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.

Development of a low back pain care pathway in an academic hospital system: results of a consensus process.

BACKGROUND: Low back pain (LBP) is the leading cause of disability worldwide and a significant component of healthcare expenditures. Clinical practice guidelines (CPGs) have been highlighted as a key resource to improve the quality of care. This study aimed to develop a clinical pathway for LBP based on CPGs in an academic health system. METHODS: We conducted a modified Delphi study of clinicians caring for patients with LBP who were asked to rate 21 CPG-informed seed statements through an online survey. The goal was to identify statements that achieved a minimum of 80% consensus among panelists. RESULTS: Thirty-five healthcare providers participated as panelists. The majority of participants were male (68.6%), had MD or DO (62.9%) degrees, and were clinicians (73.8%) working in neurosurgery (36.1%), orthopedics (25.7%), emergency medicine (14.3%), or physical therapy (11.4%). Initially, consensus was reached on 20 of 21 seed statements. One statement did not reach consensus in the initial round and was revised into two separate statements based on feedback from panelists. One of these statements achieved consensus in the second review round. All statements reaching consensus were incorporated into a care pathway consisting of diagnosis, evaluation, and treatment for LBP. CONCLUSION: Healthcare providers across various disciplines supported statements interpreting current CPGs related to care for LBP. This study represents a step toward supporting guideline-concordant care for LBP. Additional research is needed to assess how such pathways impact actual clinical care.

Thoracolumbar fascia mobility and chronic low back pain: Phase 1 of a pilot and feasibility study assessing repeated measures and the influence of paraspinal muscle contraction.

BACKGROUND: Differential movement, or shear strain (SS), between layers of thoracolumbar fascia is reduced with chronic low back pain. To provide a foundation for clinical research involving SS, this study assessed temporal stability and the effect of paraspinal muscle contraction on SS in persons with chronic low back pain. METHODS: We used ultrasound imaging to measure SS in adults self-reporting low back pain ≥1 year. Images were obtained by placing a transducer 2-3 cm lateral to L2-3 with participants lying prone and relaxed on a table moving the lower extremities downward 15°, for 5 cycles at 0.5 Hz. To assess paraspinal muscle contraction effects, participants raised the head slightly from the table. SS was calculated using 2 computational methods. Method 1 averaged the maximum SS from each side during the third cycle. Method 2 used the maximum SS from any cycle (2-4) on each side, prior to averaging. SS was also assessed after a 4-week no manual therapy period. RESULTS: Of 30 participants (n = 14 female), mean age was 40 years; mean BMI 30.1. Mean (SE) SS in females with paraspinal muscle contraction was 66% (7.4) (method 1) and 78% (7.8) (method 2); 54% (6.9) (method 1) and 67% (7.3) (method 2) in males. With muscles relaxed, mean SS in females was 77% (7.6) (method 1) or 87% (6.8) (method 2); 63% (7.1) (method 1) and 78% (6.4) (method 2) in males. Mean SS decreased 8-13% in females and 7-13% in males after 4-weeks CONCLUSION: Mean SS in females was higher than males at each timepoint. Paraspinal muscle contraction temporarily reduced SS. Over a 4-week no-treatment period, mean SS (with paraspinal muscles relaxed) decreased. Methods less likely to induce muscle guarding and enabling assessment with broader populations are needed.

Intervention Fidelity in Pain Pragmatic Trials for Nonpharmacologic Pain Management: Nuanced Considerations for Determining PRECIS-2 Flexibility in Delivery and Adherence.

Nonpharmacological treatments are considered first-line pain management strategies, but they remain clinically underused. For years, pain-focused pragmatic clinical trials (PCTs) have generated evidence for the enhanced use of nonpharmacological interventions in routine clinical settings to help overcome implementation barriers. The Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2) framework describes the degree of pragmatism across 9 key domains. Among these, "flexibility in delivery" and "flexibility in adherence," address a key goal of pragmatic research by tailoring approaches to settings in which people receive routine care. However, to maintain scientific and ethical rigor, PCTs must ensure that flexibility features do not compromise delivery of interventions as designed, such that the results are ethically and scientifically sound. Key principles of achieving this balance include clear definitions of intervention core components, intervention monitoring and documentation that is sufficient but not overly burdensome, provider training that meets the demands of delivering an intervention in real-world settings, and use of an ethical lens to recognize and avoid potential trial futility when necessary and appropriate. PERSPECTIVE: This article presents nuances to be considered when applying the PRECIS-2 framework to describe pragmatic clinical trials. Trials must ensure that patient-centered treatment flexibility does not compromise delivery of interventions as designed, such that measurement and analysis of treatment effects is reliable.

Thoracolumbar fascia mobility and chronic low back pain: Phase 2 of a pilot and feasibility study including multimodal chiropractic care.

BACKGROUND: Thoracolumbar fascia mobility observed with ultrasound imaging and calculated as shear strain is lower in persons with chronic low back pain. This pilot and feasibility trial assessed thoracolumbar shear strain in persons with chronic low back pain following spinal manipulation and over an 8-week course of multimodal chiropractic care. METHODS: Adults self-reporting chronic low back pain ≥ 1 year participated between September 2019 and April 2021 in a trial using ultrasound imaging to measure thoracolumbar shear strain. Ultrasound imaging occurred 2-3 cm lateral to L2-3 while participants relaxed prone on an automated table moving the lower extremities downward 15 degrees, for 5 cycles at 0.5 Hz. Pain intensity on an 11-point numerical rating scale, disability, pain interference, and global improvement were also collected. Participants received 8-weeks of twice-weekly chiropractic care including spinal manipulation, education, exercise, self-management advice and myofascial therapies. Shear strain was computed using 2 methods. The highest shear strain from movement cycles 2, 3, or 4 was averaged over right and left sides for each participant. Alternately, the highest shear strain from movement cycle 3 was used. All data were analyzed over time using mixed-effects models. Estimated mean changes are reported. RESULTS: Of 20 participants completing 8-weeks of chiropractic care (female n = 11), mean (SD) age was 41 years (12.6); mean BMI was 28.5 (6.2). All clinical outcomes improved at 8-weeks. Mean (95% confidence interval) pain intensity decreased 2.7 points (- 4.1 to - 1.4) for females and 2.1 points (- 3.7 to 0.4) for males. Mean Roland-Morris disability score decreased by 5 points (- 7.2 to - 2.8) for females, 2.3 points (- 4.9 to 0.2) for males. Mean PROMIS pain interference T-score decreased by 8.7 points (- 11.8 to - 5.5) for females, 5.6 points (- 9.5 to - 1.6) for males. Mean shear strain at 8-weeks increased in females 5.4% (- 9.9 to 20.8) or 15% (- 0.5 to 30.6), decreasing in males 6.0% (- 24.2 to 12.2) or 2% (- 21.0 to 16.8) depending on computational method. CONCLUSION: Spinal manipulation does not likely disrupt adhesions or relax paraspinal muscles enough to immediately affect shear strain. Clinical outcomes improved in both groups, however, shear strain only increased in females following 8-weeks of multimodal chiropractic care. Trial registration ClinicalTrials.gov registration is NCT03916705.

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.

Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems.

Introduction: Pragmatic clinical trials (PCTs) can overcome implementation challenges for bringing evidence-based therapies to people living with pain and co-occurring conditions, providing actionable information for patients, providers, health systems, and policy makers. All studies, including those conducted within health systems that have a history of advancing equitable care, should make efforts to address justice and equity. Methods: Drawing from collective experience within pragmatic pain clinical trials networks, and synthesizing relevant literature, our multidisciplinary working group examined challenges related to integrating justice and equity into pragmatic pain management research conducted in large, integrated health systems. Our analysis draws from military and veteran health system contexts but offers strategies to consider throughout the lifecycle of pragmatic research more widely. Results: We found that PCTs present a unique opportunity to address major influences on health inequities by occupying a space between research, healthcare delivery, and the complexities of everyday life. We highlight key challenges that require attention to support complementary advancement of justice and equity via pragmatic research, offering several strategies that can be pursued. Conclusions: Efforts are needed to engage diverse stakeholders broadly and creatively in PCTs, such as through dedicated health equity working groups and other collaborative relationships with stakeholders, to support robust and inclusive approaches to research design and implementation across study settings. These considerations, while essential to pain management research, offer important opportunities toward achieving more equitable healthcare and health systems to benefit people living with pain and co-occurring conditions.

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.

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.

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.

Learning the neurobiology of pain: A scoping review of pain education from an instructional design perspective.

OBJECTIVES: Learning modern pain biology concepts can improve important clinical outcomes for people with chronic pain. The primary purpose of this scoping review is to examine and report characteristics of chronic musculoskeletal pain education programs from an instructional design perspective. METHODS: Following PRISMA-ScR guidelines, PubMed, Medline, and CINAHL databases were systematically searched. Articles included expert recommendations and those reporting pain education programs used in clinical trials enrolling adults with chronic neuromusculoskeletal pain and published in English between 1990 and 2021. Three authors independently evaluated articles for eligibility through title, abstract, and full text review. Instructional design characteristics such as learning outcomes, support materials, learning assessment methods, and key concepts communicated were summarized. RESULTS: The search revealed 5260 articles of which 40 were included: 27 clinical studies, 7 expert recommendations, and 6 articles reporting on pain education from participant perspectives. Detailed reporting of instructional design characteristics informing replication in subsequent studies is sparse. Most included trials used only lecture and did not assess participant learning. CONCLUSIONS: More comprehensive reporting of pain education programs is needed to facilitate replicability. PRACTICAL IMPLICATIONS: This article proposes detailed and standardized reporting of trials using pain education programs employing a modified version of the TIDieR checklist.

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.

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.

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).

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.

Effects of Chiropractic Care on Strength, Balance, and Endurance in Active-Duty U.S. Military Personnel with Low Back Pain: A Randomized Controlled Trial.

Objectives: To investigate whether chiropractic care influences strength, balance, and/or endurance in active-duty United States military personnel with low back pain (LBP). Design: This study employed a prospective randomized controlled trial using a pragmatic treatment approach. Participants were randomly allocated to 4 weeks of chiropractic care or to a wait-list control. Interventions: Chiropractic care consisted of spinal manipulation, education, advice, and reassurance. Settings/Location: Naval Air Technical Training Center branch clinic at the Naval Hospital Pensacola Florida. Subjects: One hundred ten active-duty military personnel 18-40 years of age with self-reported LBP. Outcome measures: Isometric pulling strength from a semisquat position was the primary outcome. Secondary outcomes were single-leg balance with eyes open and eyes closed, and trunk muscle endurance using the Biering-Sorensen test. Patient-reported outcomes such as pain severity and disability were also measured. Outcomes were measured at baseline and 4 weeks. Linear mixed-effects regression models over baseline and 4 weeks were used for analysis. Results: Participants had mean age of 30 years (18-40), 17% were female, 33% were non-white, and 86% reported chronic LBP. Mean maximum pulling strength in the chiropractic group increased by 5.08 kgs and decreased by 7.43 kgs in the wait-list group, with a statistically significant difference in mean change between groups (p = 0.003). Statistically significant differences in mean change between groups were also observed in trunk muscle endurance (13.9 sec, p = 0.002) and balance with eyes closed (0.47 sec, p = 0.01), but not in balance with eyes open (1.19 sec, p = 0.43). Differences in mean change between groups were statistically significant in favor of chiropractic for LBP-related disability, pain intensity and interference, and fear-avoidance behavior. Conclusions: Active-duty military personnel receiving chiropractic care exhibited improved strength and endurance, as well as reduced LBP intensity and disability, compared with a wait-list control.

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.