Multimodal chiropractic care for migraine: A pilot randomized controlled trial.

BACKGROUND: Spinal manipulation may reduce migraine frequency, but effects of multimodal chiropractic care on migraine frequency have not been evaluated. METHODS: We conducted a pilot randomized controlled trial comparing multimodal chiropractic care + enhanced usual care (MCC+) versus enhanced usual care alone (EUC) among adult women with episodic migraine. EUC was comprised of usual medical care and migraine education literature. MCC+ participants received 10 sessions of chiropractic care over 14 weeks. Primary aims evaluated feasibility of recruitment, retention, protocol adherence, and safety. Change in migraine days was a secondary aim. RESULTS: Of 422 patients screened, 61 were randomized over 20 months. Fifty-seven (93%) completed daily migraine logs during the intervention, 51 (84%) completed final follow-up, and 45 (74%) completed all assessments. Twenty-four of 29 MCC+ participants (83%) attended > 75% of the chiropractic sessions. Ninety-eight non-serious adverse events were reported by 26 participants (43%) with 39 events among 11 EUC participants and 59 events among 15 MCC+ participants. MCC+ participants experienced greater reductions in migraine days (-2.9 days for MCC+ vs. -1.0 days for EUC, difference = -1.9; 95% confidence interval: -3.5, -0.4). CONCLUSIONS: Pre-specified feasibility criteria were not met, but deficits were remediable. Preliminary data support a definitive trial of MCC+ for migraine. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov (NCT03177616).

Perceptions of Chiropractic Care Among Women With Migraine: A Qualitative Substudy Using a Grounded-Theory Framework.

OBJECTIVE: The purpose of this study was to characterize expectations, attitudes, and experiences of individuals with migraine who were randomly assigned to receive chiropractic care delivered within a randomized controlled trial in a hospital-based integrative care center. METHODS: This qualitative substudy was conducted as a part of a 2-arm pilot pragmatic randomized controlled trial investigating a multimodal model of chiropractic care for women with episodic migraine (4-13 migraines per month). Women were randomly assigned to chiropractic care (10 sessions over 14 weeks) plus enhanced usual care vs enhanced usual care alone. Semistructured interviews were conducted at baseline and 14-week follow-up with 15 randomly selected participants from the 29 participants randomized to the chiropractic group. Qualitative analysis was performed by 2 independent reviewers using a constant comparative method of analysis for generating grounded theory. RESULTS: Integrating baseline and follow-up interviews, 3 themes emerged: over the course of treatment with chiropractic care, participants became more aware of the role of musculoskeletal tension, pain, and posture in triggering migraine; participants revised their prior conceptions of chiropractic care beyond spinal manipulation; and participants viewed the chiropractor-patient relationship as an essential and valuable component to effectively managing their migraines. CONCLUSION: In this qualitative study, women with episodic migraine after receiving comprehensive chiropractic care described chiropractic as a multimodal intervention where they learned about musculoskeletal contributions to migraine, discovered new ways to affect their symptoms, and developed a collaborative patient-practitioner relationship. The results of this study provide insights into perceptions of chiropractic care among women with migraine and suggestions for future trials.

Development and Implementation of the Integrative Toolbox for Headache Management.

Patients with migraine are interested in integrative therapies and overall wellness. They also suffer from social isolation as they try to manage a chronic medical condition. We implemented a three-part workshop structured as a group visit that teaches multiple integrative therapies from specialists and offers a chance for shared support and learning.

The Impact of Spinal Manipulation on Migraine Pain and Disability: A Systematic Review and Meta-Analysis.

BACKGROUND: Several small studies have suggested that spinal manipulation may be an effective treatment for reducing migraine pain and disability. We performed a systematic review and meta-analysis of published randomized clinical trials (RCTs) to evaluate the evidence regarding spinal manipulation as an alternative or integrative therapy in reducing migraine pain and disability. METHODS: PubMed and the Cochrane Library databases were searched for clinical trials that evaluated spinal manipulation and migraine-related outcomes through April 2017. Search terms included: migraine, spinal manipulation, manual therapy, chiropractic, and osteopathic. Meta-analytic methods were employed to estimate the effect sizes (Hedges' g) and heterogeneity (I2 ) for migraine days, pain, and disability. The methodological quality of retrieved studies was examined following the Cochrane Risk of Bias Tool. RESULTS: Our search identified 6 RCTs (pooled n = 677; range of n = 42-218) eligible for meta-analysis. Intervention duration ranged from 2 to 6 months; outcomes included measures of migraine days (primary outcome), migraine pain/intensity, and migraine disability. Methodological quality varied across the studies. For example, some studies received high or unclear bias scores for methodological features such as compliance, blinding, and completeness of outcome data. Due to high levels of heterogeneity when all 6 studies were included in the meta-analysis, the 1 RCT performed only among chronic migraineurs was excluded. Heterogeneity across the remaining studies was low. We observed that spinal manipulation reduced migraine days with an overall small effect size (Hedges' g = -0.35, 95% CI: -0.53, -0.16, P < .001) as well as migraine pain/intensity. CONCLUSIONS: Spinal manipulation may be an effective therapeutic technique to reduce migraine days and pain/intensity. However, given the limitations to studies included in this meta-analysis, we consider these results to be preliminary. Methodologically rigorous, large-scale RCTs are warranted to better inform the evidence base for spinal manipulation as a treatment for migraine.

Qigong Training Positively Impacts Both Posture and Mood in Breast Cancer Survivors With Persistent Post-surgical Pain: Support for an Embodied Cognition Paradigm.

Theories of embodied cognition hypothesize interdependencies between psychological well-being and physical posture. The purpose of this study was to assess the feasibility of objectively measuring posture, and to explore the relationship between posture and affect and other patient centered outcomes in breast cancer survivors (BCS) with persistent postsurgical pain (PPSP) over a 12-week course of therapeutic Qigong mind-body training. Twenty-one BCS with PPSP attended group Qigong training. Clinical outcomes were pain, fatigue, self-esteem, anxiety, depression, stress and exercise self-efficacy. Posture outcomes were vertical spine and vertical head angles in the sagittal plane, measured with a 3D motion capture system in three conditions: eyes open (EO), eyes open relaxed (EOR) and eyes closed (EC). Assessments were made before and after the Qigong training. The association between categorical variables (angle and mood) was measured by Cramer's V. In the EO condition, most participants who improved in fatigue and anxiety scales also had better vertical head values. For the EOR condition, a moderate correlation was observed between changes in vertical head angle and changes in fatigue scale. In the EC condition, most of the participants who improved in measures of fatigue also improved vertical head angle. Additionally, pain severity decreased while vertical spine angle improved. These preliminary findings support that emotion and other patient centered outcomes should be considered within an embodied framework, and that Qigong may be a promising intervention for addressing biopsychosocially complex interventions such as PPSP in BCSs.

"Making Peace with Our Bodies": A Qualitative Analysis of Breast Cancer Survivors' Experiences with Qigong Mind-Body Exercise.

Objectives: Breast cancer treatment leaves breast cancer survivors (BCS) with an array of lasting side effects, including persistent postsurgical pain (PPSP). In this study, we explored the perceptions of BCS with PPSP as they learned Qigong mind-body exercise (QMBE), a multimodal practice rooted in Traditional Chinese Medicine. Methods: Participants included 18 female BCS treated for stage 0-III breast cancer and experiencing PPSP. Participants were taught QMBE over 12 weeks. Semi-structured interviews were conducted before and after the intervention. Results: BCS disclosed a disconnect between mind and body that emerged during treatment. They perceived QMBE as moving meditation, which enabled them to reconnect mind and body, lessen their pain, and make peace with their bodies. Conclusion: These women's experiences both inform the promise of integrating QMBE and related mind-body exercise into PPSP clinical practice guidelines and suggest new areas of research regarding the role of multimodal interventions for holistic healing in BCS.

Qigong Mind-Body Exercise as a Biopsychosocial Therapy for Persistent Post-Surgical Pain in Breast Cancer: A Pilot Study.

Purpose: To assess the feasibility, safety, and preliminary effectiveness of a 12-week multimodal Qigong Mind-Body Exercise (QMBE) program for breast cancer survivors with persistent post-surgical pain (PPSP). Methods: This was a single-arm mixed-methods pilot study. Primary outcome measures were feasibility (recruitment, adherence) and safety. Validated self-report questionnaires were used to evaluate a constellation of interdependent symptoms, including pain, fatigue, mood, exercise, interoceptive awareness, and health-related quality of life at baseline and 12 weeks. A subset of the instruments was administered 6 months postintervention. Shoulder range of motion and grip strength were objectively assessed at baseline and 12 weeks. Qualitative interviews were conducted at baseline and 12 weeks. Results: Twenty-one participants were enrolled; 18 and 17 participants, respectively, completed the 12-week and 6-month outcome assessment. No serious adverse events were reported. Statistically significant improvements were observed at 12 weeks in pain severity and interference, fatigue, anxiety, depression, perceived stress, self-esteem, pain catastrophizing, and several subdomains of quality of life, interoceptive awareness, and shoulder range of motion. Changes in pain, fatigue, pain catastrophizing, anxiety, depression, and quality of life were clinically meaningful. Postintervention effects were sustained at 6 months. Conclusions: QMBE is a safe and gentle multimodal intervention that shows promise in conferring a broad range of psychosocial and physical benefits for breast cancer survivors with PPSP. Results support the value of future studies evaluating the impact of QMBE on multiple outcomes relevant to breast cancer survivors with PPSP.

Patient Disclosure of Complementary and Integrative Health Approaches in an Academic Health Center.

BACKGROUND: Effective patient-doctor communication about complementary and integrative health (CIH) is crucial to coordinate multimodal treatment for complex conditions. While rates of patient disclosure of CIH use to physicians have increased in the United States over the last 30 years, many patients still do not disclose these facts. Integrating CIH approaches within academic medical centers may enhance the communication, but this has not been explicitly studied. OBJECTIVE: To examine rates of patient disclosure of CIH to physicians and reasons for nondisclosure. METHODS: We surveyed 1177 patients at an academic center's CIH clinic regarding their CIH use and disclosure of CIH use to their physician. RESULTS: Of the 1067 who responded to the disclosure questions, 80.1% had discussed their CIH use with their physician, while 19.9% did not. Of those who did not disclose, lack of physician inquiry was reported by 58% as the principal reason. DISCUSSION: Within an academic center, there is still a need to improve communication about CIH use. Possible strategies might include continued education of both patients and physicians about CIH and communication skills and integration of CIH disclosure into routine patient health questionnaires.

Integrating Chiropractic Care Into the Treatment of Migraine Headaches in a Tertiary Care Hospital: A Case Series.

This case series illustrates an integrated model of care for migraine that combines standard neurological care with chiropractic treatment. For each patient, we describe the rationale for referral, diagnosis by both the neurologist and chiropractor, the coordinated care plan, communication between the neurologist and chiropractor based on direct face-to-face "hallway" interaction, medical notes, team meetings, and clinical outcomes. Findings are evaluated within the broader context of the multicause nature of migraine and the impact of integrative chiropractic. Suggestions for future areas of research evaluating integrative approaches are discussed.

Cost-Effectiveness of a Team-Based Integrative Medicine Approach to the Treatment of Back Pain.

OBJECTIVES: To report the results of health economic analyses comparing two treatment approaches for chronic low back pain (CLBP). DESIGN: Observational prospective cohort study comparing effectiveness and cost-effectiveness of CLBP care provided at an integrative care clinic with that provided in other clinics within the same hospital. CLBP-related medical utilization, function, quality of life, and days of work incapacity were self-reported at baseline, 3, 6, and 12 months. SETTINGS/LOCATION: Osher Clinical Center (OCC) based at a tertiary academic hospital (Brigham and Women's Hospital [BWH]) and other clinics at BWH. SUBJECTS: CLBP patients seeking care at OCC or non-OCC BWH clinics. INTERVENTIONS: Integrative or conventional care for CLBP as prescribed by the treating clinician(s). OUTCOME MEASURES: Quality-adjusted life years (QALYs) were estimated per treatment approach based on the SF-12. Cost per QALY gained was evaluated using an incremental cost-effectiveness ratio (ICER). ICERs based on CLBP-specific effectiveness measures (Roland Disability Questionnaire [RDQ] and bothersomeness of pain [BOP]) were exploratory outcomes. RESULTS: Total adjusted annual CLBP-related costs per patient were greater in the OCC versus non-OCC group ($11,526.73 vs. $6,810.63). Between group differences in QALYs were small and ICER estimate of cost per QALY gained was high ($436,676). However, unadjusted mean direct costs per patient decreased over time in the OCC group. Savings in direct costs of $391 (95% confidence interval: -1,078 to 1,861) were observed in the OCC group for the 6- to 12-month period, driven primarily by reduced medication usage. ICERs based on adjusted RDQ and BOP group differences showed cost of $2,073 and $4,203 for a one-point reduction per respective scale. CONCLUSIONS: When adjusted for baseline differences, self-reported costs were higher in the OCC group with only small effects on QALYs. However, trends toward decreased direct expenditures and medication usage over time warrant further investigation. Future studies evaluating potential benefits of integrative care models for the management of CLBP should employ randomized designs, longer observational periods, and explore multiple metrics of cost-effectiveness.

Can Tai Chi and Qigong Postures Shape Our Mood? Toward an Embodied Cognition Framework for Mind-Body Research.

Dynamic and static body postures are a defining characteristic of mind-body practices such as Tai Chi and Qigong (TCQ). A growing body of evidence supports the hypothesis that TCQ may be beneficial for psychological health, including management and prevention of depression and anxiety. Although a variety of causal factors have been identified as potential mediators of such health benefits, physical posture, despite its visible prominence, has been largely overlooked. We hypothesize that body posture while standing and/or moving may be a key therapeutic element mediating the influence of TCQ on psychological health. In the present paper, we summarize existing experimental and observational evidence that suggests a bi-directional relationship between body posture and mental states. Drawing from embodied cognitive science, we provide a theoretical framework for further investigation into this interrelationship. We discuss the challenges involved in such an investigation and propose suggestions for future studies. Despite theoretical and practical challenges, we propose that the role of posture in mind-body exercises such as TCQ should be considered in future research.

A Multidisciplinary Integrative Medicine Team in the Treatment of Chronic Low-Back Pain: An Observational Comparative Effectiveness Study.

OBJECTIVES: Chronic low-back pain (CLBP) is burdensome and costly, and a common condition for which adults use integrative therapies. The effectiveness of multidisciplinary integrative approaches has not been well studied. The purpose of this observational study was to compare characteristics and outcomes of CLBP patients treated at the Osher Clinical Center (OCC) versus other clinics at Brigham and Women's Hospital. DESIGN: Observational comparative effectiveness study. SETTING: Tertiary care hospital. SUBJECTS: Patients ≥21 years with 3+ months of CLBP or 6+ months of intermittent low-back pain. INTERVENTION: All patients were observed for 12 months. OCC patients received care at the integrative clinic (7.3 visits on average over 13 weeks); non-OCC patients received usual care at other clinics of the same hospital. OUTCOME MEASURES: Primary outcomes: change from baseline to 6 months in functional status (Roland Disability Questionnaire [RDQ]) and bothersomeness of pain (BOP). SECONDARY OUTCOMES: change in RDQ and BOP at 3 and 12 months, percentages of patients with clinically meaningful (≥30%) improvements. RESULTS: One hundred fifty-six OCC and 153 non-OCC participants were enrolled; follow-up was 90.4 and 98.0%, respectively, at 12 months. There were substantial differences in baseline characteristics between groups. For RDQ, the adjusted mean group difference was nonsignificant at 6 months; for BOP, the differences were significant, but clinically small. At 12 months, the observed benefit on RDQ was significant and clinically meaningful; for BOP, there were significant, but clinically small differences. Percentages of patients with ≥30% improvements in RDQ were significantly greater in the OCC group only at 12 months, and both 6 and 12 months for BOP. CONCLUSIONS: Baseline characteristics can differ between those who select different sources of healthcare for CLBP. While benefits seen in the OCC versus non-OCC clinics were not large, further evaluation through randomized trials might be warranted to provide a more definitive evaluation.

Tai Chi for Reducing Dual-task Gait Variability, a Potential Mediator of Fall Risk in Parkinson's Disease: A Pilot Randomized Controlled Trial.

OBJECTIVES: To assess the feasibility and inform design features of a fully powered randomized controlled trial (RCT) evaluating the effects of Tai Chi (TC) in Parkinson's disease (PD) and to select outcomes most responsive to TC assessed during off-medication states. DESIGN: Two-arm, wait-list controlled RCT. SETTINGS: Tertiary care hospital. SUBJECTS: Thirty-two subjects aged 40-75 diagnosed with idiopathic PD within 10 years. INTERVENTIONS: Six-month TC intervention added to usual care (UC) versus UC alone. OUTCOME MEASURES: Primary outcomes were feasibility-related (recruitment rate, adherence, and compliance). Change in dual-task (DT) gait stride-time variability (STV) from baseline to 6 months was defined, a priori, as the clinical outcome measure of primary interest. Other outcomes included: PD motor symptom progression (Unified Parkinson's Disease Rating Scale [UPDRS]), PD-related quality of life (PDQ-39), executive function (Trail Making Test), balance confidence (Activity-Specific Balance Confidence Scale, ABC), and Timed Up and Go test (TUG). All clinical assessments were made in the off-state for PD medications. RESULTS: Thirty-two subjects were enrolled into 3 sequential cohorts over 417 days at an average rate of 0.08 subjects per day. Seventy-five percent (12/16) in the TC group vs 94% (15/16) in the UC group completed the primary 6-month follow-up assessment. Mean TC exposure hours overall: 52. No AEs occurred during or as a direct result of TC exercise. Statistically nonsignificant improvements were observed in the TC group at 6 months in DT gait STV (TC [20.1%] vs UC [-0.1%] group [effect size 0.49; P = .47]), ABC, TUG, and PDQ-39. UPDRS progression was modest and very similar in TC and UC groups. CONCLUSIONS: Conducting an RCT of TC for PD is feasible, though measures to improve recruitment and adherence rates are needed. DT gait STV is a sensitive and logical outcome for evaluating the combined cognitive-motor effects of TC in PD.

Establishing an Integrative Medicine Program Within an Academic Health Center: Essential Considerations.

Integrative medicine (IM) refers to the combination of conventional and "complementary" medical services (e.g., chiropractic, acupuncture, massage, mindfulness training). More than half of all medical schools in the United States and Canada have programs in IM, and more than 30 academic health centers currently deliver multidisciplinary IM care. What remains unclear, however, is the ideal delivery model (or models) whereby individuals can responsibly access IM care safely, effectively, and reproducibly in a coordinated and cost-effective way.Current models of IM across existing clinical centers vary tremendously in their organizational settings, principal clinical focus, and services provided; practitioner team composition and training; incorporation of research activities and educational programs; and administrative organization (e.g., reporting structure, use of medical records, scope of clinical practice) and financial strategies (i.e., specific business plans and models for sustainability).In this article, the authors address these important strategic issues by sharing lessons learned from the design and implementation of an IM facility within an academic teaching hospital, the Brigham and Women's Hospital at Harvard Medical School; and review alternative options based on information about IM centers across the United States.The authors conclude that there is currently no consensus as to how integrative care models should be optimally organized, implemented, replicated, assessed, and funded. The time may be right for prospective research in "best practices" across emerging models of IM care nationally in an effort to standardize, refine, and replicate them in preparation for rigorous cost-effectiveness evaluations.

Within-team Patterns of Communication and Referral in Multimodal Treatment of Chronic Low Back Pain Patients by an Integrative Care Team.

BACKGROUND: Nonspecific chronic low back pain (CLBP) is a highly prevalent and costly public health problem with few treatment options that provide consistent and greater than modest benefits. Treatment of CLBP is shifting from unimodal to multimodal and multidisciplinary approaches, including biopsychosocially-based complementary and integrative care. Multidisciplinary approaches require unique levels of communication and coordination amongst clinicians; however, to date few studies have evaluated patterns of communication and decision making amongst clinicians collaborating in the care of challenging patients with CLBP. METHODS: As part of an observational study evaluating the effectiveness and cost-effectiveness of an integrative, team-based care model for the treatment of CLBP, we used multiple qualitative research methods to characterize within-team cross-referral and communication amongst jointly-trained practitioners representing diverse biomedical and complementary disciplines. Patterns of communication and coordinated care are summarized for 3 cases of CLBP treated by multiple members (≥3) of an integrative medical team embedded within an academic hospital. RESULTS: Patients were aged from 36 to 88 years with varied comorbidities. Qualitative content analysis revealed 5 emergent themes regarding integrative patient care and treatment decision in this clinic: (1) the fundamental importance of the clinic's formal teamwork training; (2) the critical communicative and collaborative function of regular team meetings; (3) the importance to patient care goals of having the varied disciplines practicing "under one roof"; (4) a universal commitment to understanding and treating patients as whole persons; and (5) a shared philosophy of helping patients to help themselves. These key themes are all interconnected and form the foundation of the clinic's culture. CONCLUSIONS: Our qualitative findings provide context for current trends in enhancing patient-centered, coordinated, and team-based care; efforts towards better understanding interprofessional communication; overcoming barriers to successful collaboration; and identifying best practices for fostering clinical teamwork and a strong team identity. Our findings also support the need for further qualitative research, in combination with quantitative research, for evaluating the effectiveness and cost-effectiveness of resource-intensive integrative models for the treatment of chronic conditions.