The association of biomarkers with pain and function in acute and subacute low back pain: a secondary analysis of an RCT.

BACKGROUND: Low back pain (LBP) is a common musculoskeletal condition and a major cause of disability worldwide. Previous studies have found associations of biomarkers with pain and pain-related disability in LBP patients. This study aimed to explore the association between serum biomarkers and pain and disability in patients with acute or subacute axial LBP. METHODS: This study was ancillary to a parent randomized controlled trial. Enrolled participants were randomized into three intervention groups: one of two types of spinal manipulation or medical care. In the parent study, 107 adults who experienced a new episode of LBP within 3 months prior to enrollment were recruited. For this study, 90 of these 107 participants consented to have blood samples obtained, which were drawn immediately before the beginning of treatment. Seven biomarkers were chosen based on previous literature and analyzed. Clinical outcomes were pain and Oswestry Disability Index (ODI) evaluated at baseline and 4 weeks. Spearman's |r| was used to study the association of initial levels of each biomarker with pain and ODI scores at baseline and with changes in outcome scores from baseline to 4 weeks (end of treatment) within each intervention group. RESULTS: At baseline, 4 of 7 biomarkers had an association with pain that was |r| ≥ .20: neuropeptide Y (NPY) (r = 0.23, p = .028), E-Selectin (r = 0.22, p = .043), vitamin D ((r = - 0.32, p = .002), and c-reactive protein (CRP) (r = 0.37, p = .001). No baseline biomarker had an association with disability that was |r| ≥ 0.20. For the correlations of baseline biomarkers with 4-week change in outcomes, vitamin D showed a correlation with change in disability and/or pain (|r| ≥ 0.20, p > .05) in manipulation-related groups, while CRP, NPY, and E-selectin along with TNFα, Substance P and RANTES showed at least one correlation with change in pain or disability (|r| ≥ 0.20, p > .05) in at least one of the treatment groups. CONCLUSIONS: In 90 LBP patients, the analyzed biomarkers, especially vitamin D, represent a small set of potential candidates for further research aimed at individualizing patient care. Overall, the associations investigated in the current study are an initial step in identifying the direct mechanisms of LBP and predicting outcomes of manipulation-related treatments or medical care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01211613, Date of Registration: September 29, 2010, https://clinicaltrials.gov/ct2/show/NCT01211613?term=schneider&cond=Low+Back+Pain&cntry=US&state=US%3APA&draw=2&rank=1.

Comparative Effectiveness of Usual Care With or Without Chiropractic Care in Patients with Recurrent Musculoskeletal Back and Neck Pain.

BACKGROUND: Chiropractic care is a popular alternative for back and neck pain, with efficacy comparable to usual care in randomized trials. However, the effectiveness of chiropractic care as delivered through conventional care settings remains largely unexplored. OBJECTIVE: To evaluate the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. STUDY DESIGN: Prospective cohort study using propensity score-matched controls. PARTICIPANTS: Using retrospective electronic health record data, we developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. MAIN MEASURES: Main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care. KEY RESULTS: Both groups' (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. (severity - 0.10 (95% CI - 0.30, 0.10), interference - 0.07 (- 0.31, 0.16), bothersomeness - 0.1 (- 0.39, 0.19)). After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group ($1996 [SD = 3874] vs $1086 [SD = 1212], p = .034). Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072). CONCLUSIONS: We found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.

Dose-response and efficacy of spinal manipulation for care of cervicogenic headache: a dual-center randomized controlled trial.

BACKGROUND CONTEXT: The optimal number of visits for the care of cervicogenic headache (CGH) with spinal manipulative therapy (SMT) is unknown. PURPOSE: The present study aimed to identify the dose-response relationship between visits for SMT and chronic CGH outcomes and to evaluate the efficacy of SMT by comparison with a light-massage control. STUDY DESIGN/SETTING: This is a two-site, open-label randomized controlled trial. PATIENT SAMPLE: Participants were 256 adults with chronic CGH. OUTCOME MEASURES: The primary outcome was days with CGH in the previous 4 weeks evaluated at the 12- and 24-week primary end points. Secondary outcomes included CGH days at remaining end points, pain intensity, disability, perceived improvement, medication use, and patient satisfaction. METHODS: Participants were randomized to four dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated three times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks. The present study was funded by the National Center for Complementary and Integrative Health (R01AT006330) and is registered at ClinicalTrials.gov (NCT01530321). The authors declare no conflicts of interest. RESULTS: A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. Cervicogenic headache days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary end points, and were similar in magnitude at the remaining end points (p<.05). Differences between other SMT doses and control were smaller in magnitude (p>.05). Cervicogenic headache intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary outcome. CONCLUSIONS: There was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half and about 3 more days per month than for the light-massage control.

Best Practices for Chiropractic Care for Older Adults: A Systematic Review and Consensus Update.

OBJECTIVE: The purpose of this study was to update evidence-based recommendations on the best practices for chiropractic care of older adults. METHODS: The project consisted of a systematic literature review and a consensus process. The following were searched from October 2009 through January 2016: MEDLINE, Index to Chiropractic Literature, CINAHL (Cumulative Index to Nursing and Allied Health Literature), AMED (Allied and Complementary Medicine Database), Alt HealthWatch, Cochrane Database of Systematic Reviews, and Cochrane Registry of Controlled Trials. Search terms were: (manipulation, spinal OR manipulation, chiropractic OR chiropract*) AND (geriatric OR "older adult*"). Two reviewers independently screened articles and abstracts using inclusion and exclusion criteria. The systematic review informed the project steering committee, which revised the previous recommendations. A multidisciplinary panel of experts representing expertise in practice, research, and teaching in a variety of health professions serving older adults rated the revised recommendations. The RAND Corporation/University of California, Los Angeles methodology for a modified Delphi consensus process was used. RESULTS: A total of 199 articles were found; after exclusion criteria were applied, 6 articles about effectiveness or efficacy and 6 on safety were added. The Delphi process was conducted from April to June 2016. Of the 37 Delphi panelists, 31 were DCs and 6 were other health care professionals. Three Delphi rounds were conducted to reach consensus on all 45 statements. As a result, statements regarding the safety of manipulation were strengthened and additional statements were added recommending that DCs advise patients on exercise and that manipulation and mobilization contribute to general positive outcomes beyond pain reduction only. CONCLUSIONS: This document provides a summary of evidence-informed best practices for doctors of chiropractic for the evaluation, management, and manual treatment of older adult patients.

Effects of Diaphragmatic Breathing Patterns on Balance: A Preliminary Clinical Trial.

OBJECTIVE: The purpose of this study was to determine the feasibility of performing a larger study to determine if training in diaphragmatic breathing influences static and dynamic balance. METHODS: A group of 13 healthy persons (8 men, 5 women), who were staff, faculty, or students at the University of Western States participated in an 8-week breathing and balance study using an uncontrolled clinical trial design. Participants were given a series of breathing exercises to perform weekly in the clinic and at home. Balance and breathing were assessed at the weekly clinic sessions. Breathing was evaluated with Liebenson's breathing assessment, static balance with the Modified Balance Error Scoring System, and dynamic balance with OptoGait's March in Place protocol. RESULTS: Improvement was noted in mean diaphragmatic breathing scores (1.3 to 2.6, P < .001), number of single-leg stance balance errors (7.1 to 3.8, P = .001), and tandem stance balance errors (3.2 to 0.9, P = .039). A decreasing error rate in single-leg stance was associated with improvement in breathing score within participants over the 8 weeks of the study (-1.4 errors/unit breathing score change, P < .001). Tandem stance performance did not reach statistical significance (-0.5 error/unit change, P = .118). Dynamic balance was insensitive to balance change, being error free for all participants throughout the study. CONCLUSION: This proof-of-concept study indicated that promotion of a costal-diaphragmatic breathing pattern may be associated with improvement in balance and suggests that a study of this phenomenon using an experimental design is feasible.

Does case misclassification threaten the validity of studies investigating the relationship between neck manipulation and vertebral artery dissection stroke? No.

BACKGROUND: The purported relationship between cervical manipulative therapy (CMT) and stroke related to vertebral artery dissection (VAD) has been debated for several decades. A large number of publications, from case reports to case-control studies, have investigated this relationship. A recent article suggested that case misclassification in the case-control studies on this topic resulted in biased odds ratios in those studies. DISCUSSION: Given its rarity, the best epidemiologic research design for investigating the relationship between CMT and VAD is the case-control study. The addition of a case-crossover aspect further strengthens the scientific rigor of such studies by reducing bias. The most recent studies investigating the relationship between CMT and VAD indicate that the relationship is not causal. In fact, a comparable relationship between vertebral artery-related stroke and visits to a primary care physician has been observed. The statistical association between visits to chiropractors and VAD can best be explained as resulting from a patient with early manifestation of VAD (neck pain with or without headache) seeking the services of a chiropractor for relief of this pain. Sometime after the visit the patient experiences VAD-related stroke that would have occurred regardless of the care received. This explanation has been challenged by a recent article putting forth the argument that case misclassification is likely to have biased the odds ratios of the case-control studies that have investigated the association between CMT and vertebral artery related stroke. The challenge particularly focused on one of the case-control studies, which had concluded that the association between CMT and vertebral artery related stroke was not causal. It was suggested by the authors of the recent article that misclassification led to an underestimation of risk. We argue that the information presented in that article does not support the authors' claim for a variety of reasons, including the fact that the assumptions upon which their analysis is based lack substantiation and the fact that any possible misclassification would not have changed the conclusion of the study in question. CONCLUSION: Current evidence does not support the notion that misclassification threatens the validity of recent case-control studies investigating the relationship between CMT and VAD. Hence, the recent re-analysis cannot refute the conclusion from previous studies that CMT is not a cause of VAD.

Dose-response of spinal manipulation for cervicogenic headache: study protocol for a randomized controlled trial.

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT01530321).

US chiropractors' attitudes, skills and use of evidence-based practice: A cross-sectional national survey.

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.

Cost analysis related to dose-response of spinal manipulative therapy for chronic low back pain: outcomes from a randomized controlled trial.

OBJECTIVE: The purpose of this analysis is to report the incremental costs and benefits of different doses of spinal manipulative therapy (SMT) in patients with chronic low back pain (LBP). METHODS: We randomized 400 patients with chronic LBP to receive a dose of 0, 6, 12, or 18 sessions of SMT. Participants were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a doctor of chiropractic. Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity. The main health outcomes were the number of pain-free days and disability-free days. Multiple regression was performed on outcomes and log-transformed cost data. RESULTS: Lost productivity accounts for most societal costs of chronic LBP. Cost of treatment and lost productivity ranged from $3398 for 12 SMT sessions to $3815 for 0 SMT sessions with no statistically significant differences between groups. Baseline patient characteristics related to increase in costs were greater age (P = .03), greater disability (P = .01), lower quality-adjusted life year scores (P = .01), and higher costs in the period preceding enrollment (P < .01). Pain-free and disability-free days were greater for all SMT doses compared with control, but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days (P = .03) and 19.8 disability-free days (P = .04). No statistically significant group differences in quality-adjusted life years were noted. CONCLUSIONS: A dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days. Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity.

A path analysis of the effects of the doctor-patient encounter and expectancy in an open-label randomized trial of spinal manipulation for the care of low back pain.

BACKGROUND: The doctor-patient encounter (DPE) and associated patient expectations are potential confounders in open-label randomized trials of treatment efficacy. It is therefore important to evaluate the effects of the DPE on study outcomes. METHODS: Four hundred participants with chronic low back pain (LBP) were randomized to four dose groups: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for six weeks. They received light massage control at visits when manipulation was not scheduled. Treating chiropractors were instructed to have equal enthusiasm for both interventions. A path analysis was conducted to determine the effects of dose, patient expectations of treatment success, and DPE on LBP intensity (100-point scale) at the end of care (6 weeks) and primary endpoint (12 weeks). Direct, indirect, and total standardized effects (ßtotal) were computed. Expectations and DPE were evaluated on Likert scales. The DPE was assessed as patient-rated perception of chiropractor enthusiasm, confidence, comfort with care, and time spent. RESULTS: The DPE was successfully balanced across groups, as were baseline expectations. The principal finding was that the magnitude of the effects of DPE on LBP at 6 and 12 weeks (|ß|total = 0.22 and 0.15, p < .05) were comparable to the effects of dose of manipulation at those times (|ß|total = 0.11 and 0.12, p < .05). In addition, baseline expectations had no notable effect on follow-up LBP. Subsequent expectations were affected by LBP, DPE, and dose (p < .05). CONCLUSIONS: The DPE can have a relatively important effect on outcomes in open-label randomized trials of treatment efficacy. Therefore, attempts should be made to balance the DPE across treatment groups and report degree of success in study publications. We balanced the DPE across groups with minimal training of treatment providers. TRIAL REGISTRATION: ClinicalTrials.gov NCT00376350.

Dose-response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial.

BACKGROUND CONTEXT: There have been no full-scale trials of the optimal number of visits for the care of any condition with spinal manipulation. PURPOSE: To identify the dose-response relationship between visits to a chiropractor for spinal manipulation and chronic low back pain (cLBP) outcomes and to determine the efficacy of manipulation by comparison with a light massage control. STUDY DESIGN/SETTING: Practice-based randomized controlled trial. PATIENT SAMPLE: Four hundred participants with cLBP. OUTCOME MEASURES: The primary cLBP outcomes were the 100-point modified Von Korff pain intensity and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status. METHODS: One hundred participants with cLBP were randomized to each of four dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, they received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks. RESULTS: For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks and sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per six manipulation sessions at 12 and 52 weeks for both variables (p<.025). At 12 weeks, the greatest differences from the no-manipulation control were found for 12 sessions (8.6 pain and 7.6 disability points, p<.025); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points, p<.025). CONCLUSIONS: The number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.

Development and psychometric evaluation of an evidence-based practice questionnaire for a chiropractic curriculum.

OBJECTIVE: The purposes of this study were to describe the questionnaire development process for evaluating elements of an evidence-based practice (EBP) curriculum in a chiropractic program and to report on initial reliability and validity testing for the EBP knowledge examination component of the questionnaire. METHODS: The EBP knowledge test was evaluated with students enrolled in a doctor of chiropractic program in the University of Western States. The initial version was tested with a sample of 374 and a revised version with a sample of 196 students. Item performance and reliability were assessed using item difficulty, item discrimination, and internal consistency. An expert panel assessed face and content validity. RESULTS: The first version of the knowledge examination demonstrated a low internal consistency (Kuder-Richardson 20 = 0.55), and a few items had poor item difficulty and discrimination. This resulted in an expansion in the number of items from 20 to 40, as well as a revision of the poorly performing items from the initial version. The Kuder-Richardson 20 of the second version was 0.68; 32 items had item difficulties of between 0.20 and 0.80, and 26 items had item discrimination values of 0.20 or greater. CONCLUSIONS: A questionnaire for evaluating a revised EBP-integrated curriculum was developed and evaluated. Psychometric testing of the EBP knowledge component provided some initial evidence for acceptable reliability and validity.

Evaluation of the effects of an evidence-based practice curriculum on knowledge, attitudes, and self-assessed skills and behaviors in chiropractic students.

OBJECTIVE: The purpose of this study was to evaluate the effects of an evidence-based practice (EBP) curriculum incorporated throughout a chiropractic doctoral program on EBP knowledge, attitudes, and self-assessed skills and behaviors in chiropractic students. METHODS: In a prospective cohort design, students from the last entering class under an old curriculum were compared with students in the first 2 entering classes under a new EBP curriculum during the 9th and 11th quarters of the 12-quarter doctoral program at the University of Western States in Portland, OR (n = 370 students at matriculation). Analysis of variance (ANOVA) was performed using a 3-cohort × 2-quarter repeated cross-sectional factorial design to assess the effect of successive entering classes and stage of the students' education. RESULTS: For the knowledge exam (primary outcome), there was a statistically significant cohort effect with each succeeding cohort showing better performance (P < .001); students also performed slightly better in the 11th quarter than in the 9th quarter (P < .05). A similar pattern in cohort and quarter effects was found with behavior self-appraisal for greater time accessing databases such as PubMed. Student self-appraisal of their skills was higher in the 11th than the 9th quarter. All cohorts rejected a set of sentinel misconceptions about application of scientific literature (practice attitudes). CONCLUSIONS: The implementation of the EBP curriculum at this institution resulted in acquisition of knowledge necessary to access and interpret scientific literature, the retention and improvement of skills over time, and the enhancement of self-reported behaviors favoring use of quality online resources.

A pilot randomized controlled trial comparing the efficacy of exercise, spinal manipulation, and neuro emotional technique for the treatment of pregnancy-related low back pain.

BACKGROUND: This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy. METHODS: Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events. RESULTS: Fifty-seven participants were randomized into the exercise (n = 22), spinal manipulation (n = 15), and Neuro Emotional Technique (n = 20) treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically meaningful or statistically significant differences between groups in any analysis. CONCLUSIONS: This pilot study demonstrated feasibility for recruitment, compliance, safety, and affordability for conducting a larger study in the future. Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain, but the study was not powered to detect the between-group differences as statistically significant. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT00937365).

Evidence-Based Practice and Chiropractic Care.

Evidence-based practice has had a growing impact on chiropractic education and the delivery of chiropractic care. For evidence-based practice to penetrate and transform a profession, the penetration must occur at 2 levels. One level is the degree to which individual practitioners possess the willingness and basic skills to search and assess the literature. Chiropractic education received a significant boost in this realm in 2005 when the National Center for Complementary and Alternative Medicine awarded 4 chiropractic institutions R25 education grants to strengthen their research/evidence-based practice curricula. The second level relates to whether the therapeutic interventions commonly employed by a particular health care discipline are supported by clinical research. A growing body of randomized controlled trials provides evidence of the effectiveness and safety of manual therapies.

Pilot controlled trial of mindfulness meditation and education for dementia caregivers.

OBJECTIVES: The objectives of this study were to evaluate whether a mindfulness meditation intervention may be effective in caregivers of close relatives with dementia and to help refine the protocol for future larger trials. DESIGN: The design was a pilot randomized trial to evaluate the effectiveness of a mindfulness meditation intervention adapted from the Mindfulness-Based Cognitive Therapy program in relation to two comparison groups: an education class based on Powerful Tools for Caregivers serving as an active control group and a respite-only group serving as a pragmatic control. SETTINGS/LOCATION: This study was conducted at the Oregon Health & Science University, Portland, OR. SUBJECTS: The subjects were community-dwelling caregivers aged 45-85 years of close relatives with dementia. INTERVENTIONS: The two active interventions lasted 7 weeks, and consisted of one 90-minute session per week along with at-home implementation of knowledge learned. The respite-only condition provided the same duration of respite care that was needed for the active interventions. OUTCOME MEASURES: Subjects were assessed prior to randomization and again after completing classes at 8 weeks. The primary outcome measure was a self-rated measure of caregiver stress, the Revised Memory and Behavior Problems Checklist (RMBPC). Secondary outcome measures included mood, fatigue, self-efficacy, mindfulness, salivary cortisols, cytokines, and cognitive function. We also evaluated self-rated stress in the subjects' own environment, expectancy of improvement, and credibility of the interventions. RESULTS: There were 31 caregivers randomized and 28 completers. There was a significant effect on RMBPC by group covarying for baseline RMBPC, with both active interventions showing improvement compared with the respite-only group. Most of the secondary outcome measures were not significantly affected by the interventions. There was an intervention effect on the caregiver self-efficacy measure and on cognitive measures. Although mindfulness was not impacted by the intervention, there were significant correlations between mindfulness and self-rated mood and stress scores. CONCLUSIONS: Both mindfulness and education interventions decreased the self-rated caregiver stress compared to the respite-only control.

Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache.

OBJECTIVE: Objective clinical measures for use as surrogate markers of cervicogenic headache (CGH) pain have not been established. In this analysis, we investigate relationships between objective physical examination (PE) measures with self-reported CGH outcomes. METHODS: This is an exploratory analysis of data generated by attention control PE from an open-label randomized clinical trial. Of 80 subjects, 40 were randomized to 8 treatments (spinal manipulative therapy or light massage control) and 8 PE over 8 weeks. The remaining subjects received no PE. Physical examination included motion palpation of the cervical and upper thoracic regions, active cervical range of motion (ROM) and associated pain, and algometric pain threshold evaluated over articular pillars. Self-reported outcomes included CGH and neck pain and disability, number of CGH headaches, and related disability days. Associations between PE and self-reported outcomes were evaluated using generalized linear models, adjusting for sociodemographic differences and study group. RESULTS: At baseline, number of CGH and disability days were strongly associated with cervical active ROM (P < .001 to .037). Neck pain and disability were strongly associated with ROM-elicited pain (P < .001 to .035) but not later in the study. After the final treatment, pain thresholds were strongly associated with week 12 neck pain and disability and CGH disability and disability days (P < or = .001 to .048). CONCLUSIONS: Cervical ROM was most associated with the baseline headache experience. However, 4 weeks after treatment, algometric pain thresholds were most associated. No one PE measure remained associated with the self-reported headache outcomes over time.

A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache.

OBJECTIVE: The purpose of this article was to present a preliminary model to identify the effects of expectancy of treatment success and the patient-provider encounter (PPE) on outcomes in an open-label randomized trial. METHODS: Eighty participants with chronic cervicogenic headache (CGH) were randomized to 4 groups: 2 levels of treatment dose (8 or 16) and 2 levels of therapy from a chiropractor (spinal manipulation or light massage). Providers were instructed to have equal enthusiasm for all care. Structural equation modeling with standardized path coefficients (beta) was used in a path analysis to identify the effects of patient expectancy and the PPE on CGH pain. The model included monthly pain from baseline to 12 weeks. Expectancy and PPE were evaluated on Likert scales. The patient-provider encounter was measured as patient perception of chiropractor enthusiasm, confidence, and comfort with care. RESULTS: Baseline patient expectancy was balanced across groups. The PPE measures were balanced across groups and consistent over the 8-week treatment period. Treatment and baseline pain had the strongest effects on pain outcomes (|beta| = .46-.59). Expectations had little effect on pain (abs value(beta) < .15). The patient-provider encounter had a weak effect on pain (abs value(beta)= .03-.27) and on subsequent confidence in treatment success (abs value(beta)= .09 and .12). CONCLUSIONS: Encouraging equipoise in the PPE and balancing expectancy across treatment groups may protect against some confounding related to the absence of blinding in a randomized controlled trial of pain. In this trial, their effects were found to be small relative to the effects of treatment and baseline values.