidenced in correlations with legacy measures. PROMIS Anxiety and Depression target general mental health (e.g., stress, depression), and PROMIS Pain Interference and Physical Function static-short forms target whole-body outcomes among participants with symptomatic knee osteoarthritis. Floor effects in the PROMIS Anxiety and Depression scores should be considered if needing to distinguish among patients with very low levels of these outcomes. TRIAL REGISTRATION: Clinicaltrials.gov NCT01258985. Registered 10 December 2010.

A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

BACKGROUND: Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. METHODS/DESIGN: A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ≥21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. DISCUSSION: This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short- and long-term effectiveness. The trial also explores multiple outcomes to elucidate the potential mechanisms of Tai Chi and aerobic exercise and the generalizability of these interventions across instructors. Results of this study are expected to have important public health implications for patients with a major disabling disease that incurs substantial health burdens and economic costs. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01420640 , registered 18 August 2011.

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.

Medication and supplement use for managing joint symptoms among patients with knee and hip osteoarthritis: a cross-sectional study.

BACKGROUND: The purpose was to determine the professionally-guided and self-guided medication and supplement use for joint symptom management among patients with knee and/or hip osteoarthritis (OA) in an urban hospital-based outpatient orthopedic practice. METHODS: The study design was cross-sectional. Patients diagnosed by radiographs and clinical symptoms with knee and/or hip OA were recruited from an inner-city hospital-based outpatient orthopaedic office. A total of 184 patients were queried for their participation. Four investigator-generated, interview-based questionnaires were used. Sampling error was ±7.84%. Logistic regression models and Fisher Exact Tests were performed to determine factors that may be associated with negative behaviors related to medication or supplement use (e.g., reporting medication as ineffective, using multiple medications in the same day to manage symptoms). Odds ratios (OR) and 95% confidence intervals (CI) were calculated for significant findings. RESULTS: Among the 162 participants, a majority reported professionally-guided recommendations and over 40% reported at least one self-guided intervention. 37 participants reported dual-use during the same day, and among those,15 reported dual-use at the same time. Among participants taking multiple interventions in the same day, 40.5% reported using prescription and over-the-counter medications. Use of multiple medications or supplements in one day was more common among participants who reported OA at multiple joints (OR [95% CI]=2.48 [1.03 to 5.96]) but less common among participants who did not complete high school (OR [95% CI]=0.26 [0.08 to 0.83]). Of the 15 participants who reported dual-use at the same time, 11 were professionally-guided, 5 were professional and self-guided, and 1 was solely self-guided. Overall, 28% of participants reported their intervention as ineffective, sought an alternative method to achieve symptomatic relief, or were prescribed a stronger medication. Participants who reported not always taking their medication consistently for 2 weeks were more likely to report their medication as ineffective (OR [95% CI]=2.87 [1.19 to 6.92]). CONCLUSIONS: Both professional and self-guided medications and supplements are used by inner city OA patients to manage their joint symptoms. It is important for clinicians to discuss with these patients how to effectively manage multiple joint symptoms, the importance of taking medications as prescribed, and what they should if they believe a treatment is ineffective or their medication runs out.

Joint inflammation and early degeneration induced by high-force reaching are attenuated by ibuprofen in an animal model of work-related musculoskeletal disorder.

We used our voluntary rat model of reaching and grasping to study the effect of performing a high-repetition and high-force (HRHF) task for 12 weeks on wrist joints. We also studied the effectiveness of ibuprofen, administered in the last 8 weeks, in attenuating HRHF-induced changes in these joints. With HRHF task performance, ED1+ and COX2+ cells were present in subchondral radius, carpal bones and synovium; IL-1alpha and TNF-alpha increased in distal radius/ulna/carpal bones; chondrocytes stained with Terminal deoxynucleotidyl Transferase- (TDT-) mediated dUTP-biotin nick end-labeling (TUNEL) increased in wrist articular cartilages; superficial structural changes (e.g., pannus) and reduced proteoglycan staining were observed in wrist articular cartilages. These changes were not present in normal controls or ibuprofen treated rats, although IL-1alpha was increased in reach limbs of trained controls. HRHF-induced increases in serum C1,2C (a biomarker of collagen I and II degradation), and the ratio of collagen degradation to synthesis (C1,2C/CPII; the latter a biomarker of collage type II synthesis) were also attenuated by ibuprofen. Thus, ibuprofen treatment was effective in attenuating HRHF-induced inflammation and early articular cartilage degeneration.