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

ABSTRACT: 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.Twenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone.Outpatient.Thirty-five adults with opioid-treated CLBP (?30 morphine-equivalent mg/day) for 3 + months enrolled; none withdrew.Eight weekly therapist-led MM sessions and at-home practice.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.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.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.

SUBMITTER: Zgierska AE

PROVIDER: S-EPMC5836724 | biostudies-literature | 2017 May/Jun

REPOSITORIES: biostudies-literature

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

Zgierska Aleksandra E AE Ircink James J Burzinski Cindy A CA Mundt Marlon P MP

Journal of opioid management 20170501 3

<h4>Objective</h4>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.<h4>Design</h4>Twenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone.<h4>Setting</h4>Outpatient.<h4>Participants</h4>Thirty-five adults with opioid-trea ...[more]

PMID: 28829518

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Project description:ObjectiveAlthough 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.Design26-week pilot randomized controlled trial comparing MM-based intervention, combined with usual care, to usual care alone.SettingOutpatient.PatientsAdults with CLBP treated with ≥30 mg of morphine-equivalent dose (MED) per day for 3 months or longer.InterventionsTargeted 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 measuresFeasibility 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.ResultsThirty-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.ConclusionsMM-based intervention is feasible, acceptable, and safe in opioid-treated CLBP.

Project description:BACKGROUND:Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. OBJECTIVES:The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI's ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. METHODS:Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants' own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance, perceived stress, and mindfulness were completed before and after the intervention period via Web-based surveys. RESULTS:We enrolled 44 adults were enrolled and 31 adults completed all study activities. There were no group differences on demographics or important variables at baseline. Participants rated the IMMI arm higher than the Access to Guided Meditation arm on Client Satisfaction Questionnaire. IMMI was able to increase home practice behavior significantly compared to the Access to Guided Meditation arm: days practiced (P=.05), total minutes (P=.01), and average minutes (P=.05). As expected, there were no significant differences on health outcomes. CONCLUSIONS:In conclusion, IMMI was found to be feasible and acceptable. The IMMI arm had increased daily meditation practice compared with the Access to Guided Meditation control group. More interaction through staff and/or through built-in email or text reminders may increase daily practice even more. Future studies will examine IMMI's efficacy at improving health outcomes in the general population and also compare it directly to the well-studied mindfulness-based group interventions to evaluate relative efficacy. TRIAL REGISTRATION:Clinicaltrials.gov NCT02655835; http://clinicaltrials.gov/ct2/show/NCT02655835 (Archived by WebCite at http://www.webcitation/ 6jUDuQsG2).

Project description:Several studies have reported that mindfulness meditation has a potential effect in controlling headaches, such as migraine and tension-type headache; however, its role remains controversial. This review assessed the evidence regarding the effects of mindfulness meditation for primary headache pain.Only English databases (PubMed, Cochrane Central Register of Controlled Trials [the Cochrane Library], PsycINFO, Psychology and behavioral science collection, PsyArticles, Web of Science, and Scopus) were searched from their inception to November 2016 with the keywords ("meditation" or "mindfulness" or "vipassana" or "dzogchen" or "zen" or "integrative body-mind training" or "IBMT" or "mindfulness-based stress reduction" or "MBSR" or "mindfulness-based cognitive therapy" or "MBCT" and "Headache" or "Head pain" or "Cephalodynia" or "Cephalalgia" or "Hemicrania" or "Migraine"). Titles, abstracts, and full-text articles were screened against study inclusion criteria: controlled trials of structured meditation programs for adult patients with primary headache pain. The quality of studies included in the meta-analysis was assessed with the Yates Quality Rating Scale. The meta-analysis was conducted with Revman 5.3.Ten randomized controlled trials and one controlled clinical trial with a combined study population of 315 patients were included in the study. When compared to control group data, mindfulness meditation induced significant improvement in pain intensity (standardized mean difference, -0.89; 95% confidence interval, -1.63 to -0.15; P = 0.02) and headache frequency (-0.67; -1.24 to -0.10; P = 0.02). In a subgroup analysis of different meditation forms, mindfulness-based stress reduction displayed a significant positive influence on pain intensity (P < 0.000). Moreover, 8-week intervention had a significant positive effect (P < 0.000).Mindfulness meditation may reduce pain intensity and is a promising treatment option for patients. Clinicians may consider mindfulness meditation as a viable complementary and alternative medical option for primary headache.

Project description:BackgroundChronic low back pain (CLBP) is a significant problem affecting millions of people worldwide. Three widely implemented psychological techniques used for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). This study aimed to evaluate the relative immediate (pre- to post-treatment) and longer term (pre-treatment to 3- and 6-month follow-ups) effects of group, videoconference-delivered CT, BA, and MM for CLBP.MethodsThis is a secondary analysis of a three-arm, randomized clinical trial comparing the effects of three active treatments-CT, BA, and MM-with no inert control condition. Participants were N = 302 adults with CLBP, who were randomized to condition. The primary outcome was pain interference, and other secondary outcomes were also examined. The primary study end-point was post-treatment. Intent-to-treat analyses were undertaken for each time point, with the means of the changes in outcomes compared among the three groups using an analysis of variance (ANOVA). Effect sizes and confidence intervals are also reported.ResultsMedium-to-large effect size reductions in pain interference were found within BA, CT, and MM (ds from - .71 to - 1.00), with gains maintained at both follow-up time points. Effect sizes were generally small to medium for secondary outcomes for all three conditions (ds from - .20 to - .71). No significant between-group differences in means or changes in outcomes were found at any time point, except for change in sleep disturbance from pre- to post-treatment, improving more in BA than MM (d = - .49).ConclusionsThe findings from this trial, one of the largest telehealth trials of psychological treatments to date, critically determined that group, videoconference-delivered CT, BA, and MM are effective for CLBP and can be implemented in clinical practice to improve treatment access. The pattern of results demonstrated similar improvements across treatments and outcome domains, with effect sizes consistent with those observed in prior research testing in-person delivered and multi-modal psychological pain treatments. Thus, internet treatment delivery represents a tool to scale up access to evidence-based chronic pain treatments and to overcome widespread disparities in healthcare.Trial registrationClinicaltrials.gov, NCT03687762.

Project description:BackgroundTraditional mindfulness-based stress reduction programs are resource intensive for providers and time- and cost-intensive for participants, but the use of mobile technologies may be particularly convenient and cost-effective for populations that are busy, less affluent, or geographically distant from skilled providers. Women in southern Louisiana live in a vulnerable, disaster-prone region and are highly stressed, making a mobile program particularly suited to this population.ObjectiveThis study aimed to (1) assess the feasibility and acceptability of a mobile mindfulness app in real-world conditions in a pilot study of a community sample of women residing in southern Louisiana, (2) describe predictors of app usage, and (3) assess the effect of the app on secondary health outcomes.MethodsWomen were recruited from an oil spill study on health. A total of 236 women completed a baseline survey, were offered the mobile mindfulness program, and completed a follow-up survey. Subjects were asked to download and use the app for at least 30 days for 10 min. All study procedures were completed on the web. Primary outcomes were feasibility and acceptability of the app and characteristics of app utilization. Secondary outcomes included mindfulness, depression, perceived stress, sleep quality, physical activity, BMI, and healthy eating.ResultsOverall, 74.2% (236/318) of subjects completed the follow-up survey, and 13.5% (43/318) used the app. The main barrier to app usage was lack of time, cited by 37% (16/43) of users and 48.7% (94/193) of nonusers of the app. Women who chose to use the app were more highly educated (16/43, 63% had a college education vs 65/193, 33.7% of nonparticipants; P<.001), had higher incomes (23/43, 58% had incomes >US $50,000 per year vs 77/193, 43.0% of nonparticipants), and were employed (34/43, 79% vs 122/193, 63.2% of nonparticipants; P=.047). Those who engaged with the app did so at high levels, with 72% (31/43) of participants self-reporting the completion of some or all sessions and 74% (32/43) reporting high levels of satisfaction with the app. Participation with the app had a beneficial impact on depression (odds ratio [OR] 0.3, 95% CI 0.11-0.81), sleep quality (OR 0.1, 95% CI 0.02-0.96), sleep duration (OR 0.3, 95% CI 0.07-0.86), sleep latency (OR 0.3, 95% CI 0.11-0.81), and physical activity (2.8 95% CI 1.0-7.8), but mindfulness scores did not change from baseline to follow-up.ConclusionsThe Headspace mobile mindfulness app was easy and cost-effective to implement and acceptable to those who participated, but few women elected to try it. The unique characteristics of this southern Louisiana population suggest that more intense promotion of the benefits of mindfulness training is needed, perhaps in conjunction with some therapist or researcher support. Several short-term benefits of the app were identified, particularly for depression and sleep.

Project description:ProblemMindfulness training includes mindfulness meditation, which has been shown to improve both attention and self-awareness. Medical providers in the intensive care unit often deal with difficult situations with strong emotions, life-and-death decisions, and both interpersonal and interprofessional conflicts. The effect of mindfulness meditation training on healthcare providers during acute care tasks such as cardiopulmonary resuscitation remains unknown. Mindfulness meditation has the potential to improve provider well-being and reduce stress in individuals involved in resuscitation teams, which could then translate into better team communication and delivery of care under stress. A better understanding of this process could lead to more effective training approaches, improved team performance, and better patient outcomes.InterventionAll participants were instructed to use a mindfulness meditation device (Muse™ headband) at home for 7 min twice a day or 14 min daily over the 4-week training period. This device uses brainwave sensors to monitor active versus relaxing brain activity and provides real-time feedback.ContextWe conducted a single-group pretest-posttest convergent mixed-methods study. We enrolled 24 healthcare providers, comprising 4 interprofessional code teams, including physicians, nurses, respiratory therapists, and pharmacists. Each team participated in a simulation session immediately before and after the mindfulness training period. Each session consisted of two simulated cardiopulmonary arrest scenarios. Both quantitative and qualitative outcomes were assessed.OutcomeThe median proportion of participants who used the device as prescribed was 85%. Emotional balance, as measured by the critical positivity ratio, improved significantly from pretraining to posttraining (p = .02). Qualitative findings showed that mindfulness meditation changed how participants responded to work-related stress, including stress in real-code situations. Participants described the value of time for self-guided practice with feedback from the device, which then helped them develop individual approaches to meditation not reliant on the technology. Time measures during the simulated scenarios improved, specifically, time to epinephrine in Scenario 1 (p = .03) and time to defibrillation in Scenario 2 (p = .02), improved. In addition, team performance, such as teamwork (p = .04), task management (p = .01), and overall performance (p = .04), improved significantly after mindfulness meditation training. Physiologic stress (skin conductance) improved but did not reach statistical significance (p = .11).Lessons learnedMindfulness meditation practice may improve individual well-being and team function in high-stress clinical environments. Our results may represent a foundation to design larger confirmatory studies.

Dataset Information

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

Publications

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

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