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.

Characteristics of Chiropractic Patients in the Veterans Health Administration During the COVID-19 Pandemic: A Cross-Sectional Analysis.

OBJECTIVE: The purpose of this study was to determine whether patient characteristics were associated with face-to-face (F2F) and telehealth visits for those receiving chiropractic care for musculoskeletal conditions in the US Veterans Health Administration (VHA) during the COVID-19 pandemic. METHODS: A retrospective cross-sectional analysis of all patients (veterans, dependents, and spouses) who received chiropractic care nationwide at the VHA from March 1, 2020, to February 28, 2021, was performed. Patients were allocated into 1 of the following 3 groups: only telehealth visits, only F2F visits, and combined F2F and telehealth visits. Patient characteristics included age, sex, race, ethnicity, marital status, and Charlson Comorbidity Index. Multinomial logistic regression estimated associations of these variables with visit type. RESULTS: The total number of unique patients seen by chiropractors between March 2020 and February 2021 was 62 658. Key findings were that patients of non-White race and Hispanic or Latino ethnicity were more likely to attend telehealth-only visits (Black [odds ratio 1.20, 95% confidence interval {1.10-1.31}], other races [1.36 {1.16-1.59}], and Hispanic or Latino [1.35 {1.20-1.52}]) and combination telehealth and F2F care (Black [1.32 {1.25-1.40}], other races [1.37 {1.23-1.52}], and Hispanic or Latino [1.63 {1.51-1.76}]). Patients younger than 40 years of age were more likely to choose telehealth visits ([1.13 {1.02-1.26}], 66-75 years [1.17 {1.01-1.35}], and >75 years [1.26 {1.06-1.51}] vs those 40-55 years of age). Sex, visit frequency, and Charlson Comorbidity Index showed significant relationships as well, while marital status did not. CONCLUSION: During the COVID-19 pandemic, VHA patients with musculoskeletal complaints using chiropractic telehealth were more ethnically and racially diverse than those using F2F care alone.

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).

Risk of Treatment Escalation in Recipients vs Nonrecipients of Spinal Manipulation for Musculoskeletal Cervical Spine Disorders: An Analysis of Insurance Claims.

OBJECTIVE: The purpose of this study was to evaluate the relationship between treatment escalation and spinal manipulation in a retrospective cohort of people diagnosed with musculoskeletal disorders of the cervical spine. METHODS: We used retrospective analysis of insurance claims data (2012-2018) from a single Fortune 500 company. After isolating the first episode of care, we categorized 58 147 claims into 7951 unique patient episodes. Treatment escalation included claims where imaging, injection, emergency room, or surgery was present. Modified Poisson regression was used to determine the relative risk of treatment escalation comparing recipients vs nonrecipients of spinal manipulation, adjusted for age, sex, episode duration, and risk scores. RESULTS: The sample was 55% women, with a mean age of 44 years (range, 18-103). Treatment escalation was present in 42% of episodes overall: 2448 (46%) associated with other care and 876 (26%) associated with spinal manipulation. The estimated risk of any treatment escalation was 2.38 times higher in those who received other care than in those who received spinal manipulation (95% confidence interval, 2.22-2.55, P = .001). CONCLUSION: Among episodes of care associated with neck pain diagnoses, those associated with other care had twice the risk of any treatment escalation compared with those associated with spinal manipulation. In the United States, over 90% of spinal manipulation is provided by doctors of chiropractic; therefore, these findings are relevant and should be considered in addressing solutions for neck pain. Additional research investigating the factors influencing treatment escalation is necessary to moderate the use of high-cost and guideline-incongruent procedures in people with neck pain.

Characteristics and Practice Patterns of U.S. Veterans Health Administration Doctors of Chiropractic: A Cross-sectional Survey.

OBJECTIVE: The purpose of this study was to survey U.S. Veterans Health Administration (VA) chiropractors to assess current demographic and professional characteristics, including practice parameters, interprofessional collaboration, academic experience, and scholarly activity. METHODS: A cross-sectional survey was performed from August 21, 2019, to September 6, 2019, including all chiropractors identified with any VA appointment. REDCap software was used to conduct the survey. Data from surveys were exported to Microsoft Excel for data analysis. RESULTS: Of the 177 providers solicited, 118 returned completed surveys (67% response rate). Respondents predominantly self-reported as white (84%) and male (77.1%), with a mean age of 47 years, and reported spending at least 75% of time on clinical care. Most respondents reported being VA employees (96%) with full-time appointments (94%). Approximately half reported having prior hospital training (48%), supervising chiropractic students (53%) and students in other health professions (47%), and authoring or coauthoring ≥1 peer-reviewed publications (42%). Respondents reported performing an average of 6 to 15 new-patient consultations and 31 to 60 follow-up visits per week. Most patient referrals to chiropractic care originated from primary care providers, with low back conditions without radiculopathy as the most frequently seen condition. Diversified manipulation and flexion-distraction techniques, along with myofascial therapies, therapeutic exercises, and self-management advice, were the most commonly reported interventions. CONCLUSION: We report provider and practice characteristics from chiropractors working in a large, integrated health care system. Most are full-time employees, work in physical medicine departments, and have held their position for up to 5 years. The majority of respondents report diagnostic and treatment approaches concordant with current clinical practice guidelines.

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.

Changes in the Use of Telehealth and Face-To-Face Chiropractic Care in the Department of Veterans Affairs Before and After the COVID-19 Pandemic.

OBJECTIVE: The purpose of this study was to describe the use of face-to-face and telehealth chiropractic care in the U.S. Veterans Health Administration (VHA) before and after the declaration of the COVID-19 pandemic. METHODS: A cross-sectional study was performed of VHA administrative data, including monthly numbers of unique patients and visits for face-to-face and telehealth (synchronous video or telephone) chiropractic care from October 1, 2019, to March 31, 2021. RESULTS: During the pre-pandemic phase (October 2019 to February 2020), a mean of 28 930 (SD 289) total monthly visits were conducted face-to-face (99.9%). In March 2020, total monthly visits decreased to 17.0% of the pre-pandemic average, 25.0% being face-to-face, with over a 200-fold increase in telehealth visits (rising to 1331 visits) compared to the pre-pandemic average. April showed the lowest number of face-to-face visits at (4094). May-October 2020 showed that face-to-face visits increase on average by 70.7% per month, while telehealth visits averaged 17.3% per month. October-February 2020 had total monthly visits plateau at a mean of 22 250 (76.9% of the pre-pandemic average). Telehealth visits reduced to a mean of 1245 monthly visits over this 5-month period, a drop of -5.6% of the average of monthly visits. In March 2021, total monthly visits (31 221) exceeded the pre-pandemic average for the first time since January 2020; 4.0% remained in telehealth. CONCLUSION: Face-to-face visits decreased early in the pandemic but increased after May 2020. Chiropractic telehealth use rapidly increased during the early stage of the COVID-19 pandemic, and decreased later, but remained slightly higher than pre-pandemic levels.

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.

Promoting the use of self-management in novice chiropractors treating individuals with spine pain: the design of a theory-based knowledge translation intervention.

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

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.

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.

Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: a trial with adaptive allocation.

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

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.

Effect of spinal manipulation thrust magnitude on trunk mechanical activation thresholds of lateral thalamic neurons.

OBJECTIVES: High-velocity low-amplitude spinal manipulation (HVLA-SM), as performed by doctors who use manual therapy (eg, doctors of chiropractic and osteopathy), results in mechanical hypoalgesia in clinical settings. This hypoalgesic effect has previously been attributed to alterations in peripheral and/or central pain processing. The objective of this study was to determine whether thrust magnitude of a simulated HVLA-SM alters mechanical trunk response thresholds in wide dynamic range (WDR) and/or nociceptive specific (NS) lateral thalamic neurons. METHODS: Extracellular recordings were carried out in the thalamus of 15 anesthetized Wistar rats. Lateral thalamic neurons having receptive fields, which included the lumbar dorsal-lateral trunk, were characterized as either WDR (n=22) or NS (n=25). Response thresholds to electronic von Frey (rigid tip) mechanical trunk stimuli were determined in 3 directions (dorsal-ventral, 45° caudalward, and 45° cranialward) before and immediately after the dorsal-ventral delivery of a 100-millisecond HVLA-SM at 3 thrust magnitudes (control, 55%, 85% body weight). RESULTS: There was a significant difference in mechanical threshold between 85% body weight manipulation and control thrust magnitudes in the dorsal-ventral direction in NS neurons (P=.01). No changes were found in WDR neurons at either HVLA-SM thrust magnitude. CONCLUSIONS: This study is the first to investigate the effect of HVLA-SM thrust magnitude on WDR and NS lateral thalamic mechanical response threshold. Our data suggest that, at the single lateral thalamic neuron level, there may be a minimal spinal manipulative thrust magnitude required to elicit an increase in trunk mechanical response thresholds.

Neural responses to the mechanical parameters of a high-velocity, low-amplitude spinal manipulation: effect of preload parameters.

OBJECTIVE: The purpose of this study was to determine how the preload that precedes a high-velocity, low-amplitude spinal manipulation (HVLA-SM) affects muscle spindle input from lumbar paraspinal muscles both during and after the HVLA-SM. METHODS: Primary afferent activity from muscle spindles in lumbar paraspinal muscles were recorded from the L6 dorsal root in anesthetized cats. High-velocity, low-amplitude spinal manipulation of the L6 vertebra was preceded either by no preload or systematic changes in the preload magnitude, duration, and the presence or absence of a downward incisural point. Immediate effects of preload on muscle spindle responses to the HVLA-SM were determined by comparing mean instantaneous discharge frequencies (MIF) during the HVLA-SM's thrust phase with baseline. Longer lasting effects of preload on spindle responses to the HVLA-SM were determined by comparing MIF during slow ramp and hold movement of the L6 vertebra before and after the HVLA-SM. RESULTS: The smaller compared with the larger preload magnitude and the longer compared with the shorter preload duration significantly increased (P = .02 and P = .04, respectively) muscle spindle responses during the HVLA-SM thrust. The absence of preload had the greatest effect on the change in MIF. Interactions between preload magnitude, duration, and downward incisural point often produced statistically significant but arguably physiologically modest changes in the passive signaling properties of the muscle spindle after the manipulation. CONCLUSION: Because preload parameters in this animal model were shown to affect neural responses to an HVLA-SM, preload characteristics should be taken into consideration when judging this intervention's therapeutic benefit in both clinical efficacy studies and in clinical practice.