Developing an initial set of quality indicators for chiropractic care: a scoping review.

BACKGROUND: Quality indicators are standardized, evidence-based measures of health care quality. Currently, there is no basic set of quality indicators for chiropractic care published in peer-reviewed literature. The goal of this research is to develop a preliminary set of quality indicators, measurable with administrative data. METHODS: We conducted a scoping review searching PubMed/MEDLINE, CINAHL, and Index to Chiropractic Literature databases. Eligible articles were published after 2011, in English, developing/reporting best practices and clinical guidelines specifically developed for, or directly applicable to, chiropractic care. Eligible non-peer-reviewed sources such as quality measures published by the Centers for Medicare and Medicaid Services and the Royal College of Chiropractors quality standards were also included. Following a stepwise eligibility determination process, data abstraction identified specific statements from included sources that can conceivably be measured with administrative data. Once identified, statements were transformed into potential indicators by: 1) Generating a brief title and description; 2) Documenting a source; 3) Developing a metric; and 4) Assigning a Donabedian category (structure, process, outcome). Draft indicators then traversed a 5-step assessment: 1) Describes a narrowly defined structure, process, or outcome; 2) Quantitative data can conceivably be available; 3) Performance is achievable; 4) Metric is relevant; 5) Data are obtainable within reasonable time limits. Indicators meeting all criteria were included in the final set. RESULTS: Literature searching revealed 2562 articles. After removing duplicates and conducting eligibility determination, 18 remained. Most were clinical guidelines (n = 10) and best practice recommendations (n = 6), with 1 consensus and 1 clinical standards development study. Data abstraction and transformation produced 204 draft quality indicators. Of those, 57 did not meet 1 or more assessment criteria. After removing duplicates, 70 distinct indicators remained. Most indicators matched the Donabedian category of process (n = 35), with 31 structure and 4 outcome indicators. No sources were identified to support indicator development from patient perspectives. CONCLUSIONS: This article proposes a preliminary set of 70 quality indicators for chiropractic care, theoretically measurable with administrative data and largely obtained from electronic health records. Future research should assess feasibility, achieve stakeholder consensus, develop additional indicators including those considering patient perspectives, and study relationships with clinical outcomes. TRIAL REGISTRATION: Open Science Framework, https://osf.io/t7kgm.

Health-Related Quality of Life Among United States Service Members with Low Back Pain Receiving Usual Care Plus Chiropractic Care vs Usual Care Alone: Secondary Outcomes of a Pragmatic Clinical Trial.

OBJECTIVE: This study examines Patient-Reported Outcome Measurement Information System (PROMIS®)-29 v1.0 outcomes of chiropractic care in a multi-site, pragmatic clinical trial and compares the PROMIS measures to: 1) worst pain intensity from a numerical pain rating 0-10 scale, 2) 24-item Roland-Morris Disability Questionnaire (RMDQ); and 3) global improvement (modified visual analog scale). DESIGN: A pragmatic, prospective, multisite, parallel-group comparative effectiveness clinical trial comparing usual medical care (UMC) with UMC plus chiropractic care (UMC+CC). SETTING: Three military treatment facilities. SUBJECTS: 750 active-duty military personnel with low back pain. METHODS: Linear mixed effects regression models estimated the treatment group differences. Coefficient of repeatability to estimate significant individual change. RESULTS: We found statistically significant mean group differences favoring UMC+CC for all PROMIS®-29 scales and the RMDQ score. Area under the curve estimates for global improvement for the PROMIS®-29 scales and the RMDQ, ranged from 0.79 to 0.83. CONCLUSIONS: Findings from this pre-planned secondary analysis demonstrate that chiropractic care impacts health-related quality of life beyond pain and pain-related disability. Further, comparable findings were found between the 24-item RMDQ and the PROMIS®-29 v1.0 briefer scales.

A systematic review of chiropractic care for fall prevention: rationale, state of the evidence, and recommendations for future research.

BACKGROUND: Falls in older adults are a significant and growing public health concern. There are multiple risk factors associated with falls that may be addressed within the scope of chiropractic training and licensure. Few attempts have been made to summarize existing evidence on multimodal chiropractic care and fall risk mitigation. Therefore, the broad purpose of this review was to summarize this research to date. BODY: Systematic review was conducted following PRISMA guidelines. Databases searched included PubMed, Embase, Cochrane Library, PEDro, and Index of Chiropractic Literature. Eligible study designs included randomized controlled trials (RCT), prospective non-randomized controlled, observational, and cross-over studies in which multimodal chiropractic care was the primary intervention and changes in gait, balance and/or falls were outcomes. Risk of bias was also assessed using the 8-item Cochrane Collaboration Tool. The original search yielded 889 articles; 21 met final eligibility including 10 RCTs. One study directly measured the frequency of falls (underpowered secondary outcome) while most studies assessed short-term measurements of gait and balance. The overall methodological quality of identified studies and findings were mixed, limiting interpretation regarding the potential impact of chiropractic care on fall risk to qualitative synthesis. CONCLUSION: Little high-quality research has been published to inform how multimodal chiropractic care can best address and positively influence fall prevention. We propose strategies for building an evidence base to inform the role of multimodal chiropractic care in fall prevention and outline recommendations for future research to fill current evidence gaps.

Multimodal chiropractic care for migraine: A pilot randomized controlled trial.

BACKGROUND: Spinal manipulation may reduce migraine frequency, but effects of multimodal chiropractic care on migraine frequency have not been evaluated. METHODS: We conducted a pilot randomized controlled trial comparing multimodal chiropractic care + enhanced usual care (MCC+) versus enhanced usual care alone (EUC) among adult women with episodic migraine. EUC was comprised of usual medical care and migraine education literature. MCC+ participants received 10 sessions of chiropractic care over 14 weeks. Primary aims evaluated feasibility of recruitment, retention, protocol adherence, and safety. Change in migraine days was a secondary aim. RESULTS: Of 422 patients screened, 61 were randomized over 20 months. Fifty-seven (93%) completed daily migraine logs during the intervention, 51 (84%) completed final follow-up, and 45 (74%) completed all assessments. Twenty-four of 29 MCC+ participants (83%) attended > 75% of the chiropractic sessions. Ninety-eight non-serious adverse events were reported by 26 participants (43%) with 39 events among 11 EUC participants and 59 events among 15 MCC+ participants. MCC+ participants experienced greater reductions in migraine days (-2.9 days for MCC+ vs. -1.0 days for EUC, difference = -1.9; 95% confidence interval: -3.5, -0.4). CONCLUSIONS: Pre-specified feasibility criteria were not met, but deficits were remediable. Preliminary data support a definitive trial of MCC+ for migraine. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov (NCT03177616).

Psychometric properties of chronic low back pain diagnostic classification systems: a systematic review.

OBJECTIVES: To identify and critically appraise studies evaluating psychometric properties of functionally oriented diagnostic classification systems for Non-Specific Chronic Low Back Pain (NS-CLBP). METHODS: This review employed methodology consistent with PRISMA guidelines. Electronic databases and journals: (PubMed, EMBASE, Cochrane, PEDro, CINAHL, Index to chiropractic literature, ProQuest, Physical Therapy, Journal of Physiotherapy, Canadian Physiotherapy and Physiotherapy Theory and Practice) were searched from inception until January 2020. Included studies evaluated the validity and reliability of NS-CLBP diagnostic classification systems in adults. Risk of bias was assessed using a Critical Appraisal Tool. RESULTS: Twenty-two studies were eligible: Five investigated inter-rater reliability, and 17 studies analyzed validity of O'Sullivan's classification system (OCS, n = 15), motor control impairment (MCI) test battery (n = 1), and Pain Behavior Assessment (PBA, n = 1). Evidence from multiple low risk of bias studies demonstrates that OCS has moderate to excellent inter-rater reliability (kappa > 0.4). Also, two low risk of bias studies support of OCS-MCI subcategory. Three tests within the MCI test battery show acceptable inter- and intra-rater reliability for clinical use (the "sitting knee extension," the "one leg stance," and the "pelvic tilt" tests). Evidence for the reliability and validity of the PBA is limited to one high bias risk study. CONCLUSIONS: Multiple low risk of bias studies demonstrate strong inter-rater reliability for OCS classification specifically OCS-MCI subcategory. Future studies with low risk of bias are needed to evaluate reliability and validity of the MCI test battery and the PBA.

Chiropractic Services and Diagnoses for Low Back Pain in 3 U.S. Department of Defense Military Treatment Facilities: A Secondary Analysis of a Pragmatic Clinical Trial.

OBJECTIVE: The purpose of this study was to describe the diagnoses and chiropractic services performed by doctors of chiropractic operating within 3 military treatment facilities for patients with low back pain (LBP). METHODS: This was a descriptive secondary analysis of a pragmatic clinical trial comparing usual medical care (UMC) plus chiropractic care to UMC alone for U.S. active-duty military personnel with LBP. Participants who were allocated to receive UMC plus 6 weeks of chiropractic care and who attended at least 1 chiropractic visit (n = 350; 1547 unique visits) were included in this analysis. International Classification of Diseases and Current Procedural Terminology codes were transcribed from chiropractic treatment paper forms. The number of participants receiving each diagnosis and service and the number of each service on unique visits was tabulated. Low back pain and co-occurring diagnoses were grouped into neuropathic, nociceptive, bone and/or joint, general pain, and nonallopathic lesions categories. Services were categorized as evaluation, active interventions, and passive interventions. RESULTS: The most reported pain diagnoses were lumbalgia (66.1%) and thoracic pain (6.6%). Most reported neuropathic pain diagnoses were sciatica (4.9%) and lumbosacral neuritis or radiculitis (2.9%). For the nociceptive pain, low back sprain and/or strain (15.8%) and lumbar facet syndrome (9.2%) were most common. Most reported diagnoses in the bone and/or joint category were intervertebral disc degeneration (8.6%) and spondylosis (6.0%). Tobacco use disorder (5.7%) was the most common in the other category. Chiropractic care was compromised of passive interventions (94%), with spinal manipulative therapy being the most common, active interventions (77%), with therapeutic exercise being most common, and a combination of passive and active interventions (72%). CONCLUSION: For the sample in this study, doctors of chiropractic within 3 military treatment facilities diagnosed, managed, and provided clinical evaluations for a range of LBP conditions. Although spinal manipulation was the most commonly used modality, chiropractic care included a multimodal approach, comprising of both active and passive interventions a majority of the time.

Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain.

BACKGROUND: Low back pain is a leading cause of disability in veterans. Chiropractic care is a well-integrated, nonpharmacological therapy in Veterans Affairs health care facilities, where doctors of chiropractic provide therapeutic interventions focused on the management of low back pain and other musculoskeletal conditions. However, important knowledge gaps remain regarding the effectiveness of chiropractic care in terms of the number and frequency of treatment visits needed for optimal outcomes in veterans with low back pain. DESIGN: This pragmatic, parallel-group randomized trial at four Veterans Affairs sites will include 766 veterans with chronic low back pain who are randomly allocated to a course of low-dose (one to five visits) or higher-dose (eight to 12 visits) chiropractic care for 10 weeks (Phase 1). After Phase 1, participants within each treatment arm will again be randomly allocated to receive either monthly chiropractic chronic pain management for 10 months or no scheduled chiropractic visits (Phase 2). Assessments will be collected electronically. The Roland Morris Disability Questionnaire will be the primary outcome for Phase 1 at week 10 and Phase 2 at week 52. SUMMARY: This trial will provide evidence to guide the chiropractic dose in an initial course of care and an extended-care approach for veterans with chronic low back pain. Accurate information on the effectiveness of different dosing regimens of chiropractic care can greatly assist health care facilities, including Veterans Affairs, in modeling the number of doctors of chiropractic that will best meet the needs of patients with chronic low back pain.

The Impact of Spinal Manipulation on Migraine Pain and Disability: A Systematic Review and Meta-Analysis.

BACKGROUND: Several small studies have suggested that spinal manipulation may be an effective treatment for reducing migraine pain and disability. We performed a systematic review and meta-analysis of published randomized clinical trials (RCTs) to evaluate the evidence regarding spinal manipulation as an alternative or integrative therapy in reducing migraine pain and disability. METHODS: PubMed and the Cochrane Library databases were searched for clinical trials that evaluated spinal manipulation and migraine-related outcomes through April 2017. Search terms included: migraine, spinal manipulation, manual therapy, chiropractic, and osteopathic. Meta-analytic methods were employed to estimate the effect sizes (Hedges' g) and heterogeneity (I2 ) for migraine days, pain, and disability. The methodological quality of retrieved studies was examined following the Cochrane Risk of Bias Tool. RESULTS: Our search identified 6 RCTs (pooled n = 677; range of n = 42-218) eligible for meta-analysis. Intervention duration ranged from 2 to 6 months; outcomes included measures of migraine days (primary outcome), migraine pain/intensity, and migraine disability. Methodological quality varied across the studies. For example, some studies received high or unclear bias scores for methodological features such as compliance, blinding, and completeness of outcome data. Due to high levels of heterogeneity when all 6 studies were included in the meta-analysis, the 1 RCT performed only among chronic migraineurs was excluded. Heterogeneity across the remaining studies was low. We observed that spinal manipulation reduced migraine days with an overall small effect size (Hedges' g = -0.35, 95% CI: -0.53, -0.16, P < .001) as well as migraine pain/intensity. CONCLUSIONS: Spinal manipulation may be an effective therapeutic technique to reduce migraine days and pain/intensity. However, given the limitations to studies included in this meta-analysis, we consider these results to be preliminary. Methodologically rigorous, large-scale RCTs are warranted to better inform the evidence base for spinal manipulation as a treatment for migraine.

Current Evidence for Diagnosis of Common Conditions Causing Low Back Pain: Systematic Review and Standardized Terminology Recommendations.

OBJECTIVE: The purpose of this systematic review is to evaluate and summarize current evidence for diagnosis of common conditions causing low back pain and to propose standardized terminology use. METHODS: A systematic review of the scientific literature was conducted from inception through December 2018. Electronic databases searched included PubMed, MEDLINE, CINAHL, Cochrane, and Index to Chiropractic Literature. Methodological quality was assessed with the Scottish Intercollegiate Guidelines Network checklists. RESULTS: Of the 3995 articles screened, 36 (8 systematic reviews and 28 individual studies) met final eligibility criteria. Diagnostic criteria for identifying likely discogenic, sacroiliac joint, and zygapophyseal (facet) joint pain are supported by clinical studies using injection-confirmed tissue provocation or anesthetic procedures. Diagnostic criteria for myofascial pain, sensitization (central and peripheral), and radicular pain are supported by expert consensus-level evidence. Criteria for radiculopathy and neurogenic claudication are supported by studies using combined expert-level consensus and imaging findings. CONCLUSION: The absence of high-quality, objective, gold-standard diagnostic methods limits the accuracy of current evidence-based criteria and results in few high-quality studies with a low risk of bias in patient selection and reference standard diagnosis. These limitations suggest practitioners should use evidence-based criteria to inform working diagnoses rather than definitive diagnoses for low back pain. To avoid the unnecessary complexity and confusion created by multiple overlapping and nonspecific terms, adopting International Association for the Study of Pain terminology and definitions is recommended.

Development of an Evidence-Based Practical Diagnostic Checklist and Corresponding Clinical Exam for Low Back Pain.

OBJECTIVE: The purpose of this study was to use scientific evidence to develop a practical diagnostic checklist and corresponding clinical exam for patients presenting with low back pain (LBP). METHODS: An iterative process was conducted to develop a diagnostic checklist and clinical exam for LBP using evidence-based diagnostic criteria. The checklist and exam were informed by a systematic review focused on summarizing current research evidence for office-based clinical evaluation of common conditions causing LBP. RESULTS: Diagnostic categories contained within the checklist and exam include nociceptive pain, neuropathic pain, and sensitization. Nociceptive pain subcategories include discogenic, myofascial, sacroiliac, and zygapophyseal (facet) joint pain. Neuropathic pain categories include neurogenic claudication, radicular pain, radiculopathy, and peripheral entrapment (piriformis and thoracolumbar syndrome). Sensitization contains 2 subtypes, central and peripheral sensitization. The diagnostic checklist contains individual diagnostic categories containing evidence-based criteria, applicable examination procedures, and checkboxes to record clinical findings. The checklist organizes and displays evidence for or against a working diagnosis. The checklist may help to ensure needed information is obtained from a patient interview and exam in a variety of primary spine care settings (eg, medical, chiropractic). CONCLUSION: The available evidence informs reasonable working diagnoses for many conditions causing or contributing to LBP. A practical diagnostic process including an exam and checklist is offered to guide clinical evaluation and demonstrate evidence for working diagnoses in clinical settings.

Development of a Clinical Decision Aid for Chiropractic Management of Common Conditions Causing Low Back Pain in Veterans: Results of a Consensus Process.

OBJECTIVE: The purpose of this study was to develop a clinical decision aid for chiropractic management of common conditions causing low back pain (LBP) in veterans receiving treatment in US Veterans Affairs (VA) health care facilities. METHODS: A consensus study using an online, modified Delphi technique and Research Electronic Data Capture web application was conducted among VA doctors of chiropractic. Investigators reviewed the scientific literature pertaining to diagnosis and treatment of nonsurgical, neuromusculoskeletal LBP. Thirty seed statements summarizing evidence for chiropractic management, a graphical stepped management tool outlining diagnosis-informed treatment approaches, and support materials were then reviewed by an expert advisory committee. Email notifications invited 113 VA chiropractic clinicians to participate as Delphi panelists. Panelists rated the appropriateness of the seed statements and the stepped process on a 1-to-9 scale using the RAND/University of California, Los Angeles methodology. Statements were accepted when both the median rating and 80% of all ratings occurred within the highly appropriate range. RESULTS: Thirty-nine panelists (74% male) with a mean (standard deviation) age of 46 (11) years and clinical experience of 17 (11) years participated in the study. Accepted statements addressed included (1) essential components of chiropractic care, (2) treatments for conditions causing or contributing to LBP, (3) spinal manipulation mechanisms, (4) descriptions and mechanisms of commonly used chiropractic interventions, and (5) a graphical stepped clinical management tool. CONCLUSION: This study group produced a chiropractic clinical decision aid for LBP management, which can be used to support evidence-based care decisions for veterans with LBP.

Interprofessional Attitudes and Interdisciplinary Practices for Older Adults With Back Pain Among Doctors of Chiropractic: A Descriptive Survey.

OBJECTIVE: The purpose of this study is to report on attitudes of doctors of chiropractic (DCs) toward integrative medicine and their self-reported interdisciplinary practices for older adults with back pain. METHODS: This descriptive survey was conducted with licensed DCs in a Midwestern community in the United States. Respondents completed a 53-item postal survey of demographics, practice characteristics, referral and co-management patterns, attitudes toward interdisciplinary practice, and the Integrative Medicine-30 Questionnaire (IM-30). Descriptive statistical analysis was performed. RESULTS: Fifty-seven DCs completed the survey (29% response). Geriatric-focused chiropractic practices were uncommon (<15%), although 56% reported that 25% to 49% of the patients treated each week were older adults. Respondents had a moderate orientation toward collaboration with other health care providers (IM-30 mean [standard deviation] 61.3 [11.5]). The IM-30 subscales placed DCs high on measures of integrative medicine safety; moderate on patient-centeredness, openness to working with other providers, and referral readiness; and low on learning from alternative paradigms. Doctors of chiropractic most referred older patients to neurologists, family physicians, massage therapists, orthopedists, and other chiropractors. Doctors of chiropractic reported the highest levels of co-management with family physicians, physical therapists, and massage therapists. Most DCs (92%) were confident in their own ability to manage back pain in older adults, with modest confidence expressed for treatments from professionals using manual therapies. Most (77%) responded that older patients would experience the most improvement if DCs collaborated with another chiropractor, rather than with medical professionals. CONCLUSION: Doctors of chiropractic in one geographic community are moderately oriented toward interprofessional practice with other health care providers for older adults with back pain. Follow-up studies in representative national and international samples are recommended.

Stakeholder expectations from the integration of chiropractic care into a rehabilitation setting: a qualitative study.

BACKGROUND: Few studies have investigated patient and provider expectations of chiropractic care, particularly in multidisciplinary settings. This qualitative study explored stakeholder expectations of adding a chiropractor to the healthcare team at a rehabilitation specialty hospital. METHODS: The research methodology was an organizational case study with an inpatient facility for persons recovering from complex neurological conditions serving as the setting. Sixty stakeholders, including patients, families, hospital staff, and administrators, were interviewed or participated in focus groups in June 2015. Semi-structured questions guided the interview sessions which were digitally audiorecorded and transcribed. Data were entered into a qualitative software program to conduct content analysis using an iterative approach to identify key themes. RESULTS: Expectations for the chiropractic program were mostly positive with themes consistently reported across stakeholder groups. The central domain, making progress, encompassed the organizational mission to empower patients to reach hospital discharge and return to life in the community. Higher order goals, characterized as achieving whole person healing, encompassed patients' quality of life, self-efficacy, and activities of daily living. Stakeholders expected the addition of chiropractic to help patients progress toward these goals by improving pain management and physical functioning. Pain management themes included pain intensity, medication use, and pain-related behaviors, while functional improvement themes included muscle tone, extremity function, and balance and mobility. In addition to these direct effects on clinical outcomes, stakeholders also expected indirect effects of chiropractic care on healthcare integration. This indirect effect was expected to increase patient participation in other providers' treatments leading to improved care for the patient across the team and facility-level outcomes such as decreased length of stay. CONCLUSIONS: Stakeholders expected the addition of chiropractic care to a rehabilitation specialty hospital to benefit patients through pain management and functional improvements leading to whole person healing. They also expected chiropractic to benefit the healthcare team by facilitating other therapies in pursuit of the hospital mission, that is, moving patients towards discharge. Understanding stakeholder expectations may allow providers to align current expectations with what may be reasonable, in an effort to achieve appropriate clinical outcomes and patient and staff satisfaction.

Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process.

OBJECTIVE: The purpose of this study was to develop an integrated care pathway for doctors of chiropractic, primary care providers, and mental health professionals who manage veterans with low back pain, with or without mental health comorbidity, within Department of Veterans Affairs health care facilities. METHODS: The research method used was a consensus process. A multidisciplinary investigative team reviewed clinical guidelines and Veterans Affairs pain and mental health initiatives to develop seed statements and care algorithms to guide chiropractic management and collaborative care of veterans with low back pain. A 5-member advisory committee approved initial recommendations. Veterans Affairs-based panelists (n = 58) evaluated the pathway via e-mail using a modified RAND/UCLA methodology. Consensus was defined as agreement by 80% of panelists. RESULTS: The modified Delphi process was conducted in July to December 2016. Most (93%) seed statements achieved consensus during the first round, with all statements reaching consensus after 2 rounds. The final care pathway addressed the topics of informed consent, clinical evaluation including history and examination, screening for red flags, documentation, diagnostic imaging, patient-reported outcomes, adverse event reporting, chiropractic treatment frequency and duration standards, tailored approaches to chiropractic care in veteran populations, and clinical presentation of common mental health conditions. Care algorithms outlined chiropractic case management and interprofessional collaboration and referrals between doctors of chiropractic and primary care and mental health providers. CONCLUSION: This study offers an integrative care pathway that includes chiropractic care for veterans with low back pain.

Patient-centered professional practice models for managing low back pain in older adults: a pilot randomized controlled trial.

BACKGROUND: Low back pain is a debilitating condition for older adults, who may seek healthcare from multiple providers. Few studies have evaluated impacts of different healthcare delivery models on back pain outcomes in this population. The purpose of this study was to compare clinical outcomes of older adults receiving back pain treatment under 3 professional practice models that included primary medical care with or without chiropractic care. METHODS: We conducted a pilot randomized controlled trial with 131 community-dwelling, ambulatory older adults with subacute or chronic low back pain. Participants were randomly allocated to 12 weeks of individualized primary medical care (Medical Care), concurrent medical and chiropractic care (Dual Care), or medical and chiropractic care with enhanced interprofessional collaboration (Shared Care). Primary outcomes were low back pain intensity rated on the numerical rating scale and back-related disability measured with the Roland-Morris Disability Questionnaire. Secondary outcomes included clinical measures, adverse events, and patient satisfaction. Statistical analyses included mixed-effects regression models and general estimating equations. RESULTS: At 12 weeks, participants in all three treatment groups reported improvements in mean average low back pain intensity [Shared Care: 1.8; 95% confidence interval (CI) 1.0 to 2.6; Dual Care: 3.0; 95% CI 2.3 to 3.8; Medical Care: 2.3; 95% CI 1.5 to 3.2)] and back-related disability (Shared Care: 2.8; 95% CI 1.6 to 4.0; Dual Care: 2.5; 95% CI 1.3 to 3.7; Medical Care: 1.5; 95% CI 0.2 to 2.8). No statistically significant differences were noted between the three groups on the primary measures. Participants in both models that included chiropractic reported significantly better perceived low back pain improvement, overall health and quality of life, and greater satisfaction with healthcare services than patients who received medical care alone. CONCLUSIONS: Professional practice models that included primary care and chiropractic care led to modest improvements in low back pain intensity and disability for older adults, with chiropractic-inclusive models resulting in better perceived improvement and patient satisfaction over the primary care model alone. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01312233 , 4 March 2011.

Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation.

BACKGROUND: Spinal manipulation (SM) is used commonly for treating low back pain (LBP). Spinal stiffness is routinely assessed by clinicians performing SM. Flexion-relaxation ratio (FRR) was shown to distinguish between LBP and healthy populations. The primary objective of this study was to examine the association of these two physiological variables with patient-reported pain intensity and disability in adults with chronic LBP (>12 weeks) receiving SM. METHODS: A single-arm trial provided 12 sessions of side-lying thrust SM in the lumbosacral region over 6 weeks. Inclusion criteria included 21-65 years old, Roland-Morris Disability Questionnaire (RMDQ) score ≥ 6 and numerical pain rating score ≥ 2. Spinal stiffness and FRR were assessed pre-treatment at baseline, after 2 weeks and after 6 weeks of treatment. Lumbar spine global stiffness (GS) were calculated from the force-displacement curves obtained using i) hand palpation, ii) a hand-held device, and iii) an automated indenter device. Lumbar FRR was assessed during trunk flexion-extension using surface electromyography. The primary outcomes were RMDQ and pain intensity measured by visual analog scale (VAS). Mixed-effects regression models were used to analyze the data. RESULTS: The mean age of the 82 participants was 45 years; 48% were female; and 84% reported LBP >1 year. The mean (standard deviation) baseline pain intensity and RMDQ were 46.1 (18.1) and 9.5 (4.3), respectively. The mean reduction (95% confidence interval) after 6 weeks in pain intensity and RMDQ were 20.1 mm (14.1 to 26.1) and 4.8 (3.7 to 5.8). There was a small change over time in the palpatory GS but not in the hand-held or automated GS, nor in FRR. The addition of each physiologic variable did not affect the model-estimated changes in VAS or RMDQ over time. There was no association seen between physiological variables and LBP intensity. Higher levels of hand-held GS at L3 and automated GS were significantly associated with higher levels of RMDQ (p = 0.02 and 0.03, respectively) and lower levels of flexion and extension FRR were significantly associated with higher levels of RMDQ (p = 0.02 and 0.008, respectively) across the 3 assessment time points. CONCLUSIONS: Improvement in pain and disability observed in study participants with chronic LBP was not associated with the measured GS or FRR. TRIAL REGISTRATION: NCT01670292 on clinicaltrials.gov, August 2, 2012.

Effect of Spinal Manipulation of Upper Cervical Vertebrae on Blood Pressure: Results of a Pilot Sham-Controlled Trial.

OBJECTIVE: The purpose of this pilot sham-controlled clinical trial was to estimate the treatment effect and safety of toggle recoil spinal manipulation for blood pressure management. METHODS: Fifty-one participants with prehypertension or stage 1 hypertension (systolic blood pressure ranging from 135 to 159 mm Hg or diastolic blood pressure ranging from 85 to 99 mm Hg) were allocated by an adaptive design to 2 treatments: toggle recoil spinal manipulation or a sham procedure. Participants were seen by a doctor of chiropractic twice weekly for 6 weeks and remained on their antihypertensive medications, as prescribed, throughout the trial. Blood pressure was assessed at baseline and after study visits 1, 6 (week 3), and 12 (week 6), with the primary end point at week 6. Analysis of covariance was used to compare mean blood pressure changes from baseline between groups at each end point, controlling for sex, age, body mass index, and baseline blood pressure. RESULTS: Adjusted mean change from baseline to week 6 was greater in the sham group (systolic, -4.2 mm Hg; diastolic, -1.6 mm Hg) than in the spinal manipulation group (systolic, 0.6 mm Hg; diastolic, 0.7 mm Hg), but the difference was not statistically significant. No serious and few adverse events were noted. CONCLUSIONS: Six weeks of toggle recoil spinal manipulation did not lower systolic or diastolic blood pressure when compared with a sham procedure. No serious adverse events from either treatment were reported. Our results do not support a larger clinical trial. Further research to understand the potential mechanisms of action involving upper cervical manipulation on blood pressure is warranted before additional clinical investigations are conducted.

Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain.

BACKGROUND: Low back pain (LBP) is a major health issue due to its high prevalence rate and socioeconomic cost. While spinal manipulation (SM) is recommended for LBP treatment by recently published clinical guidelines, the underlying therapeutic mechanisms remain unclear. Spinal stiffness is routinely examined and used in clinical decisions for SM delivery. It has also been explored as a predictor for clinical improvement. Flexion-relaxation phenomenon has been demonstrated to distinguish between LBP and healthy populations. The primary objective of the current study is to collect preliminary estimates of variability and effect size for the associations of these two physiological measures with patient-centered outcomes in chronic LBP patients. Additionally biomechanical characteristics of SM delivery are collected with the intention to explore the potential dose-response relationship between SM and LBP improvement. METHODS/DESIGN: This is a prospective, observational study applying side-lying, high velocity, low amplitude SM as treatment for patients with LBP over a course of 6 weeks. Approximately 80 participants will be enrolled if they present with chronic LBP of 1, 2 or 3 in Quebec Task Force Classification for spinal disorders, a Roland-Morris Disability Questionnaire (RMDQ) score ≥ 6, and persistent LBP ≥ 2 with a maximum ≥ 4 using numerical rating scale. Patient-centered outcomes include LBP using visual analog scale, RMDQ, and PROMIS-29. Lumbar spine stiffness is assessed using palpation, a hand-held instrumented device, and an automated device. Flexion-relaxation is assessed using surface electromyography at the third level of the lumbar spine. Biomechanical characteristics of SM are assessed using a self-reported, itemized description system, as well as advanced kinetic measures that will be applied to estimate forces and moments at the lumbar segment level targeted by SM. DISCUSSION: Beside alterations in material properties of the passive components of the spine, increased neuromuscular activity may also contribute to a stiffened spine. Examining changes in both spinal stiffness and flexion-relaxation along the course of the treatment provides an opportunity to understand if the therapeutic effect of SM is associated with its action on active and/or passive components of the spine. TRIAL REGISTRATION: NCT01670292 on clinicaltrials.gov.

Prevalence of radiographic findings in individuals with chronic low back pain screened for a randomized controlled trial: secondary analysis and clinical implications.

OBJECTIVE: The purpose of this study is to measure the prevalence of graded disc degeneration, spondylolisthesis, transitional segmentation, and the distribution of sacral slope in patients 21 to 65 years of age with chronic low back pain (CLBP). METHODS: This retrospective study analyzed 247 digital lumbar radiographic series obtained during a randomized controlled trial of chiropractic patients with CLBP. Chronic low back pain was defined as pain in the low back lasting 12 weeks or longer. Radiographic findings of disc degeneration, spondylolisthesis, and lumbosacral transitional segmentation were graded by 2 authors using established classification criteria. Sacral slope was measured with a digital tool contained within imaging software. RESULTS: Lumbosacral transitional segments graded I to IV (Castellvi classification) were present in 14% of cases. Lumbar disc degeneration was most prevalent at L3-4 (49%), followed by L4-5 (42%), L2-3 (41%), L5-S1 (37%), and L1-2 (29%). Isthmic spondylolisthesis was present in 5% of cases, with L5 the most common location. Degenerative spondylolisthesis demonstrated a prevalence of 18%, most commonly occurring at L4. The prevalence of degenerative spondylolisthesis was 51% for women aged 50 to 59 years and 24% for men in the same age range. CONCLUSIONS: Moderate-severe disc degeneration, multilevel disc narrowing, and degenerative spondylolisthesis were common in individuals with CLBP with age more than 40 years. Isthmic spondylolisthesis was not more prevalent than what has been reported in other populations. Transitional segmentation was identified in a minority of participants, with some of these exhibiting accessory joints or fusion. Mean sacral slope in individuals with CLBP was not substantially different from mean slopes reported in other populations.