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.

The Use of Multispectral Imaging in DIEP Free Flap Perforator Selection: A Case Study.

Perforator selection is of paramount importance when performing a Deep Inferior Epigastric Perforator flap. Technological advancements within imaging modalities have proved invaluable in preoperative planning and intraoperative assessment. Computed tomographic angiography remains the gold standard for preoperative perforator mapping, while color ultrasound Doppler is considered more reliable for determining vessel caliber. Intraoperatively, an imaging modality that provides sequential, real-time assessment of various perforators' supply to the flap would provide helpful insight to determine which perforator will optimize flap viability, especially of the most distal, lateral margins. Multispectral imaging, a variant of near infrared imaging, has emerged as an alternative method to assess tissue viability in the operating room as well as postoperatively. Unlike Spy technology, which is invasive and cost ineffective, the SnapshotNIR (KD203) is a handheld multispectral imaging device utilizing NIR to measure the oxygenation of the hemoglobin in the area to calculate the tissue oxygen content (StO2) displayed in a color image. The following case of a 46-year-old woman undergoing tertiary breast reconstruction for treatment of progressive grade 2 capsular contracture illustrates the utility and ease of KD203 application to intra-operative perforator determination in deep inferior epigastric perforator flap assessment.

Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial).

BACKGROUND: Low back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP. METHODS AND STUDY DESIGN: The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently. DISCUSSION: The TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT. TRIAL REGISTRATION: ClinicalTrials.govNCT02647658 Registered Jan. 6, 2016.

Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial.

BACKGROUND: Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations. METHODS/DESIGN: This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records. DISCUSSION: This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02224183.

"We're all in this together": A qualitative study of predominantly low income minority participants in a yoga trial for chronic low back pain.

OBJECTIVE: To explore the experiences of low-income minority adults taking part in a yoga dosing trial for chronic low back pain. DESIGN: Individual semi-structured interviews were conducted with nineteen participants recruited from a randomized yoga dosing trial for predominantly low-income minority adults with chronic low back pain. Interviews discussed the impact of yoga on low back pain and emotions; other perceived advantages or disadvantages of the intervention; and facilitators and barriers to practicing yoga. Interviews were audio taped and transcribed, coded using ATLAS.ti software, and analyzed with inductive and deductive thematic analysis methods. SETTING: Boston Medical Center, Boston, MA, USA. RESULTS: Participants viewed yoga as a means of pain relief and attributed improved mood, greater ability to manage stress, and enhanced relaxation to yoga. Overall, participants felt empowered to self-manage their pain. Some found yoga to be helpful in being mindful of their emotions and accepting of their pain. Trust in the yoga instructors was a commonly cited facilitator for yoga class attendance. Lack of time, motivation, and fear of injury were reported barriers to yoga practice. CONCLUSIONS: Yoga is a multidimensional treatment for low back pain that has the potential to favorably impact health in a predominantly low-income minority population.

Participant Characteristics Associated with Symptomatic Improvement from Yoga for Chronic Low Back Pain.

CONTEXT: Studies suggest that yoga is effective for moderate to severe chronic low back pain (cLBP) in diverse predominantly lower socioeconomic status populations. However, little is known about factors associated with benefit from the yoga intervention. OBJECTIVE: Identify factors at baseline independently associated with greater efficacy among participants in a study of yoga for cLBP. DESIGN: From September-December 2011, a 12-week randomized dosing trial was conducted comparing weekly vs. twice-weekly 75-minute hatha yoga classes for 95 predominantly low-income minority adults with nonspecific cLBP. Participant characteristics collected at baseline were used to determine factors beyond treatment assignment (reported in the initial study) that predicted outcome. We used bivariate testing to identify baseline characteristics associated with improvement in function and pain, and included select factors in a multivariate linear regression. SETTING: Recruitment and classes occurred in an academic safety-net hospital and five affiliated community health centers in Boston, Massachusetts. PARTICIPANTS: Ninety-five adults with nonspecific cLBP, ages ranging from 20-64 (mean 48) years; 72 women and 23 men. OUTCOME MEASURES: Primary outcomes were changes in back-related function (modified Roland-Morris Disability Questionnaire, RMDQ; 0-23) and mean low back pain intensity (0-10) in the previous week, from baseline to week 12. RESULTS: Adjusting for group assignment, baseline RMDQ, age, and gender, foreign nationality and lower baseline SF36 physical component score (PCS) were independently associated with improvement in RMDQ. Greater than high school education level, cLBP less than 1 year, and lower baseline SF36 PCS were independently associated with improvement in pain intensity. Other demographics including race, income, gender, BMI, and use of pain medications were not associated with either outcome. CONCLUSIONS: Poor physical health at baseline is associated with greater improvement from yoga in back-related function and pain. Race, income, and body mass index do not affect the potential for a person with low back pain to experience benefit from yoga.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

BACKGROUND: Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. METHODS/DESIGN: This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.

Embodied health: the effects of a mind-body course for medical students.

OBJECTIVE: An effective career in medicine requires empathy and compassion, yet the demands of a medical education increase stress and decrease students' ability to connect with patients. However, research suggests mind-body practices improve psychological well-being. This study aimed to evaluate the psychological effects on medical students of an 11-week elective course, Embodied Health or EH, which combines yoga and meditation with neuroscience didactics. METHODS: The effects on 27 first- and second-year medical students were evaluated via surveys in four areas: empathy, perceived stress, self-regulation, and self-compassion. Scales used were 1. Jefferson Scale of Physician Empathy, which measures empathy among health students and professionals and medical students on a scale of 1 (least empathetic) to 7 (most empathetic); 2. Cohen's Perceived Stress Scale, a measure of the perceived uncontrollability of respondents' lives, from 0 (least stressed) to 4 (most stressed); 3. Self-Regulation Questionnaire, which measures the development and maintenance of planned behavior to achieve goals, from 1 (least self-regulated) to 5 (most self-regulated); and 4. Self-Compassion Scale, which measures self-criticism, from 1 (least self-compassionate) to 5 (most self-compassionate). Students also reflected on EH's impact on their well-being in a post-course essay. RESULTS: Self-regulation and self-compassion rose 0.13 (SD 0.20, p=0.003) and 0.28 (SD 0.61, p=0.04), respectively. Favorable changes were also seen in empathy and perceived stress, which went up by 0.11 (SD 0.50, p=0.30) and down by 0.05 (SD 0.62, p=0.70), respectively; these changes did not reach statistical significance. Students' essays were found to discuss the following recurrent themes: 1) Reconnection between mind and body; 2) Community in a competitive environment; 3) Increased mindfulness; 4) Confidence in use of mind-body skills with patients; and 5) Stress management. These themes overlapped with the measures EH affected quantitatively. CONCLUSION: A mind-body course for medical students increased self-regulation and self-compassion. Qualitative themes discussed in students' post-course essays reflected these effects.