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Author(s): Roseen, Eric J; Kasali, Bolanle Aishat; Corcoran, Kelsey; Masselli, Kelsey; Laird, Lance; Saper, Robert B; Alford, Daniel P; Cohen, Ezra; Lisi, Anthony; Atlas, Steven J; Bean, Jonathan F; Evans, Roni; Bussieres, Andre | Abstract: IntroductionBack and neck pain are the leading causes of disability worldwide. Doctors of chiropractic (DCs) are trained to manage these common conditions and can provide non-pharmacological treatment aligned with international clinical practice guidelines. Although DCs practice in over 90 countries, chiropractic care is rarely available within integrated healthcare delivery systems. A lack of DCs in private practice, particularly in low-income communities, may also limit access to chiropractic care. Improving collaboration between medical providers and community-based DCs, or embedding DCs in medical settings such as hospitals or community health centres, will improve access to evidence-based care for musculoskeletal conditions.Methods and analysesThis scoping review will map studies of DCs working with or within integrated healthcare delivery systems. We will use the recommended six-step approach for scoping reviews. We will search three electronic data bases including Medline, Embase and Web of Science. Two investigators will independently review all titles and abstracts to identify relevant records, screen the full-text articles of potentially admissible records, and systematically extract data from selected articles. We will include studies published in English from 1998 to 2020 describing medical settings that have established formal relationships with community-based DCs (eg, shared medical record) or where DCs practice in medical settings. Data extraction and reporting will be guided by the Proctor Conceptual Model for Implementation Research, which has three domains: clinical intervention, implementation strategies and outcome measurement. Stakeholders from diverse clinical fields will offer feedback on the implications of our findings via a web-based survey.Ethics and disseminationEthics approval will not be obtained for this review of published and publicly accessible data, but will be obtained for the web-based survey. Our results will be disseminated through conference presentations and a peer-reviewed publication. Our findings will inform implementation strategies that support the adoption of chiropractic care within integrated healthcare delivery systems.

IntroductionBack and neck pain are the leading causes of disability worldwide. Doctors of chiropractic (DCs) are trained to manage these common conditions and can provide nonpharmacologic treatment aligned with international clinical practice guidelines. Although DCs practice in at least 90 countries, chiropractic care is often not available within integrated health care delivery systems. A lack of DCs in private practice, particularly in low-income communities, may also limit access to chiropractic care. Improved collaboration between medical providers and community-based DCs, or embedding DCs in medical settings such as hospitals or community health centers, will improve access to evidence-based care for musculoskeletal conditions.Methods and analysesThis scoping review will map studies of DCs working with or within integrated health care delivery systems. We will use the recommended six-step approach for scoping reviews. We will search three electronic data bases including Medline, Embase, and Web of Science. Two investigators will independently review all titles and abstracts to identify relevant records, screen the full-text articles of potentially admissible records, and systematically extract data from selected articles. We will include studies published in English from 1998 to 2020 describing medical settings that have established formal relationships with community-based DCs (e.g., shared medical record) or where DCs practice in medical settings. Data extraction and reporting will be guided by the Proctor Conceptual Model for Implementation Research, which has three domains: clinical intervention; implementation strategies; and outcome measurement. Stakeholders from diverse clinical fields will offer feedback on the implications of our findings via a web-based survey.Ethics and disseminationEthics approval will not be obtained for this review of published and publicly accessible data. Our results will be disseminated through conference presentations and a peer-reviewed publication. Our findings will inform implementation strategies that support the adoption of chiropractic care within integrated health care delivery systems.Strengths and limitations of this studyThis scoping review will be among the first to comprehensively map literature of doctors of chiropractic (DCs) working with or within military, veteran or civil integrated health care delivery systems.The literature search strategy is comprehensive and potentially generalizable to a global DC workforce, and relevant to other nonpharmacologic therapy providers who typically work in the community, e.g., acupuncturists, psychologists.A multidisciplinary team with diverse clinical and research expertise will inform our scoping review across all stages of the work.We have organized our search strategy and extraction form/guide around standardized terminology from the field of implementation science. It may be challenging to identify relevant studies, or extract all useful information, if original research does not use this terminology.Non-English articles describing the implementation of chiropractic care in a medical setting may be missed.

Background: Clinical practice guidelines generally recommend clinicians use self-management support (SMS) when managing patients with spine pain. However, even within the educational setting, the implementation of SMS remains suboptimal. The objectives of this study were to 1) estimate the organizational readiness for change toward using SMS at the Canadian Memorial Chiropractic College (CMCC), Toronto, Ontario from the perspective of directors and deans, 2) estimate the attitudes and self-reported behaviours towards using evidence-based practice (EBP), and beliefs about pain management among supervisory clinicians and chiropractic interns, 3) identify potential barriers and enablers to using SMS, and 4) design a theory-based tailored Knowledge Translation (KT) intervention to increase the use of SMS. Methods: Mixed method design. We administered three self-administered questionnaires to assess clinicians’ and interns’ attitudes and behaviours toward EBP, beliefs about pain management, and practice style. In addition, we conducted 3 focus groups with clinicians and interns based on the Theoretical Domain Framework (TDF) to explore their beliefs about using SMS for patients with spine pain. Data were analysed using deductive thematic analysis by 2 independent assessors. A panel of 7 experts mapped behaviour change techniques to key barriers identified informing the design of a KT intervention. Results: Participants showed high level of EBP knowledge, positive attitude of EBP, and moderate frequency of EBP use. A number of barrier factors were identified from clinicians (N = 6) and interns (N = 16) corresponding to 7 TDF domains: Knowledge; Skills; Environmental context and resources; Emotion; Beliefs about Capabilities; Memory, attention & decision making; and Social Influence. To address these barriers, the expert panel proposed a multifaceted KT intervention composed of a webinar and online educational module on a SMS guided by the Brief Action Planning, clinical vignettes, training workshop, and opinion leader support. Conclusion: SMS strategies can help maximizing the health care services for patients with spine pain. This may in turn optimize patients’ health. The proposed theory-based KT intervention may facilitate the implementation of SMS among clinicians and interns.

Cervicogenic headache is a prevalent and costly pain condition commonly treated by chiropractors. There is evidence to support the effectiveness for spinal manipulation, but the dose of treatment required to achieve maximal relief remains unknown. The purpose of this paper is to describe the methodology for a randomized controlled trial evaluating the dose–response of spinal manipulation for chronic cervicogenic headache in an adult population. This is a mixed-methods, two-site, prospective, parallel groups, observer-blind, randomized controlled trial conducted at university-affiliated research clinics in the Portland, OR and Minneapolis, MN areas. The primary outcome is patient reported headache frequency. Other outcomes include self-reported headache intensity, disability, quality of life, improvement, neck pain intensity and frequency, satisfaction, medication use, outside care, cervical motion, pain pressure thresholds, health care utilization, health care costs, and lost productivity. Qualitative interviews are also conducted to evaluate patients’ expectations of treatment. With growing concerns regarding the costs and side effects of commonly used conventional treatments, greater numbers of headache sufferers are seeking other approaches to care. This is the first full-scale randomized controlled trial assessing the dose–response of spinal manipulation therapy on outcomes for cervicogenic headache. The results of this study will provide important evidence for the management of cervicogenic headache in adults. ClinicalTrials.gov (Identifier: NCT01530321 )

Background: Online education programs are becoming a popular means to disseminate knowledge about evidence-based practice (EBP) among healthcare practitioners. This mode of delivery also offers a viable and potentially sustainable solution for teaching consistent EBP content to learners over time and across multiple geographical locations. We conducted a study with 3 main aims: 1) develop an online distance-learning program about the principles of evidence-based practice (EBP) for chiropractic providers; 2) test the effectiveness of the online program on the attitudes, skills, and use of EBP in a sample of chiropractors; and 3) determine the feasibility of expanding the program for broader-scale implementation. This study was conducted from January 2013 to September 2014. Methods: This was an exploratory randomized trial in which 293 chiropractors were allocated to either an online EBP education intervention or a waitlist control. The online EBP program consisted of 3 courses and 4 booster lessons, and was developed using educational resources created in previous EBP educational programs at 4 chiropractic institutions. Participants were surveyed using a validated EBP instrument (EBASE) with 3 rescaled (0 to 100) subscores: Attitudes, Skills, and Use of EBP. Multiple regression was used to compare groups, adjusting for personal and practice characteristics. Satisfaction and compliance with the program was evaluated to assess feasibility. Results: The Training Group showed modest improvement compared to the Waitlist Group in attitudes (∆ =6.2, p < .001) and skills (∆ =10.0, p < .001) subscores, but not the use subscore (∆ = -2.3, p = .470). The majority of participants agreed that the educational program was 'relevant to their profession' (84 %) and 'was worthwhile' (82 %). Overall, engagement in the online program was less than optimal, with 48 % of the Training Group, and 42 % of the Waitlist Group completing all 3 of the program courses. Conclusions: Online EBP training leads to modest improvements in chiropractors' EBP attitudes and skill, but not their use of EBP. This online program can be delivered to a wide national audience, but requires modification to enable greater individualization and peer-to-peer interaction. Our results indicate that it is feasible to deliver an online EBP education on a broad scale, but that this mode of education alone is not sufficient for making large changes in chiropractors' use of EBP. Refereed/Peer-reviewed

Randomized controlled trial using mixed methods.To evaluate the relative effectiveness of high-dose supervised exercise with and without spinal manipulation and low-dose home exercise for chronic neck pain.Neck pain is a common global health care complaint with considerable social and economic impact. Systematic reviews have found exercise therapy (ET) to be effective for neck pain, either alone or in combination with spinal manipulation. However, it is unclear to what extent spinal manipulation adds to supervised exercise or how supervised high-dose exercise compares with low-dose home exercise.Two hundred and seventy patients with chronic neck pain were studied at an outpatient clinic. Patients were randomly assigned one of the following interventions: (1) high-dose supervised strengthening exercise with spinal manipulation (exercise therapy combined with spinal manipulation therapy [ET + SMT]), (2) high-dose supervised strengthening exercise (ET) alone, or (3) low-dose home exercise and advice (HEA). The primary outcome was patient-rated pain at baseline and at 4, 12, 26, and 52 weeks. Secondary measures were disability, health status, global perceived effect, medication use, and satisfaction.At 12 weeks, there was a significant difference in patient-rated pain between ET + SMT and HEA (1.3 points, P0.001) and ET and HEA (1.1 points, P = 0.001). Although there were smaller group differences in patient-rated pain at 52 weeks (ET + SMT vs. HEA, 0.2 points, P0.05; ET vs. HEA, 0.3 points, P0.05), linear mixed model analyses incorporating all time points yielded a significant advantage for the 2 supervised exercise groups (ET + SMT vs. HEA, P = 0.03; ET vs. HEA, P = 0.02). Similar results were observed for global perceived effect and satisfaction.Supervised strengthening exercise with and without spinal manipulation performed similarly, yielding better outcomes than home exercise particularly in the short term. Various stakeholders' perspectives should be considered carefully when making recommendations regarding these therapies, taking into account side effects, preferences, and costs.

A consistent theme running through the healthcare debate is the need for new care models that include collaborative, team-based care. There is also growing recognition that interprofessional education is critical to achieving collaborative, patient-centered care. Not unlike conventional, biomedical professions, CAM (complementary and alternative medicine) professions have also educated students in silos with little interaction between various disciplines. Northwestern Health Sciences University, under their NIH NCCAM-funded R-25 grant, is breaking new ground in requiring that their students in chiropractic, massage, and OAM complete a common course in evidence informed practice. A previous Explore column described the core competencies that the students are required to achieve. This column focuses on the practicalities and challenges of offering a course to students enrolled in three different degree programs. Perhaps it will stimulate readers to consider how we might achieve interprofessional education that brings together all health professional students, biomedical and CAM.

Objective The purpose of this white paper is to help inform the chiropractic clinical research agenda with a focus on the United States. Methods and Discussion The recommendations and action items from 2 previous articles published in 1997 are discussed within the context of 3 broad topics: research culture, research infrastructure, and clinical research studies. Progress made toward the action items in these areas is summarized. A summary of findings is presented of the most influential clinical research studies during the past decade performed by or with major contributions by chiropractic investigators. In light of the current evidence and previous recommendations, new clinical research recommendations are proposed. Conclusions Based on the assessment of the scientific literature and research currently underway, it is evident that members of the chiropractic research community have made important progress in becoming active players in the clinical research arena. During the past decade, the work of chiropractic researchers has contributed substantially to the amount and quality of the evidence for or against spinal manipulation in the management of low back pain, neck pain, headache, and other conditions.

Despite the many published randomized clinical trials (RCTs), a substantial number of reviews and several national clinical guidelines, much controversy still remains regarding the evidence for or against efficacy of spinal manipulation for low back pain and neck pain.To reassess the efficacy of spinal manipulative therapy (SMT) and mobilization (MOB) for the management of low back pain (LBP) and neck pain (NP), with special attention to applying more stringent criteria for study admissibility into evidence and for isolating the effect of SMT and/or MOB.RCTs including 10 or more subjects per group receiving SMT or MOB and using patient-oriented primary outcome measures (eg, patient-rated pain, disability, global improvement and recovery time).Articles in English, Danish, Swedish, Norwegian and Dutch reporting on randomized trials were identified by a comprehensive search of computerized and bibliographic literature databases up to the end of 2002. Two reviewers independently abstracted data and assessed study quality according to eight explicit criteria. A best evidence synthesis incorporating explicit, detailed information about outcome measures and interventions was used to evaluate treatment efficacy. The strength of evidence was assessed by a classification system that incorporated study validity and statistical significance of study results. Sixty-nine RCTs met the study selection criteria and were reviewed and assigned validity scores varying from 6 to 81 on a scale of 0 to 100. Forty-three RCTs met the admissibility criteria for evidence.Acute LBP: There is moderate evidence that SMT provides more short-term pain relief than MOB and detuned diathermy, and limited evidence of faster recovery than a commonly used physical therapy treatment strategy. Chronic LBP: There is moderate evidence that SMT has an effect similar to an efficacious prescription nonsteroidal anti-inflammatory drug, SMT/MOB is effective in the short term when compared with placebo and general practitioner care, and in the long term compared to physical therapy. There is limited to moderate evidence that SMT is better than physical therapy and home back exercise in both the short and long term. There is limited evidence that SMT is superior to sham SMT in the short term and superior to chemonucleolysis for disc herniation in the short term. However, there is also limited evidence that MOB is inferior to back exercise after disc herniation surgery. Mix of acute and chronic LBP: SMT/MOB provides either similar or better pain outcomes in the short and long term when compared with placebo and with other treatments, such as McKenzie therapy, medical care, management by physical therapists, soft tissue treatment and back school. Acute NP: There are few studies, and the evidence is currently inconclusive. Chronic NP: There is moderate evidence that SMT/MOB is superior to general practitioner management for short-term pain reduction but that SMT offers at most similar pain relief to high-technology rehabilitative exercise in the short and long term. Mix of acute and chronic NP: The overall evidence is not clear. There is moderate evidence that MOB is superior to physical therapy and family physician care, and similar to SMT in both the short and long term. There is limited evidence that SMT, in both the short and long term, is inferior to physical therapy.Our data synthesis suggests that recommendations can be made with some confidence regarding the use of SMT and/or MOB as a viable option for the treatment of both low back pain and NP. There have been few high-quality trials distinguishing between acute and chronic patients, and most are limited to shorter-term follow-up. Future trials should examine well-defined subgroups of patients, further address the value of SMT and MOB for acute patients, establish optimal number of treatment visits and consider the cost-effectiveness of care.

Objective To conduct a pilot study in preparation for a full-scale randomized clinical trial assessing conservative treatments for acute and subacute neck pain. Study design Prospective, randomized pilot study. Setting Primary contact chiropractic and medical clinics. Patients Ages 21 to 65 with current episode of neck pain less than 12 weeks in duration. Outcome measures Patient self-report questionnaires and cervical spine motion were assessed at baseline and 3 and 12 weeks postrandomization. Interventions Chiropractic spinal manipulation, prescription medications, and self-care education. Results Recruitment took place over a 1-month period. Twenty-eight patients were randomized to treatment, and 1 patient (medical care group) refused their treatment assignment and was lost to further follow-up. Twenty-three patients were either “very satisfied” or “completely satisfied” with the care they received in the study. More than half the patients reported 75% or 100% improvement (n = 17). No between-group comparisons were planned or performed due to the small sample size. Conclusion Recruitment of patients appears feasible for a full-scale randomized clinical trial evaluating chiropractic spinal manipulation, medical care, and self-care education for acute and subacute neck pain. Patient and provider compliance with study protocols was excellent, and the pilot study allowed us to further develop and optimize our data collection processes. Although pilot studies such as these require substantial time, money, and effort, they provide valuable information for future research efforts.

Objective: There are fundamental differences between the administration of medications and the application of manual procedures, such as those used by chiropractors. The objective of this study was to gather preliminary information on how to address these differences in the design of a multisite, randomized placebo-controlled trial of chiropractic care for women with chronic pelvic pain (CPP). Design: Pilot study for a multisite, randomized, placebo-controlled clinical trial. Setting: Three chiropractic research clinics in the midwest United States. Subjects: Thirty-nine (39) women with CPP of at least 6 months' duration, diagnosed by board-certified gynecologists. Interventions: The active intervention consisted of the chiropractic technique, lumbar spine flexion-distraction, combined with manual Trigger Point Therapy. The placebo intervention consisted of a sham chiropractic procedure performed with an instrument combined with effleurage (light massage). Outcome measures: The primary outcome measure was...

A randomized, parallel-group, single-blinded clinical trial was performed. After a 1-week baseline period, patients were randomized to 11 weeks of therapy, with posttreatment follow-up assessment 3, 6, and 12 months later.To compare the relative efficacy of rehabilitative neck exercise and spinal manipulation for the management of patients with chronic neck pain.Mechanical neck pain is a common condition associated with substantial morbidity and cost. Relatively little is known about the efficacy of spinal manipulation and exercise for chronic neck pain. Also, the combination of both therapies has yet to be explored.Altogether, 191 patients with chronic mechanical neck pain were randomized to receive 20 sessions of spinal manipulation combined with rehabilitative neck exercise (spinal manipulation with exercise), MedX rehabilitative neck exercise, or spinal manipulation alone. The main outcome measures were patient-rated neck pain, neck disability, functional health status (as measured by Short Form-36 [SF-36]), global improvement, satisfaction with care, and medication use. Range of motion, muscle strength, and muscle endurance were assessed by examiners blinded to patients' treatment assignment.Clinical and demographic characteristics were similar among groups at baseline. A total of 93% of the patients completed the intervention phase. The response rate for the 12-month follow-up period was 84%. Except for patient satisfaction, where spinal manipulative therapy and exercise were superior to spinal manipulation with (P = 0.03), the group differences in patient-rated outcomes after 11 weeks of treatment were not statistically significant (P = 0.13). However, the spinal manipulative therapy and exercise group showed greater gains in all measures of strength, endurance, and range of motion than the spinal manipulation group (P0.05). The spinal manipulation with exercise group also demonstrated more improvement in flexion endurance and in flexion and rotation strength than the MedX group (P0.03). The MedX exercise group had larger gains in extension strength and flexion-extension range of motion than the spinal manipulation group (P0.05). During the follow-up year, a greater improvement in patient-rated outcomes were observed for spinal manipulation with exercise and for MedX exercise than for spinal manipulation alone (P = 0.01). Both exercise groups showed very similar levels of improvement in patient-rated outcomes, although the spinal manipulation and exercise group reported greater satisfaction with care (P0.01).For chronic neck pain, the use of strengthening exercise, whether in combination with spinal manipulation or in the form of a high-technology MedX program, appears to be more beneficial to patients with chronic neck pain than the use of spinal manipulation alone. The effect of low-technology exercise or spinal manipulative therapy alone, as compared with no treatment or placebo, and the optimal dose and relative cost effectiveness of these therapies, need to be evaluated in future studies.

Background: Chronic headache is a prevalent condition with substantial socioeconomic impact. Complementary or alternative therapies are increasingly being used by patients to treat headache pain, and spinal manipulative therapy (SMT) is among the most common of these. Objective: To assess the efficacy/effectiveness of SMT for chronic headache through a systematic review of randomized clinical trials. Study Selection: Randomized clinical trials on chronic headache (tension, migraine and cervicogenic) were included in the review if they compared SMT with other interventions or placebo. The trials had to have at least 1 patient-rated outcome measure such as pain severity, frequency, duration, improvement, use of analgesics, disability, or quality of life. Studies were identified through a comprehensive search of MEDLINE (1966-1998) and EMBASE (19741998). Additionally, all available data from the Cumulative Index of Nursing and Allied Health Literature, the Chiropractic Research Archives Collection, and the Manual, Alternative, and Natural Therapies Information System were used, as well as material gathered through the citation tracking, and hand searching of nonindexed chiropractic, osteopathic, and manual medicine journals. Data Extraction: Information about outcome measures, interventions and effect sizes was used to evaluate treatment efficacy. Levels of evidence were determined by a classification system incorporating study validity and statistical significance of study results. Two authors independently extracted data and performed methodological scoring of selected trials. Data Synthesis: Nine trials involving 683 patients with chronic headache were included. The methodological quality (validity) scores ranged from 21 to 87 (100-point scale). The trials were too heterogeneous in terms of patient clinical characteristic, control groups, and outcome measures to warrant statistical pooling. Based on predefined criteria, there is moderate evidence that SMT has shortterm efficacy similar to amitriptyline in the prophylactic treatment of chronic tension-type headache and migraine. SMT does not appear to improve outcomes when added to soft-tissue massage for episodic tension-type headache. There is moderate evidence that SMT is more efficacious than massage for cervicogenic headache. Sensitivity analyses showed that the results and the overall study conclusions remained the same even when substantial changes in the prespecified assumptions/rules regarding the evidence determination were applied. Conclusions: SMT appears to have a better effect than massage for cervicogenic headache. It also appears that SMT has an effect comparable to commonly used first-line prophylactic prescription medications for tension-type headache and migraine headache. This conclusion rests upon a few trials of adequate methodological quality. Before any firm conclusions can be drawn, further testing should be done in rigorously designed, executed, and analyzed trials with follow-up periods of sufficient length. (J Manipulative Physiol Ther 2001;24: 457-66)

Background: Pediatric otitis media with effusion is a common and costly condition. Although chiropractors have anecdotally claimed success in treating otitis media, there is little research to support their claims. Objective: A pilot study was undertaken for the purpose of assessing the feasibility of conducting a full-scale randomized clinical trial investigating the efficacy of chiropractic spinal manipulative therapy (SMT) for children with chronic otitis media with effusion. Methods: This study was a prospective, parallel-group, observer-blinded, randomized feasibility study. Twenty-two patients, ages 6 months to 6 years, received either active chiropractic SMT or placebo chiropractic SMT. Otoscopy and tympanometry were used to create a middle ear status profile, and daily diaries were collected. Results: Five newspaper advertisements over 6 months generated 105 responses. Twenty patients subsequently qualified and were randomized into the study. Collection of tympanometric and otoscopic data proved to be challenging. Compliance with the treatment and evaluation protocols and daily diaries was excellent. There were no reports of serious side effects as a result of either the active or placebo chiropractic treatments. Conclusion: Recruitment for a randomized controlled trial is feasible and could be enhanced by medical collaboration. Patients and parents are able and willing to participate in a study comparing active SMT and placebo SMT. Parents were extremely compliant with the daily diaries, suggesting that similar quality-of-life and functional status measures can be successfully used in a larger trial. We found the objective outcomes assessment involving tympanometry and otoscopy extremely challenging and should be performed by experienced examiners in future studies. (J Manipulative Physiol Ther 1999; 22:292–8)

The NIH National Center for Complementary and Alternative Medicine (NCCAM) has funded two rounds of R25 education grants. The first set of R25 grants were awarded to conventional schools and focused on integrating CAM content into health professions education programs. Grants were awarded to medical and nursing schools predominantly, with one grant going to the American Medical Student Association and one grant being awarded to an institution integrating CAM into nursing, medicine and pharmacy. The second round of R25 grants were awarded to CAM institutions and focused on introducing evidence-based practice into curricula of CAM schools including schools of chiropractic, naturopathic, and acupuncture and Oriental medicine. Although not an explicit objective of the grant program, one of the most significant and enduring outcomes reported by investigators has been culture change. This article describes individual and organizational culture changes that occurred at Northwestern Health Sciences University.

Background Back-related leg pain (BRLP) is a common variation of low back pain (LBP), with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP. In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care. Methods/Design This study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT). A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122) and Quad Cities area in Iowa and Illinois (n = 70) to the research clinics at WHCCS and PCCR, respectively. It compares two interventions: chiropractic spinal manipulative therapy (SMT) plus home exercise program (HEP) to HEP alone (minimal intervention comparison) for patients with subacute or chronic back-related leg pain. Discussion Back-related leg pain (BRLP) is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP. This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important patient-oriented and objective biomechanical outcome measures. Trial Registration ClinicalTrials.gov NCT00494065

Background context Several conservative therapies have been shown to be beneficial in the treatment of chronic low back pain (CLBP), including different forms of exercise and spinal manipulative therapy (SMT). The efficacy of less time-consuming and less costly self-care interventions, for example, home exercise, remains inconclusive in CLBP populations. Purpose The purpose of this study was to assess the relative efficacy of supervised exercise, spinal manipulation, and home exercise for the treatment of CLBP. Study design/setting An observer-blinded and mixed-method randomized clinical trial conducted in a university research clinic in Bloomington, MN, USA. Patient sample Individuals, 18 to 65 years of age, who had a primary complaint of mechanical LBP of at least 6-week duration with or without radiating pain to the lower extremity were included in this trial. Outcome measures Patient-rated outcomes were pain, disability, general health status, medication use, global improvement, and satisfaction. Trunk muscle endurance and strength were assessed by blinded examiners, and qualitative interviews were performed at the end of the 12-week treatment phase. Methods This prospective randomized clinical trial examined the short- (12 weeks) and long-term (52 weeks) relative efficacy of high-dose, supervised low-tech trunk exercise, chiropractic SMT, and a short course of home exercise and self-care advice for the treatment of LBP of at least 6-week duration. The study was approved by local institutional review boards. Results A total of 301 individuals were included in this trial. For all three treatment groups, outcomes improved during the 12 weeks of treatment. Those who received supervised trunk exercise were most satisfied with care and experienced the greatest gains in trunk muscle endurance and strength, but they did not significantly differ from those receiving chiropractic spinal manipulation or home exercise in terms of pain and other patient-rated individual outcomes, in both the short- and long-term. Conclusions For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance and strength. Although the short- and long-term differences between groups in patient-rated pain, disability, improvement, general health status, and medication use consistently favored the supervised exercise group, the differences were relatively small and not statistically significant for these individual outcomes.

Background Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM) and conventional therapies, while also incorporating patient choice, has yet to be tested for chronic LBP. The primary aim of this study is to determine the relative clinical effectiveness of 1) monodisciplinary chiropractic care and 2) multidisciplinary integrative care in 200 adults with non-acute LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure is patient-rated back pain. Secondary aims compare the treatment approaches in terms of frequency of symptoms, low back disability, fear avoidance, self-efficacy, general health status, improvement, satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods, and cost-effectiveness and cost utility will be assessed. Methods and Design This paper describes the design of a randomized clinical trial (RCT), with cost-effectiveness and qualitative studies conducted alongside the RCT. Two hundred participants ages 18 and older are being recruited and randomized to one of two 12-week treatment interventions. Patient-rated outcome measures are collected via self-report questionnaires at baseline, and at 4, 12, 26, and 52 weeks post-randomization. Objective outcome measures are assessed at baseline and 12 weeks by examiners blinded to treatment assignment. Health care cost data is collected by self-report questionnaires and treatment records during the intervention phase and by monthly phone interviews thereafter. Qualitative interviews, using a semi-structured format, are conducted with patients at the end of the 12-week treatment period and also with providers at the end of the trial. Discussion This mixed-methods randomized clinical trial assesses clinical effectiveness, cost-effectiveness, and patients' and providers' perceptions of care, in treating non-acute LBP through evidence-based individualized care delivered by monodisciplinary or multidisciplinary care teams. Trial registration ClinicalTrials.gov NCT00567333

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. Trial Registration NCT00269321 and NCT00269308

Objective To better understand the experiences and problems encountered by research assistants (RAs) involved in clinical trials to improve the process of RA training for future studies. Design A 1-time focus group of research assistants was conducted. Setting A chiropractic college in the United States during a national chiropractic research agenda conference. Subjects Eight research assistants from 2 teaching institutions, who are directly involved in clinical trials and have patient-centered responsibilities, such as recruiting patients, interviewing patients, and collecting data. Main outcome measures Responses to predetermined questions were qualitatively compiled. Question topics included research assistants’ experiences while administering phone screens, questionnaires, and informed consents. Results Research assistants involved in this focus group expressed they were adequately trained in telephone screening and administering informed consent but felt they required more training in administering self-report questionnaires to patients. The majority of problems they encountered were related to a lack of information. To improve training of future RAs, more detailed study information is necessary, such as how to describe study treatments and how to give questionnaire instructions. Conclusions The comparability of responses by the members of this focus group was interesting. Members had similar experiences within clinical trials and found that the problems encountered were common across studies.

STUDY DESIGN Randomized clinical trial. OBJECTIVES To compare the effects of spinal manipulation combined with low-tech rehabilitative exercise, MedX rehabilitative exercise, or spinal manipulation alone in patient self-reported outcomes over a two-year follow-up period. SUMMARY OF BACKGROUND DATA There have been few randomized clinical trials of spinal manipulation and rehabilitative exercise for patients with neck pain, and most have only reported short-term outcomes. METHODS One hundred ninety-one patients with chronic neck pain were randomized to 11 weeks of one of the three treatments. Patient self-report questionnaires measuring pain, disability, general health status, improvement, satisfaction, and OTC medication use were collected after 5 and 11 weeks of treatment and 3, 6, 12, and 24 months after treatment. Data were analyzed taking into account all time points using repeated measures analyses. RESULTS Ninety-three percent (178) of randomized patients completed the 11-week intervention phase, and 76% (145) provided data at all evaluation time points over the two-year follow-up period. A difference in patient-rated pain with no group-time interaction was observed in favor of the two exercise groups [F(2141) = 3.2; P= 0.04]. There was also a group difference in satisfaction with care [F(2143) = 7.7; P= 0.001], with spinal manipulation combined with low-tech rehabilitative exercise superior to MedX rehabilitative exercise (P = 0.02) and spinal manipulation alone (P < 0.001). No significant group differences were found for neck disability, general health status, improvement, and OTC medication use, although the trend over time was in favor of the two exercise groups. CONCLUSION The results of this study demonstrate an advantage of spinal manipulation combined with low-tech rehabilitative exercise and MedX rehabilitative exercise versus spinal manipulation alone over two years and are similar in magnitude to those observed after one-year follow-up. These results suggest that treatments including supervised rehabilitative exercise should be considered for chronic neck pain sufferers. Further studies are needed to examine the cost effectiveness of these therapies and how spinal manipulation compares to no treatment or minimal intervention.

Objective: To determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with BRLP.Design: Controlled pragmatic trial with allocation by minimization conducted from 2007 to 2011. (ClinicalTrials.gov: NCT00494065).Setting: 2 research centers (Minnesota and Iowa).Patients: Persons aged 21 years or older with BRLP for least 4 weeks.Intervention: 12 weeks of SMT plus HEA or HEA alone.Background: Back-related leg pain (BRLP) is often disabling and costly, and there is a paucity of research to guide its management.Results: Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over HEA (difference, 10 percentage points [95% CI, 2 to 19]; P = 0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P = 0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.Measurements: The primary outcome was patient-rated BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks. Blinded objective tests were done at 12 weeks.Limitation: Patients and providers could not be blinded.Conclusion: For patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.

Objectives: The first objective was to determine if chiropractic spinal manipulative therapy (SMT) in addition to optimal medical management resulted in clinically important changes in asthma-related outcomes in children. The second objective was to assess the feasibility of conducting a full-scale, randomized clinical trial in terms of recruitment, evaluation, treatment, and ability to deliver a sham SMT procedure. Study Design: Prospective clinical case series combined with an observer-blinded, pilot randomized clinical trial with a 1-year follow-up period. Setting: Primary contact, college outpatient clinic, and a pediatric hospital. Patients: A total of 36 patients aged 6 to 17 years with mild and moderate persistent asthma were admitted to the study. Outcome Measures: Pulmonary function tests; patient- and parent- or guardian-rated asthma-specific quality of life, asthma severity, and improvement; am and pm peak expiratory flow rates; and diary-based day and nighttime symptoms. Interventions: Twenty chiropractic treatment sessions were scheduled during the 3-month intervention phase. Patients were randomly assigned to receive either active SMT or sham SMT in addition to their standardized ongoing medical management. Results: It is possible to blind the participants to the nature of the SMT intervention, and a full-scale trial with the described design is feasible to conduct. At the end of the 12-week intervention phase, objective lung function tests and patient-rated day and nighttime symptoms based on diary recordings showed little or no change. Of the patient-rated measures, a reduction of approximately 20% in β2 bronchodilator use was seen (P =.10). The quality of life scores improved by 10% to 28% (P

Objectives: To assess the feasibility of patient recruitment, the ability of patients and clinicians to comply with study protocols, and the use of data collection instruments to collect cost-effectiveness data, and to obtain variability estimates for sample-size calculations for a full-scale trial. Study Design: Prospective, observer-blinded, pilot randomized clinical trial. Setting: Primary contact chiropractic and medical clinics. Patients: Ages 20 to 65 years, with low back-related radiating leg pain (sciatica). Outcome Measures: Self-report questionnaires were administered at baseline and 3 and 12 weeks after randomization. The measures included leg and back pain severity, frequency and bothersomeness of symptoms, leg/back disability, medication use, global improvement, satisfaction, and health care utilization. Interventions: Medical care, chiropractic care, and epidural steroid injections. Results: A total of 706 persons were screened by phone to determine initial eligibility. Of these, over 90% of those persons contacted did not meet the entrance criteria. The most common reason for disqualification was that the duration of the complaint was longer than 3 months. Twenty patients were randomized into the study. All 3 groups showed substantial improvements in the main patient-rated outcomes at the end of the 12-week intervention phase. For leg pain, back pain, frequency and bothersomeness of leg symptoms, and Roland-Morris disability score, the percent improvement varied from 50% to 84%, and the corresponding effect sizes ranged from 0.8 to 2.2. Bothersomeness of leg symptoms was the most responsive outcome associated with the largest magnitude of effect size. All within-group changes from baseline were statistically significant ( P Conclusions: Pilot studies such as these are important for the determination of the feasibility of conducting costly, larger scale trials. Recruitment for a full-scale study of sciatica of 2 to 12 weeks duration is not feasible, given the methods used in this pilot study. Our results do indicate, however, that there are substantial numbers of patients with sciatica more chronic in nature who would be interested in participating in a similar study. In addition, collaboration with a local health maintenance organization would likely facilitate clinician referrals and optimize the recruitment process. Patient and provider compliance was high in the pilot study, which indicates that most study protocols are feasible. Additionally, we were able to collect complete outcomes data, including those regarding health care use. A suggested modification by investigators and outside consultants has resulted in the replacement of the medication group with a minimal intervention control group (ie, self-care advice). As a result, a second pilot study of patients with sciatica of more than 4 weeks duration has been planned before a full-scale trial is attempted. (J Manipulative Physiol Ther 2000;23:536-44)

Purpose Neck pain (NP) is a common condition in old age, leading to impaired functional ability and decreased independence. Spinal manipulation and exercise are common and effective treatments for the general NP population; however, their effectiveness among seniors is unknown. The primary aim of this randomized clinical trail was to assess the relative shortand long-term clinical effectiveness of spinal manipulative therapy (SMT) and supervised rehabilitative exercise (SRE), both in combination with and compared to home exercise (HE) alone, in NP patients 65 years and older.

Purpose Evidence to date suggests there is no one treatment approach which is clearly superior for low back pain (LBP). It is plausible that combining treatments with small to moderate effect sizes will improve patient outcomes. Additional benefit might also be achieved by individualizing treatment plans according to patient presentation, for example, by addressing psychosocial factors. Our objective was to assess the relative clinical effectiveness of: 1) mono-disciplinary chiropractic care versus 2) multi-disciplinary integrative care for LBP, within the context of defined clinical care pathways.

Background Evidence based practice (EBP) is being increasingly utilized by health care professionals as a means of improving the quality of health care. The introduction of EBP principles into the chiropractic profession is a relatively recent phenomenon. There is currently a lack of information about the EBP literacy level of US chiropractors and the barriers/facilitators to the use of EBP in the chiropractic profession. Methods A nationwide EBP survey of US chiropractors was administered online (Nov 2012-Mar 2013) utilizing a validated self-report instrument (EBASE) in which three sub-scores are reported: attitudes, skills and use. Means, medians, and frequency distributions for each of the sub-scores were generated. Descriptive statistics were used to analyze the demographic characteristics of the sample. Means and proportions were calculated for all of the responses to each of the questions in the survey. Results A total of 1,314 US chiropractors completed the EBASE survey; the sample appeared to be representative of the US chiropractic profession. Respondents were predominantly white (94.3%), male (75%), 47 (+/− 11.6) years of age, and in practice for more than 10 years (60%). EBASE sub-score means (possible ranges) were: attitudes, 31.4 (8–40); skills, 44.3 (13–65); and use, 10.3 (0–24). Survey participants generally held favorable attitudes toward EBP, but reported less use of EBP. A minority of participants indicated that EBP coursework (17%) and critical thinking (29%) were a major part of their chiropractic education. The most commonly reported barrier to the use of EBP was “lack of time”. Almost 90% of the sample indicated that they were interested in improving their EBP skills. Conclusion American chiropractors appear similar to chiropractors in other countries, and other health professionals regarding their favorable attitudes towards EBP, while expressing barriers related to EBP skills such as research relevance and lack of time. This suggests that the design of future EBP educational interventions should capitalize on the growing body of EBP implementation research developing in other health disciplines. This will likely include broadening the approach beyond a sole focus on EBP education, and taking a multilevel approach that also targets professional, organizational and health policy domains. Electronic supplementary material The online version of this article (doi:10.1186/s12998-015-0060-0) contains supplementary material, which is available to authorized users.

Purpose Elderly residents in long term care (LTC) settings experience a myriad of health complaints that may be amenable to complementary and alternative medicine (CAM) therapies. However, specialized training addressing the unique features of geriatric health care, particularly in LTC settings, will be required if CAM professionals are to play a meaningful role. The purpose of this presentation is to describe an evidence informed geriatric fellowship program at a CAM institution which educates acupuncture, chiropractic and massage therapy practitioners.

Purpose There is insufficient information published on the topic of complementary and alternative medicine (CAM) clinical services within geriatric settings. The purpose of this presentation is to describe results of a CAM demonstration project carried out within two geriatric facilities. Acupuncture and Oriental medicine (AOM), chiropractic, and massage clinical services were integrated into the facilities and data systematically collected. We prospectively gathered information on all patient visits provided by the CAM clinicians.