How well do participants in clinical trials represent the U.S. population with chronic neck or back pain?

BACKGROUND: Randomized clinical trials (RCTs) are the gold standard for assessing treatment effectiveness; however, they have been criticized for generalizability issues such as how well trial participants represent those who receive the treatments in clinical practice. We assessed the representativeness of participants from eight RCTs for chronic spine pain in the U.S., which were used for an individual participant data meta-analysis on the cost-effectiveness of spinal manipulation for spine pain. In these clinical trials, spinal manipulation was performed by chiropractors. METHODS: We conducted a retrospective secondary analysis of RCT data to compare trial participants' socio-demographic characteristics, clinical features, and health outcomes to a representative sample of (a) U.S. adults with chronic spine pain and (b) U.S. adults with chronic spine pain receiving chiropractic care, using secondary data from the National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS). We assessed differences between trial and U.S. spine populations using independent t-tests for means and z-tests for proportions, accounting for the complex multi-stage survey design of the NHIS and MEPS. RESULTS: We found the clinical trials had an under-representation of individuals from health disparity populations with lower percentages of racial and ethnic minority groups (Black/African American 7% lower, Hispanic 8% lower), less educated (No high school degree 19% lower, high school degree 11% lower), and unemployed adults (25% lower) with worse health outcomes (physical health scores 2.5 lower and mental health scores 5.3 lower using the SF-12/36) relative to the U.S. population with spine pain. While the odds of chiropractic use in the U.S. are lower for individuals from health disparity populations, the trials also under-represented these populations relative to U.S. adults with chronic spine pain who visit a chiropractor. CONCLUSIONS: Health disparity populations are not well represented in spine pain clinical trials. Embracing key community-based approaches, which have shown promise for increasing participation of underserved communities, is needed.

Examining Resilient Pain Behaviors for Chronic Low Back Pain: A Scoping Review.

OBJECTIVES: The objective of this scoping review was to examine resilience and resilient pain behaviors for those with CLBP in relation to resilience definitions, operationalization (e.g. trait or behavior), and application of theoretical frameworks. DESIGN: This scoping review examined resilience and resilient pain behaviors for those with CLBP in relation to resilience definitions, operationalization (e.g. trait or behavior), and application of theoretical frameworks. DATA SOURCES: To gather data, we used five databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Ovid MEDLINE, PsycInfo, and Scopus. REVIEW/ANALYSIS METHODS: Authors used a systematic data charting spreadsheet (Microsoft Excel) to review and analyze the extracted data. RESULTS: A total of 26 articles, from 2011-2021, were included in the final analysis. A majority of articles were conducted in the United States (11) and cross-sectional secondary data analysis design (13). Resilience definitions varied across the studies. Three studies operationalized resilience as a trait and only one as a behavior. Most studies (20) did not include a theoretical framework. CONCLUSION: The majority cross-sectional design and heterogeneity of a resilience definition indicates resilience research is still emerging. The lack of operationalized resilience, specifically as a behavior, and the limited use of theoretical frameworks suggest advancements in resilience pain research are needed. NURSING PRACTICE IMPLICATIONS: This research has implications for nursing practice to support nurse's holistic perspective and the ability to incorporate resilience within nursing care. This research provides the initial steps to developing standard resilience definitions and frameworks to guide nursing practice.

Effectiveness of spinal manipulation and biopsychosocial self-management compared to medical care for low back pain: a randomized trial study protocol.

BACKGROUND: Chronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis. METHODS: We have designed a phase 3 randomized trial with a 2 × 2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10-12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients' intervention assignment. DISCUSSION: By targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03581123.

Survey analysis to determine the impact of evidence informed practice education upon East Asian medicine faculty clinical instruction and students' skills, knowledge, attitudes and behaviors within a master's degree program.

BACKGROUND: Between 2013 and 2018 Pacific College of Health and Science (formerly Pacific College of Oriental Medicine) trained faculty and developed curriculum in evidence informed practice (EIP), with support from a grant from the National Institutes of Health (NIH). A three-credit (45 h) Foundations of EIP course, and online EIP learning modules (developed as part of a previous NIH R25 award), were used for faculty and student training. In addition, EIP was incorporated into 73% of the East Asian medicine degree program. Clinical integration of EIP in the College clinic was enhanced by improving access to reference sources, including additional EIP-related questions to the patient intake forms, requiring the use of a patient-centered outcome instrument, and assessing students' clinical EIP competencies. METHODS: Master's degree students' self-reported EIP skills, knowledge, attitudes and behaviors were assessed before and after taking the Foundations of EIP course using a 17-question paper-based survey with an additional open-ended comments section. The survey was administered in 29 courses across all three Pacific College campuses. Clinical faculty self-reported EIP instruction, focusing on the EIP content and instructional approaches that were utilized, was evaluated on the New York City campus using a paper-based survey before and after changes were made to enhance the clinical integration of EIP. RESULTS: A total of 1181 completed EIP-course surveys consisting of 657 pre-EIP course surveys and 524 post-EIP course surveys were analyzed. There was a statistically significant improvement in students' EIP skills, knowledge and behaviors after completing the EIP course. Students' perception of the importance of EIP was high before and after the EIP course. Little change in Faculty's EIP-related clinical instruction was evident following the EIP-related changes that were made to the Clinic. CONCLUSION: Our study suggests that the three-credit (45 h) EIP course was effective at improving the EIP skills, knowledge and behaviors of this group of East Asian medicine students who were undertaking a master's degree that qualified them for licensure in acupuncture in the US. These students also demonstrated a high level of recognition for the importance of research and EIP both before and after the course. Training faculty clinical supervisors and providing greater access to evidence sources in the College clinic did not appear to increase EIP instructional activity.

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain.

BACKGROUND: Mindfulness-based interventions (MBIs) are evidence-based nonpharmacological treatments for treating chronic pain. However, the predominant MBI, mindfulness-based stress reduction, has features that pose significant implementation barriers. OBJECTIVES: This study will test two approaches to delivering MBIs for improving Veterans' chronic pain and mental health comorbidities. These two approaches address key implementation barriers. METHODS: We will conduct a four-site, three-arm pragmatic randomized controlled trial, Learning to Apply Mindfulness to Pain (LAMP), to test the effectiveness of two MBIs at improving pain and mental health comorbidities. Mobile+Group LAMP consists of prerecorded modules presented by a mindfulness instructor that are viewed in an online group setting and interspersed with discussions led by a facilitator. Mobile LAMP consists of the same prerecorded modules but does not include a group component. We will test whether either of these MBIs will be more effective than usual care at improving chronic pain and whether the Mobile+Group LAMP will be more effective than Mobile LAMP at improving chronic pain. Comparisons for the primary hypotheses will be conducted with continuous outcomes (Brief Pain Inventory interference score) repeated at 10 weeks, 6 months, and 12 months. The secondary hypotheses are that Mobile+Group LAMP and Mobile LAMP will be more effective than usual care at improving secondary outcomes (e.g., post-traumatic stress disorder, depression). We will also confirm the comparisons for the primary and secondary hypotheses in gender-specific strata. IMPLICATIONS: This trial is expected to result in two approaches for delivering MBIs that will optimize engagement, adherence, and sustainability and be able to reach large numbers of Veterans.

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

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

Spinal rehabilitative exercise or manual treatment for the prevention of cervicogenic headache in adults.

This is the protocol for a review and there is no abstract. The objectives are as follows: To quantify and compare the short- and long-term effects of manual treatment and spinal rehabilitative exercise for cervicogenic headache, classified according to the International Headache Society's (IHS) diagnostic criteria, with an active or placebo/sham comparison or wait-list control.

Spinal rehabilitative exercise or manual treatment for the prevention of tension-type headache in adults.

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the short- and long-term effects of manual treatment and spinal rehabilitative exercise for the prevention of tension-type headache in adults.

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

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

"I know it's changed": a mixed-methods study of the meaning of Global Perceived Effect in chronic neck pain patients.

PURPOSE: Global Perceived Effect (GPE) is a commonly used outcome measure for musculoskeletal conditions like neck pain; however, little is known regarding the factors patients take into account when determining their GPE. The overall objective of this work was to describe the thematic variables, which comprise the GPE from the patient's perspective. METHODS: This was a mixed-methods study in which qualitative data were collected within a randomized clinical trial assessing exercise and manual therapy for chronic neck pain. A consecutive sample of 106 patients who completed the trial intervention took part in semi-structured interviews querying the meaning of GPE. Quantitative measures were collected through self-report questionnaires. Interview transcripts were analyzed using content analysis to identify themes, which were then quantified to assess potential relationships. RESULTS: A model of GPE for chronic neck pain emerged comprised of five main themes: neck symptoms (cited by 85%), biomechanical performance (38%), activities of daily living (31%), self-efficacy (10%), and need for other treatment (6%). Influencing factors included those contributing to GPE: treatment process (64%), biomechanical performance (51%), self-efficacy (16%), and the nature of the condition (8%). Factors, which detracted from GPE or prevented recovery included perceived nature of condition (58%), required daily activities (10%), lack of diagnosis (5%), and history of failed treatment (5%). CONCLUSIONS: GPE appears to capture chronic neck pain patient perceptions of change in different domains important to their individual pain experiences that may not be captured by other outcome instruments. Thus, GPE is a suitable patient-oriented outcome that can complement other measures in research and clinical practice. Importantly, many chronic neck pain patients believe it impossible to reach complete recovery because of a perceived intractable aspect of their neck condition; this has important implications regarding long-term disability and health-seeking behaviors.

Low back pain in children and adolescents: a systematic review and meta-analysis evaluating the effectiveness of conservative interventions.

PURPOSE: To identify and evaluate the effectiveness of conservative treatment approaches used in children and adolescents to manage and prevent low back pain (LBP). METHODS: Five electronic databases and the reference lists of systematic reviews were searched for relevant studies. Randomised controlled trials (RCTs) were considered eligible for inclusion if they enrolled a sample of children or adolescents (<18 years old) and evaluated the effectiveness of any conservative intervention to treat or prevent LBP. Two authors independently screened search results, extracted data, assessed risk of bias using the PEDro scale, and rated the quality of evidence using the GRADE criteria. RESULTS: Four RCTs on intervention and eleven RCTs on prevention of LBP were included. All included studies had a high risk of bias scoring ≤7 on the PEDro scale. For the treatment of LBP, a supervised exercise program compared to no treatment improved the average pain intensity over the past month by 2.9 points (95 % CI 1.6-4.1) measured by a 0-10 scale (2 studies; n = 125). For the prevention of LBP, there was moderate quality evidence to suggest back education and promotion programs are not effective in reducing LBP prevalence in children and adolescents. CONCLUSIONS: While exercise interventions appear to be promising to treat LBP in children and adolescents, there is a dearth of research data relevant to paediatric populations. Future studies conducted in children and adolescents with LBP should incorporate what has been learnt from adult LBP research and be of rigorous methodological quality.

Exploring patient satisfaction: a secondary analysis of a randomized clinical trial of spinal manipulation, home exercise, and medication for acute and subacute neck pain.

OBJECTIVE: The purpose of this study was to assess satisfaction with specific aspects of care for acute neck pain and explore the relationship between satisfaction with care, neck pain, and global satisfaction. METHODS: This study was a secondary analysis of patient satisfaction from a randomized trial of spinal manipulation therapy (SMT) delivered by doctors of chiropractic, home exercise and advice (HEA) delivered by exercise therapists, and medication (MED) prescribed by a medical doctors for acute/subacute neck pain. Differences in satisfaction with specific aspects of care were analyzed using a linear mixed model. The relationship between specific aspects of care and (1) change in neck pain (primary outcome of the randomized trial) and (2) global satisfaction were assessed using Pearson's correlation and multiple linear regression. RESULTS: Individuals receiving SMT or HEA were more satisfied with the information and general care received than MED group participants. Spinal manipulation therapy and HEA groups reported similar satisfaction with information provided during treatment; however, the SMT group was more satisfied with general care. Satisfaction with general care (r = -0.75 to -0.77; R(2) = 0.55-0.56) had a stronger relationship with global satisfaction compared with satisfaction with information provided (r = -0.65 to 0.67; R(2) = 0.39-0.46). The relationship between satisfaction with care and neck pain was weak (r = 0.17-0.38; R(2) = 0.08-0.21). CONCLUSIONS: Individuals with acute/subacute neck pain were more satisfied with specific aspects of care received during spinal manipulation therapy or home exercise interventions compared to receiving medication. The relationship between neck pain and satisfaction with care was weak.

Exploring Gender Differences in Veterans in a Secondary Analysis of a Randomized Controlled Trial of Mindfulness for Chronic Pain.

Background: Although studies have documented higher rates of chronic pain among women Veterans compared to men Veterans, there remains a lack of comprehensive information about potential contributors to these disparities. Materials and Methods: This study examined gender differences in chronic pain and its contributors among 419 men and 392 women Veterans, enrolled in a mindfulness trial for chronic pain. We conducted descriptive analyses summarizing distributions of baseline measures, obtained by survey and through the electronic health record. Comparisons between genders were conducted using chi-square tests for categorical variables and t-tests for continuous measures. Results: Compared to men, women Veterans were more likely to have chronic overlapping pain conditions and had higher levels of pain interference and intensity. Women had higher prevalence of psychiatric and sleep disorder diagnoses, greater levels of depression, anxiety, post-traumatic stress disorder, fatigue, sleep disturbance, stress and pain catastrophizing, and lower levels of pain self-efficacy and participation in social roles and activities. However, women were less likely to smoke or have a substance abuse disorder and used more nonpharmacological pain treatment modalities. Conclusion: Among Veterans seeking treatment for chronic pain, women differed from men in their type of pain, had greater pain intensity and interference, and had greater prevalence and higher levels of many known biopsychosocial contributors to pain. Results point to the need for pain treatment that addresses the comprehensive needs of women Veterans.Clinical Trial Registration Number: NCT04526158. Patient enrollment began on December 4, 2020.

Telehealth Mindfulness-Based Interventions for Chronic Pain: The LAMP Randomized Clinical Trial.

Importance: Although mindfulness-based interventions (MBIs) are evidence-based treatments for chronic pain and comorbid conditions, implementing them at scale poses many challenges, such as the need for dedicated space and trained instructors. Objective: To examine group and self-paced, scalable, telehealth MBIs, for veterans with chronic pain, compared to usual care. Design, Setting, and Participants: This was a randomized clinical trial of veterans with moderate to severe chronic pain, recruited from 3 Veterans Affairs facilities from November 2020 to May 2022. Follow-up was completed in August 2023. Interventions: Two 8-week telehealth MBIs (group and self-paced) were compared to usual care (control). The group MBI was done via videoconference with prerecorded mindfulness education and skill training videos by an experienced instructor, accompanied by facilitated discussions. The self-paced MBI was similar but completed asynchronously and supplemented by 3 individual facilitator calls. Main Outcomes and Measures: The primary outcome was pain-related function using the Brief Pain Inventory interference scale at 3 time points: 10 weeks, 6 months, and 1 year. Secondary outcomes included biopsychosocial outcomes: pain intensity, physical function, anxiety, fatigue, sleep disturbance, participation in social roles and activities, depression, patient ratings of improvement of pain, and posttraumatic stress disorder. Results: Among 811 veterans randomized (mean [SD] age, 54.6 [12.9] years; 387 [47.7%] women), 694 participants (85.6%) completed the trial. Averaged across all 3 time points, pain interference scores were significantly lower for both MBIs compared to usual care (group MBI vs control difference: -0.4 [95% CI, -0.7 to -0.2]; self-paced vs control difference: -0.7 [95% CI, -1.0 to -0.4]). Additionally, both MBI arms had significantly better scores on the following secondary outcomes: pain intensity, patient global impression of change, physical function, fatigue, sleep disturbance, social roles and activities, depression, and posttraumatic stress disorder. Both group and self-paced MBIs did not significantly differ from one another. The probability of 30% improvement from baseline compared to control was greater for group MBI at 10 weeks and 6 months, and for self-paced MBI, at all 3 time points. Conclusions and Relevance: In this randomized clinical trial, scalable telehealth MBIs improved pain-related function and biopsychosocial outcomes compared to usual care among veterans with chronic pain. Relatively low-resource telehealth-based MBIs could help accelerate and improve the implementation of nonpharmacological pain treatment in health care systems. Trial Registration: ClinicalTrials.gov Identifier: NCT04526158.

Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial.

BACKGROUND: Mechanical neck pain is a common condition that affects an estimated 70% of persons at some point in their lives. Little research exists to guide the choice of therapy for acute and subacute neck pain. OBJECTIVE: To determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770) SETTING: 1 university research center and 1 pain management clinic in Minnesota. PARTICIPANTS: 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks. INTERVENTION: 12 weeks of SMT, medication, or HEA. MEASUREMENTS: The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks after randomization. Secondary measures were self-reported disability, global improvement, medication use, satisfaction, general health status (Short Form-36 Health Survey physical and mental health scales), and adverse events. Blinded evaluation of neck motion was performed at 4 and 12 weeks. RESULTS: For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P ≤ 0.010), and HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome. LIMITATIONS: Participants and providers could not be blinded. No specific criteria for defining clinically important group differences were prespecified or available from the literature. CONCLUSION: For participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine, National Institutes of Health.

Extracting Complementary and Integrative Health Approaches in Electronic Health Records.

Complementary and Integrative Health (CIH) has gained increasing popularity in the past decades. While the evidence bases to support them are growing, there is still a gap in understanding their effects and potential adverse events using real-world data. The overall goal of this study is to represent information pertinent to both psychological and physical CIH approaches (specifically, using examples of music therapy, chiropractic, and aquatic exercise in this study) in an electronic health record (EHR) system. We also aim to evaluate the ability of existing natural language processing (NLP) systems to identify CIH approaches. A total of 300 notes were randomly selected and manually annotated. Annotations were made for status, symptom, and frequency of each approach. This set of annotations was used as a gold standard to evaluate the performance of NLP systems used in this study (specifically BioMedICUS, MetaMap, and cTAKES) for extracting CIH concepts. Venn diagram was used to investigate the consistency of medical records searching by Current Procedural Terminology (CPT) codes and CIH approaches keywords in SQL. Since CPT codes usually do not have specific mentions of CIH approaches, the Venn diagram had less overlap with those found in clinical notes for all three CIH therapies. The three NLP systems achieved 0.41 in average lenient match F1-score in all three CIH approaches, respectively. BioMedICUS achieved the best performance in aquatic exercise with an F1-score of 0.66. This study contributes to the overall representation of CIH in clinical note and lays a foundation for using EHR for clinical research for CIH approaches.

Identifying body awareness-related brain network changes after Spring Forest Qigong™ practice or P.Volve low-intensity exercise in adults with chronic low back pain: a feasibility Phase I Randomized Clinical Trial.

Background: Chronic low back pain (cLBP) affects the quality of life of 52 million Americans and leads to an enormous personal and economic burden. A multidisciplinary approach to cLBP management is recommended. Since medication has limited efficacy and there are mounting concerns about opioid addiction, the American College of Physicians and American Pain Society recommend non-pharmacological interventions, such as mind and body approaches (e.g., Qigong, yoga, Tai Chi) before prescribing medications. Of those, Qigong practice might be most accessible given its gentle movements and because it can be performed standing, sitting, or lying down. The three available Qigong studies in adults with cLBP showed that Qigong reduced pain more than waitlist and equally well than exercise. Yet, the duration and/or frequency of Qigong practice were low (<12 weeks or less than 3x/week). The objectives of this study were to investigate the feasibility of practicing Spring Forest Qigong™ or performing P.Volve low intensity exercises 3x/week for 12 weeks, feasibility of recruitment, data collection, delivery of the intervention as intended, as well as identify estimates of efficacy on brain function and behavioral outcomes after Qigong practice or exercise. To our knowledge, this is the first study investigating the feasibility of the potential effect of Qigong on brain function in adults with cLBP. Methods: We conducted a feasibility Phase I Randomized Clinical Trial. Of the 36 adults with cLBP recruited between January 2020 and June 2021, 32 were enrolled and randomized to either 12 weeks of remote Spring Forest Qigong™ practice or remote P.Volve low-intensity exercises. Participants practiced at least 3x/week for 41min/session with online videos. Our main outcome measures were the Numeric Pain Rating Scale (highest, average, and lowest cLBP pain intensity levels in the prior week), assessed weekly and fMRI data (resting-state and task-based fMRI tasks: pain imagery, kinesthetic imagery of a Qigong movement, and robot-guided shape discrimination). We compared baseline resting-state connectivity and brain activation during fMRI tasks in adults with cLBP with data from a healthy control group (n=28) acquired in a prior study. Secondary outcomes included measures of function, disability, body awareness, kinesiophobia, balance, self-efficacy, core muscle strength, and ankle proprioceptive acuity with a custom-build device. Results: Feasibility of the study design and methods was demonstrated with 30 participants completing the study (94% retention) and reporting high satisfaction with the programs; 96% adherence to P.Volve low-intensity exercises, and 128% of the required practice intensity for Spring Forest Qigong™ practice. Both groups saw promising reductions in low back pain (effect sizes Cohen's d =1.01-2.22) and in most other outcomes ( d =0.90-2.33). Markers of ankle proprioception were not significantly elevated in the cLBP group after the interventions. Brain imaging analysis showed weaker parietal operculum and insula network connectivity in adults with cLBP (n=26), compared to data from a healthy control group (n=28). The pain imagery task elicited lower brain activation of insula, parietal operculum, angular gyrus and supramarginal gyrus at baseline in adults with cLBP than in healthy adults. Adults with cLBP had lower precentral gyrus activation than healthy adults for the Qigong movement and robot task at baseline. Pre-post brain function changes showed individual variability: Six (out of 13) participants in the Qigong group showed increased activation in the parietal operculum, angular gyrus, supramarginal gyrus, and precentral gyrus during the Qigong fMRI task. Interpretation: Our data indicate the feasibility and acceptability of using Spring Forest Qigong™ practice or P.Volve low-intensity exercises for cLBP relief showing promising results in terms of pain relief and associated symptoms. Our brain imaging results indicated brain function improvements after 12 weeks of Qigong practice in some participants, pointing to the need for further investigation in larger studies. Trial registration number: ClinicalTrials.gov: NCT04164225 .

Effectiveness of Spinal Manipulation and Biopsychosocial Self-Management compared to Medical Care for Low Back Pain: A Randomized Trial Study Protocol.

Background Chronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis. Methods We have designed a phase 3 randomized trial with a 2x2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10-12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients' intervention assignment. Discussion By targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem. Trial registration: ClinicalTrials.gov Identifier: NCT03581123.

Annotating Music Therapy, Chiropractic and Aquatic Exercise Using Electronic Health Record.

Complementary and Integrative Health (CIH) has gained increasing popularity in the past decades. The overall goal of this study is to represent information pertinent to music therapy, chiropractic and aquatic exercise in an EHR system. A total of 300 clinical notes were randomly selected and manually annotated. Annotations were made for status, symptom and frequency of each approach. This set of annotations was used as a gold standard to evaluate performance of NLP systems used in this study (specifically BioMedICUS, MetaMap and cTAKES) for extracting CIH concepts. Three NLP systems achieved an average lenient match F1-score of 0.50 in all three CIH approaches. BioMedICUS achieved the best performance in music therapy with an F1-score of 0.73. This study is a pilot to investigate CIH representation in clinical note and lays a foundation for using EHR for clinical research for CIH approaches.

Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial.

BACKGROUND: Low back pain (LBP) is influenced by interrelated biological, psychological, and social factors, however current back pain management is largely dominated by one-size fits all unimodal treatments. Team based models with multiple provider types from complementary professional disciplines is one way of integrating therapies to address patients' needs more comprehensively. METHODS: This parallel group randomized clinical trial conducted from May 2007 to August 2010 aimed to evaluate the relative clinical effectiveness of 12 weeks of monodisciplinary chiropractic care (CC), versus multidisciplinary integrative care (IC), for adults with sub-acute and chronic LBP. The primary outcome was pain intensity and secondary outcomes were disability, improvement, medication use, quality of life, satisfaction, frequency of symptoms, missed work or reduced activities days, fear avoidance beliefs, self-efficacy, pain coping strategies and kinesiophobia measured at baseline and 4, 12, 26 and 52 weeks. Linear mixed models were used to analyze outcomes. RESULTS: 201 participants were enrolled. The largest reductions in pain intensity occurred at the end of treatment and were 43% for CC and 47% for IC. The primary analysis found IC to be significantly superior to CC over the 1-year period (P = 0.02). The long-term profile for pain intensity which included data from weeks 4 through 52, showed a significant advantage of 0.5 for IC over CC (95% CI 0.1 to 0.9; P = 0.02; 0 to 10 scale). The short-term profile (weeks 4 to 12) favored IC by 0.4, but was not statistically significant (95% CI - 0.02 to 0.9; P = 0.06). There was also a significant advantage over the long term for IC in some secondary measures (disability, improvement, satisfaction and low back symptom frequency), but not for others (medication use, quality of life, leg symptom frequency, fear avoidance beliefs, self-efficacy, active pain coping, and kinesiophobia). Importantly, no serious adverse events resulted from either of the interventions. CONCLUSIONS: Participants in the IC group tended to have better outcomes than the CC group, however the magnitude of the group differences was relatively small. Given the resources required to successfully implement multidisciplinary integrative care teams, they may not be worthwhile, compared to monodisciplinary approaches like chiropractic care, for treating LBP. Trial registration NCT00567333.