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.

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.

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.

Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a qualitative study with veteran stakeholders from a pilot trial of multimodal chiropractic care.

BACKGROUND: Low back pain (LBP) is common among military veterans seeking treatment in Department of Veterans Affairs (VA) healthcare facilities. As chiropractic services within VA expand, well-designed pragmatic trials and implementation studies are needed to assess clinical effectiveness and program uptake. This study evaluated veteran stakeholder perceptions of the feasibility and acceptability of care delivery and research processes in a pilot trial of multimodal chiropractic care for chronic LBP. METHODS: The qualitative study was completed within a mixed-method, single-arm, pragmatic, pilot clinical trial of chiropractic care for LBP conducted in VA chiropractic clinics. Study coordinators completed semi-structured, in person or telephone interviews with veterans near the end of the 10-week trial. Interviews were audiorecorded and transcribed verbatim. Qualitative content analysis using a directed approach explored salient themes related to trial implementation and delivery of chiropractic services. RESULTS: Of 40 participants, 24 completed interviews (60% response; 67% male gender; mean age 51.7 years). Overall, participants considered the trial protocol and procedures feasible and reported that the chiropractic care and recruitment methods were acceptable. Findings were organized into 4 domains, 10 themes, and 21 subthemes. Chiropractic service delivery domain encompassed 3 themes/8 subthemes: scheduling process (limited clinic hours, scheduling future appointments, attendance barriers); treatment frequency (treatment sufficient for LBP complaint, more/less frequent treatments); and chiropractic clinic considerations (hire more chiropractors, including female chiropractors; chiropractic clinic environment; patient-centered treatment visits). Outcome measures domain comprised 3 themes/4 subthemes: questionnaire burden (low burden vs. time-consuming or repetitive); relevance (items relevant for LBP study); and timing and individualization of measures (questionnaire timing relative to symptoms, personalized approach to outcomes measures). The online data collection domain included 2 themes/4 subthemes: user concerns (little difficulty vs. form challenges, required computer skills); and technology issues (computer/internet access, junk mail). Clinical trial planning domain included 2 themes/5 subthemes: participant recruitment (altruistic service by veterans, awareness of chiropractic availability, financial compensation); and communication methods (preferences, potential barriers). CONCLUSIONS: This qualitative study highlighted veteran stakeholders' perceptions of VA-based chiropractic services and offered important suggestions for conducting a full-scale, veteran-focused, randomized trial of multimodal chiropractic care for chronic LBP in this clinical setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254719.

Care Outcomes for Chiropractic Outpatient Veterans (COCOV): a single-arm, pragmatic, pilot trial of multimodal chiropractic care for U.S. veterans with chronic low back pain.

BACKGROUND: Over 25% of veterans seeking care at U.S. Veterans Health Administration facilities have chronic low back pain (LBP), with high rates of mental health comorbidities. The primary objective of this study was to assess the feasibility of participant recruitment, retention, and electronic data collection to prepare for the subsequent randomized trial of multimodal chiropractic care for pain management of veterans with chronic low back pain. The secondary objectives were to estimate effect sizes and variability of the primary outcome and choose secondary outcomes for the full-scale trial. METHODS: This single-arm pilot trial enrolled 40 veterans with chronic LBP at one Veterans Health Administration facility for a 10-week course of pragmatic multimodal chiropractic care. Recruitment was by (1) provider referral, (2) invitational letter from the electronic health record pre-screening, and (3) standard direct recruitment. We administered patient-reported outcome assessments through an email link to REDCap, an electronic data capture platform, at baseline and 5 additional timepoints. Retention was tracked through adherence to the treatment plan and completion rates of outcome assessments. Descriptive statistics were calculated for baseline characteristics and outcome variables. RESULTS: We screened 91 veterans over 6 months to enroll our goal of 40 participants. Seventy percent were recruited through provider referrals. Mean age (range) was 53 (22-79) years and 23% were female; 95% had mental health comorbidities. The mean number of chiropractic visits was 4.5 (1-7). Participants adhered to their treatment plan, with exception of 3 who attended only their first visit. All participants completed assessments at the in-person baseline visit and 80% at the week 10 final endpoint. We had no issues administering assessments via REDCap. We observed clinically important improvements on the Roland-Morris Disability Questionnaire [mean change (SD): 3.6 (6.1)] and on PROMIS® pain interference [mean change (SD): 3.6 (5.6)], which will be our primary and key secondary outcome, respectively, for the full-scale trial. CONCLUSIONS: We demonstrated the feasibility of participant recruitment, retention, and electronic data collection for conducting a pragmatic clinical trial of chiropractic care in a Veterans Health Administration facility. Using the pilot data and lessons learned, we modified and refined a protocol for a full-scale, multisite, pragmatic, National Institutes of Health-funded randomized trial of multimodal chiropractic care for veterans with chronic LBP that began recruitment in February 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT03254719.

Educator's Learning Alignment Instrument (ELAI).

OBJECTIVE: To report the development and initial testing of a questionnaire designed to assess the concept of learning alignment within chiropractic college courses. METHODS: A 36-item questionnaire, Educator's Learning Alignment Instrument (ELAI), was created to evaluate how learning goals, course activities, and assessments align within a college course. Questionnaire development was informed by learning theories and tested using a 2-phased electronic survey mechanism among a chiropractic college faculty. Phase 1 included completing the ELAI for a currently implemented course. Phase 2 included questions about confidential reports generated from ELAI data. RESULTS: Thirty-one of 46 (67%) respondents completed an ELAI. Twelve (38%) participated in phase 2. Twenty-one (68%) courses demonstrated consistent learning focus across goals, activities, and assessments. Aggregate data from early, middle, and late chiropractic program courses revealed progressive shifts toward higher-level learning. Eighty-seven percent of courses contained 1 or more individual learning areas with potentially misaligned goals, activities, or assessment. Ninety-seven percent of respondents completed ELAI questions within 20 minutes. Most (87%) phase 2 respondents noted the report accurately reflected the course. Sixty-seven percent of phase 2 respondents agreed that confidential reports provided useful information to inform course design. CONCLUSION: The ELAI is a nonburdensome instrument that can facilitate faculty reflection on how aligned learning concepts are applied in a course and provide novel data to assess general learning focus within college courses and within programs. Results indicate ELAI questions can be revised to improve clarity. Additional research comparing ELAI responses from experts, peer educators, and students is recommended.

High-velocity, low-amplitude spinal manipulation training of prescribed forces and thrust duration: A pilot study.

OBJECTIVE: High-velocity, low-amplitude spinal manipulation (HVLA-SM) may generate different therapeutic effects depending on force and duration characteristics. Variability among clinicians suggests training to target specific thrust duration and force levels is necessary to standardize dosing. This pilot study assessed an HVLA-SM training program using prescribed force and thrust characteristics. METHODS: Over 4 weeks, chiropractors and students at a chiropractic college delivered thoracic region HVLA-SM to a prone mannequin in six training sessions, each 30 minutes in duration. Force plates embedded in a treatment table were used to measure force over time. Training goals were 350 and 550 Newtons (N) for peak force and ≤150 ms for thrust duration. Verbal and visual feedback was provided after each training thrust. Assessments included 10 consecutive thrusts for each force target without feedback. Mixed-model regression was used to analyze assessments measured before, immediately following, and 1, 4, and 8 weeks after training. RESULTS: Error from peak force target, expressed as adjusted mean constant error (standard deviation), went from 107 N (127) at baseline, to 0.2 N (41) immediately after training, and 32 N (53) 8 weeks after training for the 350 N target, and 63 N (148), -6 N (58), and 9 N (87) for the 550 N target. Student median values met thrust duration target, but doctors' were >150 ms immediately after training. CONCLUSION: After participation in an HVLA-SM training program, participants more accurately delivered two prescribed peak forces, but accuracy decreased 1 week afterwards. Future HVLA-SM training research should include follow-up of 1 week or more to assess skill retention.

Be good, communicate, and collaborate: a qualitative analysis of stakeholder perspectives on adding a chiropractor to the multidisciplinary rehabilitation team.

Background: While chiropractors are integrating into multidisciplinary settings with increasing frequency, the perceptions of medical providers and patients toward adding chiropractors to existing healthcare teams is not well-understood. This study explored the qualities preferred in a chiropractor by key stakeholders in a neurorehabilitation setting. Methods: This qualitative analysis was part of a multi-phase, organizational case study designed to evaluate the planned integration of a chiropractor into a multidisciplinary rehabilitation team. The setting was a 62-bed rehabilitation specialty hospital located in the northeastern United States. Participants included patients, families, community members, and professional staff of the administrative, medical, nursing, and therapy departments. Data collection consisted of audiotaped, individual interviews and profession-specific focus groups guided by a semi-structured interview schedule. Transcripts were imported into a qualitative data analysis program for data analysis. An iterative coding process using thematic content analysis categorized key themes and domains. Results: Sixty participants were interviewed in June 2015, including 48 staff members, 6 patients, 4 family members, and 2 community members. Our analysis generated a conceptual model of The Preferred Chiropractor for Multidisciplinary Rehabilitation Settings composed of 5 domains and 13 themes. The central domain, Patient-Centeredness, or the provision of healthcare that is respectful, responsive, and inclusive of the patient's values, preferences, and needs, was mentioned in all interviews and linked to all other themes. The Professional Qualities domain highlighted clinical acumen, efficacious treatment, and being a safe practitioner. Interpersonal Qualities encouraged chiropractors to offer patients their comforting patience, familiar connections, and emotional intelligence. Interprofessional Qualities emphasized teamwork, resourcefulness, and openness to feedback as characteristics to enhance the chiropractor's ability to work within an interdisciplinary setting. Organizational Qualities, including personality fit, institutional compliance, and mission alignment were important attributes for working in a specific healthcare organization. Conclusions: Our findings provide an expanded view of the qualities that chiropractors might bring to multidisciplinary healthcare settings. Rather than labeling stakeholder perceptions as good, bad or indifferent as in previous studies, these results highlight specific attributes chiropractors might cultivate to enhance the patient outcomes and the experience of healthcare, influence clinical decision-making and interprofessional teamwork, and impact healthcare organizations.