A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy.

STUDY OBJECTIVE: To investigate the efficacy, safety, pharmacodynamics, and pharmacokinetics of liposomal bupivacaine (LB) administered via ultrasound-guided sciatic nerve block in the popliteal fossa in participants undergoing bunionectomy. DESIGN: Two-part, randomized, double-blind, active-controlled trial (NCT05157841). SETTING: Operating room, postanesthesia care unit, and health care facility (6 sites). PATIENTS: Adults with American Society of Anesthesiologists physical status classification ≤3 and body mass index ≥18 to <40 kg/m2 undergoing elective distal metaphyseal osteotomy. INTERVENTIONS: Part A participants were randomized 1:1:1 to LB 266 mg, LB 133 mg, or bupivacaine hydrochloride 50 mg (BUPI). Part B participants were randomized 1:1 to LB (at the dose established by part A) or BUPI. MEASUREMENTS: The primary endpoint was area under the curve (AUC) of numerical rating scale (NRS) pain intensity scores 0-96 h after surgery. Secondary endpoints included total postsurgical opioid consumption, opioid-free status 0-96 h after surgery, and pharmacokinetic endpoints. MAIN RESULTS: Part A enrolled 22 participants per group. In part B, additional participants were randomized to LB 133 mg (n = 59) and BUPI (n = 60) (185 total). LB 133 mg had significant reductions versus BUPI in the AUC of NRS pain intensity score (least squares mean [LSM], 207.4 vs 371.4; P < 0.00001) and total opioid consumption 0-96 h after surgery (LSM, 17.7 [95% confidence interval (CI), 13.7, 22.8] morphine milligram equivalents [MMEs] vs 45.3 [95% CI, 35.1, 58.5] MMEs; P < 0.00001) and an increased proportion of opioid-free participants (24.4% vs 6%; odds ratio, 5.04 [95% CI, 2.01, 12.62]; P = 0.0003) in parts A + B. Adverse events were similar across groups. CONCLUSIONS: LB 133 mg administered via sciatic nerve block in the popliteal fossa after bunionectomy demonstrated superior and long-lasting postsurgical pain control versus BUPI. The clinical relevance of these findings is supported by concurrent reductions in pain and opioid consumption over 4 days after surgery and a significantly greater percentage of participants remaining opioid-free.

Comprehensive Assessment of Implementation Factors Related to Worksite Exercise in Firefighters.

OBJECTIVE: This study sought to identify key implementation factors to a 12-month worksite exercise intervention in career firefighters. METHODS: Implementation factors related to the hybrid type 1 effectiveness-implementation trial were assessed by exercise adherence, implementation questionnaires, focus groups, and observations from stakeholders. RESULTS: The primary identified implementation themes spanned intrapersonal, interpersonal, and institutional factors including: 1. Time and desire to exercise on shift; 2. Financial incentives to exercise; 3. Structured fitness programs; 4. Group competition, cohesion, and camaraderie; 5. Leadership engagement and support; and 6. Health, fitness, and occupational preparedness benefits. CONCLUSIONS: Future worksite exercise programs should address the barriers and facilitators identified herein and consider utilizing a hybrid delivery approach combining supervised and telehealth exercise interventions to optimize enthusiasm, adherence and improve safety and health.

Comparison of Supervised and Telehealth Delivery of Worksite Exercise for Prevention of Low Back Pain in Firefighters: A Cluster Randomized Trial.

OBJECTIVE: This study assessed worksite exercise delivered by on-site supervision (supervised) or telehealth to reduce lost work time (LWT) related to low back pain (LBP) in firefighters. METHODS: A cluster randomized controlled trial assigned 264 career firefighters to supervised (n = 86) or telehealth (n = 95) back and core exercises 2×/week for 12 months, or control (n = 83). RESULTS: 58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = 5, telehealth n = 5). Participants in the control group experienced 1.15 times as many hours of LWT as the supervised group, and 5.51 times as many hours of LWT as the telehealth group. CONCLUSIONS: Worksite exercise, delivered by on-site supervision or telehealth, can reduce LWT related to LBP in career firefighters.

The Global Spine Care Initiative: resources to implement a spine care program.

PURPOSE: The purpose of this report is to describe the development of a list of resources necessary to implement a model of care for the management of spine-related concerns anywhere in the world, but especially in underserved communities and low- and middle-income countries. METHODS: Contents from the Global Spine Care Initiative (GSCI) Classification System and GSCI care pathway papers provided a foundation for the resources list. A seed document was developed that included resources for spine care that could be delivered in primary, secondary and tertiary settings, as well as resources needed for self-care and community-based settings for a wide variety of spine concerns (e.g., back and neck pain, deformity, spine injury, neurological conditions, pathology and spinal diseases). An iterative expert consensus process was used using electronic surveys. RESULTS: Thirty-five experts completed the process. An iterative consensus process was used through an electronic survey. A consensus was reached after two rounds. The checklist of resources included the following categories: healthcare provider knowledge and skills, materials and equipment, human resources, facilities and infrastructure. The list identifies resources needed to implement a spine care program in any community, which are based upon spine care needs. CONCLUSION: To our knowledge, this is the first international and interprofessional attempt to develop a list of resources needed to deliver care in an evidence-based care pathway for the management of people presenting with spine-related concerns. This resource list needs to be field tested in a variety of communities with different resource capacities to verify its utility. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: model of care and implementation.

PURPOSE: Spine-related disorders are a leading cause of global disability and are a burden on society and to public health. Currently, there is no comprehensive, evidence-based model of care for spine-related disorders, which includes back and neck pain, deformity, spine injury, neurological conditions, spinal diseases, and pathology, that could be applied in global health care settings. The purposes of this paper are to propose: (1) principles to transform the delivery of spine care; (2) an evidence-based model that could be applied globally; and (3) implementation suggestions. METHODS: The Global Spine Care Initiative (GSCI) meetings and literature reviews were synthesized into a seed document and distributed to spine care experts. After three rounds of a modified Delphi process, all participants reached consensus on the final model of care and implementation steps. RESULTS: Sixty-six experts representing 24 countries participated. The GSCI model of care has eight core principles: person-centered, people-centered, biopsychosocial, proactive, evidence-based, integrative, collaborative, and self-sustaining. The model of care includes a classification system and care pathway, levels of care, and a focus on the patient's journey. The six steps for implementation are initiation and preparation; assessment of the current situation; planning and designing solutions; implementation; assessment and evaluation of program; and sustain program and scale up. CONCLUSION: The GSCI proposes an evidence-based, practical, sustainable, and scalable model of care representing eight core principles with a six-step implementation plan. The aim of this model is to help transform spine care globally, especially in low- and middle-income countries and underserved communities. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: classification system for spine-related concerns.

PURPOSE: The purpose of this report is to describe the development of a classification system that would apply to anyone with a spine-related concern and that can be used in an evidence-based spine care pathway. METHODS: Existing classification systems for spinal disorders were assembled. A seed document was developed through round-table discussions followed by a modified Delphi process. International and interprofessional clinicians and scientists with expertise in spine-related conditions were invited to participate. RESULTS: Thirty-six experts from 15 countries participated. After the second round, there was 95% agreement of the proposed classification system. The six major classifications included: no or minimal symptoms (class 0); mild symptoms (i.e., neck or back pain) but no interference with activities (class I); moderate or severe symptoms with interference of activities (class II); spine-related neurological signs or symptoms (class III); severe bony spine deformity, trauma or pathology (class IV); and spine-related symptoms or destructive lesions associated with systemic pathology (class V). Subclasses for each major class included chronicity and severity when different interventions were anticipated or recommended. CONCLUSIONS: An international and interprofessional group developed a comprehensive classification system for all potential presentations of people who may seek care or advice at a spine care program. This classification can be used in the development of a spine care pathway, in clinical practice, and for research purposes. This classification needs to be tested for validity, reliability, and consistency among clinicians from different specialties and in different communities and cultures. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: methodology, contributors, and disclosures.

PURPOSE: The purpose of this report is to describe the Global Spine Care Initiative (GSCI) contributors, disclosures, and methods for reporting transparency on the development of the recommendations. METHODS: World Spine Care convened the GSCI to develop an evidence-based, practical, and sustainable healthcare model for spinal care. The initiative aims to improve the management, prevention, and public health for spine-related disorders worldwide; thus, global representation was essential. A series of meetings established the initiative's mission and goals. Electronic surveys collected contributorship and demographic information, and experiences with spinal conditions to better understand perceptions and potential biases that were contributing to the model of care. RESULTS: Sixty-eight clinicians and scientists participated in the deliberations and are authors of one or more of the GSCI articles. Of these experts, 57 reported providing spine care in 34 countries, (i.e., low-, middle-, and high-income countries, as well as underserved communities in high-income countries.) The majority reported personally experiencing or having a close family member with one or more spinal concerns including: spine-related trauma or injury, spinal problems that required emergency or surgical intervention, spinal pain referred from non-spine sources, spinal deformity, spinal pathology or disease, neurological problems, and/or mild, moderate, or severe back or neck pain. There were no substantial reported conflicts of interest. CONCLUSION: The GSCI participants have broad professional experience and wide international distribution with no discipline dominating the deliberations. The GSCI believes this set of papers has the potential to inform and improve spine care globally. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: World Spine Care executive summary on reducing spine-related disability in low- and middle-income communities.

PURPOSE: Spinal disorders, including back and neck pain, are major causes of disability, economic hardship, and morbidity, especially in underserved communities and low- and middle-income countries. Currently, there is no model of care to address this issue. This paper provides an overview of the papers from the Global Spine Care Initiative (GSCI), which was convened to develop an evidence-based, practical, and sustainable, spinal healthcare model for communities around the world with various levels of resources. METHODS: Leading spine clinicians and scientists around the world were invited to participate. The interprofessional, international team consisted of 68 members from 24 countries, representing most disciplines that study or care for patients with spinal symptoms, including family physicians, spine surgeons, rheumatologists, chiropractors, physical therapists, epidemiologists, research methodologists, and other stakeholders. RESULTS: Literature reviews on the burden of spinal disorders and six categories of evidence-based interventions for spinal disorders (assessment, public health, psychosocial, noninvasive, invasive, and the management of osteoporosis) were completed. In addition, participants developed a stratification system for surgical intervention, a classification system for spinal disorders, an evidence-based care pathway, and lists of resources and recommendations to implement the GSCI model of care. CONCLUSION: The GSCI proposes an evidence-based model that is consistent with recent calls for action to reduce the global burden of spinal disorders. The model requires testing to determine feasibility. If it proves to be implementable, this model holds great promise to reduce the tremendous global burden of spinal disorders. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: care pathway for people with spine-related concerns.

PURPOSE: The purpose of this report is to describe the development of an evidence-based care pathway that can be implemented globally. METHODS: The Global Spine Care Initiative (GSCI) care pathway development team extracted interventions recommended for the management of spinal disorders from six GSCI articles that synthesized the available evidence from guidelines and relevant literature. Sixty-eight international and interprofessional clinicians and scientists with expertise in spine-related conditions were invited to participate. An iterative consensus process was used. RESULTS: After three rounds of review, 46 experts from 16 countries reached consensus for the care pathway that includes five decision steps: awareness, initial triage, provider assessment, interventions (e.g., non-invasive treatment; invasive treatment; psychological and social intervention; prevention and public health; specialty care and interprofessional management), and outcomes. The care pathway can be used to guide the management of patients with any spine-related concern (e.g., back and neck pain, deformity, spinal injury, neurological conditions, pathology, spinal diseases). The pathway is simple and can be incorporated into educational tools, decision-making trees, and electronic medical records. CONCLUSION: A care pathway for the management of individuals presenting with spine-related concerns includes evidence-based recommendations to guide health care providers in the management of common spinal disorders. The proposed pathway is person-centered and evidence-based. The acceptability and utility of this care pathway will need to be evaluated in various communities, especially in low- and middle-income countries, with different cultural background and resources. These slides can be retrieved under Electronic Supplementary Material.

The Global Spine Care Initiative: a systematic review for the assessment of spine-related complaints in populations with limited resources and in low- and middle-income communities.

PURPOSE: The purpose of this systematic literature review was to develop recommendations for the assessment of spine-related complaints in medically underserved areas with limited resources. METHODS: We conducted a systematic review and best evidence synthesis of guidelines on the assessment of spine-related complaints. Independent reviewers critically appraised eligible guidelines using the Appraisal of Guidelines for Research and Evaluation-II criteria. Low risk of bias clinical practice guidelines was used to develop recommendations. In accordance with the mandate of the Global Spinal Care Initiative (GSCI), recommendations were selected that could be applied to medically underserved areas and low- and middle-income countries by considering the limited access and costs of diagnostic technologies. RESULTS: We screened 3069 citations; 20 guidelines were eligible for critical appraisal. We used 13 that had a low risk of bias that targeted neck and back pain. CONCLUSIONS: When assessing patients with spine-related complaints in medically underserved areas and low- and middle-income countries, we recommend that clinicians should: (1) take a clinical history to determine signs or symptoms suggesting serious pathology (red flags) and psychological factors (yellow flags); (2) perform a physical examination (musculoskeletal and neurological); (3) do not routinely obtain diagnostic imaging; (4) obtain diagnostic imaging and/or laboratory tests when serious pathologies are suspected, and/or presence of progressive neurologic deficits, and/or disabling persistent pain; (5) do not perform electromyography or nerve conduction studies for diagnosis of intervertebral disc disease with radiculopathy; and (6) do not perform discography for the assessment of spinal disorders. This information can be used to inform the GSCI care pathway and model of care. These slides can be retrieved under Electronic Supplementary Material.

Global Forum: Spine Research and Training in Underserved, Low and Middle-Income, Culturally Unique Communities: The World Spine Care Charity Research Program's Challenges and Facilitators.

The World Spine Care (WSC), established by volunteers from 5 continents, is dedicated to providing sustainable, evidence-based spine care to individuals and communities in low and middle-income countries consistent with available health-care resources and integrated within the local culture. The research committee approves and oversees the WSC's collaborative research and training projects worldwide and serves to create a sustainable research community for underserved populations focused on preventing disability from spinal disorders. The purpose of this article is to describe 4 projects overseen by the WSC research committee and to discuss several challenges and specific facilitators that allowed successful completion of initiatives. These novel projects, which involved establishing spine surgery expertise and data collection in the WSC clinics and surrounding communities, all met their aims. This was achieved by overcoming language and resource challenges, adapting to local customs, and taking time to build mutual respect and to nurture relationships with local investigators and stakeholders.

In evidence-based medicine, more research is not always better .

Commentary On: Castro-Sánchez AM, Lara-Palomo IC, Matarán-Peñarrocha GA, Fernández-de-las-Peñas C, Saavedra-Hernández M, Cleland J, et al. Short-term effectiveness of spinal manipulative therapy versus functional technique in patients with chronic non-specific low back pain: a pragmatic randomized controlled trial. Spine J 2016:16:302-312 (in this issue).

A systematic review comparing the costs of chiropractic care to other interventions for spine pain in the United States.

BACKGROUND: Although chiropractors in the United States (US) have long suggested that their approach to managing spine pain is less costly than other health care providers (HCPs), it is unclear if available evidence supports this premise. METHODS: A systematic review was conducted using a comprehensive search strategy to uncover studies that compared health care costs for patients with any type of spine pain who received chiropractic care or care from other HCPs. Only studies conducted in the US and published in English between 1993 and 2015 were included. Health care costs were summarized for studies examining: 1. private health plans, 2. workers' compensation (WC) plans, and 3. clinical outcomes. The quality of studies in the latter group was evaluated using a Consensus on Health Economic Criteria (CHEC) list. RESULTS: The search uncovered 1276 citations and 25 eligible studies, including 12 from private health plans, 6 from WC plans, and 7 that examined clinical outcomes. Chiropractic care was most commonly compared to care from a medical physician, with few details about the care received. Heterogeneity was noted among studies in patient selection, definition of spine pain, scope of costs compared, study duration, and methods to estimate costs. Overall, cost comparison studies from private health plans and WC plans reported that health care costs were lower with chiropractic care. In studies that also examined clinical outcomes, there were few differences in efficacy between groups, and health care costs were higher for those receiving chiropractic care. The effects of adjusting for differences in sociodemographic, clinical, or other factors between study groups were unclear. CONCLUSIONS: Although cost comparison studies suggest that health care costs were generally lower among patients whose spine pain was managed with chiropractic care, the studies reviewed had many methodological limitations. Better research is needed to determine if these differences in health care costs were attributable to the type of HCP managing their care.

Commentary: we can tell where it hurts, but can we tell where the pain is coming from or where we should manipulate?

The shared decision making process has become increasingly important in the management of spinal disorders where there remains a variety of treatment options. Spinal manipulative therapy (SMT) is often recommended as a conservative option by evidence based clinical practice guidelines and a treatment modality frequently utilized by chiropractors and other clinicians who offer SMT to their patients. This article serves as a commentary to a review of the methods that are often used by chiropractors to determine the site for applying their manipulative intervention. Though it may be easy to criticize any review of this type of literature and point out shortcomings there are strong take away messages for the clinician interested in employing SMT as a part of their treatment protocol. Most notably, clinicians can be reassured that a history on the localization of pain, tissue palpation, provocative testing, range of motion testing and the demonstration by the patient of the locus and description of pain have reasonable consistency between observers. What this paper does not inform us on is the nature of the lesion causing the pain or where the manipulation should be applied to obtain the best outcome.

Shared decision making through informed consent in chiropractic management of low back pain.

OBJECTIVE: The purpose of this study was to propose questions that may be helpful to educate patients considering treatment approaches to manage low back pain (LBP) and to determine if the information currently presented in informed consent (IC) documents at chiropractic colleges is sufficient to help a patient considering chiropractic management of LBP make a fully informed decision. METHODS: Questions to inform decision making for a patient contemplating any intervention for LBP were developed by the authors based on their clinical and research experience. Answers to the questions were suggested based on findings from recent clinical practice guidelines and systematic reviews. Institutions that are members of the Association of Chiropractic Colleges (ACC) were surveyed and asked to provide a copy of the IC documents currently used in their outpatient educational clinics. The IC documents were analyzed to determine if they stated (or implied) information that may be helpful in addressing each of the proposed questions. RESULTS: The list of 20 questions included 4 questions on each of the following 5 topics: condition, proposed treatment, potential benefits, potential harms, and possible alternatives. A total of 21 ACC institutions were contacted, of which 20 responded. The number of questions that could potentially be answered with information provided in the IC documents ranged from 2 to 13, with a mean of 6.5, including a mean of 3.6 stated answers and 2.9 implied answers. CONCLUSIONS: Some information to help patients consider chiropractic management of LBP is currently included in the IC documents used in clinics of ACC institutions. However, many of the questions that could help achieve shared decision making are not included. Modifying IC documents may help patients understand the nature, benefits, harms, costs, and alternatives to LBP care.