Mindfulness-based Interventions for Chronic Low Back Pain: A Systematic Review and Meta-analysis.

OBJECTIVE: This systematic review aimed to compile existing evidence examining the effects of mindfulness-based interventions (MBIs) for chronic low back pain (CLBP). CLBP leads to millions of disabled individuals in the United States each year. Current pharmacologic treatments are only modestly effective and may present long-term safety issues. MBIs, which have an excellent safety profile, have been shown in prior studies to be effective in treating CLBP yet remained underutilized. DESIGN: Ovid/Medline, PubMed, Embase, and the Cochrane Library were searched for randomized controlled trials (RCTs), pilot RCTs, and single-arm studies that explored the effectiveness of MBIs in CLBP. METHODS: Separate searches were conducted to identify trials that evaluated MBIs in reducing pain intensity in individuals with CLBP. A meta-analysis was then performed using R v3.2.2, Metafor package v 1.9-7. RESULTS: Eighteen studies used validated patient-reported pain outcome measures and were therefore included in the meta-analysis. The MBIs included mindfulness meditation, mindfulness-based stress reduction, mindfulness-based cognitive therapy, mindfulness-oriented recovery enhancement, acceptance and commitment therapy, dialectical behavioral therapy, meditation-cognitive behavioral therapy, mindfulness-based care for chronic pain, self-compassion course, and loving-kindness course. Pain intensity scores were reported using a numerical rating scale (0 to 10) or an equivalent scale. The meta-analysis revealed that MBIs have a beneficial effect on pain intensity with a large-sized effect in adults with CLBP. CONCLUSIONS: MBIs seem to be beneficial in reducing pain intensity. Although these results were informative, findings should be carefully interpreted due to the limited data the high variability in study methodologies, small sample sizes, inclusion of studies with high risk of bias, and reliance on pre-post treatment differences with no attention to maintenance of effects. More large-scale RCTs are needed to provide reliable effect size estimates for MBIs in persons with CLBP.

To be aware, or to accept, that is the question: Differential roles of awareness of automaticity and pain acceptance in opioid misuse.

BACKGROUND: Individuals with chronic low back pain (CLBP) are commonly prescribed long-term opioid therapy (LTOT) for analgesia, placing this population at increased risk for opioid misuse and opioid use disorder. Acceptance of aversive experiences (e.g., chronic pain) and awareness of automatic thoughts and behaviors (i.e., automaticity) are two facets of dispositional mindfulness that may serve as protective mechanisms against opioid misuse risk. Therefore, the aim of the current study was to examine the differential contributions of these constructs to opioid misuse risk among adults with CLBP receiving LTOT. METHODS: Data were obtained from a sample of 770 adults with opioid-treated CLBP. Bivariate correlations and hierarchical linear regression analyses were used to determine whether chronic pain acceptance and awareness of automatic thoughts and behaviors explained a statistically significant portion of variance in opioid misuse risk after accounting for the effects of other relevant confounders. RESULTS: Hierarchical regression results revealed that chronic pain acceptance and awareness of automatic thoughts and behaviors contributed a significant portion in the variance of opioid misuse risk. Awareness of automatic thoughts and behaviors was negatively associated with opioid misuse risk, such that individuals with lower levels of awareness of automaticity were at higher risk of opioid misuse. By contrast, pain acceptance was not associated with opioid misuse. CONCLUSIONS: Findings suggest that awareness of automaticity may buffer against opioid misuse risk. Interventions designed to strengthen awareness of automaticity (e.g., mindfulness-based interventions) might be especially efficacious among this population.

Adjunctive osteopathic therapy for hospitalized COVID-19 patients: A feasibility-oriented chart review study with matched controls.

Background: Osteopathic manipulative treatment (OMT) may improve outcomes during COVID-related respiratory distress - the most common cause of death from novel coronavirus (SARS-CoV-2). Outcomes from OMT treatments of respiratory distress during the COVID-19 pandemic have not been reported. Objective: Assess adjunctive OMT in hospitalized patients with SARS-CoV-2 and respiratory distress. Design: Feasibility oriented retrospective observational cohort study. Setting: COVID-19 (non-ICU) ward in a tertiary academic medical center. Methods: Inpatients received daily OMT treatments of rib raising, abdominal diaphragm doming, thoracic pump and pedal pump. Primary outcomes were procedural acceptance, satisfaction, side effects, and adverse events. Secondary outcomes were patient-reported clinical change after therapy; number of hospital days; need during hospitalization for high-flow oxygen, C-PAP/BiPAP or intensive care; need for supplementary oxygen at discharge; and discharge disposition. Participants: Hospitalized adults with SARS-CoV-2 infection and respiratory distress. Results: OMT (n = 27) and Control (n = 152) groups were similar in demographics and most laboratory studies. 90% of patients accepted OMT and reported high satisfaction (4.26/±0.71 (maximum 5)), few negative effects, no adverse events, and positive clinical change (5.07 ± 0.96 (maximum 7)). Although no significant differences were found in secondary outcomes, OMT patients trended towards fewer hospital days than Controls (p = 0.053; Cohen's d = 0.22), a relationship that trended towards correlation with number of co-morbidities (p = 0.068). Conclusion: Hospitalized patients with respiratory distress and COVID-19 reported acceptance, satisfaction, and greater ease of breathing after a four-part OMT protocol, and appear to have a shorter length of hospitalization. Randomized controlled trials are needed to confirm these results.

Mindfulness-Based Stress Reduction Live Online During the COVID-19 Pandemic: A Mixed Methods Feasibility Study.

Objectives: To assess the feasibility, acceptability, and effects of Mindfulness Based Stress Reduction (MBSR) live online during the COVID-19 shutdown. Design: Mixed-methods study using a sequential explanatory design. Settings/location: Cohorts 1-4 took place in-person and Cohorts 5-6 took place over Zoom following the onset of the COVID-19 pandemic. Subjects: Participants were paying members of the general public enrolled in one of six live MBSR courses. Interventions: All MBSR courses followed the standard 8-week MBSR curriculum, led by experienced instructors. Outcome measures: Feasibility measured via class attendance, acceptability measured via the adapted Treatment Satisfaction Survey, and MBSR course effects measured by a focus group with Cohort 5, and the following assessments completed by all cohorts: Perceived Stress Scale-10, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9 and the 36-item Short Form Survey. Results: 73 adults participated in six live MBSR courses (48 in the four in-person courses; 25 in the two online courses). Most of the participants identified as white, non-Hispanic, middle-aged females, with annual household income >$100,000. Course completion, defined as at least 6/8 classes attended, did not differ between in-person and online cohorts (84.1% versus 67.6%, respectively, p = 0.327). Participants in Cohort 5 who completed the course (n = 10) rated it as very important and useful for stress coping, and reported high likelihood of continuing their mindfulness practice (all ratings: between 8 and 10 on a 1-10 Likert scale), with open-ended responses corroborating their numerical ratings. Focus group (n = 6) responses indicated that online MBSR was positively received, reduced perceived loss of control, and improved quality of life and morale during the pandemic. Conclusions: Delivering MBSR live online can be feasible and acceptable for the general public, and is potentially beneficial, including during the social upheaval of the COVID-19 pandemic. Online delivery could help expand access to MBSR and address health inequities.

Mindfulness-based interventions for substance use disorders.

BACKGROUND: Substance use disorders (SUDs) are highly prevalent and associated with a substantial public health burden. Although evidence-based interventions exist for treating SUDs, many individuals remain symptomatic despite treatment, and relapse is common.Mindfulness-based interventions (MBIs) have been examined for the treatment of SUDs, but available evidence is mixed. OBJECTIVES: To determine the effects of MBIs for SUDs in terms of substance use outcomes, craving and adverse events compared to standard care, further psychotherapeutic, psychosocial or pharmacological interventions, or instructions, waiting list and no treatment. SEARCH METHODS: We searched the following databases up to April 2021: Cochrane Drugs and Alcohol Specialised Register, CENTRAL, PubMed, Embase, Web of Science, CINAHL and PsycINFO. We searched two trial registries and checked the reference lists of included studies for relevant randomized controlled trials (RCTs). SELECTION CRITERIA: RCTs testing a MBI versus no treatment or another treatment in individuals with SUDs. SUDs included alcohol and/or drug use disorders but excluded tobacco use disorders. MBIs were defined as interventions including training in mindfulness meditation with repeated meditation practice. Studies in which SUDs were formally diagnosed as well as those merely demonstrating elevated SUD risk were eligible. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: Forty RCTs met our inclusion criteria, with 35 RCTs involving 2825 participants eligible for meta-analysis. All studies were at high risk of performance bias and most were at high risk of detection bias. Mindfulness-based interventions (MBIs) versus no treatment Twenty-four RCTs included a comparison between MBI and no treatment. The evidence was uncertain about the effects of MBIs relative to no treatment on all primary outcomes: continuous abstinence rate (post: risk ratio (RR) = 0.96, 95% CI 0.44 to 2.14, 1 RCT, 112 participants; follow-up: RR = 1.04, 95% CI 0.54 to 2.01, 1 RCT, 112 participants); percentage of days with substance use (post-treatment: standardized mean difference (SMD) = 0.05, 95% CI -0.37 to 0.47, 4 RCTs, 248 participants; follow-up: SMD = 0.21, 95% CI -0.12 to 0.54, 3 RCTs, 167 participants); and consumed amount (post-treatment: SMD = 0.10, 95% CI -0.31 to 0.52, 3 RCTs, 221 participants; follow-up: SMD = 0.33, 95% CI 0.00 to 0.66, 2 RCTs, 142 participants). Evidence was uncertain for craving intensity and serious adverse events. Analysis of treatment acceptability indicated MBIs result in little to no increase in study attrition relative to no treatment (RR = 1.04, 95% CI 0.77 to 1.40, 21 RCTs, 1087 participants). Certainty of evidence for all other outcomes was very low due to imprecision, risk of bias, and/or inconsistency. Data were unavailable to evaluate adverse events. Mindfulness-based interventions (MBIs) versus other treatments (standard of care, cognitive behavioral therapy, psychoeducation, support group, physical exercise, medication) Nineteen RCTs included a comparison between MBI and another treatment. The evidence was very uncertain about the effects of MBIs relative to other treatments on continuous abstinence rate at post-treatment (RR = 0.80, 95% CI 0.45 to 1.44, 1 RCT, 286 participants) and follow-up (RR = 0.57, 95% CI 0.28 to 1.16, 1 RCT, 286 participants), and on consumed amount at post-treatment (SMD = -0.42, 95% CI -1.23 to 0.39, 1 RCT, 25 participants) due to imprecision and risk of bias. The evidence suggests that MBIs reduce percentage of days with substance use slightly relative to other treatments at post-treatment (SMD = -0.21, 95% CI -0.45 to 0.03, 5 RCTs, 523 participants) and follow-up (SMD = -0.39, 95% CI -0.96 to 0.17, 3 RCTs, 409 participants). The evidence was very uncertain about the effects of MBIs relative to other treatments on craving intensity due to imprecision and inconsistency. Analysis of treatment acceptability indicated MBIs result in little to no increase in attrition relative to other treatments (RR = 1.06, 95% CI 0.89 to 1.26, 14 RCTs, 1531 participants). Data were unavailable to evaluate adverse events. AUTHORS' CONCLUSIONS: In comparison with no treatment, the evidence is uncertain regarding the impact of MBIs on SUD-related outcomes. MBIs result in little to no higher attrition than no treatment. In comparison with other treatments, MBIs may slightly reduce days with substance use at post-treatment and follow-up (4 to 10 months). The evidence is uncertain regarding the impact of MBIs relative to other treatments on abstinence, consumed substance amount, or craving. MBIs result in little to no higher attrition than other treatments. Few studies reported adverse events.

Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial.

OBJECTIVE: Chronic low back pain (CLBP) is disabling and costly. Existing therapies have proven suboptimal, with many patients resorting to long-term opioid therapy, which can cause harms. Cognitive behavioral (CBT) and mindfulness-based (MBT) therapies can be effective and offer unique skills for safe pain coping. This article describes the protocol for a study evaluating comparative effectiveness of CBT and MBT in adults with opioid-treated CLBP. DESIGN: Pragmatic, multi-center randomized controlled trial (RCT). SETTINGS: Community and outpatient care. PARTICIPANTS: Planned enrollment of 766 adults (383/group) with CLBP treated with long-term opioids (≥3 months; ≥15 mg/day morphine-equivalent dose). INTERVENTIONS: CBT or MBT consisting of eight weekly therapist-led, two-hour group sessions, and home practice (≥30 min/day, 6 days/week) during the 12-month study. MAIN OUTCOME MEASURES: Main outcome measures, collected by self-report at baseline, then three, six, nine and 12 months post-entry, include co-primary measures: pain intensity (Numeric Rating Scale) and function (Oswestry Disability Index), and secondary measures: quality of life (Medical Outcomes Study) and average daily opioid dose (Timeline Followback). Baseline scores of depression, anxiety, and opioid misuse questionnaires will be assessed as potential contributors to the heterogeneity of treatment response. Intention-to-treat, linear mixed-effects analysis will examine treatment effectiveness. Qualitative data will augment the quantitative measures. CONCLUSIONS: This will be the largest RCT comparing CBT and MBT in opioid-treated CLBP. It will provide evidence on the impact of these interventions, informing clinical decisions about optimal therapy for safe, effective care, improving quality of life and decreasing opioid-related harm among adults with refractory CLBP.

Mindfulness practice predicts interleukin-6 responses to a mindfulness-based alcohol relapse prevention intervention.

Chronic alcohol misuse can result in chronically elevated interleukin (IL)-6, a pro-inflammatory cytokine, in the bloodstream. Given that Mindfulness-Based Relapse Prevention (MBRP) has been shown to reduce alcohol misuse, MBRP might also be effective in reducing IL-6 concentrations. Past research has found, however, that IL-6 does not respond consistently to mindfulness-based interventions. Building on prior studies, we examined whether between-person variability in engagement with mindfulness training (i.e., formal mindfulness practice time) is associated with between-person variability in changes in serum IL-6, using data from a randomized controlled trial evaluating MBRP for Alcohol Dependence (MBRP-A). Participants were 72 alcohol dependent adults (mean age = 43.4 years, 63.9% male, 93.1% White) who received a minimum dose (i.e., at least four sessions) of MBRP-A either at the start of the trial (n = 46) or after a 26-week delay (n = 26). IL-6 concentrations did not significantly change from pre- to post-intervention for the full sample. Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27). The association between practice time and IL-6 changes remained significant when controlling for intervention timing (i.e., immediate or after the 26-week delay), demographic characteristics, and changes in mindful awareness, obsessive-compulsive drinking, and depressive symptoms. The association between practice time and IL-6 changes was not significant when omitting the minimum treatment dose requirement. Overall, results suggest that the level of engagement in mindfulness training may predict changes in the inflammatory pathophysiology in adults with alcohol dependence.

Mindfulness-based relapse prevention for alcohol dependence: Findings from a randomized controlled trial.

OBJECTIVES: To assess the effects of mindfulness-based relapse prevention for alcohol dependence (MBRP-A) intervention on drinking and related consequences. METHODS: 123 alcohol-dependent adults in early recovery, recruited from outpatient treatment programs, were randomly assigned to MBRP-A (intervention plus usual-care; N = 64) or Control (usual-care-alone; N = 59) group. MBRP-A consisted of eight-weekly sessions and home practice. Outcomes were assessed at baseline, 8 weeks and 26 weeks (18 weeks post-intervention), and compared between groups using repeated measures analysis. RESULTS: Outcome analysis included 112 participants (57 MBRP-A; 55 Control) who provided follow-up data. Participants were 41.0 ±â€¯12.2 years old, 56.2% male, and 91% white. Prior to "quit date," they reported drinking on 59.4 ±â€¯34.8% (averaging 6.1 ±â€¯5.0 drinks/day) and heavy drinking (HD) on 50.4 ±â€¯35.5% of days. Their drinking reduced after the "quit date" (before enrollment) to 0.4 ±â€¯1.7% (HD: 0.1 ±â€¯0.7%) of days. At 26 weeks, the MBRP-A and control groups reported any drinking on 11.5 ±â€¯22.5% and 5.9 ±â€¯11.6% of days and HD on 4.5 ±â€¯9.3% and 3.2 ±â€¯8.7% of days, respectively, without between-group differences (ps ≥ 0.05) in drinking or related consequences during the follow-up period. Three MBRP-A participants reported "relapse," defined as three-consecutive HD days, during the study. Subgroup analysis indicated that greater adherence to session attendance and weekly home practice minutes were associated with improved outcomes. CONCLUSIONS: MBRP-A as an adjunct to usual-care did not show to improve outcomes in alcohol-dependent adults in early recovery compared to usual-care-alone; a return to drinking and relapse to HD were rare in both groups. However, greater adherence to MBRP-A intervention may improve long-term drinking-related outcomes.

Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review.

OBJECTIVES: Nonpharmacologic approaches have been characterized as the preferred means to treat chronic noncancer pain by the Centers for Disease Control and Prevention. There is evidence that mindfulness-based interventions (MBIs) are effective for pain management, yet the typical MBI may not be feasible across many clinical settings due to resource and time constraints. Brief MBIs (BMBIs) could prove to be more feasible and pragmatic for safe treatment of pain. The aim of the present article is to systematically review evidence of BMBI's effects on acute and chronic pain outcomes in humans. METHODS: A literature search was conducted using PubMed, PsycINFO, and Google Scholar and by examining the references of retrieved articles. Articles written in English, published up to August 16, 2017, and reporting on the effects of a BMBI (i.e., total contact time <1.5 h, with mindfulness as the primary therapeutic technique) on a pain-related outcome (i.e., pain outcome, pain affect, pain-related function/quality of life, or medication-related outcome) were eligible for inclusion. Two authors independently extracted the data and assessed risk of bias. RESULTS: Twenty studies meeting eligibility criteria were identified. Studies used qualitative (n = 1), within-group (n = 3), or randomized controlled trial (n = 16) designs and were conducted with clinical (n = 6) or nonclinical (i.e., experimentally-induced pain; n = 14) samples. Of the 25 BMBIs tested across the 20 studies, 13 were delivered with audio/video recording only, and 12 were delivered by a provider (participant-provider contact ranged from 3 to 80 min). Existing evidence was limited and inconclusive overall. Nevertheless, BMBIs delivered in a particular format-by a provider and lasting more than 5 min-showed some promise in the management of acute pain. CONCLUSIONS: More rigorous large scale studies conducted with pain populations are needed before unequivocally recommending BMBI as a first-line treatment for acute or chronic pain.

Benefits of 8-wk Mindfulness-based Stress Reduction or Aerobic Training on Seasonal Declines in Physical Activity.

Mindfulness-based stress reduction (MBSR) and aerobic exercise training (AET) programs improve health and well-being. Exercise participation has been related to mindfulness and may be altered by MBSR training. PURPOSE: This study aimed to compare 8 wk of MBSR, AET, and no-treatment control during the fall season on objectively measured physical activity in healthy adults. METHODS: Participants (n = 66) wore an ActiGraph GT3X+ accelerometer for 7 d prerandomization and after 8 wk MBSR or AET interventions, or neither (control). Mean daily minutes (min) of moderate-to-vigorous physical activities (MVPA) were calculated along with weekly time spent in bouts of MVPA ≥10 min (MVPABouts) to assess physical activity sufficient to meet national guidelines. Groups were compared on pairwise changes in outcomes across time. Effect sizes were calculated using Cohen's d. RESULTS: Sufficient data (≥3 weekdays, ≥1 weekend day, and ≥10 h·d) were obtained from 49 participants (18 MBSR, 14 AET, and 17 control). Daily MVPA decreased in all groups from prerandomization to postintervention (August to November); control decreased 17.9 ± 25.7 min·d, MBSR decreased 5.7 ± 7.5 min·d, and AET decreased 7.4 ± 14.3 min·d (mean ± SD), without significant differences among the groups (all P > 0.05). MVPABouts decreased 77.3 ± 106.6 min·wk in control and 15.5 ± 37.0 min·wk in MBSR (between-group difference: P = 0.08; d = 0.86), whereas it increased by 5.7 ± 64.1 min·wk in AET (compared with control: P = 0.029; d = 0.97; compared with MBSR; P = 0.564; d = 0.29). CONCLUSION: Data from participants in a randomized controlled trial showed that although AET increases MVPA bouts compared with no treatment, MBSR training may also mitigate the influence of shorter day length and cooler weather on participation in physical activities. Future research is needed to determine how MBSR affects exercise to inform interventions. Interventions combining MBSR and exercise may be particularly successful at increasing physical activity participation.

Meditation or exercise for preventing acute respiratory infection (MEPARI-2): A randomized controlled trial.

BACKGROUND: Practice of meditation or exercise may enhance health to protect against acute infectious illness. OBJECTIVE: To assess preventive effects of meditation and exercise on acute respiratory infection (ARI) illness. DESIGN: Randomized controlled prevention trial with three parallel groups. SETTING: Madison, Wisconsin, USA. PARTICIPANTS: Community-recruited adults who did not regularly exercise or meditate. METHODS: 1) 8-week behavioral training in mindfulness-based stress reduction (MBSR); 2) matched 8-week training in moderate intensity sustained exercise (EX); or 3) observational waitlist control. Training classes occurred in September and October, with weekly ARI surveillance through May. Incidence, duration, and area-under-curve ARI global severity were measured using daily reports on the WURSS-24 during ARI illness. Viruses were identified multiplex PCR. Absenteeism, health care utilization, and psychosocial health self-report assessments were also employed. RESULTS: Of 413 participants randomized, 390 completed the trial. In the MBSR group, 74 experienced 112 ARI episodes with 1045 days of ARI illness. Among exercisers, 84 had 120 episodes totaling 1010 illness days. Eighty-two of the controls had 134 episodes with 1210 days of ARI illness. Mean global severity was 315 for MBSR (95% confidence interval 244, 386), 256 (193, 318) for EX, and 336 (268, 403) for controls. A prespecified multivariate zero-inflated regression model suggested reduced incidence for MBSR (p = 0.036) and lower global severity for EX (p = 0.042), compared to control, not quite attaining the p<0.025 prespecified cut-off for null hypothesis rejection. There were 73 ARI-related missed-work days and 22 ARI-related health care visits in the MBSR group, 82 days and 21 visits for exercisers, and 105 days and 24 visits among controls. Viruses were identified in 63 ARI episodes in the MBSR group, compared to 64 for EX and 72 for control. Statistically significant (p<0.05) improvements in general mental health, self-efficacy, mindful attention, sleep quality, perceived stress, and depressive symptoms were observed in the MBSR and/or EX groups, compared to control. CONCLUSIONS: Training in mindfulness meditation or exercise may help protect against ARI illness. LIMITATIONS: This trial was likely underpowered. TRIAL REGISTRATION: Clinicaltrials.gov NCT01654289.

Cost of opioid-treated chronic low back pain: Findings from a pilot randomized controlled trial of mindfulness meditation-based intervention.

OBJECTIVE: Opioid-treated chronic low back pain (CLBP) is debilitating, costly, and often refractory to existing treatments. This secondary analysis aims to pilot-test the hypothesis that mindfulness meditation (MM) can reduce economic burden related to opioid-treated CLBP. DESIGN: Twenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone. SETTING: Outpatient. PARTICIPANTS: Thirty-five adults with opioid-treated CLBP (≥30 morphine-equivalent mg/day) for 3 + months enrolled; none withdrew. INTERVENTION: Eight weekly therapist-led MM sessions and at-home practice. OUTCOME MEASURES: Costs related to self-reported healthcare utilization, medication use (direct costs), lost productivity (indirect costs), and total costs (direct + indirect costs) were calculated for 6-month pre-enrollment and postenrollment periods and compared within and between the groups. RESULTS: Participants (21 MM; 14 control) were 20 percent men, age 51.8 ± 9.7 years, with severe disability, opioid dose of 148.3 ± 129.2 morphine-equivalent mg/d, and individual annual income of $18,291 ± $19,345. At baseline, total costs were estimated at $15,497 ± 13,677 (direct: $10,635 ± 9,897; indirect: $4,862 ± 7,298) per participant. Although MM group participants, compared to controls, reduced their pain severity ratings and pain sensitivity to heat stimuli (p < 0.05), no statistically significant within-group changes or between-group differences in direct and indirect costs were noted. CONCLUSIONS: Adults with opioid-treated CLBP experience a high burden of disability despite the high costs of treatment. Although this pilot study did not show a statistically significant impact of MM on costs related to opioid-treated CLBP, MM can improve clinical outcomes and should be assessed in a larger trial with long-term follow-up.

Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience.

BACKGROUND: Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM). However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. OBJECTIVE: To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A) intervention in a 26-week randomized controlled trial. METHODS: 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N = 64) or control (usual care alone; N = 59). Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. RESULTS: Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. CONCLUSIONS: A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

Mindfulness Meditation-Based Intervention Is Feasible, Acceptable, and Safe for Chronic Low Back Pain Requiring Long-Term Daily Opioid Therapy.

OBJECTIVE: Although mindfulness meditation (MM) is increasingly used for chronic pain treatment, limited evidence supports its clinical application for opioid-treated chronic low back pain (CLBP). The goal of this study was to determine feasibility, acceptability, and safety of an MM-based intervention in patients with CLBP requiring daily opioid therapy. DESIGN: 26-week pilot randomized controlled trial comparing MM-based intervention, combined with usual care, to usual care alone. SETTING: Outpatient. PATIENTS: Adults with CLBP treated with ≥30 mg of morphine-equivalent dose (MED) per day for 3 months or longer. INTERVENTIONS: Targeted MM-based intervention consisted of eight weekly 2-hour group sessions and home practice (30 minutes/d, 6 days/wk) during the study. "Usual care" for opioid-treated CLBP was provided to participants by their regular clinicians. OUTCOME MEASURES: Feasibility and acceptability of the MM intervention were assessed by adherence to intervention protocol and treatment satisfaction among experimental participants. Safety was evaluated by inquiry about side effects/adverse events and opioid dose among all study participants. RESULTS: Thirty-five participants enrolled during the 10-week recruitment period. The mean age (±standard deviation) was 51.8 ± 9.7 years; the patients were predominantly female, with substantial CLBP-related pain and disability, and treated with 148.3 ± 129.2 mg of MED per day. All participants completed baseline assessments; none missed both follow-up assessments or withdrew. Among experimental participants (n = 21), 19 attended 1 or more intervention sessions and 14 attended 4 or more. They reported, on average, 164.0 ± 122.1 minutes of formal practice per week during the 26-week study and 103.5 ± 111.5 minutes of brief, informal practice per week. Seventeen patients evaluated the intervention, indicating satisfaction; their qualitative responses described the course as useful for pain management (n = 10) and for improving pain coping skills (n = 8). No serious adverse events or safety concerns occurred among the study participants. CONCLUSIONS: MM-based intervention is feasible, acceptable, and safe in opioid-treated CLBP.

Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial.

OBJECTIVE: To assess benefits of mindfulness meditation and cognitive behavioral therapy (CBT)-based intervention for opioid-treated chronic low back pain (CLBP). DESIGN: 26-week parallel-arm pilot randomized controlled trial (Intervention and Usual Care versus Usual Care alone). SETTING: Outpatient. SUBJECTS: Adults with CLBP, prescribed ≥30 mg/day of morphine-equivalent dose (MED) for at least 3 months. METHODS: The intervention comprised eight weekly group sessions (meditation and CLBP-specific CBT components) and 30 minutes/day, 6 days/week of at-home practice. Outcome measures were collected at baseline, 8, and 26 weeks: primary-pain severity (Brief Pain Inventory) and function/disability (Oswestry Disability Index); secondary-pain acceptance, opioid dose, pain sensitivity to thermal stimuli, and serum pain-sensitive biomarkers (Interferon-γ; Tumor Necrosis Factor-α; Interleukins 1ß and 6; C-reactive Protein). RESULTS: Thirty-five (21 experimental, 14 control) participants were enrolled and completed the study. They were 51.8 ± 9.7 years old, 80% female, with severe CLBP-related disability (66.7 ± 11.4), moderate pain severity (5.8 ± 1.4), and taking 148.3 ± 129.2 mg/day of MED. Results of the intention-to-treat analysis showed that, compared with controls, the meditation-CBT group reduced pain severity ratings during the study (P = 0.045), with between-group difference in score change reaching 1 point at 26 weeks (95% Confidence Interval: 0.2,1.9; Cohen's d = 0.86), and decreased pain sensitivity to thermal stimuli (P < 0.05), without adverse events. Exploratory analyses suggested a relationship between the extent of meditation practice and the magnitude of intervention benefits. CONCLUSIONS: Meditation-CBT intervention reduced pain severity and sensitivity to experimental thermal pain stimuli in patients with opioid-treated CLBP.

Hypertonic dextrose injection (prolotherapy) for knee osteoarthritis: Long term outcomes.

OBJECTIVE: Knee osteoarthritis (OA) is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. Recent 52-week randomized controlled and open label studies have reported improvement of knee OA-specific outcomes compared to baseline status, and blinded saline control injections and at-home exercise therapy (p<0.05). However, long term effects of prolotherapy for knee OA are unknown. We therefore assessed long-term effects of prolotherapy on knee pain, function and stiffness among adults with knee OA. DESIGN: Post clinical-trial, open-label follow-up study. SETTING: Outpatient; adults with mild-to-severe knee OA completing a 52-week prolotherapy study were enrolled. INTERVENTION AND OUTCOME MEASURES: Participants received 3-5 monthly interventions and were assessed using the validated Western Ontario McMaster University Osteoarthritis Index, (WOMAC, 0-100 points), at baseline, 12, 26, 52 weeks, and 2.5 years. RESULTS: 65 participants (58±7.4 years old, 38 female) received 4.6±0.69 injection sessions in the initial 17-week treatment period. They reported progressive improvement in WOMAC scores at all time points in excess of minimal clinical important improvement benchmarks during the initial 52-week study period, from 13.8±17.4 points (23.6%) at 12 weeks, to 20.9±2.8 points, (p<0.05; 35.8% improvement) at 2.5±0.6 years (range 1.6-3.5 years) in the current follow-up analysis. Among assessed covariates, none were predictive of improvement in the WOMAC score. CONCLUSIONS: Prolotherapy resulted in safe, significant, progressive improvement of knee pain, function and stiffness scores among most participants through a mean follow-up of 2.5 years and may be an appropriate therapy for patients with knee OA refractory to other conservative care.

Pharmacological and toxicological profile of opioid-treated, chronic low back pain patients entering a mindfulness intervention randomized controlled trial.

OBJECTIVE: Refractory chronic low back pain (CLBP) often leads to treatment with long-term opioids. Our goal was to describe the pharmaco-toxicological profile of opioid-treated CLBP patients and identify potential areas for care optimization. DESIGN: Cross-sectional analysis. SETTING: Outpatient primary care. PARTICIPANTS: CLBP patients prescribed ≥ 30 mg/d of morphine-equivalent dose (MED) for ≥3 months. OUTCOME MEASURES: Self-reported clinical, medication (verified) and substance use, and urine drug testing (UDT) data were collected. RESULTS: Participants (N = 35) were 51.8 ± 9.7 years old, 80 percent female with CLBP for 14.2 ± 10.1 years, treated with opioids for 7.9 ± 5.7 years, with severe disability (Oswestry Disability Index score: 66.7 ± 11.4), and average pain score of 5.6 ± 1.5 (0-10 rating scale). Participants reported using tobacco (N = 14), alcohol (N = 9) and illicit drugs or unprescribed medications (N = 10). On average, participants took 13.4 ± 6.8 daily medications, including 4.7 ± 1.8 pain-modulating and 4.7 ± 2.0 sedating medications. Among prescribed opioids, 57.1 percent were long-acting and 91.4 percent were short-acting, with a total of 144.5 ± 127.8 mg/d of MED. Sixteen participants were prescribed benzodiazepines and/or zolpidem/ zaleplon. Fifteen participants had UDT positive for illicit drugs or unprescribed medications; in addition, eight tested positive for alcohol and 19 for cotinine. Compared to those with negative UDTs, those with positive UDTs (N = 15) received lower daily "total" and "extended release" opioid doses, and were more likely to test positive for cotinine (p < 0.05). CONCLUSIONS: Study findings corroborate existing evidence for high medication burden and high likelihood of substance misuse among opioid-treated CLBP patients. Further research is needed to help understand causality and ways to optimize care and clinical outcomes.

Dextrose and morrhuate sodium injections (prolotherapy) for knee osteoarthritis: a prospective open-label trial.

OBJECTIVES: This study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status. DESIGN: This was a prospective three-arm uncontrolled study with 1-year follow-up. SETTING: The setting was outpatient. PARTICIPANTS: The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined). INTERVENTION: The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach. OUTCOME MEASURES: The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction. RESULTS: The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events. CONCLUSIONS: Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.

Randomized controlled trial of mindfulness meditation and exercise for the prevention of acute respiratory infection: possible mechanisms of action.

Background. A randomized trial suggests that meditation and exercise may prevent acute respiratory infection (ARI). This paper explores potential mediating mechanisms. Methods. Community-recruited adults were randomly assigned to three nonblinded arms: 8-week mindfulness-based stress reduction (N = 51), moderate-intensity exercise (N = 51), or wait-list control (N = 52). Primary outcomes were ARI illness burden (validated Wisconsin Upper Respiratory Symptom Survey). Potential mediators included self-reported psychophysical health and exercise intensity (baseline, 9 weeks, and 3 months). A Baron and Kenny approach-based mediational analysis model, adjusted for group status, age, and gender, evaluated the relationship between the primary outcome and a potential mediator using zero-inflated modeling and Sobel testing. Results. Of 154 randomized, 149 completed the trial (51, 47, and 51 in meditation, exercise, and control groups) and were analyzed (82% female, 94% Caucasian, 59.3 ± SD 6.6 years old). Mediational analyses suggested that improved mindfulness (Mindful Attention Awareness Scale) at 3 months may mediate intervention effects on ARI severity and duration (P < 0.05); 1 point increase in the mindfulness score corresponded to a shortened ARI duration by 7.2-9.6 hours. Conclusions. Meditation and exercise may decrease the ARI illness burden through increased mindfulness. These preliminary findings need confirmation, if confirmed, they would have important policy and clinical implications. This trial registration was Clinicaltrials.gov: NCT01057771.

Abbreviated mindfulness intervention for job satisfaction, quality of life, and compassion in primary care clinicians: a pilot study.

PURPOSE: Burnout, attrition, and low work satisfaction of primary care physicians are growing concerns and can have a negative influence on health care. Interventions for clinicians that improve work-life balance are few and poorly understood. We undertook this study as a first step in investigating whether an abbreviated mindfulness intervention could increase job satisfaction, quality of life, and compassion among primary care clinicians. METHODS: A total of 30 primary care clinicians participated in an abbreviated mindfulness course. We used a single-sample, pre-post design. At 4 points in time (baseline, and 1 day, 8 weeks, and 9 months postintervention), participants completed a set of online measures assessing burnout, anxiety, stress, resilience, and compassion. We used a linear mixed-effects model analysis to assess changes in outcome measures. RESULTS: Participants had improvements compared with baseline at all 3 follow-up time points. At 9 months postintervention, they had significantly better scores (1) on all Maslach Burnout Inventory burnout subscales-Emotional Exhaustion (P =.009), Depersonalization (P = .005), and Personal Accomplishment (P <.001); (2) on the Depression (P =.001), Anxiety (P =.006), and Stress (P = .002) subscales of the Depression Anxiety Stress Scales-21; and (3) for perceived stress (P = .002) assessed with the Perceived Stress Scale. There were no significant changes on the 14-item Resilience Scale and the Santa Clara Brief Compassion Scale. CONCLUSIONS: In this uncontrolled pilot study, participating in an abbreviated mindfulness training course adapted for primary care clinicians was associated with reductions in indicators of job burnout, depression, anxiety, and stress. Modified mindfulness training may be a time-efficient tool to help support clinician health and well-being, which may have implications for patient care.