Article: Spinal manipulative therapy and exercise for older adults with chronic low back pain:a randomized clinical trial

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Article co-written by Michele Maiers, Northwestern Health Sciences University Executive Director of Research and Innovation. The article was published in Chiropractic and Manual Therapies in 2019 and is online access only.
Abstract

Background: Low back pain (LBP) is a common disabling condition in older adults which often limits physical function and diminishes quality of life. Two clinical trials in older adults have shown spinal manipulative therapy (SMT) results in similar or small improvements relative to medical care; however, the effectiveness of adding SMT or rehabilitative exercise to home exercise is unclear. 

Methods: We conducted a randomized clinical trial assessing the comparative effectiveness of adding SMT or supervised rehabilitative exercise to home exercise in adults 65 or older with sub-acute or chronic LBP. Treatments were provided over 12-weeks and self-report outcomes were collected at 4, 12, 26, and 52 weeks. The primary outcome was pain severity. Secondary outcomes included back disability, health status, medication use, satisfaction with care, and global improvement. Linear mixed models were used to analyze outcomes. The primary analysis included longitudinal outcomes in the short (week 4–12) and long-term (week 4–52). An omnibus test assessing differences across all groups over the year was used to control for multiplicity. Secondary analyses included outcomes at each time point and responder analyses. This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration. 

Results: 241 participants were randomized and 230 (95%) provided complete primary outcome data. The primary analysis showed group differences in pain over the one-year were small and not statistically significant. Pain severity was reduced by 30 to 40% after treatment in all 3 groups with the largest difference (eight percentage points) favoring SMT and home exercise over home exercise alone. Group differences at other time points ranged from 0 to 6 percentage points with no consistent pattern favoring one treatment. One-year post-treatment pain reductions diminished in all three groups. Secondary self-report outcomes followed a similar pattern with no important group differences, except satisfaction with care, where the two combination groups were consistently superior to home exercise alone. 

Conclusions: Adding spinal manipulation or supervised rehabilitative exercise to home exercise alone does not appear to improve pain or disability in the short- or long-term for older adults with chronic low back pain but did enhance satisfaction with care.

Article: Spinal manipulation, epidural injections, and self-care for sciatica: A pilot study for a randomized clinical trial

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Article co-written by Michele Maiers, Northwestern Health Sciences University Executive Director of Research and Innovation. The article was published in the Journal of Manipulative and Physiological Therapeutics in 2003.
Abstract

Objective: To assess the feasibility of recruiting sciatica patients and to evaluate their compliance in preparation for a full-scale randomized clinical trial. We also aimed to determine the responsiveness of key outcome measures.

Methods: Thirty-two subjects were randomly assigned to spinal manipulation (n=11), epidural steroid injections (n=11), or self-care education (n=10). No between-group comparisons were planned because of the small sample size.

Results: At week 12 (the end of the treatment phase), the outcome measures indicating the most improvement/change were the Oswestry disability score (mean, 22.9; SD, 19.9; effect size [ES], 1.8), leg pain severity (mean, 2.9; SD, 1.7; ES, 1.7), and if the symptoms were bothersome (mean, 25.2; SD, 16.0; ES, 1.6). Twenty-four patients were either “very satisfied” or “completely satisfied,” and 22 of 32 patients reported 75% or 100% improvement. After 52 weeks, the outcome measure showing the most improvement/change was leg pain severity (mean, 2.3; SD, 2.6; ES, 1.35), followed by the Oswestry disability score (mean, 15.6; SD, 20; ES, 1.2) and if symptoms were bothersome (mean, 18.1; SD, 22.6; ES, 1.1). Eighteen patients were either “very satisfied” or “completely satisfied,” and 15 of 32 patients reported 75% or 100% improvement.

Conclusions: The results of this pilot study suggest that it is feasible to recruit subacute and chronic sciatica patients and to obtain their compliance for a full-scale randomized clinical.

 

Article: Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials

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Article co-written by Michele Maiers, Northwestern Health Sciences University's Executive Director of Research and Innovation. It was published by BMC Musculoskeletal Disorders in 2007, and was made available via online access.
Abstract

Background: Low back pain (LBP) and neck pain (NP) are common conditions in old age, leading to impaired functional ability and decreased independence. Manual and exercise therapies are common and effective therapies for the general LBP and NP populations. However, these treatments have not been adequately researched in older LBP and NP sufferers.

The primary aim of these studies is to assess the relative clinical effectiveness of 1) manual treatment plus home exercise, 2) supervised rehabilitative exercise plus home exercise, and 3) home exercise alone, in terms of patient-rated pain, for senior LBP and NP patients. Secondary aims are to compare the three treatment approaches in regards to patient-rated disability, general health status, satisfaction, improvement and medication use, as well as objective outcomes of spinal motion, trunk strength and endurance, and functional ability. Cost-effectiveness and cost-utility will also be assessed. Finally, using qualitative methods, older LBP and NP patient's perceptions of treatment will be explored and described.

Methods/Design: This paper describes the design of two multi-methods clinical studies focusing on elderly patients with non-acute LBP and NP. Each study includes a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study. Four hundred and eighty participants (240 per study), ages 65 and older, will be recruited and randomized to one of three, 12-week treatment programs. Patient-rated outcome measures are collected via self-report questionnaires at baseline and at 4, 12, 26, and 52 weeks post-randomization. Objective outcomes are assessed by examiners masked to treatment assignment at baseline and 12 weeks. Health care cost data is collected through standardized clinician forms, monthly phone interviews, and self-report questionnaires throughout the study. Qualitative interviews using a semi-structured format are conducted at the end of the 12 week treatment period.

Discussion: To our knowledge, these are the first randomized clinical trials to comprehensively address clinical effectiveness, cost-effectiveness, and patients' perceptions of commonly used treatments for elderly LBP and NP sufferers.

Article: Ways of knowing: Integrating research Into CAM education and holism Into conventional health professional education

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Article co-written by Michele Maiers, Northwestern Health Sciences University Executive Director of Research and Innovation. The article is the author manuscript made available by NIH Public Access. It was published in its final edited form in Explore (NY). Citation: Explore (NY). 2008; 4(4): 278-281.
Abstract

Content on integrative healthcare and complementary and alternative medicine 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. 

Article: Racial inequities in integrative healthcare

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A policy statement written by Michele Maiers, Northwestern Health Sciences University's Executive Director of Research and Innovation, and Chuck Sawyer, Special Assistant to the President.
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A complex legacy of racism in the United States continues to create health inequities among people of color. Systemic biases in education, employment, housing, healthcare, access to food, accumulation of wealth, and the legal system contribute to poorer health among communities of color. These social determinants of health are driving factors behind the “weathering hypothesis”, where chronic exposure to discrimination and disadvantage lead to accelerated decline in health outcomes, particularly among Black individuals. Black Americans experience greater rates of disease in nearly every major indicator of physical health as compared to other racial and ethnic groups in the United States. Infant mortality among African Americans is twice the national average, and the life expectancy for Black men and women is consistently shorter than their White counterparts.  While this report focuses primarily on Black communities and other persons of color, we acknowledge many groups similarly face discrimination based on gender identity, sexual orientation, social class, and ability.

Article: Differences in function and comorbidities between older adults and nonusers of chiropractic and osteopathic manipulation: a cross-sectional analysis of the 2012 National Health Interview Survey

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This article was co-written by Northwestern Health Sciences University researchers Michele Maiers and Mary L. Forte. It was published in the Journal of Manipulative and Physiological Therapeutics and was made available online by the NIH/National Library of Medicine in 2019. Citation: 2019 July; 42(6); 450-460.
Abstract

Objective: The purpose of this cross-sectional study was to compare functional limitations and comorbidity prevalence between older adult users and nonusers of chiropractic and osteopathic (DC/DO) manipulation to inform provider training.

Methods: We conducted a secondary analysis of the 2012 National Health Interview Survey data. Adults age 65 or older who responded to the survey were included. Descriptive statistics are reported for adults who used DC/DO manipulation (vs nonusers) regarding function, comorbidities, musculoskeletal complaints, and medical services. Weighted percentages were derived using SAS and compared with χ2 tests.

Results: The DC/DO users were more often female, overweight or obese, and of white race than nonusers. More DC/DO users reported arthritis (55.3% vs 47.0%, <0.01) or asthma (15.0% vs 10.0%, P < .01) than nonusers; hypertension (61.9% vs 55.5%, P = .02) and diabetes (20.3% vs 15.7%, P = .02) were more prevalent in nonusers; and other comorbidities were comparable. The DC/DO users reported more joint pain/stiffness (55.7% vs 44.8%), chronic pain (19.8% vs 14.2%), low back pain (27.8% vs 18.4%), low back with leg pain (18.8% vs 10.6%), and neck pain (24.2% vs 13.1%) than nonusers (all P < .01). Functional limitations affected two-thirds overall, but DC/DO users reported more difficulties stooping and bending; other limitations were comparable. One in 9 reported activities of daily living or instrumental activities of daily living limitations; nonusers were more affected. Surgery was more common among DC/DO users (26.1% vs 19.3%, <0.01); emergency room visits were comparable.

Conclusion: Differences existed between older adult manipulation users and nonusers, especially surgical utilization, musculoskeletal complaints, and comorbidities; functional differences were modest. Our findings highlight areas for provider training and awareness regarding comorbidity burden and management needs in older patients who may simultaneously use manipulation and medical care for musculoskeletal complaints.

Article: Culturally sensitive chiropractic care of the transgender community

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Article co-written by Michele Maiers, Northwestern Health Sciences University's Executive Director of Research and Innovation. The article was published in August 2017 by the Journal of Chiropractic Humanities and was made available online by ScienceDirect
Abstract

Objectives: Transgender individuals commonly experience barriers to quality health care and may suffer from unique musculoskeletal complaints. Although these needs are often inadequately addressed within the health care system, they could be attended to by the chiropractic community. This narrative review describes best practices for delivering culturally sensitive care to transgender patients within the context of chiropractic offices.

Methods: A literature search generated peer-reviewed material on culturally competent care of the transgender community. Google Scholar and trans-health RSS feeds on social media were also searched to find relevant gray literature. Information pertinent to a chiropractic practice was identified and summarized.

Results: Contemporary definitions of transgender, gender identity, and sexual orientation provide a framework for culturally sensitive language and clinic culture. Small changes in record keeping and office procedures can contribute to a more inclusive environment for transgender patients and improve a chiropractor's ability to collect important health history information. Special considerations during a musculoskeletal examination may be necessary to properly account for medical and nonmedical practices transgender patients may use to express their gender. Chiropractors should be aware of health care and social and advocacy resources for transgender individuals and recommend them to patients who may need additional support.

Conclusions: Small yet intentional modifications within the health care encounter can enable chiropractors to improve the health and well-being of transgender individuals and communities.

Article: Adverse events among seniors receiving spinal maniupation and exercise in a randomized clinical trial

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Article co-written by Northwestern Health Sciences University researchers. The article was published in Manual Therapy and was made available online by Elsevier in 2015.
Abstract

Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making.

This paper provides a detailed report of AE experienced by elderly participants in a randomized comparative effectiveness trial of SMT and exercise for chronic NP.

AE data, consistent with CONSORT recommendations, were collected on elderly participants who received 12 weeks of SMT with home exercise, supervised plus home exercise, or home exercise alone. Standardized questions were asked at each treatment; participants were additionally encouraged to report AE as they occurred. Qualitative interviews documented participants' experiences with AE. Descriptive statistics and content analysis were used to categorize and report these data.

Compliance was high among the 241 randomized participants. Non-serious AE were reported by 130/194 participants. AE were reported by three times as many participants in supervised plus home exercise, and nearly twice as many as in SMT with home exercise, as in home exercise alone. The majority of AE were musculoskeletal in nature; several participants associated AE with specific exercises. One incapacitating AE occurred when a participant fell during supervised exercise session and fractured their arm. One serious adverse event of unknown relationship occurred to an individual who died from an aneurysm while at home. Eight serious, non-related AE also occurred.

Musculoskeletal AE were common among elderly participants receiving SMT and exercise interventions for NP. As such, they should be expected and discussed when developing care plans.

Article: Patient outcomes at a traditional Chinese medicine teaching clinic: a prospective data collection project

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Article co-written by Michele Maiers, Northwestern Health Sciences University's Executive Director of Research and Innovation. The article was published in The Journal of Alternative and Complementary Medicine in 2008. Citation: The Journal of Alternative and Complementary Medicine. Volume 14, Number 9, 2998, pp. 1083-1088
Abstract

 Objective: The purpose of this study was to describe patients who seek treatment at an acupuncture and Oriental medicine teaching clinic in the United States, and to systematically measure and describe patients' responses after treatment using a prospective study design.

Design: This is a prospective survey of clinic patients at intake and one month following the initial treatment.

Settings and location: Data were collected in an acupuncture and Oriental medicine teaching clinic located in Bloomington, Minnesota.

Subjects: Of 661 new patients who met eligibility criteria, 485 consented to participate.

Interventions: Patients were administered two self-report questionnaires: one prior to their initial treatment, and a second sent by mail one month later.

Outcome measures: Data collected at intake included demographics such as age, gender, race, ethnicity, education, and employment, as well as main presenting complaint and chronicity. Patients were also asked at intake whether they had consulted with another health care provider, if they were under continued care, and if they had previous experience with Traditional Chinese Medicine (TCM) treatment. Outcome measures included severity, improvement, and satisfaction. Patients were additionally asked if they continued with TCM care for their presenting condition.

Results: Demographics of patients presenting to this teaching clinic were similar to those reported in other outpatient TCM settings. The majority of patients had no previous experience with TCM, and a large percentage was referred by students. Pain was the most common presenting condition, followed closely by wellness care. One month following treatment, most patients reported improvement and satisfaction with care.

Conclusions: Standardized data collection and follow-up resulted in a description of patients and outcomes in an acupuncture and Oriental medicine teaching clinic, which can be used for research, educational, quality assurance, and marketing purposes.

 

Article: The development of a prospective data collection process in a Traditional Chinese Medicine teaching clinic

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Article co-written by Michele Maiers, Northwestern Health Sciences University Executive Director of Research and Innovation. The article was published in the Journal of Alternative and Complementary Medicine, Volume 15, Number 3; 2009; pp. 305-320.
Abstract

Objective: There is a growing need for students and practitioners of Traditional Chinese Medicine to gain experience with standardized data collection, patient outcomes measurement, and practice-based research. The purpose of this paper is to describe the development of a process for standardized data collection that could eventually be adopted for clinical, research, and quality assurance purposes. Settings/location: The setting for this study was an acupuncture and Oriental medicine teaching clinic in Bloomington, Minnesota. 

Methods: Four (4) aspects of data collection were assessed and improved, including intake and post-treatment questionnaires, follow-up with patients, integration of data collection into clinic flow, and commitment of resources to the project. 

Outcome measures: The outcomes measures were data collection and missing data rates, burden on patients and clinic staff, and efficiency of data entry. Results: Revision to the data collection process resulted in decreased burden to patients and staff, more detailed and aggressive follow-up protocols, enhanced training for clinic staff, and increased personnel and data related resources.

 Conclusions: The systematic collection of descriptive and clinical characteristics can be accomplished in a teaching clinic with thoughtful attention paid to data collection protocols, dedicated resources, and the involvement of all relevant personnel.