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.

Participating in Complementary and Integrative Health Approaches Is Associated With Veterans' Patient-reported Outcomes Over Time.

BACKGROUND: Veterans Affairs is dedicated to providing a Whole Health approach to care, including offering complementary and integrative health (CIH) approaches to Veterans. OBJECTIVE: The objective of this study was to examine the association of CIH participation with Veterans' patient-reported outcomes over time. RESEARCH DESIGN: A survey of patient-reported outcomes at 5 timepoints: baseline, 2, 4, 6, and 12 months. SUBJECTS: Veterans participating in any type of CIH approach at 2 Veterans Affairs medical centers. MEASURES: Mixed hierarchical models with repeated variables were used to test the hypothesis that participating in any CIH approach would be associated with Veterans' overall physical/mental health [Patient-Reported Outcomes Measurement Information System 28 (PROMIS 28)], pain intensity, perceived stress (Perceived Stress Scale-4), and engagement in their care (Patient Activation Measure-13), controlling for age, male sex, site, participation in other CIH approaches, and surveys completed. RESULTS: We received 401 surveys from 119 Veterans (72% male, age range: 29-85 y) across all timepoints. Yoga participation was related to decreases in perceived stress (P<0.001), while tai chi participation was associated with improvements in overall PROMIS 28 physical and mental health functioning (P<0.02). Specific types of CIH were associated with significant improvements in PROMIS 28 subscales: meditation participation with physical functioning at 2, 6, and 12 months; tai chi participation with anxiety at 2 and 6 months, and ability to participate in social role activities at 2 months. No CIH approach was associated with Veterans' pain or engagement in their care. CONCLUSION: As specific CIH approaches are associated with improvements in patient-reported outcomes, clinicians, Veterans, and family members may use this information in discussions of nonpharmacological options to address health and well-being.

The Connectedness of Mental Health Providers Referring Patients to a Treatment Study for Post-Traumatic Stress: A Social Network Study.

We conducted a process evaluation in the context of a Hybrid Type 1 randomized controlled trial testing two treatments for post-traumatic stress, using a web-based social network survey and semi-structured interviews to illustrate the relationship between providers' influence and likelihood of referring patients to the RCT. Providers with high indegree centrality (designated by other providers as someone they seek information from) were significantly more likely to refer patients to the RCT, and serve as an influence to others' referral behavior. Interviews provided additional data to consider for future studies aimed at increasing the uptake of evidence-based practices.

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.

Individual Treatment of Posttraumatic Stress Disorder Using Mantram Repetition: A Randomized Clinical Trial.

OBJECTIVE: Previous studies suggest that group "mantram" (sacred word) repetition therapy, a non-trauma-focused complementary therapy for posttraumatic stress disorder (PTSD), may be an effective treatment for veterans. The authors compared individually delivered mantram repetition therapy and another non-trauma-focused treatment for PTSD. METHOD: The study was a two-site, open-allocation, blinded-assessment randomized trial involving 173 veterans diagnosed with military-related PTSD from two Veterans Affairs outpatient clinics (January 2012 to March 2014). The mantram group (N=89) learned skills for silent mantram repetition, slowing thoughts, and one-pointed attention. The comparison group (N=84) received present-centered therapy, focusing on currently stressful events and problem-solving skills. Both treatments were delivered individually in eight weekly 1-hour sessions. The primary outcome measure was change in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS) and by self-report. Secondary outcome measures included insomnia, depression, anger, spiritual well-being, mindfulness, and quality of life. Intent-to-treat analysis was conducted using linear mixed models. RESULTS: The mantram group had significantly greater improvements in CAPS score than the present-centered therapy group, both at the posttreatment assessment (between-group difference across time, -9.98, 95% CI=-3.63, -16.00; d=0.49) and at the 2-month follow-up (between-group difference, -9.34, 95% CI=-1.50, -17.18; d=0.46). Self-reported PTSD symptom severity was also lower in the mantram group compared with the present-centered therapy group at the posttreatment assessment, but there was no difference at the 2-month follow-up. Significantly more participants in the mantram group (59%) than in the present-centered therapy group (40%) who completed the 2-month follow-up no longer met criteria for PTSD (p<0.04). However, the percentage of participants in the mantram group (75%) compared with participants in the present-centered therapy group (61%) who experienced clinically meaningful changes (≥10-point improvements) in CAPS score did not differ significantly between groups. Reductions in insomnia were significantly greater for participants in the mantram group at both posttreatment assessment and 2-month follow-up. CONCLUSIONS: In a sample of veterans with PTSD, individually delivered mantram repetition therapy was generally more effective than present-centered therapy for reducing PTSD symptom severity and insomnia.

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.