Real-World Massage Therapy Produces Meaningful Effectiveness Signal for Primary Care Patients with Chronic Low Back Pain: Results of a Repeated Measures Cohort Study.

OBJECTIVE: While efficacy of massage and other nonpharmacological treatments for chronic low back pain is established, stakeholders have called for pragmatic studies of effectiveness in "real-world" primary health care. The Kentucky Pain Research and Outcomes Study evaluated massage impact on pain, disability, and health-related quality of life for primary care patients with chronic low back pain. We report effectiveness and feasibility results, and make comparisons with established minimal clinically important differences. METHODS: Primary care providers referred eligible patients for 10 massage sessions with community practicing licensed massage therapists. Oswestry Disability Index and SF-36v2 measures obtained at baseline and postintervention at 12 and 24 weeks were analyzed with mixed linear models and Tukey's tests. Additional analyses examined clinically significant improvement and predictive patient characteristics. RESULTS: Of 104 enrolled patients, 85 and 76 completed 12 and 24 weeks of data collection, respectively. Group means improved at 12 weeks for all outcomes and at 24 weeks for SF-36v2's Physical Component Summary and Bodily Pain Domain. Of those with clinically improved disability at 12 weeks, 75% were still clinically improved at 24 weeks ( P < 0.01). For SF-36v2 Physical and Mental Component Summaries, 55.4% and 43.4%, respectively, showed clinically meaningful improvement at 12 weeks, 46.1% and 30.3% at 24 weeks. For Bodily Pain Domain, 49.4% were clinically improved at 12 weeks, 40% at 24 weeks. Adults older than age 49 years had better pain and disability outcomes than younger adults. CONCLUSIONS: Results provide a meaningful signal of massage effect for primary care patients with chronic low back pain and call for further research in practice settings using pragmatic designs with control groups.

Using the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) model in clinical research: Application to refine a practice-based research network (PBRN) study.

BACKGROUND: Pragmatic clinical trials (PCTs) are increasingly recommended to evaluate interventions in real-world conditions. Although PCTs share a common approach of evaluating variables from actual clinical practice, multiple characteristics can differ. These differences affect interpretation of the trial. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) model was developed in 2009 by the CONSORT Work Group on Pragmatic Trials, published by Thorpe et al, to aid in trial design. PRECIS provides clarity about the generalizability and applicability of a trial by depicting multiple study characteristics. We recently completed a National Institutes of Health-sponsored pilot study examining health-related outcomes for 2 complementary therapies for chronic low back pain in patients referred by primary care providers in the Kentucky Ambulatory Network. In preparation for a larger study, we sought to characterize the pragmatic features of the study to aid in our design decisions. The purpose of this article is to introduce clinical researchers to the PRECIS model while demonstrating its application to refine a practice based research network study. METHOD: We designed an exercise using an audience response system integrated with a Works in Progress presentation to experienced researchers at the University of Kentucky to examine our study methodologies of parameters suggested by the PRECIS model. RESULTS: The exercise went smoothly and participants remained engaged throughout. The study received an overall summary score of 30.17 (scale of 0 to 48; a higher score indicates a more pragmatic approach), with component scores that differentiate design components of the study. A polar chart is presented to depict the pragmatism of the overall study methodology across each of these components. CONCLUSIONS: The study was not as pragmatic as expected. The exercise results seem to be useful in identifying necessary refinements to the study methodology that may benefit future study design and increase generalizability. Readers can identify how the PRECIS model may be used to provide clarity and transparency for proposed or existing studies and may wish to replicate our exercise in planning their own studies.

The Intersection of Massage Practice and Research: Community Massage Therapists as Research Personnel on an NIH-funded Effectiveness Study.

INTRODUCTION: Few NIH funded studies give community massage therapists the opportunity to become study personnel. A recent NIH/NCCAM-funded study investigating chronic low back pain (CLBP) recruited, trained, and utilized community massage practitioners (CMPs) as study personnel. This study's aim was to determine whether health-related outcomes for CLBP improve when patients are referred from primary care to select CAM modalities including massage therapy (MT). The purpose of this paper is to report the results of the study's three massage practice-driven study objectives which were to: 1) identify challenges and solutions to recruiting and retaining ample CMPs, 2) develop a practice-informed protocol reflecting real-world MT, and 3) determine the extent to which CMPs comply with rigorous research methodology in their clinical practices as study personnel. METHODS: Eligible CMPs in urban and rural Kentucky counties were identified through licensure board records, professional organizations, and personal contact opportunities. Interested CMPs completed 6 CE hours of research and Human Subjects Protection training and agreed to comply with a study protocol reflecting MT as practiced. Once trained, study CMPs were matched with study participants to provide and document up to 10 MT sessions per participant. RESULTS: Utilizing prominent MT community members proved invaluable to CMP recruitment and protocol development. CMP recruitment challenges included mixed interest, low number of available rural CMPs, busy clinic schedules, and compensation. Ethics CE credits were offered to encourage CMP interest. A total of 28 Kentucky licensed massage therapists with 5-32 years of experience completed study training. A total of 127 CLBP patients consented to participate (n = 104 for MT). Twenty-five CMPs were assigned CLBP patients and provided 1-10 treatments for 94 study participants. Treatment documentation was provided by CMPs for 97% of treatments provided. CONCLUSIONS: When recruitment, retention, and protocol compliance challenges are met, CMPs are valuable study personnel for practice-based research reflecting real-world MT practice.

Impact of two types of Internet-based information on medical students' performance in an Objective Structured Clinical Exam (OSCE).

OBJECTIVES: Internet-based information has potential to impact physician-patient relationships. This study examined medical students' interpretation and response to such information presented during an objective clinical examination. METHOD: Ninety-three medical students who had received training for a patient centered response to inquiries about alternative treatments completed a comprehensive examination in their third year. In 1 of 12 objective structured clinical exams, a SP presented Internet-based information on l-theanine - an amino acid available as a supplement. In Condition A, materials were from commercial websites; in Condition B, materials were from the PubMed website. RESULTS: Analyses revealed no significant differences between Conditions in student performance or patient (SP) satisfaction. Students in Condition A rated the information less compelling than students in Condition B (z=-1.78, p=.037), and attributed less of the treatment's action to real vs. placebo effects (z=-1.61, p=.053). CONCLUSIONS: Students trained in a patient centered response to inquiries about alternative treatment perceived the credibility of the two types of Internet-based information differently but were able to respond to the patient without jeopardizing patient satisfaction. Approach to information was superficial. Training in information evaluation may be warranted.

Toward Interdisciplinary Care: Bridging the Divide between Biomedical and Alternative Health Care Providers.

PURPOSE: Responding to suggestions that physicians are obligated to inquire fully about complementary and alternative medicine (CAM) use and its scientific evidence, to acknowledge patients' health beliefs and practices, and to accommodate diverse healing practices, our interdisciplinary CAM integration project created an advisory committee (AC) composed of CAM practitioners and institutional personnel to incorporate CAM- related information into health professions training. We report on the collaborative process and describe group members' perceptions of medicine and clinical teaching. METHODS: Information collected from the first two years' quarterly meetings, the first annual retreat, and other venues was analyzed in conjunction with semi-structured in-person interviews of 10 biomedical and CAM practitioner committee members. Data were analyzed using qualitative methodology and N5 software to identify themes and patterns. RESULTS: Analysis confirmed expectations that allopathic and CAM AC members held different views of health and healing. Member comments reflected points of tension that clustered into three intertwined themes: what constitutes evidence, interaction with the patient, and the relative importance of experience in learning. Recommendations for designing interdisciplinary CAM curricula are presented. CONCLUSION: Differences between CAM and allopathic providers were frequent but did not obviate common goals or collaboration. Results demonstrate the potential for collaboration between these groups and our activities may be useful to others seeking to implement interdisciplinary care, particularly between CAM and allopathic providers.

Innovations in integrative healthcare education: a healing journey for cancer patients in ontario and an online interdisciplinary CAM course for allied health students in Kentucky.

Content on integrative healthcare and complementary and alternative medicine (CAM) is being taught in hundreds of educational programs across the country. Nursing, medical, osteopathic, chiropractic, acupuncture, naturopathic, and other programs are finding creative and innovative ways to include these approaches in new models of education and practice. This column spotlights such innovations in integrative healthcare and CAM education and presents readers with specific educational interventions they can adapt into new or ongoing educational efforts at their institution or programs. We invite readers to submit brief descriptions of efforts in their institutions that reflect the creativity, diversity, and interdisciplinary nature of the field.

Communication about complementary and alternative medicine: perspectives of primary care clinicians.

BACKGROUND: People in the United States are using complementary and alternative medicine (CAM) increasingly while they are also receiving conventional care. National population-based surveys and studies in primary care settings have documented inadequate communication about CAM between patients and their conventional healthcare providers. Most studies about CAM communication have surveyed urban practices and focused on physicians. Information about how physicians and non-physician in rural areas clinicians communicate with their patients about CAM is needed to develop strategies for improving the quality of care for patients in rural areas. OBJECTIVE: To investigate how primary care clinicians in the Kentucky Ambulatory Network (KAN) communicate with patients about CAM and to determine interest in additional education about CAM. METHODS: A self-administered survey was mailed to 112 community clinicians in a research network of largely rural practices. KAN members include primary care physicians, nurse practitioners, certified nurse midwives, and physician assistants practicing in 32 counties in central and eastern Kentucky. RESULTS: Of 102 deliverable surveys, 65 (64%) were returned. Sixty-one (94%) clinicians reported patient CAM use. Few clinicians consistently asked patients about CAM. A positive attitude toward patient CAM use was associated with clinician comfort in advising patients. Most clinicians recommended CAM to patients. Seventy percent of KAN clinicians expressed interest in continuing education about CAM. CONCLUSIONS: Kentucky primary care clinicians are aware of their patients' CAM use and are motivated to learn more about CAM so that they can appropriately advise their patients. They need evidence-based, clinically relevant education about CAM to provide better patient care.

Collecting Information About a CAM Practitioner's Practice: A Preliminary Report of a Self-Interview Methodology.

To prepare allopathic providers to advise patients about complementary and alternative medicine (CAM) therapies, the University of Kentucky CAM curriculum integration project has identified and trained CAM practitioners to coteach, precept, and demonstrate their respective practices. This project is interested in integrating CAM practitioners as teachers into this university and has formed a multidisciplinary committee for advice. The committee has recognized the importance of increased understanding of CAM practices to enhance communication within itself and to decide to which CAM practices students should receive exposure. This article reports our attempt to create a CAM practice description, based on questions general to CAM practice and specific to a particular approach. Because there is limited existing systematic research on CAM practice characteristics, these questions may interest researchers conducting qualitative studies, especially those seeking an example of questions to ask CAM practitioners. We also believe this practice description will be of general interest.