Yoga Versus Education for Veterans with Chronic Low Back Pain: a Randomized Controlled Trial.

BACKGROUND: Yoga is effective for chronic low back pain (cLBP) in civilians but understudied among Veterans. OBJECTIVE: Determine whether yoga is more effective than an educational book for improving disability and pain among Veterans with cLBP. DESIGN, SETTING, AND PARTICIPANTS: Veterans diagnosed with cLBP at a VA medical center enrolled in a randomized controlled trial from March to December of 2015. INTERVENTIONS: Twelve weekly hatha yoga classes or education using The Back Pain Helpbook. MEASURES: Co-primary outcomes were changes from baseline at 12 weeks in back-related disability on the modified Roland Morris Disability Questionnaire and pain on the Defense & Veterans Pain Rating Scale. Secondary outcomes were global improvement, patient satisfaction, pain medication use, and post-traumatic stress symptoms. An intention-to-treat approach was used in primary analyses. RESULTS: One hundred twenty Veterans (mean age, 55.5 [SD = 16.9]; 11 [9%] women; mean number of chronic conditions, 5.5) were randomized to yoga (n = 62) and education (n = 58). At 12 weeks, reductions in back-related disability in yoga (mean difference [MD] = - 3.50, 95% CI: - 5.03, - 1.97) were not significantly different than education (MD = - 2.55, 95% CI: - 4.10, - 0.99; between-group difference: - 0.95 [95% CI: - 3.14, 1.23], p = 0.39). For pain, there was no significant difference between yoga (MD = - 1.01, 95% CI: - 1.67, - 0.35) and education (MD = - 0.81, 95% CI: - 1.36, - 0.27; between-group difference: - 0.20, 95% CI: - 1.06, 0.66, p = 0.65). More yoga than education participants reported being very much or extremely improved (39% vs 19%, OR = 3.71, 95% CI: 1.37, 10.02, p = 0.01) and very satisfied with treatment (60% vs 31%, OR = 4.28, 95% CI: 1.70, 10.77, p = 0.002). No differences in pain medication use or post-traumatic stress symptoms were observed at 12 weeks. No serious adverse events were reported in either group. CONCLUSION: Twelve weekly yoga classes were not more effective than an education intervention for improving pain or disability outcomes among mostly older male Veterans with cLBP and multiple comorbid health conditions. GOV IDENTIFIER: NCT02224183.

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER), a pragmatic trial for conservative chronic low back pain treatment.

BACKGROUND: Chronic low back pain (cLBP) is a common and highly disabling problem world-wide. Although many treatment options exist, it is unclear how to best sequence the multitude of care options to provide the greatest benefit to patients. METHODS: The Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response (SCEPTER) trial uses a pragmatic, randomized, stepped design. Enrollment targets 2529 participants from 20 Veterans Affairs (VA) medical centers. Participants with chronic low back pain will first be randomized to one of three options: 1) an internet-based self-management program (Pain EASE); 2) a tailored physical therapy program (Enhanced PT); or 3) continued care with active monitoring (CCAM), a form of usual care. Participants not achieving a 30% or 2-point reduction on the study's primary outcome (Brief Pain Inventory Pain Interference (BPI-PI) subscale), 3 months after beginning treatment may undergo re-randomization in a second step to cognitive behavioral therapy for chronic pain, spinal manipulation therapy, or yoga. Secondary outcomes include pain intensity, back pain-related disability, depression, and others. Participants will be assessed every three months until 12 months after initiating their final trial therapy. Companion economic and implementation analyses are also planned. RESULTS: The SCEPTER trial is currently recruiting and enrolling participants. CONCLUSIONS: Trial results will inform treatment decisions for the stepped management of chronic low back pain - a common and disabling condition. Additional analyses will help tailor treatment selection to individual patient characteristics, promote efficient resource use, and identify implementation barriers of interventions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT04142177.

The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA) trial: Design and methods.

Being overweight or obese is a primary modifiable risk factor that exacerbates disease progression and mobility disability in older knee osteoarthritis (OA) patients. Lifestyle interventions combining exercise with dietary weight loss (EX+DWL) yield meaningful improvements in mobility and weight loss that are superior to EX or DWL alone. Unfortunately, community access to practical, sustainable weight management interventions remains limited and places knee OA patients at increased risk of mobility disability. The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis patients (CLIP-OA), was a two-arm, 18 month randomized-controlled, comparative effectiveness trial designed to contrast the effects of an evidence-based, theory-driven EX+DWL intervention, personalized to patient needs and delivered by our community partners, with those of the Arthritis Foundation's Walk With Ease (WWE) standard of care self-management program in the treatment of knee OA patients with overweight or obesity. The primary outcome of the CLIP-OA trial was mobility performance assessed using the 400-m walk test (400MWT). Secondary outcomes included weight loss, pain, select quality of life and social cognitive variables, and cost-effectiveness of intervention delivery. Findings from the CLIP-OA trial will determine the comparative and cost-effectiveness of the EX+DWL and WWE interventions on key clinical outcomes and has the potential to offer a sustainable medium for intervention delivery that can promote widely accessible weight management among knee OA patients with overweight or obesity. Trial Registration: NCT02835326.

Secondary Outcomes from a Randomized Controlled Trial of Yoga for Veterans with Chronic Low-Back Pain.

Chronic low-back pain (cLBP) is a prevalent condition, and rates are higher among military veterans. cLBP is a persistent condition, and treatment options have either modest effects or a significant risk of side-effects, which has led to recent efforts to explore mind-body intervention options and reduce opioid medication use. Prior studies of yoga for cLBP in community samples, and the main results of a recent trial with military veterans, indicate that yoga can reduce back-related disability and pain intensity. Secondary outcomes from the trial of yoga with military veterans are presented here. In the study, 150 military veterans (Veterans Administration patients) with cLBP were randomized to either yoga or a delayed-treatment group receiving usual care between 2013 and 2015. Assessments occurred at baseline, 6 weeks, 12 weeks, and 6 months. Intent-to-treat analyses were conducted. Yoga classes lasting 60 minutes each were offered twice weekly for 12 weeks. Yoga sessions consisted of physical postures, movement, focused attention, and breathing techniques. Home practice guided by a manual was strongly recommended. The primary outcome measure was Roland-Morris Disability Questionnaire scores after 12 weeks. Secondary outcomes included pain intensity, pain interference, depression, fatigue, quality of life, self-efficacy, and medication usage. Yoga participants improved more than delayed-treatment participants on pain interference, fatigue, quality of life, and self-efficacy at 12 weeks and/or 6 months. Yoga participants had greater improvements across a number of important secondary health outcomes compared to controls. Benefits emerged despite some veterans facing challenges with attending yoga sessions in person. The findings support wider implementation of yoga programs for veterans, with attention to increasing accessibility of yoga programs in this population.

Rethinking endometriosis care: applying the chronic care model via a multidisciplinary program for the care of women with endometriosis.

Endometriosis is a chronic, painful disease without a cure. Due largely to chronic pain, endometriosis can lead to significant physical, mental, relationship, and financial burdens. Within the conventional single provider model of care-in which the patient is primarily taken care of by her physician and complementary strategies based on psychology, nutrition, pain medicine, pelvic physical therapy, and so on may not be readily available in a coordinated manner-most women with endometriosis live with unresolved pain and the consequences of that pain. We therefore propose that there is an urgent need to search for alternative models of care. In the current paper, we discuss our experiences with an model of care in which we adopt a long-term, patient-focused, and multidisciplinary chronic care model for women with endometriosis. Our objective is to improve long-term clinical outcomes for women with endometriosis. For geographical areas and healthcare systems in which it is feasible, we propose consideration of this multidisciplinary model of care as an alternative to the single provider model and offer guidance for those considering establishment of such a program. We also initiate a conversation about which clinical outcomes pertaining to endometriosis are important and should be tracked to assess the efficacy and value of multidisciplinary and other endometriosis healthcare models.

Physical Activity and Performance Impact Long-term Quality of Life in Older Adults at Risk for Major Mobility Disability.

INTRODUCTION: Older adults are a rapidly growing segment of the U.S. POPULATION: Mobility problems that lead to further disability can be addressed through physical activity interventions. Quality of life outcome results are reported from a large trial of physical activity for sedentary older adults at risk for mobility disability. METHODS: Data were from the Lifestyle Interventions and Independence for Elders study. This multisite RCT compared physical activity to health education among 1,635 randomly assigned sedentary older adults at risk for mobility disability in 2010-2011. Measures included demographics; comorbidity; a timed 400-meter walk; the Short Physical Performance Battery; and the Quality of Well-Being Scale (0-1.0 scale). Baseline and long-term follow-up (2.6 years) health-related quality of life data were collected as a secondary outcome. Multivariate linear regression modeling was used to examine covariates of health-related quality of life over time in 2017. RESULTS: The sample had an overall mean Quality of Well-Being score of 0.613. Both groups declined in quality of life over time, but assignment to the physical activity intervention resulted in a slower decline in health-related quality of life scores (p=0.03). Intervention attendance was associated with higher health-related quality of life for both groups. Baseline characteristics including younger age, fewer comorbid conditions, non-white ethnicity, and faster 400-meter walk times were also associated with higher health-related quality of life over time. CONCLUSIONS: Declining mobility measured by physical performance is associated with lower quality of life in sedentary older adults. Physical activity interventions can slow the decline in quality of life, and targeting specific subgroups may enhance the effects of such interventions.

Yoga for Military Veterans with Chronic Low Back Pain: A Randomized Clinical Trial.

INTRODUCTION: Chronic low back pain (cLBP) is prevalent, especially among military veterans. Many cLBP treatment options have limited benefits and are accompanied by side effects. Major efforts to reduce opioid use and embrace nonpharmacological pain treatments have resulted. Research with community cLBP patients indicates that yoga can improve health outcomes and has few side effects. The benefits of yoga among military veterans were examined. DESIGN: Participants were randomized to either yoga or delayed yoga treatment in 2013-2015. Outcomes were assessed at baseline, 6 weeks, 12 weeks, and 6 months. Intention-to-treat analyses occurred in 2016. SETTING/PARTICIPANTS: One hundred and fifty military veterans with cLBP were recruited from a major Veterans Affairs Medical Center in California. INTERVENTION: Yoga classes (with home practice) were led by a certified instructor twice weekly for 12 weeks, and consisted primarily of physical postures, movement, and breathing techniques. MAIN OUTCOME MEASURES: The primary outcome was Roland-Morris Disability Questionnaire scores after 12 weeks. Pain intensity was identified as an important secondary outcome. RESULTS: Participant characteristics were mean age 53 years, 26% were female, 35% were unemployed or disabled, and mean back pain duration was 15 years. Improvements in Roland-Morris Disability Questionnaire scores did not differ between the two groups at 12 weeks, but yoga participants had greater reductions in Roland-Morris Disability Questionnaire scores than delayed treatment participants at 6 months -2.48 (95% CI= -4.08, -0.87). Yoga participants improved more on pain intensity at 12 weeks and at 6 months. Opioid medication use declined among all participants, but group differences were not found. CONCLUSIONS: Yoga improved health outcomes among veterans despite evidence they had fewer resources, worse health, and more challenges attending yoga sessions than community samples studied previously. The magnitude of pain intensity decline was small, but occurred in the context of reduced opioid use. The findings support wider implementation of yoga programs for veterans. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02524158.

Cost-effectiveness of the LIFE Physical Activity Intervention for Older Adults at Increased Risk for Mobility Disability.

BACKGROUND: Losing the ability to walk safely and independently is a major concern for many older adults. The Lifestyle Interventions and Independence for Elders study recently demonstrated that a physical activity (PA) intervention can delay the onset of major mobility disability. Our objective is to examine the resources required to deliver the PA intervention and calculate the incremental cost-effectiveness compared with a health education intervention. METHODS: The Lifestyle Interventions and Independence for Elders study enrolled 1,635 older adults at risk for mobility disability. They were recruited at eight field centers and randomly assigned to either PA or health education. The PA program consisted of 50-minute center-based exercise 2× weekly, augmented with home-based activity to achieve a goal of 150 min/wk of PA. Health education consisted of weekly workshops for 26 weeks, and monthly sessions thereafter. Analyses were conducted from a health system perspective, with a 2.6-year time horizon. RESULTS: The average cost per participant over 2.6 years was US$3,302 and US$1,001 for the PA and health education interventions, respectively. PA participants accrued 0.047 per person more Quality-Adjusted Life-Years (QALYs) than health education participants. PA interventions costs were slightly higher than other recent PA interventions. The incremental cost-effectiveness ratios were US$42,376/major mobility disability prevented and US$49,167/QALY. Sensitivity analyses indicated that results were relatively robust to varied assumptions. CONCLUSIONS: The PA intervention costs and QALYs gained are comparable to those found in other studies. The ICERS are less than many commonly recommended medical treatments. Implementing the intervention in non-research settings may reduce costs further.

Instruments for measuring mental health recovery: a systematic review.

Persons in recovery, providers, and policymakers alike are advocating for recovery-oriented mental health care, with the promotion of recovery becoming a prominent feature of mental health policy in the United States and internationally. One step toward creating a recovery-oriented system of care is to use recovery-oriented outcome measures. Numerous instruments have been developed to assess progress towards mental health recovery. This review identifies instruments of mental health recovery and evaluates the appropriateness of their use including their psychometric properties, ease of administration, and service-user involvement in their development. A literature search using the Medline and Psych-INFO databases was conducted, identifying 21 instruments for potential inclusion in this review, of which thirteen met inclusion criteria. Results suggest only three instruments (25%) have had their psychometric properties assessed in three or more unique samples of participants. Ease of administration varied between instruments, and for the majority of instruments, development included service user involvement. This review updates and expands previous reviews of instruments to assess mental health recovery. As mental health care continues to transform to a recovery-oriented model of service delivery, this review may facilitate selection of appropriate assessments of mental health recovery for systems to use in evaluating and improving the care they provide.

An economic analysis of traditional and technology-based approaches to weight loss.

BACKGROUND: The financial burden and human losses associated with noncommunicable diseases necessitate cost-effective and efficacious interventions. PURPOSE: An economic analysis of the Lifestyle Education for Activity and Nutrition (LEAN) Study; an RCT that examined the efficacy of traditional and technology-based approaches to weight loss. METHODS: Economic analyses from an organizational perspective were conducted for four approaches: standard care control (SC); group weight-loss education (GWL); a multisensor armband (SWA); and the armband in combination with group weight-loss education (GWL+SWA). Data were collected in 2008-2009. Weight loss was the primary outcome. Total costs, costs per participant, costs per kilogram lost, and incremental cost-effectiveness ratios (ICERs) were calculated in 2010-2011. All costs are the actual expenses (i.e., staff time and materials) incurred by the LEAN study (except where noted) and reported in 2010 U.S. dollars. RESULTS: In the sample population of 197 sedentary, overweight, and obese adults (mean [±SD] age=46.9 ± 0.8 years, BMI=33.3 ± 5.2, weight=92.8 ± 18.4 kg), the GWL+SWA was the most expensive intervention in costs/participant ($365/partic) while yielding the greatest weight loss/partic (6.59 kg). The GWL was next in cost/partic ($240), but the SWA was less expensive in cost/partic ($183) and more efficacious (3.55 vs 1.86 kg/partic). The SC did not achieve significant weight loss. The SWA was the most cost effective ($51/partic/kg lost), followed by the GWL+SWA ($55) and GWL alone ($129). The ICER suggests that for each additional kilogram lost, the GWL+SWA cost $60 more than the SWA alone. CONCLUSIONS: The SWA was the most cost-effective intervention ($51/partic/kg lost). The addition of the GWL increased the efficacy of the SWA intervention but increased costs by $60/partic for each additional kilogram lost. The technology-based approaches were more cost effective and efficacious than traditional approaches in promoting weight loss via lifestyle changes in sedentary, overweight, and obese adults.