Biobehavior Life Regulation (BLR) scale for living well in chronic pain: Preliminary scale development and validation.

Currently available pain assessment scales focus on pain-related symptoms and limitations imposed by pain. Validated assessment tools that measure how pain is regulated by those who live well with pain are missing. This study seeks to fill this gap by describing the development and preliminary validation of the Biobehavior Life Regulation (BLR) scale. The BLR scale assesses engagement, social relatedness, and self-growth in the presence of chronic pain and the unpredictability of chronic pain. Sources for items included survivor strategies, patient experiences, existing scales, and unpredictable pain research. Review for suitability yielded 52 items. Validation measures were identified for engagement, social relatedness, self-growth, and unpredictability of pain. The study sample (n = 202) represented patients treated in the Phoenix VA Health Care System (n = 112) and two community clinics (n = 90). Demographic characteristics included average age of 52.5, heterogeneous in ethnicity and race at the VA, mainly Non-Hispanic White at the community clinics, 14 years of education, and pain duration of 18 years for the VA and 15.4 years for community clinics. Exploratory factor analysis using Oblimin rotation in the VA sample (n = 112) yielded a two-factor solution that accounted for 48.23% of the total variance. Confirmatory factor analysis (CFA) in the same sample showed high correlations among items in Factor 1, indicating redundancy and the need to further reduce items. The final CFA indicated a 2-factor solution with adequate fit to the data. The 2-factor CFA was replicated in Sample 2 from the community clinics (n = 90) with similarly adequate fit to the data. Factor 1, Pain Regulation, covered 8 items of engagement, social relatedness, and self-growth while Factor 2, Pain Unpredictability, covered 6 items related to the experience of unpredictable pain. Construct validity showed moderate to higher Pearson correlations between BLR subscales and relevant well-established constructs that were consistent across VA and community samples. The BLR scale assesses adaptive regulation strategies in unpredictable pain as a potential tool for evaluating regulation resources and pain unpredictability.

Didactic dissonance-embracing the tension between classroom and clinical education.

The United States is undergoing a transformation in the way pain is viewed and treated. This transformation affects pain education, as some degree of disconnect will be expected between what is taught in classroom settings and what learners observe in clinical settings. We term this disconnect "didactic dissonance" and propose a novel process to harness it as a learning tool to further pain education. Based on principles of transformative learning theory, we describe a structured, three-step process beginning with (1) priming learners to recognize didactic dissonance and identify specific examples from their education, followed by (2) encouraging learners to search the primary literature to resolve observed dissonance and reflect on the system factors that created and perpetuated the disconnect, and then (3) providing an opportunity for learner reflection and planning for how they will address similar situations in future practice and teaching environments. Fostering an environment conducive to learning-through modeling the intellectual virtues of curiosity, humility, and creativity-is a critical task for educators when implementing this process. Recognizing challenges faced by educators in both classroom and clinical settings, it may be a more feasible first step to integrate the concept of didactic dissonance into existing curricular elements. For programs able to implement the full three-step process, a discussion guide along with an example of a facilitated discussion have been provided. While proposed in the context of pain education, this transformational approach can be utilized across all topics in medical education to foster autonomous lifelong learning.

Flipping the hidden curriculum to transform pain education and culture.

Though long-sought, transformation of pain management practice and culture has yet to be realized. We propose both a likely cause-entrenchment in a biomedical model of care that is observed and then replicated by trainees-and a solution: deliberately leveraging the hidden curriculum to instead implement a sociopsychobiological (SPB) model of care. We make use of Implicit Bias Recognition and Management, a tool that helps teams to first recognize and "surface" whatever is implicit and to subsequently intervene to change whatever is found to be lacking. We describe how a practice might use iterations of recognition and intervention to move from a biomedical to a SPB model by providing examples from the Chronic Pain Wellness Center in the Phoenix Veterans Affairs Health Care System. As pain management practitioners and educators collectively leverage the hidden curriculum to provide care in the SPB model, we will not only positively transform our individual practices but also pain management as a whole.

Program Evaluation: exploring health disparities that impact chronic pain referrals within a VA Health Care System.

Introduction: The present Program Evaluation study examines sociodemographic characteristics of Veterans in the Phoenix VA Health Care System who have back pain, and specifically the likelihood of those characteristics being associated with a referral to the Chronic Pain Wellness Center (CPWC) in the year 2021. We examined the following characteristics: Race/ethnicity, gender, age, mental health diagnosis, substance use disorder diagnosis, and service-connected diagnosis. Methods: Our study used cross sectional data from the Corporate Data Warehouse for 2021. 13624 records had complete data for the variables of interest. Univariate and multivariate logistic regression was used to determine the likelihood of patients' being referred to the Chronic Pain Wellness Center. Results: The multivariate model found under-referral to be significant for younger adults and for patients who identified as Hispanic/Latinx, Black/African American, or Native American/Alaskan. Those with depressive disorders and opioid use disorders, on the other hand, were found to be more likely to be referred to the pain clinic. Other sociodemographic characteristics were not found to be significant. Discussion: Study limitations include the use of cross-sectional data, which cannot determine causality, and the inclusion of patients only if the ICD-10 codes of interest were recorded for an encounter in 2021 (i.e., a prior history of a particular diagnosis was not captured). In future efforts, we plan to examine, implement, and track the impact of interventions designed to mitigate these identified disparities in access to chronic pain specialty care.

Medication Use Evaluation of High-Dose Long-Term Opioid De-prescribing in Multiple Veterans Affairs Medical Centers.

BACKGROUND: The Opioid Safety Initiative (OSI) was implemented in 2013 to enhance the safe and appropriate use of opioids in the Veterans Health Administration (VA). Opioid use decreased nationally in subsequent years, but characterization of opioid de-prescribing practices has not been well established. OBJECTIVES: To describe changes in patient characteristics and patterns of de-prescribing since OSI implementation for opioid users at > 90 morphine equivalent daily dose for at least 90 days for those that discontinued opioids within the VA. DESIGN: Retrospective observational pre-post intervention medication use evaluation using VA data and electronic health records to identify differences in opioid de-prescribing between fiscal year 2013 (FY13; early OSI) and FY17 (late OSI). Reviewers' insights for local opioid management and de-prescribing practices collected through web-based post-data collection survey. PARTICIPANTS: Veterans prescribed high-dose long-term opioid therapy in FY13 and FY17 who subsequently discontinued opioids at 27 VA medical centers. MAIN MEASURES: Chart review data from local facility reviewers identified socioeconomic characteristics, opioid de-prescribing rationale (e.g., risk-benefit, diversion) and practices (e.g., rate of opioid discontinuation, taper monitoring activities, withdrawal monitoring), and outcomes following discontinuation. KEY RESULTS: Among 315 patients in FY13 and 322 patients in FY17 with opioid discontinuation, discontinuation rationale focused on diversion in FY13 and risk-benefit in FY17. Clinical pharmacists and pain management specialists had increased involvement in FY17 opioid discontinuations (36% versus 16%). Of all discontinuations, 56% of patients were tapered in FY13 versus 70% of patients in FY17. Tapering plans were longer in FY17 than in FY13 (163 days versus 65 days). Transitions to non-opioid pain therapy following opioid discontinuation were higher in FY17 compared to FY13 (70% versus 60%). CONCLUSIONS: Veterans discontinued from high-dose long-term opioids in FY17 were more optimally managed compared to those in FY13. Findings suggest improvements in opioid de-prescribing following OSI implementation, but interpretation is limited by study design.

Engagement in Prescription Opioid Tapering Research: the EMPOWER Study and a Coproduction Model of Success.

Patients with chronic pain experience stigma within the healthcare system. This stigma is compounded for those taking long-term prescription opioids. Often, public messaging and organizational policies have telegraphed that opioid treatment is a problem to be solved by focusing only on medication reduction efforts. Lack of data has contributed to misperceptions and poor opioid policies. In part, data collection remains poor because patients feel fractured from systems of care and are often not interested in engaging with opioid reduction mandates and research. Similarly, clinicians may fail to engage with opioid stewardship and research due to complexities that exceed their training or capacities. The EMPOWER study applies a coproduction model that engages researchers, patients, clinicians, managers, and other health system users. Key stakeholders shaped the design of the study to best ensure acceptability and engagement of the "end users"-patients who enroll in the study and the clinicians who implement the opioid tapers. Targeting the needs of any stakeholder group in isolation is suboptimal. Accordingly, we detail the EMPOWER patient-centered opioid tapering clinical research framework and specific strategies to address stakeholder concerns. We also discuss how this framework may be applied to enhance engagement in healthcare research broadly.

Mindfulness-based training for women veterans with chronic pain: A retrospective study.

The majority of women veterans experience chronic pain and many have comorbid posttraumatic stress disorder (PTSD). To enhance resilience in these veterans in terms of both physical functioning and psychosocial well-being, a mindfulness-based, trauma-informed, eight-session group pilot program was designed to target emotion regulation and social belonging. Women who engaged in treatment were asked to complete questionnaires assessing pain, functioning, and affective and social well-being before and after the program. The present retrospective research study evaluated (a) whether women who engaged in treatment showed pre-to-post treatment improvement in psychosocial and physical functioning and (b) whether women referred to the program who engaged versus did not engage in treatment differed in demographic and clinical data (i.e., pain diagnoses, mental health diagnoses, documented trauma history) obtained from medical record review. The sample consisted of 36 women who began the program and filled out a pregroup questionnaire (intent-to-treat sample; ITT) and 105 women who were referred but did not engage in treatment. The majority had a documented history of trauma, a mood disorder, and a PTSD diagnosis. ITT analyses indicated that veterans showed moderate-to-large pre-post improvements in pain severity, pain catastrophizing, physical functioning, depression, self-compassion, and positive affect. Veterans who engaged in treatment were similar to those who did not in demographics, number of pain diagnoses, and mental health diagnoses, but were more likely to have a documented history of trauma. Despite the limitations of this study, the findings are encouraging and point to the value of a future randomized controlled trial. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Implementation of the Arizona Pain and Addiction Curriculum: Findings and Implications From a Statewide Evaluation.

Purpose: The U.S. is struggling with dual crises of chronic pain and opioid overdoses. To improve statewide pain and addiction care, the Arizona Department of Health Services and 18 health education programs collaboratively created the evidence-based, comprehensive Arizona Pain and Addiction Curriculum which includes a Toolbox for Operationalization with adult learning theory applications and an annual program survey to assess curriculum implementation. The purpose of this study is to analyze the first year's survey data to better understand the implementation of a novel curriculum across all programs in the state. Materials and Methods: Program surveys were sent 6 months after curriculum publication to all 18 health education programs in Arizona to assess the 6 Ds of curriculum implementation: Degree of implementation, Difficulty of implementation, Delivery methods, Faculty Development, Didactic dissonance and Discussion Opportunities. Results: Responses from all program types (14/18 programs) indicated that there was widespread implementation of the curriculum, with 71% reporting that all ten Core Components had been included in the past academic year. The majority of programs did not find the Components difficult to implement and had implemented them through lectures. Seventy-seven percent of programs did not have a process to ensure clinical rotation supervisors are teaching content consistent with the curriculum, 77% reported not addressing student's didactic dissonance, and 77% of programs did not report asking students about their interactions with industry representatives. Conclusion: In < 1 year after creation of the Arizona Pain and Addiction Curriculum, all program types reported wide implementation with little difficulty. This may represent a first step toward the transformation of pain and addiction education, and occurred statewide, across program types. Further focus on didactic dissonance, problem solving and faculty development is indicated, along with systematic education on pharmaceutical and industry influence on learners. Other programs may benefit from adopting this curriculum and may not experience significant challenges in doing so.

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol.

Growing concerns about the safety of long-term opioid therapy and its uncertain efficacy for non-cancer pain have led to relatively rapid opioid deprescribing in chronic pain patients who have been taking opioid for years. To date, empirically supported processes for safe and effective opioid tapering are lacking. Opioid tapering programs have shown high rates of dropouts and increases in patient distress and suicidal ideation. Therefore, safe strategies for opioid deprescribing that are more likely to succeed are urgently needed. In response to this demand, the EMPOWER study has been launched to examine the effectiveness of behavioral medicine strategies within the context of patient-centered opioid tapering in outpatient settings (https://empower.stanford.edu/). The EMPOWER protocol requires an efficient process for ensuring that collaborative opioid tapering would be offered to the most appropriate patients while identifying patients who should be offered alternate treatment pathways. As a first step, clinicians need a screening tool to identify patients with Opioid Use Disorder (OUD) and to assess for OUD severity. Because such a tool is not available, the study team composed of eight chronic pain and/or addiction experts has extended a validated screening instrument to develop a brief and novel consensus screening tool to identify OUD and assess for OUD severity for treatment stratification. Our screening tool has the potential to assist busy outpatient clinicians to assess OUD among patients receiving long-term opioid therapy for chronic pain.

Adaptive Homeostatic Strategies of Resilient Intrinsic Self-Regulation in Extremes (RISE): A Randomized Controlled Trial of a Novel Behavioral Treatment for Chronic Pain.

Current treatments for chronic pain have limited benefit. We describe a resilience intervention for individuals with chronic pain which is based on a model of viewing chronic pain as dysregulated homeostasis and which seeks to restore homeostatic self-regulation using strategies exemplified by survivors of extreme environments. The intervention is expected to have broad effects on well-being and positive emotional health, to improve cognitive functions, and to reduce pain symptoms thus helping to transform the suffering of pain into self-growth. A total of 88 Veterans completed the pre-assessment and were randomly assigned to either the treatment intervention (n = 38) or control (n = 37). Fifty-eight Veterans completed pre- and post-testing (intervention n = 31, control = 27). The intervention covered resilience strengths organized into four modules: (1) engagement, (2) social relatedness, (3) transformation of pain and (4) building a good life. A broad set of standardized, well validated measures were used to assess three domains of functioning: health and well-being, symptoms, and cognitive functions. Two-way Analysis of Variance was used to detect group and time differences. Broadly, results indicated significant intervention and time effects across multiple domains: (1) Pain decreased in present severity [F ( 1, 56) = 5.02, p < 0.05, η2 p = 0.08], total pain over six domains [F ( 1, 56) = 14.52, p < 0.01, η2 p = 0.21], and pain interference [F ( 1, 56) = 6.82, p < 0.05, η2 p = 0.11]; (2) Affect improved in pain-related negative affect [F ( 1, 56) = 7.44, p < 0.01, η2 p = 0.12], fear [F ( 1, 56) = 7.70, p < 0.01, η2 p = 0.12], and distress [F ( 1, 56) = 10.87, p < 0.01, η2 p = 0.16]; (3) Well-being increased in pain mobility [F ( 1, 56) = 5.45, p < 0.05, η2 p = 0.09], vitality [F ( 1, 56) = 4.54, p < 0.05, η2 p = 0.07], and emotional well-being [F ( 1, 56) = 5.53, p < 0.05, η2 p = 0.09] Mental health symptoms and the cognitive functioning domain did not reveal significant effects. This resilience intervention based on homeostatic self-regulation and survival strategies of survivors of extreme external environments may provide additional sociopsychobiological tools for treating individuals with chronic pain that may extend beyond treating pain symptoms to improving emotional well-being and self-growth. Clinical Trial Registration: Registered with ClinicalTrials.gov (NCT04693728).

Active Long-term Care Strategies in a Group Setting for Chronic Spine Pain in 3 United States Military Veterans: A Case Series.

OBJECTIVE: The purpose of this article is to describe the management of chronic spine pain in 3 United States military veterans who participated in extended courses of chiropractic care that focused on active care strategies in a group setting. CLINICAL FEATURES: A 68-year old male veteran (case 1) with a 90% service-connected disability rating presented with chronic neck and lower back pain. An 82-year old male veteran (case 2) with a 20% service-connected disability rating presented with chronic neck and upper back pain. A 66-year old male veteran (case 3) presented with a 10% service-connected disability with chronic episodic back and neck pain. Each veteran described a desire to maintain ongoing chiropractic treatments after completion of a course of chiropractic care in which maximal therapeutic gain had been determined. Patient-Reported Outcomes Measurement Information System (PROMIS) Patient Interference Short Form 6b (PPI), PROMIS Physical Function Short Form 10b (PPF), and Pain, Enjoyment, and General Activity (PEG) outcome measurement tools were used to track response to care. INTERVENTIONS AND OUTCOME: Each veteran participated in an extended course of chiropractic visits consisting of group pain education, group cognitive behavioral strategies, group exercise, group mind-body self-regulation therapy, and optional individual manual therapy. Case 1 completed 8 extended chiropractic visits in 12 months and reported no change in PPI scores, improvement in PPF scores, and worsening PEG scores. Cases 2 and 3 completed 6 extended chiropractic visits each over a 12-month period and reported improvements in PPI, PPF, and PEG scores. CONCLUSION: This article describes the responses of 3 veterans with chronic spine pain participating in long-term care using chiropractic visits in a group setting that focused on active care strategies. Our group-based, active care approach differs from those described in literature, which commonly focus on visits with a strong emphasis on manual therapy in 1-on-1 patient encounters.

Increasing Access to Medications for Opioid Use Disorder and Complementary and Integrative Health Services in Primary Care.

OBJECTIVES: Evidence-based therapies for opioid use disorder (OUD) and chronic pain, such as medications for OUD (MOUD) and complementary and integrative health (CIH; e.g., acupuncture and meditation) therapies, exist. However, their adoption has been slow, particularly in primary care, due to numerous implementation challenges. We sought to expand the use of MOUD and CIH within primary care by using an evidence-based quality improvement (EBQI) implementation strategy. METHODS: We used EBQI to engage two facilities in the Veterans Health Administration (VHA) from June 2018 to September 2019. EBQI included multilevel stakeholder engagement, with external facilitators providing technical support, practice facilitation, and routine data feedback. We established a quality improvement (QI) team at each facility with diverse stakeholders (e.g., primary care, addiction, pain, nursing, pharmacy). We met monthly with regional stakeholders to address implementation barriers. We also convened an advisory board to ensure alignment with national priorities. RESULTS: Pre-implementation interviews indicated facility-level and provider-level barriers to prescribing buprenorphine, including strong primary care provider resistance. Both facilities developed action plans. They both conducted educational meetings (e.g., Grand Rounds, MOUD waiver trainings). Facility A also offered clinical preceptorships for newly trained primary care prescribers. Facility B used mass media and mailings to educate patients about MOUD and CIH options and dashboards to identify potential candidates for MOUD. After 15 months, both facilities increased their OUD treatment rates to the ≥ 90th percentile of VHA medical centers nationally. Exit interviews indicated an attitudinal shift in MOUD delivery in primary care. Stakeholders valued the EBQI process, particularly cross-site collaboration. IMPLICATIONS: Despite initial implementation barriers, we effectively engaged stakeholders using EBQI strategies. Local QI teams used an assortment of QI interventions and developed tools to catapult their facilities to among the highest performers in VHA OUD treatment. IMPACTS: EBQI is an effective strategy to partner with stakeholders to implement MOUD and CIH therapies.

Redefining Pain and Addiction: Creation of a Statewide Curriculum.

OBJECTIVES: In response to a declared statewide public health emergency due to opioid-related overdose deaths, the Arizona Department of Health Services guided the creation of a modern, statewide, evidence-based curriculum on pain and addiction that would be relevant for all health care provider types. METHODS: The Arizona Department of Health Services convened and facilitated 4 meetings during 4 months with a workgroup comprising the deans and curriculum representatives of all 18 medical, osteopathic, physician assistant, nurse practitioner, dental, podiatry, and naturopathic programs in Arizona. During this collaborative and iterative process, the workgroup reviewed existing curricula, established a philosophical framework, and developed a flexible and practical structure for a curriculum that would suit the needs of all program types. RESULTS: The Arizona Pain and Addiction Curriculum was finalized in June 2018. The curriculum aims to redefine pain and addiction as multidimensional public health issues and is structured as 10 core components, each supported by a detailed set of evidence-based objectives. The curriculum includes a set of annual metrics to collect from both programs (focused on implementation progress and barriers) and learners (focused on knowledge, attitudes, and practice plans). CONCLUSIONS: To our knowledge, this is the first example of a statewide collaboration among diverse health professional education programs to create a single, standard curriculum. This collaborative process and the nonproprietary Arizona Pain and Addiction Curriculum may serve as a useful template for other states to enhance pain and addiction education.

Flipping the Pain Care Model: A Sociopsychobiological Approach to High-Value Chronic Pain Care.

OBJECTIVE: Much of the pain care in the United States is costly and associated with limited benefits and significant harms, representing a crisis of value. We explore the current factors that lead to low-value pain care within the United States and provide an alternate model for pain care, as well as an implementation example for this model that is expected to produce high-value pain care. METHODS: From the perspective of aiming for high-value care (defined as care that maximizes clinical benefit while minimizing harm and cost), we describe the current evidence practice gap (EPG) for pain care in the United States, which has developed as current clinical care diverges from existing evidence. A discussion of the biomedical, biopsychosocial, and sociopsychobiological (SPB) models of pain care is used to elucidate the origins of the current EPG and the unconscious factors that perpetuate pain care systems despite poor results. RESULTS: An interprofessional pain team within the Veterans Health Administration is described as an example of a pain care system that has been designed to deliver high-value pain care and close the EPG by implementing the SPB model. CONCLUSIONS: Adopting and implementing a sociopsychobiological model may be an effective approach to address the current evidence practice gap and deliver high-value pain care in the United States. The Phoenix VA Health Care System's Chronic Pain Wellness Center may serve as a template for providing high-value, evidence-based pain care for patients with high-impact chronic pain who also have medical, mental health, and opioid use disorder comorbidities.

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.

OBJECTIVE: Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology. METHODS: EMPOWER applies patient-centered methods for voluntary prescription opioid reduction conducted within a comprehensive, multi-state, 3-arm randomized controlled comparative effectiveness study of three study arms (1) group cognitive behavioral therapy for chronic pain; (2) group chronic pain self-management; and (3) usual care (taper only). Specialized electronic data capture systems collect patient reported symptoms and satisfaction data weekly and monthly during the taper, with real-time clinical alerts and electronic feedback loops informing, documenting, and steering needed care actions. CONCLUSION: The EMPOWER study seeks to provide granular evidence on patient response to voluntary opioid tapering, and will provide evidence to inform clinical systems changes, clinical care, patient satisfaction, and patient outcomes for opioid reduction.

Making strides toward achieving the Triple Aim in the treatment of chronic low back pain with a biopsychosocial guided approach.

The Triple Aim is an effort to bring attention to improving the patient experience, improving population health and reducing healthcare costs. Chronic pain, particularly chronic low back pain, is a common disabling condition with high costs and burdens to society. The biopsychosocial model may provide a framework in which chronic low back pain may be viewed to guide new and emerging clinical care models to achieve the Triple Aim in this field of care.

Association of Spinal Manipulative Therapy With Clinical Benefit and Harm for Acute Low Back Pain: Systematic Review and Meta-analysis.

IMPORTANCE: Acute low back pain is common and spinal manipulative therapy (SMT) is a treatment option. Randomized clinical trials (RCTs) and meta-analyses have reported different conclusions about the effectiveness of SMT. OBJECTIVE: To systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. DATA SOURCES: Search of MEDLINE, Cochrane Database of Systematic Reviews, EMBASE, and Current Nursing and Allied Health Literature from January 1, 2011, through February 6, 2017, as well as identified systematic reviews and RCTs, for RCTs of adults with low back pain treated in ambulatory settings with SMT compared with sham or alternative treatments, and that measured pain or function outcomes for up to 6 weeks. Observational studies were included to assess harms. DATA EXTRACTION AND SYNTHESIS: Data extraction was done in duplicate. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. This tool has 11 items in the following domains: randomization, concealment, baseline differences, blinding (patient), blinding (care provider [care provider is a specific quality metric used by the CBN Risk of Bias tool]), blinding (outcome), co-interventions, compliance, dropouts, timing, and intention to treat. Prior research has shown the CBN Risk of Bias tool identifies studies at an increased risk of bias using a threshold of 5 or 6 as a summary score. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. MAIN OUTCOMES AND MEASURES: Pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks. FINDINGS: Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, -9.95 [95% CI, -15.6 to -4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, -0.39 [95% CI, -0.71 to -0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT. CONCLUSIONS AND RELEVANCE: Among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.