Association Among Opioid Use, Treatment Preferences, and Perceptions of Physician Treatment Recommendations in Patients With Neck and Back Pain.

OBJECTIVE: The purpose of this study was to explore the relationship between self-reported use of opioids by patients with neck and back pain and their demographics, pain characteristics, treatment preferences, and recollections of their physicians' opinions regarding treatment options. METHODS: We analyzed 2017 Gallup Poll survey data from 1680 US adults who had substantial spine pain in the past year and used logistic regression to explore the aforementioned relationships. RESULTS: Our multiple regression analysis indicated that adults with neck or back pain severe enough to have sought health care within the last year were more likely to have used opioids in the last year if they (in descending order of marginal impact) had pain that had lasted 1 year or less (adjusted odds ratio [OR] = 34.35, 90% confidence interval [CI] 17.56-74.32); concurrently used benzodiazepines (OR = 6.02, 90% CI 2.95-12.33); had Medicaid as an insurance source (OR = 3.29, 90% CI 1.40-7.48); indicated that they preferred to use pain medications prescribed by a doctor to treat physical pain (OR = 3.24, 90% CI 1.88-5.60); or were not college educated (OR = 1.83, 90% CI 1.05-3.25). Compared with patients aged 65 years and older, those aged 18 to 34 years were less likely to have used opioids in the past year (OR = 0.09, 90% CI 0.01-0.40, 0.50 for 95% CI). Respondents' perceptions of medical doctors' positive or negative opinions regarding a variety of neck and back pain treatment options were not significantly associated with opioid use. CONCLUSIONS: Patients with neck and back pain who use opioids differ from those who do not use opioids in that they are more likely to have pain that is of shorter duration, to use benzodiazepines, to have Medicaid as an insurance source, and to prefer to use pain medications. Those characteristics should be considered when developing opioid use prevention strategies.

Characteristics of US Adults Who Have Positive and Negative Perceptions of Doctors of Chiropractic and Chiropractic Care.

OBJECTIVE: The purpose of this study was to compare characteristics, likelihood to use, and actual use of chiropractic care for US survey respondents with positive and negative perceptions of doctors of chiropractic (DCs) and chiropractic care. METHODS: From a 2015 nationally representative survey of 5422 adults (response rate, 29%), we used respondents' answers to identify those with positive and negative perceptions of DCs or chiropractic care. We used the χ(2) test to compare other survey responses for these groups. RESULTS: Positive perceptions of DCs were more common than those for chiropractic care, whereas negative perceptions of chiropractic care were more common than those for DCs. Respondents with negative perceptions of DCs or chiropractic care were less likely to know whether chiropractic care was covered by their insurance, more likely to want to see a medical doctor first if they were experiencing neck or back pain, less likely to indicate that they would see a DC for neck or back pain, and less likely to have ever seen a DC as a patient, particularly in the recent past. Positive perceptions of chiropractic care and negative perceptions of DCs appear to have greater influence on DC utilization rates than their converses. CONCLUSION: We found that US adults generally perceive DCs in a positive manner but that a relatively high proportion has negative perceptions of chiropractic care, particularly the costs and number of visits required by such care. Characteristics of respondents with positive and negative perceptions were similar, but those with positive perceptions were more likely to plan to use-and to have already received-chiropractic care.

Public Perceptions of Doctors of Chiropractic: Results of a National Survey and Examination of Variation According to Respondents' Likelihood to Use Chiropractic, Experience With Chiropractic, and Chiropractic Supply in Local Health Care Markets.

OBJECTIVES: The purpose of this study was to determine whether general perceptions of doctors of chiropractic (DCs) varied according to likeliness to use chiropractic care, whether particular demographic characteristics were associated with chiropractic care use, and whether perception of DCs varied according to the per-capita supply of DCs in local health care markets. METHODS: We performed a secondary analysis of results from a 26-item nationally representative survey of 5422 members of The Gallup Panel that was conducted in the spring of 2015 (response rate, 29%) that sought to elicit the perceptions and use of DCs by US adults. We compared survey responses across: (1) respondents who had different likelihoods to use DCs for treatment of neck or back pain and (2) respondents who had different experiences using DCs. We linked respondents' zip codes to hospital referral regions for which we had the per-capita supply of DCs. Using the χ(2) test, we examined relationships between likeliness to use a DC, experience using a DC, respondent demographic variables, perceptions of DCs, and the per-capita supply of DCs in the local health care market. RESULTS: Most (61.4%) respondents believed that chiropractic care was effective at treating neck and back pain, 52.6% thought DCs were trustworthy, and 24.2% thought chiropractic care was dangerous; however, as respondents' likelihood to use a DC increased, perceptions of effectiveness and trustworthiness increased, and perceptions of danger decreased. Of all 5422 survey respondents, 744 or 13.7% indicated that they had seen a DC within the last 12 months. As one moved from distant to more recent experience using a DC, respondents were more likely to be female, married, white, and employed; those who had a distant history of using a DC were older and more likely to be retired than the other groups. A higher per-capita supply of DCs was associated with higher utilization rates and showed a more favorable regard for DCs. CONCLUSIONS: US adults often use chiropractic care, generally regard DCs favorably, and largely perceive that chiropractic care is safe. Where there is a higher per-capita supply of DCs in the local health care market, utilization and positive perceptions of chiropractic are higher.

Patient-Reported Physician Treatment Recommendations and Compliance Among U.S. Adults with Low Back Pain.

Objectives: Numerous recently published clinical care guidelines, including the 2017 American College of Physicians (ACP) Guideline for Low Back Pain (LBP), call for nonpharmacological approaches to pain management. However, little data exist regarding the extent to which these guidelines have been adopted by patients and medical doctors. The study objective was to determine patient-reported treatment recommendations by medical doctors for LBP and patient compliance with those recommendations. Design: This study used a cross-sectional web and mail survey. Settings/Location: The study was conducted among Gallup Panel members across the United States. Subjects: Survey participants included 5377 U.S. adults randomly selected among Gallup Panel members. Of those, 545 reported a visit to a medical doctor within the past year for low back pain and were asked a series of follow-up questions regarding treatment recommendations. Interventions: Participants were asked about medical doctor recommendations for both drug (acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs], opioids, benzodiazepines, Gabapentin, Neurontin, and cortisone injections) and nondrug (self-care treatments, massage, acupuncture, spinal manipulation, and physical therapy) treatments. Outcome Measures: Participants were asked to indicate if their medical doctor recommended each drug and nondrug therapy for their LBP and if they had followed each of those treatment recommendations. Results: Ninety-six percent of patients who visited a medical doctor for LBP received a recommendation for one or more pain treatments, with 81% reporting that their medical doctor recommended both drug and nondrug therapies. Seventy-six percent of respondents were recommended acetaminophen or NSAIDs, 79% were recommended self-care treatments, 37% were recommended massage, acupuncture, or spinal manipulation, and 60% were recommended physical therapy. Nearly two-thirds of our sample reported that their doctor had recommended prescription medications, including opioids, benzodiazepines, Gabapentin, Neurontin, or cortisone injections. Reported adherence to treatment recommendations ranged from 68% for acupuncture to 94% for NSAIDs. Conclusions: One year after publication of the ACP's Guideline on LBP, patients report that medical doctors recommended both pharmacological and nonpharmacological treatment approaches to patients with LBP. In the majority of cases, a combination of prescription medications and self-care were recommended, illustrating the need for additional research on the effectiveness of multi-modal treatment strategies. Patients reported that they were largely compliant with medical doctor recommendations, underscoring the influence that medical doctors have in directing patient care for LBP. These findings indicate that further work is also needed to explore the impact of personal experience, training, clinical evidence, sociocultural factors, and health plans on medical doctors therapeutic recommendations in the context of back pain.

A randomized controlled trial comparing 2 types of spinal manipulation and minimal conservative medical care for adults 55 years and older with subacute or chronic low back pain.

OBJECTIVE: Chiropractic care is used by many older patients for low back pain (LBP), but there are no published results of randomized trials examining spinal manipulation (SM) for older adults. The purpose of this study was to compare the effects of 2 biomechanically distinct forms of SM and minimal conservative medical care (MCMC) for participants at least 55 years old with subacute or chronic nonradicular LBP. METHODS: Randomized controlled trial. The primary outcome variable was low back-related disability assessed with the 24-item Roland Morris Disability questionnaire at 3, 6, 12, and 24 weeks. Participants were randomly allocated to 6 weeks of care including 12 visits of either high-velocity, low-amplitude (HVLA)-SM, low-velocity, variable-amplitude (LVVA)-SM, or 3 visits of MCMC. RESULTS: Two hundred forty participants (105 women and 135 men) ages 63.1 +/- 6.7 years without significant comorbidities. Adjusted mean Roland Morris Disability change scores (95% confidence intervals) from baseline to the end of active care were 2.9 (2.2, 3.6) and 2.7 (2.0, 3.3) in the LVVA-SM and HVLA-SM groups, respectively, and 1.6 (0.5, 2.8) in the MCMC group. There were no significant differences between LVVA-SM and HVLA-SM at any of the end points. The LVVA-SM group had significant improvements in mean functional status ranging from 1.3 to 2.2 points over the MCMC group. There were no serious adverse events associated with any of the interventions. CONCLUSIONS: Biomechanically distinct forms of SM did not lead to different outcomes in older LBP patients and both SM procedures were associated with small yet clinically important changes in functional status by the end of treatment for this relatively healthy older population. Participants who received either form of SM had improvements on average in functional status ranging from 1 to 2.2 over those who received MCMC. From an evidence-based care perspective, patient preference and clinical experience should drive how clinicians and patients make the SM procedure decision for this patient population.

Health professions education and integrative healthcare.

Over the past three decades, evidence has accumulated that demonstrates that the US healthcare system as currently structured is untenable given the cost of healthcare, poor outcomes associated with this cost, imminent shortages in many categories of health professionals, and underutilization of other health professionals. The system also faces other challenges, such as the lack of access to care and a growing demand by consumers for healthcare that offers choice, quality, convenience, affordability, and personalized care. Workforce analyses estimating needs and anticipated shortages of health professionals are projected on the current healthcare system, which generally does not include integrative healthcare and does not include complementary and alternative medicine (CAM) practitioners. This paper examines the opportunities and implications of going beyond the current paradigm of workforce planning and health professions education and offers recommendations that detail how the health of the public may be served by incorporating an integrative health perspective into health professions education and workforce planning, deployment, and utilization.

The reliability of a posterior-to-anterior spinal stiffness measuring system in a population of patients with low back pain.

OBJECTIVE: A system for measuring posterior-to-anterior spinal stiffness (PAS) was developed for use in clinical trials of manipulation for low back pain. The reliability of this device is under investigation in this study. METHODS: The PAS system uses electronic sensors to record displacement and force while a human operator provides the force of indentation. A test-retest design was used with measures repeated by the same operator within 5 minutes. Posterior-to-anterior loads were applied to each lumbar spinous process of patients lying prone on a hard flat bench. Force and displacement were recorded and used to calculate PAS. RESULTS: The subjects consisted of 22 males and 14 females; average age was 49.1 years (SD, 14.2). All subjects had low back pain of at least 4 weeks duration, with mean Roland-Morris scores of 7.6 (SD, 3.3). Spinal stiffness ranged from 4 to 26 N/mm (average, 11.2; SD, 3.5). Stiffness in the first and second tests varied on the average by 0.31 N/mm (P = .03). Standard error of the measurement was 1.62 N/mm. The single measures intraclass correlation coefficient (3,1) was 0.790 (95% confidence interval, 0.739-0.832). CONCLUSIONS: The equipment and method produced repeatable results over the short-term. The system may be sensitive enough to detect changes in spinal stiffness that occur with care.

Comparison of posteroanterior spinal stiffness measures to clinical and demographic findings at baseline in patients enrolled in a clinical study of spinal manipulation for low back pain.

OBJECTIVE: A system for measuring posterior-to-anterior spinal stiffness (PAS) was developed for use in clinical trials of manipulation for low back pain (LBP). The current report is an analysis of the baseline PAS data, with particular emphasis on relationships between PAS and clinical and demographic characteristics. METHODS: Posterior-to-anterior spinal stiffness measurements were recorded over the spinous processes of the lumbar spines from patients who had LBP. The system uses electronic sensors to record displacement and force, whereas a human operator provides the force of indentation. Clinical and outcome measures were compared with spinal stiffness. RESULTS: We recruited 192 patients (89 female and 103 male; average age, 40.0 years; SD, 9.4 years). The average Roland-Morris score was 9.7 (SD, 3.2) on a 24-point scale. The Visual Analog Scale pain scores were 55.7 (SD, 20.9) on a 100-mm scale. Stiffness values ranged from 4.16 to 39.68 N/mm (mean, 10.80 N/mm; SD, 3.72 N/mm). Females' lumbar spines were, on the average, 2 N/mm more compliant than males (P < .001). CONCLUSIONS: The PAS system of computer-monitored equipment with human operation performed well in this clinical study of LBP. Spinal stiffness was found to be different between males and females, and age and body mass index were related to PAS. We found no significant relationship between the severity or chronicity of the LBP complaint and spinal stiffness. There was little agreement between the stiff or tender segments identified by the clinicians using palpation and the segment that measured most stiff using the PAS device.

Chiropractic and CAM utilization: a descriptive review.

OBJECTIVE: To conduct a descriptive review of the scientific literature examining use rates of modalities and procedures used by CAM clinicians to manage chronic LBP and other conditions DATA SOURCES: A literature of PubMed and MANTIS was performed using the key terms Chiropractic; Low Back Pain; Utilization Rate; Use Rate; Complementary and Alternative Medicine; and Health Services in various combinations. DATA SELECTION: A total of 137 papers were selected, based upon including information about chiropractic utilization, CAM utilization and low back pain and other conditions. DATA SYNTHESIS: Information was extracted from each paper addressing use of chiropractic and CAM, and is summarized in tabular form. RESULTS: Thematic analysis of the paper topics indicated that there were 5 functional areas covered by the literature: back pain papers, general chiropractic papers, insurance-related papers, general CAM-related papers; and worker's compensation papers. CONCLUSION: Studies looking at chiropractic utilization demonstrate that the rates vary, but generally fall into a range from around 6% to 12% of the population, most of whom seek chiropractic care for low back pain and not for organic disease or visceral dysfunction. CAM is itself used by people suffering from a variety of conditions, though it is often used not as a primary intervention, but rather as an additional form of care. CAM and chiropractic often offer lower costs for comparable results compared to conventional medicine.

Commentary: the National Workshop to Develop the Chiropractic Research Agenda: 10 years on, a new set of white papers.

This commentary reports on the advances that have occurred over the 10-year period since the first National Workshop to Develop the Chiropractic Research Agenda was held and introduces the second set of white papers that were produced as a result of the 10th annual Research Agenda Conference. Four working groups were convened to update the original 5 white papers that represented the most significant results from the first workshop in 1996. Each group was to review the first report, examine the action steps and recommendations that were published in each report to see how much had been completed in the past decade, and develop new action steps and recommendations for the future. Four new articles were developed, each updating and adding significant amounts of new research to the original versions. New action steps and recommendations will help move the profession forward into the future. Chiropractic scientists have worked diligently over the past decade to address the recommendations noted in the first set of white papers. Despite significant advances in knowledge and scientific capacity, the chiropractic profession is still confronted with a large number of research challenges.

Effects of spinal manipulation on sensorimotor function in low back pain patients--A randomised controlled trial.

BACKGROUND: Low back pain (LBP) is a major health problem in industrialized societies. Spinal manipulation (SM) is often used for treating LBP, though the therapeutic mechanisms remain elusive. Research suggests that sensorimotor changes may be involved in LBP. It is hypothesized that SM may generate its beneficial effects by affecting sensorimotor functions. OBJECTIVES: To compare changes in sensorimotor function, as measured by postural sway and response to sudden load, in LBP patients following the delivery of high-velocity low amplitude (HVLA)-SM or low-velocity variable amplitude (LVVA)-SM versus a sham control intervention. DESIGN: A three-arm (1:1:1 ratio) randomized controlled trial. METHODS: A total of 221 participants who were between 21 and 65 years, having LBP intensity (numerical rating scale) ≥4 at either phone screen or the first baseline visit and ≥2 at phone screen and both baseline visits, and Quebec Task Force diagnostic classifications of 1, 2, 3 or 7 were enrolled to receive four SM treatments over two weeks. Study outcomes were measured at the first and fifth visits with the examiners blinded from participant group assignment. RESULTS: The LVVA-SM group demonstrated a significant increase in medial-to-lateral postural excursion on the soft surface at the first visit when compared to the control group. No other significant between-group differences were found for the two sensorimotor tests, whether during the first visit or over two weeks. CONCLUSIONS: It appears that short-term SM does not affect the sensorimotor functions as measured by postural sway and response to sudden load in this study.

Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation.

STUDY DESIGN: A three-arm controlled trial with adaptive allocation. OBJECTIVES: The aim of this study was to compare short-term effects of a side-lying, thrust spinal manipulation (SM) procedure and a nonthrust, flexion-distraction SM procedure in adults with subacute or chronic low back pain (LBP) over 2 weeks. SUMMARY OF BACKGROUND DATA: SM has been recommended in recently published clinical guidelines for LBP management. Previous studies suggest that thrust and nonthrust SM procedures, though distinctly different in joint loading characteristics, have similar effects on patients with LBP. METHODS: Participants were eligible if they were 21 to 54 years old, had LBP for at least 4 weeks, scored 6 or above on the Roland-Morris disability questionnaire, and met the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force Classification for Spinal Disorders. Participants were allocated in a 3:3:2 ratio to four sessions of thrust or nonthrust SM procedures directed at the lower lumbar and pelvic regions, or to a 2-week wait list control. The primary outcome was LBP-related disability using Roland-Morris Disability Questionnaire and the secondary outcomes were LBP intensity using visual analog scale, Fear-Avoidance Beliefs Questionnaire, and the 36-Item Short Form Health Survey. The study was conducted at the Palmer Center for Chiropractic Research with care provided by experienced doctors of chiropractic. Clinicians and patients were not blinded to treatment group. RESULTS: Of 192 participants enrolled, the mean age was 40 years and 54% were male. Improvement in disability, LBP intensity, Fear-Avoidance Beliefs Questionnaire-work subscale, and 36-Item Short Form Health Survey-physical health summary measure for the two SM groups were significantly greater than the control group. No difference in any outcomes was observed between the two SM groups. CONCLUSION: Thrust and nonthrust SM procedures with distinctly different joint loading characteristics demonstrated similar effects in short-term LBP improvement and both were superior to a wait list control. LEVEL OF EVIDENCE: 2.

Chiropractic: a profession at the crossroads of mainstream and alternative medicine.

Chiropractic is a large and well-established health care profession in the United States. In this overview, we briefly examine the development of chiropractic from humble and contentious beginnings to its current state at the crossroads of alternative and mainstream medicine. Chiropractic has taken on many of the attributes of an established profession, improving its educational and licensing systems and substantially increasing its market share in the past two decades. The public increasingly uses chiropractic largely for spinal pain syndromes and appears to be highly satisfied with the results. Of all the so-called alternative professions, chiropractic has made the largest inroads into private and public health care financing systems and is increasingly viewed as an effective specialty by many in the medical profession. Much of the positive evolution of chiropractic can be ascribed to a quarter century-long research effort focused on the core chiropractic procedure of spinal manipulation. This effort has helped bring spinal manipulation out of the investigational category to become one of the most studied forms of conservative treatment for spinal pain. Chiropractic theory is still controversial, but recent expansion in federal support of chiropractic research bodes well for further scientific development. The medical establishment has not yet fully accepted chiropractic as a mainstream form of care. The next decade should determine whether chiropractic maintains the trappings of an alternative health care profession or becomes fully integrated into all health care systems.

Self-reported nonmusculoskeletal responses to chiropractic intervention: a multination survey.

OBJECTIVE: To replicate a previous study of nonmusculoskeletal responses to chiropractic intervention and to establish whether such responses are influenced by the country of study, chiropractors' attitudes, and information to patients, patients' demographic profiles, and treatment regimens. METHODS: Information obtained through questionnaires by chiropractors and patients on return visit within 2 weeks of previous treatment from chiropractic practices in Canada, United States, Mexico, Hong-Kong, Japan, Australia, and South Africa. In all, 385 chiropractors collected valid data on 5607 patients. Spinal manipulation with or without additional therapy was the intervention provided by chiropractors. Outcome measures included self-reported improved nonmusculoskeletal reactions (allergy, asthma, breathing, circulation, digestion, hearing, heart function, ringing in the ears, sinus problems, urination, and others). RESULTS: The results from the previous study were largely reproduced. Positive reactions were reported by 2% to 10% of all patients and by 3% to 27% of those who reported to have such problems. Most common were improved breathing (27%), digestion (26%), and circulation (21%). Some variables were identified that somewhat influenced the outcome: patients informed that such reactions may occur (odds ratio [OR] 1.5), treatment to the upper cervical spine (OR 1.4), treatment to lower thoracic spine (OR 1.3), and female sex (OR 1.3). However, these had a very small "explanatory" value (pseudo R2 3%). CONCLUSION: A minority of patients with self-reported nonmusculoskeletal symptoms report definite improvement after chiropractic care, and very few report definite worsening. Future studies should use stringent criteria to investigate a possible treatment effect and concentrate on specific diagnostic subgroups such as digestive problems and tinnitus.

Improving Our Nation's Health Care System: Inclusion of Chiropractic in Patient-Centered Medical Homes and Accountable Care Organizations.

OBJECTIVE: This report summarizes the closing plenary session of the Association of Chiropractic Colleges Educational Conference-Research Agenda Conference 2014. The purpose of this session was to examine patient-centered medical homes and accountable care organizations from various speakers' viewpoints and to discuss how chiropractic could possibly work within, and successfully contribute to, the changing health care environment. DISCUSSION: The speakers addressed the complex topic of patient-centered medical homes and accountable care organizations and provided suggestions for what leadership strategies the chiropractic profession may need to enhance chiropractic participation and contribution to improving our nation's health. CONCLUSION: There are many factors involved in the complex topic of chiropractic inclusion in health care models. Major themes resulting from this panel included the importance of building relationships with other professionals, demonstrating data and evidence for what is done in chiropractic practice, improving quality of care, improving health of populations, and reducing costs of health care.

Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study.

STUDY DESIGN: Randomized controlled trial. OBJECTIVE: To assess changes in pain levels and physical functioning in response to standard medical care (SMC) versus SMC plus chiropractic manipulative therapy (CMT) for the treatment of low back pain (LBP) among 18 to 35-year-old active-duty military personnel. SUMMARY OF BACKGROUND DATA: LBP is common, costly, and a significant cause of long-term sick leave and work loss. Many different interventions are available, but there exists no consensus on the best approach. One intervention often used is manipulative therapy. Current evidence from randomized controlled trials demonstrates that manipulative therapy may be as effective as other conservative treatments of LBP, but its appropriate role in the healthcare delivery system has not been established. METHODS: Prospective, 2-arm randomized controlled trial pilot study comparing SMC plus CMT with only SMC. The primary outcome measures were changes in back-related pain on the numerical rating scale and physical functioning at 4 weeks on the Roland-Morris Disability Questionnaire and back pain functional scale (BPFS). RESULTS: Mean Roland-Morris Disability Questionnaire scores decreased in both groups during the course of the study, but adjusted mean scores were significantly better in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). Mean numerical rating scale pain scores were also significantly better in the group that received CMT. Adjusted mean back pain functional scale scores were significantly higher (improved) in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). CONCLUSION: The results of this trial suggest that CMT in conjunction with SMC offers a significant advantage for decreasing pain and improving physical functioning when compared with only standard care, for men and women between 18 and 35 years of age with acute LBP.

Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial.

BACKGROUND: Low back pain (LBP) is a recognized public health problem, impacting up to 80% of US adults at some point in their lives. Patients with LBP are utilizing integrative health care such as spinal manipulation (SM). SM is the therapeutic application of a load to specific body tissues or structures and can be divided into two broad categories: SM with a high-velocity low-amplitude load, or an impulse "thrust", (HVLA-SM) and SM with a low-velocity variable-amplitude load (LVVA-SM). There is evidence that sensorimotor function in people with LBP is altered. This study evaluates the sensorimotor function in the lumbopelvic region, as measured by postural sway, response to sudden load and repositioning accuracy, following SM to the lumbar and pelvic region when compared to a sham treatment. METHODS/DESIGN: A total of 219 participants with acute, subacute or chronic low back pain are being recruited from the Quad Cities area located in Iowa and Illinois. They are allocated through a minimization algorithm in a 1:1:1 ratio to receive either 13 HVLA-SM treatments over 6 weeks, 13 LVVA-SM treatments over 6 weeks or 2 weeks of a sham treatment followed by 4 weeks of full spine "doctor's choice" SM. Sensorimotor function tests are performed before and immediately after treatment at baseline, week 2 and week 6. Self-report outcome assessments are also collected. The primary aims of this study are to 1) determine immediate pre to post changes in sensorimotor function as measured by postural sway following delivery of a single HVLA-SM or LVVA-SM treatment when compared to a sham treatment and 2) to determine changes from baseline to 2 weeks (4 treatments) of HVLA-SM or LVVA-SM compared to a sham treatment. Secondary aims include changes in response to sudden loads and lumbar repositioning accuracy at these endpoints, estimating sensorimotor function in the SM groups after 6 weeks of treatment, and exploring if changes in sensorimotor function are associated with changes in self-report outcome assessments. DISCUSSION: This study may provide clues to the sensorimotor mechanisms that explain observed functional deficits associated with LBP, as well as the mechanism of action of SM. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number of NCT00830596, registered on January 27, 2009. The first participant was allocated on 30 January 2009 and the final participant was allocated on 17 March 2011.

Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center.

OBJECTIVE: To describe recruitment and enrollment experiences of 2 low back pain (LBP) randomized controlled trials (RCTs). DESIGN: Descriptive report. SETTING: Chiropractic research center in the midwest United States that is not a fee-for-service clinic. PARTICIPANTS: Both trials enrolled participants with subacute or chronic LBP without neurologic signs who had not received spinal manipulative care during the previous month. For study 1 we screened 1940 potential participants to enroll 192 participants (89 women and 103 men), mean age 40.0 +/- 9.4 years (range, 21-54 years). For study 2 we screened 1849 potential participants to enroll 240 participants (105 women and 135 men) at least 55 years old (mean, 63.1 +/- 6.7 years). INTERVENTIONS: Study 1 randomly assigned participants to 2 weeks of 2 different chiropractic techniques or a wait list control group. Study 2 randomly assigned participants to 6 weeks of 2 different chiropractic techniques or medical care consisting of 3 provider visits for medications. OUTCOME MEASURES: Recruitment source costs and yield, and baseline characteristics of enrolled versus nonparticipants were recorded. RESULTS: We conducted 3789 telephone screens for both trials to enroll 432 (11%) participants, at a cost in excess of $156,000 for recruitment efforts. The cost per call for all callers averaged $41, ranging from $4 to $300 based on recruitment method; for enrolled participants, the cost per call was $361, ranging from $33 to $750. Direct mail efforts accounted for 62% of all callers, 57% for enrolled participants, and had the second lowest cost per call for recruitment efforts. CONCLUSIONS: It is important that complementary and alternative medicine (CAM) research can be successfully conducted at CAM institutions. However, the costs associated with recruitment efforts for studies conducted at CAM institutions may be higher than expected and many self-identified participants are users of the CAM therapy. Therefore, strategies for efficient recruitment methods and targeting nonusers of CAM therapies should be developed early for CAM trials.