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      Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial

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          Abstract

          Background

          Current treatment options for chronic pain and depression are largely medication-based, which may cause adverse side effects. Integrative Medical Group Visits (IMGV) combines mindfulness techniques, evidence based integrative medicine, and medical group visits, and is a promising adjunct to medications, especially for diverse underserved patients who have limited access to non-pharmacological therapies.

          Objective

          Determine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression.

          Design

          9-week single-blind randomized control trial with a 12-week maintenance phase (intervention—medical groups; control—primary care provider visit)

          Setting

          Academic tertiary safety-net hospital and 2 affiliated federally-qualified community health centers.

          Participants

          159 predominantly low income racially diverse adults with nonspecific chronic pain and depressive symptoms.

          Interventions

          IMGV intervention– 9 weekly 2.5 hour in person IMGV sessions, 12 weeks on-line platform access followed by a final IMGV at 21 weeks.

          Measurements

          Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory). Secondary outcomes included pain medication use and utilization.

          Results

          There were no differences in pain or depression at any time point. At 9 weeks, the IMGV group had fewer emergency department visits (RR 0.32, 95% CI: 0.12, 0.83) compared to controls. At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18–0.98) compared to controls.

          Limitations

          Absence of treatment assignment concealment for patients and disproportionate group attendance in IMGV.

          Conclusion

          Results demonstrate that low-income racially diverse patients will attend medical group visits that focus on non-pharmacological techniques, however, in the attention to treat analysis there was no difference in average pain levels between the intervention and the control group.

          Trial registration

          clinicaltrials.gov NCT02262377.

          Related collections

          Most cited references70

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          Development and testing of a short form of the patient activation measure.

          The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. The measure was developed using Rasch analyses and is an interval level, unidimensional, Guttman-like measure. The current analysis is aimed at reducing the number of items in the measure while maintaining adequate precision. We relied on an iterative use of Rasch analysis to identify items that could be eliminated without loss of significant precision and reliability. With each item deletion, the item scale locations were recalibrated and the person reliability evaluated to check if and how much of a decline in precision of measurement resulted from the deletion of the item. The data used in the analysis were the same data used in the development of the original 22-item measure. These data were collected in 2003 via a telephone survey of 1,515 randomly selected adults. Principal Findings. The analysis yielded a 13-item measure that has psychometric properties similar to the original 22-item version. The scores for the 13-item measure range in value from 38.6 to 53.0 (on a theoretical 0-100 point scale). The range of values is essentially unchanged from the original 22-item version. Subgroup analysis suggests that there is a slight loss of precision with some subgroups. The results of the analysis indicate that the shortened 13-item version is both reliable and valid.
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            The Duke-UNC Functional Social Support Questionnaire. Measurement of social support in family medicine patients.

            A 14-item, self-administered, multidimensional, functional social support questionnaire was designed and evaluated on 401 patients attending a family medicine clinic. Patients were selected from randomized time-frame sampling blocks during regular office hours. The population was predominantly white, female, married, and under age 45. Eleven items remained after test-retest reliability was assessed over a 1- to 4-week follow-up period. Factor analysis and item remainder analysis reduced the remaining 11 items to a brief and easy-to-complete two-scale, eight-item functional social support instrument. Construct validity, concurrent validity, and discriminant validity are demonstrated for the two scales (confidant support--five items and affective support--three items). Factor analysis and correlations with other measures of social support suggest that the three remaining items (visits, instrumental support, and praise) are distinct entities that may need further study.
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              Treatment of chronic non-cancer pain.

              Chronic pain is a pervasive problem that affects the patient, their significant others, and society in many ways. The past decade has seen advances in our understanding of the mechanisms underlying pain and in the availability of technically advanced diagnostic procedures; however, the most notable therapeutic changes have not been the development of novel evidenced-based methods, but rather changing trends in applications and practices within the available clinical armamentarium. We provide a general overview of empirical evidence for the most commonly used interventions in the management of chronic non-cancer pain, including pharmacological, interventional, physical, psychological, rehabilitative, and alternative modalities. Overall, currently available treatments provide modest improvements in pain and minimum improvements in physical and emotional functioning. The quality of evidence is mediocre and has not improved substantially during the past decade. There is a crucial need for assessment of combination treatments, identification of indicators of treatment response, and assessment of the benefit of matching of treatments to patient characteristics. Copyright © 2011 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: Writing – original draftRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: InvestigationRole: ResourcesRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: InvestigationRole: Writing – review & editing
                Role: Formal analysisRole: Writing – review & editing
                Role: ConceptualizationRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                18 December 2019
                2019
                : 14
                : 12
                : e0225540
                Affiliations
                [1 ] Department of Family Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, United States of America
                [2 ] Department of Family Medicine, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts, United States of America
                [3 ] Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, United States of America
                [4 ] Division of General Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States of America
                Brown University, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                http://orcid.org/0000-0003-1801-7575
                Article
                PONE-D-19-18533
                10.1371/journal.pone.0225540
                6919581
                31851666
                ea6a0ccf-974e-45a8-9316-1f36e3ce3afd
                © 2019 Gardiner et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 2 July 2019
                : 5 November 2019
                Page count
                Figures: 1, Tables: 5, Pages: 20
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100006093, Patient-Centered Outcomes Research Institute;
                Award ID: 1304-6218
                Award Recipient :
                This work was supported by Award AD - 1304-6218, Patient-Centered Outcomes Research Institute (PCORI) to PG. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine and Health Sciences
                Pain Management
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Analgesics
                Opioids
                Medicine and Health Sciences
                Pain Management
                Analgesics
                Opioids
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Opioids
                Medicine and Health Sciences
                Health Care
                Patients
                Medicine and Health Sciences
                Mental Health and Psychiatry
                Mood Disorders
                Depression
                Medicine and Health Sciences
                Critical Care and Emergency Medicine
                Medicine and Health Sciences
                Health Care
                Primary Care
                Medicine and Health Sciences
                Health Care
                Quality of Life
                Medicine and Health Sciences
                Clinical Medicine
                Clinical Trials
                Randomized Controlled Trials
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Clinical Trials
                Randomized Controlled Trials
                Research and Analysis Methods
                Clinical Trials
                Randomized Controlled Trials
                Custom metadata
                Data cannot be shared publicly because of patient confidentiality. Data are available from the Boston Medical Center Institutional Data Access / Ethics Committee (contact via email) for researchers who meet the criteria for access to confidential data.

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