Primary care providers (PCPs), who provide the bulk of care for patients with chronic noncancer pain (CNCP), often report knowledge gaps, limited resources, and difficult patient encounters while managing chronic pain. This scoping review seeks to evaluate gaps identified by PCPs in providing care to patients with chronic pain.The Arksey and O’Malley framework was used for this scoping review. A broad literature search was conducted for relevant articles on gaps in knowledge and skills of PCPs and in their health care environment for managing chronic pain, with multiple search term derivatives for concepts of interest. Articles from the initial search were screened for relevance, yielding 31 studies. Inductive and deductive thematic analysis was adopted.The studies included in this review reflected a variety of study designs, settings, and methods. However, consistent themes emerged with respect to gaps in knowledge and skills for assessment, diagnosis, treatment, and interprofessional roles in chronic pain, as well as broader systemic issues including attitudes toward CNCP. A general lack of confidence in tapering high dose or ineffective opioid regimes, professional isolation, challenges in managing patients with CNCP with complex needs, and limited access to pain specialists were reported by PCPs.This scoping review revealed common elements across the selected studies that will be useful in guiding creation of targeted supports for PCPs to manage CNCP. This review also yielded insights for pain clinicians at tertiary centers for supporting their PCP colleagues as well as systemic reforms required to support patients with CNCP. CNCP is generally defined as pain persisting beyond the normally expected time for healing, with 3 months as the typical threshold for a diagnosis of chronic pain.2 Given that nearly one in five individuals in Canada experience CNCP, treating pain is a significant proportion of the care delivered by PCPs.3–9 These providers offer an early point of contact with the health care system for patients with chronic pain; they provide comprehensive care, and they can also identify patients who are in need of specialist care.10 With the increasing complexity of primary care and expectations of stronger opioid stewardship since the 2017 Canadian Guidelines for Opioid Therapy and Chronic Noncancer Pain11 publication, a need to assess the challenges faced by PCPs in providing the bulk of care to patients living with CNCP exists.Family physicians, general practitioners, nurse practitioners (NPs), clinical nurse specialists, and physician assistants are all considered primary care providers (PCPs)12–14 Even those PCPs who receive exposure to diagnosing and treating chronic pain may find it difficult to translate this knowledge into optimal outcomes for a multitude of reasons, including lack of reliable and objective measures of pain, concerns about adverse effects of analgesic treatments, and limitations in contact time with patients.15–17 It is therefore not surprising that individuals experiencing CNCP often feel that their complaints are addressed with skepticism, lack of understanding, rejection, belittlement, or blame or labeled with diagnoses such as somatic symptom disorder that implies that their pain is a psychological construct.18 Health care professionals struggle to understand the subjective nature of pain, often finding difficulty in correlating pain complaints with objective findings on physical examination and investigations, and have difficulty empathizing with patients’ suffering when secondary gain may be a consideration.19 Further, fears of contributing to opioid dependence and causing harm to patients19 are relevant concerns in the management of CNPC. Prescribing of opioids in high doses, a practice more prevalent in the past that continues to cast a shadow in current management of CNCP, is now known to carry significant risks and complications and adds complexity in CNCP care.20PCPs often receive inadequate education and training in treating and managing chronic pain.21 This can lead to professional frustration and less-than-ideal outcomes for patients with CNCP.22 Medical and nursing schools historically have not allocated significant time to teach assessment and management of pain, which has resulted in suboptimal knowledge and skill levels of PCPs treating patients with CNCP, a problem that potentially compromises patient care.21PCPs are often expected to provide comprehensive CNCP care regardless of whether their training has equipped them with the tools to do so.23 is a welcomed new addition to the postgraduate training landscape, access to advanced pain specialists historically has been limited, and the bulk of chronic pain management is delivered by PCPs.24 There is a current need to understand the challenges faced by PCPs after the recent substantive shift in opioid prescribing practices, the concurrent growth of pain medicine, and the present impetus to advance care for CNCP in Canada with the recent release of the Canadian Pain Task Force recommendations.25Though the Pain Medicine specialty training program of the Royal College of Physicians and Surgeons of Canada27The broad aims of this scoping review were to provide an overview of the perspectives of Canadian PCPs in managing CNCP, identify gaps in the existing literature, and explore the potential to use the results of this review in the future to guide continuing medical education curricula and other supports for PCPs.26 Scoping reviews further differ from systematic reviews in that they address broader topics in which different study designs may be applicable, and thus the heterogeneous nature of available literature on this subject justifies this approach of synthesizing evidence.28 Furthermore, though a scoping review has been done on PCP opioid prescribing safety measures,29 also covered in part by various publications at different time points and in multiple regions of Canada, this subject has not yet been extensively reviewed. Our review is therefore one of the first comprehensive syntheses to assimilate evidence on primary care perspectives on the management of CNCP pain.We considered a scoping review of literature followed by a discussion of the available evidence as appropriate for this topic. Scoping reviews seek to map emerging literature in terms of its volume, nature, and characteristics. In contrast to systematic reviews, scoping reviews do not answer a focused research question.26 which was updated by Levac and colleagues.27 We conducted this review as per the five stages of the Arksey and O’Malley framework: identifying the research question (stage 1), identifying relevant studies (stage 2), study selection (stage 3), charting the data (stage 4), and collating, summarizing, and reporting the results  conducted a systematic search of the following databases from their inception via the Ovid platform: MEDLINE ALL (1946–), Embase Classic/Embase (1947–), Cochrane Central Registry of Controlled Trials (1995–), and Cochrane Database of Systematic Reviews (2005–). CINAHL Complete  was also searched. The trial registries ClinicalTrials.Gov  and World Health Organization International Clinical Trials Platform were also searched. Dissertations were sought using the ProQuest Digital Dissertations International database. Lastly, books or book chapters were sought using the UHN’s Summon OneSearch discovery service. All databases and trial registries were searched on the same day, January 2, 2020. Update searching over all databases and registries was conducted on May 12, 2021.31 and the Cochrane Methodological Expectations of Cochrane Intervention Reviews32 for conducting the search. The PRESS guideline for peer-reviewing the search strategies,33 drawing upon the PRESS 2015 Guideline Evidence-Based Checklist, was used to avoid potential search errors.The search process followed the Cochrane Handbook34 was used to facilitate the MeSH and text word analysis, using target citations provided by the team.To develop comprehensive search strategies, preliminary searches were conducted, and full-text literature was mined for potential keywords and appropriate controlled vocabulary terms . The Yale MeSH AnalyzerThe search strategy concept blocks were built on the following topics: (primary care physicians or related terms) AND (chronic pain or related terms) AND (questionnaires or surveys or related terms) AND  using both controlled vocabularies and text word searching for each component. Searches were limited to English language.The Ovid MEDLINE ALL search strategy is provided in Supplemental Google Scholar searching was conducted by other members of the team, starting with the following search string: (“primary care physicians” OR “primary care doctors” OR “family physicians” OR “family doctors”) AND “chronic pain” AND (questionnaire OR survey) AND Canada. The first 200 resulting citations from Google Scholar were reviewed.Lastly, team members also hand-searched reference lists of selected articles to identify additional potentially relevant articles.35 The population of interest included Canadian PCPs including family physicians, general practitioners, nurse practitioners, and their medical learners. Publications with allied health professionals and other medical specialties were included if a participant cohort was clearly identified as PCPs. Medical learners were included as a population that could provide insights into the base education of chronic pain care that PCPs then eventually rely upon in the absence of dedicated postgraduate training. We focused on studies only in the Canadian context given important differences between countries in health care systems, including at primary and tertiary levels, and in pain education curricula between Canada and other jurisdictions. The concepts of interest were gaps in the PCPs’ knowledge and skills, barriers in addressing CNCP, and/or reported strategies for improving CNCP management. The context was patients with CNCP including chronic pain in cancer survivors; studies on acute pain, cancer pain, and palliative care were excluded. Because the goal was foremost to understand the gaps and barriers experienced by PCPs, articles focused on patient perspectives were not included in this article, although these would be highly valuable for subsequent consideration as a separate review.A population, concept, context approach was followed for this scoping review.Eligible study designs were primary empirical studies, including qualitative studies, case reports, case series, observational studies , randomized controlled trials, systematic reviews, and conference abstracts. Editorials and opinion pieces were not included.Abstracts identified within each search were imported into Rayyan, an evidence synthesis data management software, and duplicates were removed. Articles were screened independently by two reviewers (M.E. and V.M.), who reviewed titles and abstracts for relevance and eligibility. A subsequent full-text review of each article that passed the initial screening was completed independently and in duplicate, and conflicts were resolved through discussion, consensus, and input from the senior author (A.B.).Data extraction tables were constructed and pilot-tested prior to use. Comprehensive extraction of the data into 37 Specifically, we performed a reflexive, semantic, inductive, and deductive approach, which will be explained herein. The authors remained reflexive of their social and diverse professional locations and how these backgrounds informed the research project, from conception to manuscript preparation. Semantic (the meaning in language) relationships between included articles’ concepts were explored. Data were coded inductively without an a priori conceptual framework, in keeping with our research aims to provide an overview of PCPs in managing CNCP and to identify gaps in the literature.37 We subsequently deductively coded the data using the CanMEDS framework for discussion purposes and as a means by which to inform future education program development.We adopted Braun and Clarke’s thematic analysis for this scoping review.code as a “feature of the data (semantic content or latent) that appears interesting to the analyst and refers to ‘the most basic segment, or element, of the raw data or information that can be assessed in a meaningful way regarding the phenomenon.’”38 These codes were subsequently grouped into categories, based on conceptual similarities, followed by grouping into emerging themes.37 An iterative approach ensued where each reviewer subsequently ensured that each theme was coherent and representative of all of the data.36 Subsequently, the two authors compared emerging themes and came to consensus on a common coding framework.37 The common coding framework was subsequently applied to all articles included within this scoping review.37An iterative step-by-step thematic analysis was performed by two of the authors (V.M. and M.E.), where the included articles were first read in full in order to find patterns, followed by open coding of the data. Braun and Clarke defined a 39 the research team triangulated all independently coded emerging codes, subthemes, and themes to create the final coding book, and the senior author reviewed all codes, subthemes, and emerging themes, ensuring accuracy and consistency between the included manuscripts and the available literature.40 The researchers also took memos throughout the research cycle to document reflections around data inclusion and analysis. Coding was iterative in nature, meaning that any newly emerging codes and themes were reviewed against all included articles, ensuring that data extraction was complete.For credibility, confirmability, and dependability,41–66  used a quantitative design , and 5 (16%) studies used mixed methods.66 All studies described the methods used to obtain data, and all but two studies62 provided the number of participants. The number of PCP participants in these studies ranged from 6 to 710, for a total of 4389 PCPs out of 5063 participants. A subanalysis of included studies found that four of the included studies were penned by authors from Québec and focused exclusively on PCPs within Québec, with Quebec participants totaling 889, or 20% of the total PCPs captured by this scoping review.61 Additional difficulty in quantifying numbers of participants from Québec may have been captured in the 9 studies targeting PCPs across Canada, of which only 2 studies reported actual numbers of participants from Québec, capturing a further minimum of 77 PCPs from Québec, with likely additional unreported participants from Québec in the other pan-Canadian studies.59A summary description of studies included in this review is presented in 64–66 and one article focused exclusively on nurse practitioners’ perspectives.47 The remaining articles discussed perspectives of family physicians, while also including nurse practitioners63 and allied health care workers including physician assistants,60 nurses,60 pharmacists,60 dentists,58 social workers,60 physiotherapists,60 occupational therapists,60 psychologists,41 chiropractors,41 kinesiologists,41 and dietitians.41 The PCPs in the studies ranged from recently graduated physicians and NPs to those with up to 49 years of experience.41 Most geographical regions of Canada were represented, with nine studies surveying physicians all across Canada59; other studies included participants from specific provinces: Newfoundland and Labrador,64 Nova Scotia,46 British Columbia,53 Alberta,65 Saskatchewan,62 Quebec,61 and Ontario.66All included studies explored PCPs’ perspectives on managing chronic pain. Eighteen articles focused exclusively on physicians’ perceptions,66 The mixed methods studies allowed for open-ended responses on the questionnaires.59 The study implementing a randomized controlled trial design with both groups completing a workshop and the intervention group receiving an additional 10 weeks of e-mail case discussions also used a blinded assessor postintervention to assess participants’ knowledge following the intervention.51 Of the 10 studies employing a qualitative design, 5 used semistructured interviews,64 3 used focus group interviews,60 and 2 used an open-ended interview style.57Methods of evaluation for the 21 quantitative and mixed methods studies included a questionnaire or a survey to obtain participant responses.58Eight common themes were identified and grouped under the following four overarching themes: pain medicine competencies and practice, interprofessional collaboration, attitudes and therapeutic relationship skills, and strategies to reduce gaps in care .48,52,5553 and navigating modalities of treatment for CNCP.64 PCPs described struggling with assessing and quantifying patients’ pain in the absence of clear biomarkers or imaging findings supporting a diagnosis of pain.57 Multiple studies included in this review found that validated scales to measure the intensity of pain were not universally employed.49 PCPs also reported difficulty with proposing differential diagnoses for chronic pain syndromes.56 However, PCPs acknowledged the importance of recognizing and treating common comorbidities associated with chronic pain, such as anxiety and depression.56In general, both in surveys and with in-depth interviews, PCPs reported challenges with assessing pain47; however, only 50% of NPs reported using clinical practice guidelines developed by other non–nurse practitioner health professional groups.47 Despite awareness of existing tools and guidelines, many PCPs revealed in a semistructured interview that they had limited functional knowledge of or practice in using them.16 An exception to this observation was awareness of opioid prescribing guidelines, which surveyed PCPs commonly reported implementing in their practice.59Standardized assessment tools and clinical practice guidelines, along with staff education and support for implementation, were considered helpful by NPs in managing pain57 including determining when opioids were appropriate.57 One survey assessed PCPs’ pharmacological knowledge in pain management and found that many clinicians were not aware of adverse effects of commonly used analgesics.17 However, other surveys found that PCPs had concerns around overmedicating patients and adverse effects of medications, particularly in elderly patients and patients with cognitive impairments.56Across studies, PCPs also reported uncertainty in executing a stepwise approach to pain management in choosing appropriate pain medications to prescribe to patients,57The theme dominating PCPs’ practice challenges revolved around managing opioids for patients with CNCP. PCPs interviewed in two qualitative studies reported feeling unsupported in the transition from a time when opioids were recommended for treating CNCP to the current opioid crisis and guidelines recommending de-escalation of prescribed doses of opioids.58 Despite guidelines supporting the practice of tapering opioids in patients who fail to achieve pain management goals with high doses of opioids, PCPs often did not take this approach,55 though some surveyed PCPs interpreted guidelines as mandating opioid tapering.59 PCPs in several qualitative studies described challenges in deprescribing opioids in patients on high doses because patients often resisted this and expressed fear of exacerbation of their pain,59 and prescribers reported lack of knowledge in opioid deprescribing.64 PCPs interviewed also reported lacking appropriate knowledge and skill resources to assist patients in managing withdrawal symptoms during opioid tapers, often leading patients to return to previous high doses.15 Many studies reported that being aware of the risks of opioid misuse increased PCPs’ hesitancy in prescribing them57; studies indicated that PCPs wanted more education on risks and benefits of various opioids,57 and use of long-acting opioids elicited concerns from PCPs in one qualitative study about the risk of addiction despite lack of evidence that long-acting opioids increased risk of addiction compared to short-acting opioids.45 PCPs also expressed concerns that some patients with CNCP tend to exaggerate pain in order to obtain opioids.57 Conversely, PCPs interviewed were more comfortable prescribing opioids when patients expressed anxiety or avoidant behavior with respect to starting opioids.15 One PCP reported that “knowing the patient” strengthened their confidence that opioids may optimize function based on the patient’s beliefs around opioids, mental health comorbidities, and addiction risk.15Lack of knowledge and resources for opioid prescribing has translated into gaps in implementation of new guidelines and created new barriers in treating CNCP effectively. Some PCPs used a strict approach to opioid prescribing, including regimented use of opioid contracts and requiring objective evidence of pain as an indication to prescribe opioids, which was reported to complicate the provider–patient relationship45 Less-experienced PCPs reported more frequent use of the 2017 Canadian Guideline for Opioids for CNCP than more experienced PCPs,57 exercising more caution initiating opioids, and expressed fear of disciplinary action from professional regulatory bodies for inappropriate prescribing.57 Several studies reported criticism of the Canadian guidelines for opioids due to the absence of strong evidence, clear and actionable strategies, and the unavailability of the recommended resources to support avoidance or the use of lower doses of opioids.59There were some differences between the approach to prescribing opioids for less- and more-experienced PCPs. More-experienced PCPs reported recognizing their patients’ concerns and behaviors about opioids to reduce enforcement measures in opioid prescribing.56 and another 20% did not routinely screen their patients’ opioid regimes.17 A survey from 2018 documented an increased trend in the use of opioid risk tools and screening as compared to 8 years prior.42 Further, in four studies, monitoring with surveillance measures, such as urine drug screening, was deemed stressful by PCPs and was reported to create tension between the PCP and the patient.56 Monitoring opioid effectiveness by assessing for functional improvement in patients with CNCP was acknowledged by PCPs as an important factor in guiding opioid prescribing,55 and in three studies, PCPs acknowledged that opioid prescriptions should be connected to goals of functional improvement beyond pain control.57 PCPs also agreed that clear treatment goals should be established with patients prior to initiating opioids for treating CNCP.49Surveys found that only 20% PCPs used validated tools to screen for the risk of opioid misuse prior to initiating opioids,45 and other PCPs expressed the realistic concern that patients may be denied adequate treatment if PCPs do not manage their patients’ CNCP.20 A common reason for referral to pain clinics was PCPs’ concerns about opioids; however, some PCPs reported frustration with pain clinics that at times prescribe high doses of opioids for CNCP that PCPs did not feel comfortable managing or continuing to prescribe.48 PCPs also reported that patients were often initiated on opioids by other prescribers such as surgeons or pain specialists, with instructions to follow up with their PCP, creating difficulty for PCPs when deciding whether to refill patients’ requests for opioids.55 This was perceived by the PCPs as offloading responsibility without adequate communication or guidance,45 resulting in disorganized care and poor outcomes for patients, such as dependency, illegal drug use, or unintentional withdrawal.15In qualitative interviews, some PCPs questioned whether CNCP management, including opioid prescription, should be their responsibility,44 PCPs expressed interest in learning about the role of nonpharmacological pain treatment opportunities, such as cognitive behavior therapy, to manage CNCP.59 One survey found that the most frequent nonpharmacological treatment modality utilized by PCPs for treating CNCP was psychotherapy, with 20% of PCPs exercising this option.24 Referrals for consultations to physiotherapists, chiropractors, and osteopaths were reported by PCPs to improve patient self-management and satisfaction, as well as reduce the need for medications and consultations with PCPs.16 However, PCPs felt that their attempts to encourage patients to adopt lifestyle modifications, such as weight reduction, were often met with resistance from patients, who expressed preference for pharmacological therapy in one qualitative survey.57 Nevertheless, by empowering patients to be active participants in their own care, PCPs found it feasible to support them through lifestyle changes.57PCPs primarily treated patients with pharmacological therapies such as opioids, antidepressants, and anticonvulsants, whereas the use of nonpharmacological treatments such as engaging allied health colleagues was low in surveys, even if patients were able to fund these treatments.64 PCPs interviewed reported a greater likelihood of prescribing opioids to patients of low socioeconomic status compared to less affordable nonpharmacological interventions, such as physiotherapy, massage, and psychotherapy.57Geographical and financial limitations were significant barriers to PCPs prescribing nonpharmacological interventions.64 and this was perceived as impeding guideline-concordant care.54 The absence of multidisciplinary care in many clinical settings was believed by PCPs in two qualitative studies to be related to the experience of professional isolation.16 NPs felt that one of the major barriers to effective CNCP management was poor collaboration with physicians, and trusting relationships between NPs and physicians was perceived as a major facilitator by PCPs.47 PCPs also reported relying on consultations with other physicians, pharmacists, nurses, and pain specialists to formulate treatment plans for CNCP.47 PCPs highlighted the need to collaborate with pharmacists in particular to provide effective treatment for patients.47 Physicians interviewed also endorsed primary care nurses being trained in pain management to support an multidisciplinary approach,16 because nursing staff are increasingly relied upon by physicians to assess CNCP and evaluate adverse effects of pain medications.15PCPs expressed feeling unsupported in their endeavors to manage CNCP patients within the broader health care system,15 Focus group discussions found that PCPs generally felt interprofessional education sessions were useful learning for managing patients with CNCP,60 provided opportunities to be better acquainted with their colleagues and respective areas of expertise, and aided the development of a common language on the topic of pain.60 Project ECHO  was quoted as an example of an interdisciplinary collaboration, in which multiple disciplines convene simultaneously for case-based learning, with the goal of “creating a community” of health professionals; this allows for regular interaction and has been found beneficial by PCPs in chronic pain education and management.60 After participating in an interprofessional education workshop, most participants in a study indicated that they involved other health care professionals more frequently in managing CNCP.60PCPs interviewed who worked in a multidisciplinary environment were more confident in prescribing practices and CNCP management strategies.64 A lack of clearly defined referral and care paths and limited information on available resources such as pain specialists and multidisciplinary pain treatment clinics were identified as possible reasons for these limitations in semifocused interviews.54 Long wait times, with the median being 6 months16 but ranging as long as 3 to 5 years,55 were identified as a barrier to effective care for patients with CNCP. One study found that long wait times negatively affected patients, because they experienced higher pain intensity, functional interference, psychological distress , and poorer quality of life.16 Other barriers to referral to pain clinics included lack of specialized treatments outside of the context of formal pain clinics, distance from patients’ residences to the pain clinics, inability of pain clinics to offer frequent follow-up visits, and initiation of high-dose opioids by pain clinics that PCPs were not comfortable with continuing to prescribe.48There was a general consensus from PCPs in studies included in this review about the lack of available resources and access to specialists to support effective pain management.54 PCPs opined that challenges posed by low socioeconomic status of patients with CNCP impacted available treatment options.59 Five studies reported that PCPs felt the cost of medications was a major barrier in delivering effective pain management.55 Additionally, limited services available outside of major urban centers impacted patients with CNCP in rural areas, who often had more difficulty accessing recommended resources, such as physiotherapy.57One qualitative study suggested that providing good care for patients with complex CNCP would require significant transformation of the health care system.59 In one qualitative study, PCPs reported struggling with refusal to prescribe opioids to patients.57 Interviews with PCPs indicated that they had difficulty creating a trusting relationship with their patients with CNCP because of the difficulty in judging the legitimacy of patients’ requests for opioids.57 PCPs interviewed often felt torn between the goal of reducing patients’ suffering secondary to lack of effective treatments and ongoing pressure to avoid opioids.57A common theme emerged in many studies of PCPs feeling challenged by balancing adequate analgesia with opioids against avoiding potential conflicts with patients or complications such as misuse and addiction.57 Some PCPs interviewed found it difficult to trust pain statements from patients with depression or other mental health concerns, and they delegitimized pain complaints in the presence of psychiatric issues.54In two qualitative interviews, PCPs described having to engage with patients’ needs outside of CNCP and physical health, including mental health and social issues such as poverty and marginalization; this contributed to PCPs’ loss of job satisfaction, emotional exhaustion, and depersonalization.52 Patients with CNCP frequently missing appointments was “frustrating” to some PCPs, even though PCPs realized that patients with CNCP may be dealing with significant life challenges outside of appointments.54PCPs also identified the term “chronic” in CNCP as discouraging, because it implies the inability to cure the patient’s pain, evoking dismay and annoyance from patients and underscoring CNCP as a “nuisance” condition.54 Further, some PCPs expressed that “patients’ complex social needs are outside the scope of biomedical expertise, and patients with CNCP should not expect PCPs to resolve their problems.”54 The work associated with caring for patients taking opioids was termed by interviewees as “babysitting” rather than “caring,” implying a disconnect from a reciprocal therapeutic PCP–patient relationship.57 Medical trainees interviewed in another qualitative study reported struggling with the legitimacy of the patient’s experience, because it was difficult to know how to appropriately respond and treat the patient when a patient’s pain cannot be measured and quantified except through the patient’s own narrative.52One qualitative study found that PCPs had difficulty navigating broader systemic inequalities affecting patients, resulting in dismissive and stigmatizing perceptions.16 It was suggested in one qualitative study that patients’ empowerment needs were often not adequately addressed, and many patients were simply unaware of self-management strategies available to improve their CNCP.16 There was often a discrepancy in PCPs’ perceptions of adequate pain management; one survey indicated that 82% of physicians were satisfied with their patients’ treatment plans; however, almost the same number of patients with CNCP (79%) noted that their ongoing pain was severe enough that it interfered with their function.43Patients with CNCP were often viewed by PCPs as passive care consumers rather than active partners in their treatment.54 so a commonly reported barrier to effectively managing CNCP was lack of time.62 PCPs reported avoiding opioids due to time required to adequately manage initiation, monitoring, and tapering, and they felt it was a type and volume of work they were unequipped to handle.57Significantly more time is spent with patients with CNCP compared to patients with other ailments,64 PCPs expressed disappointment in medical training that emphasized curing (over caring for) patients as the cornerstone of good medical practice.52 They were also concerned that opioids were taught as the gold standard for pain management while a growing opioid-phobic medical culture urges avoidance of opioids altogether for treating CNCP.57 Medical students interviewed reported insufficient exposure to patients with CNCP, leading them to believe that such patients were “difficult,” and encounters with these patients were perceived to be challenging unpleasant tasks rather than a learning opportunity.52 In this same qualitative study, PCPs reported perceiving previous supervisors and preceptors shielding them from patients with CNCP, giving the impression that such patients had limited educational value.52 In one needs assessment survey, fewer than 10% of PCPs surveyed had taken a course involving CNCP in the past year,61 and another survey reported that 65.7% of PCPs pursued continuing medical education in other topics.54 The absence of a unified training program for PCPs providing a comprehensive approach to treating CNCP was also identified.57 In several qualitative studies, early-career PCPs expressed their interest in learning about skills and strategies necessary for safe opioid prescribing, navigating difficult conversations, and reinforcement of their ability to provide guideline-concordant care.57 However, one of these studies stated that the educational strategies to disseminate guideline recommendations may be inadequate unless they address the interpersonal aspects of patient–provider interactions and PCPs develop skills needed to navigate the multidisciplinary system.11 It was noted in two qualitative studies that current medical education curricula do not prepare PCPs to address the pressing needs of patients with CNCP related to low socioeconomic status but rather that the narrative continues to focus on the dangers of opioids themselves, instead of on adverse social conditions leading to widespread exposure to opioids.57Twelve (46%) studies in this review highlighted PCPs reporting a lack of training in medical school or higher training in treating CNCP.56 interprofessional education workshops,56 online learning modules,59 teleconsultations/electronic consultations,66 and streamlining referral pathways with clear tiered approaches to accessing tertiary pain care, such as Quebec’s Pain Centers of Expertise.Models cited as successful in addressing some gaps of care included Project ECHO interactive tele-mentoring,60 ECHO was regarded as an insightful program to learn about responsible opioid prescribing, weaning, and deprescribing.41 However, PCPs attending workshops on treating CNCP preferred face-to-face interactive learning, including conferences and lectures.56 Workshops highlighting interactive, interdisciplinary, patient-centered continuing education programs were perceived as necessary to fill knowledge gaps, foster mutual acquaintances, develop common discourses among local health care providers, and facilitate appropriate transmission of information among clinicians.51 Another survey reported small groups, online learning, or archived videos as preferred learning formats.59PCPs who attended Project ECHO tele-mentoring sessions reported an increase in overall confidence in managing patients with CNCP, citing decreased stress, learning from interprofessional colleagues, and feeling more empathetic toward their patients during clinical encounters.66 The study that incorporated a randomized control design comparing telephone consultations and usual care found no significant differences in patient outcomes, but PCPs reported satisfaction with the timely feedback on cases and found value in this means of knowledge transfer.65 In another study, e-consults were found to be beneficial in suggesting a new or additional course of action in 74% of cases, with a median response time of 1.9 days, demonstrating a means with which pain clinics may have improved waitlists and PCPs receive timely feedback.63 In a subsequent quality initiative examining e-consults, patients selected from the tertiary pain center waitlists that were appropriate for e-consults  were offered e-consults.66 Twenty-six percent of PCPs indicated that they were interested in this service, and 39% of PCP referrals were found by pain specialists to have questions that could at least be partially be managed by e-consults, demonstrating a practical means with a potential to reduce waitlists.66 PCPs expressed high satisfaction rates with both telephone and e-consults as timely for their patients and an effective means of knowledge transfer.66Alternative means of knowledge transfer was noted in three studies examining telephone consultations or electronic consultations (e-consults) for specific patients whom PCPs had referred to tertiary pain centers.16 This model enabled implementation of standardized consultation forms and evidence-based practice guidelines for the treatment of various types of CNCP syndromes, provided PCPs with tools to virtually discuss challenging clinical patient scenarios with pain specialists, and introduced new communication tools.16Other means of supporting PCPs involves creating efficiencies within the larger health care system. The creation of pain centers of expertise with an integrated and hierarchical continuum of chronic pain services with designated local primary care clinics, designated regional secondary pain clinics, and tertiary centers with multidisciplinary pain treatment centers linked to affiliated rehabilitation centers significantly reduced wait times for patients with CNCP in Quebec.This scoping review identified and synthesized the available literature in understanding PCPs’ perspectives on gaps in care in treating CNCP, including knowledge, skills, attitudes, and health care systems. Our review found 31 publications with consistent themes that could be mapped under four overarching themes: pain medicine competencies and practices, interprofessional collaboration, attitudes and therapeutic relationships, and strategies to reduce gaps in care. The perceived void of care options following the shift in opioid prescribing expectations was the challenge reported with the highest frequency, followed by the need for knowledge around pain assessment, nonpharmacological management, and interprofessional collaboration. The need for additional regional supports, means with which to effectively manage patient encounters to maximize limited time, and ongoing attitudes challenging therapeutic relationships with patients, beginning in basic medical education and carrying over into clinical practice, were consistently reported by PCPs across multiple studies in various regions of Canada. The secondary objective of this review was also achieved through identifying strategies identified by PCPs as useful in reducing some of these gaps in care, predominantly in knowledge dissemination and improving access to specialty care.70 This was felt to aptly complement this scoping review in highlighting roles that PCPs and specialist colleagues need to address in medical education to holistically address gaps identified by PCPs in caring for patients with CNCP. The use of educational frameworks as a bridge between continuing health professions education intended to address complex issues and desired outcomes has been well described in other closely related chronic pain initiatives as a means for achieving demonstrable high-quality changes with regard to patient and population outcomes.72 Though CanMEDS is a framework centered around medical education, it is notable that there are strong parallels to the domains described in the National Nursing Education Framework for nursing education.71 It was thus felt to be conceptually transferable.The four themes identified were deductively coded using the CanMEDS framework as a practical means of reorganizing themes and outlining ways in which medical education at different stages, both prior to entering and throughout practice, can address gaps in care identified by PCPs . As an e64 A stronger pain curriculum in both undergraduate and postgraduate medical education and continuing medical education courses enhancing these skills would also fulfil the CanMEDS role of “medical expert.”With regard to pain medicine education, addressing practice issues in pain assessment, opioid prescribing/deprescribing, and other pharmacological/nonpharmacological management was a clear and frequently reported topic in almost all studies.60 and Joint Adventures,51 and continues to be an underutilized aspect of managing CNCP. Given the issues of limited access to pain specialists and resources, finding ways to weave the skills of many health professionals in treating patients with CNCP is clearly a valuable adjunct to not just improving patient care but also reducing professional isolation.60 Innovative knowledge transfer strategies, whether tele-mentoring or use of technology with e-consults, can both foster increased capacity in PCPs and reduce demand on limited tertiary specialty pain clinics.66 A shared care model in treating CNCP may also lead to a community of support that enables stronger provider–patient relationships,60 supporting clinicians’ growth in the CanMEDS role of “collaborator.”The domain of interprofessional collaboration was present in many of the delivery models reporting high rates of satisfaction, such as Project ECHO16 Sharing expertise between pain medicine specialists and PCPs with ongoing support for PCPs and patients from tertiary pain centers is one approach in improving care of a challenging and undertreated chronic pain population and reducing professional isolation for PCPs.66 This type of initiative also demonstrates the CanMEDS role of “leader” and is worth consideration for adoption in other parts of Canada. Further, though it was not the purpose of this review to speak to challenges of chronic pain management in the international context, because there will certainly be differences attributable to culture, sociopolitical values, economic differences, and variations in medical practice and other factors, international readers may find elements of this review that resonate with some aspects of providing care in their respective countries and thus may find it a useful document to reflect on means with which to address gaps in CNCP care as well.Maximizing local and regional resources also falls under the CanMEDS role of “health advocate.” Though a suggested first step is to reduce disparities in specialized pain care access by increasing the capacity of PCPs to manage CNCP more effectively on their own, more work needs to be done by pain experts and health systems in streamlining referral pathways to access tertiary resources, with Quebec providing one such example.66 This may minimize less complex patient referrals to tertiary centers and increase overall resources for patients with CNCP in general.This also leads to an argument for the growth needed in the role of the CanMEDS role of “communicator,” in which those pain experts providing tertiary care need to provide strong direct communication to PCPs in active shared care of patients with CNCP and present clear plans at time of patient discharge from tertiary care programs. Further, pain experts need to continue to consider ways of reducing prolonged wait times for patients with CNCP, perhaps in part by engaging in the process of educating PCPs in pain medicine, whether through continuing education and mentorship opportunities or on an individual case-by-case basis through virtual consultations with PCPs.59 and this theme is more relational in nature, perhaps requiring a reflection of values in medical training. Several of the publications included in this review highlighted attitudes PCPs have about patients with CNCP and the need for better training in early medical education to shift some of the negative attitudes that learners are exposed to.57 These findings point toward the root causes of reportedly challenging therapeutic relationships with patients with CNCP because of the hidden curriculum in medical education.52 Medical learners need to have exposure to patients with CNCP early on in their training to ensure that they develop skills to manage pain, focusing on “care” not “cure,” and to enlighten learners that these patients do not represent something to be avoided but rather a learning opportunity.52 This baseline expectation of higher standards of behavior with respect for the diverse challenges faced by patients with CNCP care reflects the characteristics of the CanMEDS role of “professional.”This review found that development of therapeutic relationship skills was also desired by PCPs, because the CNCP population continues to be perceived as a more challenging group of patients,56 with the element of developing a support community for PCPs considered important.41 Using multiple ways of learning and continually evaluating the outcomes of their work with dedication to lifelong learning help foster the growth of the CanMEDS role of “scholar.” It would be valuable to consider further scholarly research in this area to expand conceptual thinking, based on models of continuing education, as to why these delivery models are preferred and why they may be more effective in addressing the identified gaps.With regard to preferred delivery models for continuing education of CNCP identified in this review, participants reported a preference for interactive face-to-face workshops over online learning,There are some limitations of this scoping review. First, we did not conduct an extensive gray literature search outside of Google Scholar, which may have elicited further perspectives useful to informing the research question. Second, limiting our search to publications in the English language might have excluded articles published in French as the other official Canadian language, but we noted on subanalysis that this review includes representation of perspectives from the province of Quebec. Third, we excluded literature exploring patient perspectives on what PCPs need to learn about chronic pain, which arguably is an important view on delivering patient-centered care and could easily be considered as a companion review in the future. Fourth, we excluded articles from our results with a tone that was critical of PCPs from the era of high-dose opioid prescribing, but some may argue that these perspectives may still be informative, even though these may no longer be considered best practice. The lens of the CanMEDS framework used to describe how reported gaps translate into opportunities for improvement in patient care from a medical point of view may not be wholly reflective of the values and abilities some subgroups of PCPs, such as nurse practitioners, identify with and assumes a degree of overlap of care values. Last, the use of a scoping review approach, though providing a broad snapshot of the current literature, sacrifices depth and detail that could potentially be valuable in understanding the minutiae of PCPs challenges with managing CNCP. A systematic review would perhaps be a valuable future step in addressing specific questions that arise as a result of this scoping review.73 As patients on high-dose opioids become less commonplace, educational needs will shift, but this review may also be a valuable starting point in further developing undergraduate medical education and continuing education programs. Our results also highlight themes going beyond provider-level knowledge gaps in CNCP care, including shifts needed in attitudes that will optimize patient–provider relationships and systemic issues that currently contribute to challenges experienced both by patients and their PCPs. Actionable initiatives geared toward transforming knowledge, skills, and attitudes can be informed by the issues outlined in this review, which, if combined with system-level changes, can improve outcomes of patients with CNCP in an otherwise underserviced patient population.In our scoping review of PCPs perspectives on barriers in the provision of CNCP care, we found consistent themes emerging in the Canadian literature. Though many of these themes represent anticipated challenges, this review is important in uniting findings from many PCP voices and advancing advocacy for PCPs within our respective regions, as well as at a national level, as we seek to act on recommendations made by the Canadian Pain Taskforce to address chronic pain. Further research may be useful in developing conceptual thought around continuing medical education models effective for PCPs and for addressing large-scale population health problems such as CNCP.This scoping review brings together a cumulative body of literature on Canadian PCP perspectives from coast to coast on various gaps in the provision of CNCP care at a time we collectively seek not just to simply emerge from an opioid crisis but also to move forward with the work proposed by many researchers who came before us in improving the care of patients living with CNCP.


Neck and/or shoulder pain (NSP) frequently occurs together with headache. Therefore, we explored how patients with and without concomitant NSP differ in their baseline characteristics and in perceived treatment responses to an analgesic. An anonymous survey was performed among 895 patients with headache (735 self-reported tension-type headache [TTH]) who used an analgesic fixed-dose combination containing 400 mg ibuprofen and 100 mg caffeine as a non-prescription treatment. NSP was abundant among patients in our survey (60%) and was associated with >1 additional day of headache per month. Patients with NSP reported predominantly sedentary work more frequently than those without (40 vs. 29%); they also reported physical tension/poor posture as a perceived trigger factor more frequently (70 vs. 16%). The reported pain reduction was comparable in those with and without concomitant NSP regardless of whether assessed as mean pain rating , patients experiencing a ≥50% in pain reduction (89.6 vs. 88.8%) or becoming pain-free within 2 h (57 vs. 64%). However, recurrence of pain and use of another dose within the same day were more frequent with than without NSP. We conclude that concomitant NSP is frequent in patients with headache but does not substantially alter responses to a non-prescription medication. Headache is a widespread phenomenon and affects the life of many people. Previous studies have indicated that headaches may commonly be associated with neck and/or shoulder pain (NSP) , 2. A naThe German survey  showed tOTC analgesics are only available in pharmacies in Germany. Thus, pharmacies are promising touchpoints for contacting and running surveys with headache patients to gather information on their complaints and treatment responses to analgesics. Pharmacy-based patient surveys have provided valuable information in the context of TTH and migraine , 6 and oThis non-interventional, prospective survey was run in 126 community pharmacies in Germany between February and June 2019. Patients who had purchased a branded IbuCaff product (Thomapyrin TENSION DUO) containing 400 mg ibuprofen and 100 mg caffeine and who consented were handed a questionnaire. This was to be filled out at the participants' own discretion after intake of IbuCaff to treat a pain episode. This questionnaire was to be sent to the institute that collected and analyzed the data , in an envelope provided to the participant. The survey was anonymous, i.e., no data were collected, which allowed for identifying the participants, and participants did not receive any economical support or discount on the product for participating in the study. Applicable German laws and regulations neither require nor recommend the involvement of an ethical committee for an anonymous survey like this. Accordingly, other German studies based on anonymous pharmacy-based patient surveys also did not involve ethical committee approval , 8, 9.Inclusion criteria were purchase and use of the IbuCaff product, willingness and ability to fill out the questionnaire, usage of the product according to the packaging label, and age of ≥18 years. There were no exclusion criteria. The questionnaire contained – among others – questions on demographic variables (age and gender), days of pain within the last 30 days, days with impaired activities due to pain within the last 30 days, type of pain , analgesics taken in the past for similar pain episodes , pain intensity of the treated episode  with 0 = no pain and 10 = worst pain imaginable), time to onset of pain relief , assessments of time to onset of pain relief , pain 2 h after intake of IbuCaff, intake of another tablet, recurrence of pain within the same day, efficacy, tolerability , and willingness to buy the product again and to recommend it to others. In case of handwritten notes, these were checked for adverse events (AEs). According to the recommendations by the International Headache Society, one important piece of information on the effects of headache treatments is the fraction of patients who become pain-free 2 h after treatment administration, as well as the fraction experiencing partial pain relief after 2 h ; therefop-values for group-wise comparisons were descriptive only and were done with unpaired t-tests , paired t-tests (pre- vs. post-pain intensity), Mann-Whitney tests , or contingency analyses , and depending on the type of data. A preprint of a previous version of the manuscript has been made available at https://www.preprints.org/manuscript/202011.0631/v1. Based on the suggestion of a referee, additional post-hoc analyses were performed to explore the effects of concomitant NSP within the group of headache patients with and without self-reported migraine  based on a statistical analysis plan developed by the authors and using GraphPad Prism, version 9.3.1 (by the authors). Data are reported as means ± SD and/or as medians with interquartile ranges (IQR) for continuous and as a percentage for categorical variables. In line with the exploratory character of the study, no hypothesis-testing statistical analysis was performed as recommended by various guidelines on data robustness , 13. Allaine see .n = 735) and “migraine” (n = 160) were pooled and constituted the efficacy population. In total, 304 participants suffered from headache without NSP and 538 from headache with NSP. All 1,124 subjects constituted the safety population.Among 1,124 participants fulfilling the inclusion criteria and providing analyzable questionnaires, 895 reported using IbuCaff for the treatment of headache and 110 for pain other than headache; no information on the type of pain was given in 119 questionnaires . Since nParticipants suffering from headache with or without NSP had comparable age and gender distributions . Those tWhen asked for the perceived pain triggers, a higher fraction of patients with headache plus NSP reported tension/poor posture as the main trigger of their pain  or to become pain-free . However, recurrence of pain within the same day after the intake of one tablet of IbuCaff was reported by 39% without and 55% with NSP (p < 0.0001). Accordingly, more patients with NSP took another dose of IbuCaff than those without . Although mean pain reduction after 2 h and percentages of patients experiencing pain relief were similar, more headache sufferers with NSP  would recommend IbuCaff to others and were willing to buy it again (93 vs. 84%). The effects of IbuCaff were also similar in the absence and presence of NSP if subgroups of patients with and without self-reported migraine were considered, except that the percentage of patients reporting to be pain-free after 2 h was lower in subjects with migraine (Mean baseline headache pain was greater with NSP than without see  but was migraine .p = 0.6234). This was also applied to the assessment of the perceived speed of onset of pain relief, which was largely rated as very fast or fast (p = 0.6857).The onset of pain relief after intake of the first dose of IbuCaff was similarly reported to occur mostly within 6–15 or 16–30 min in both groups (p = 0.8857). Similarly, perceived tolerability was rated as very good or good by >90% of the 842 survey participants in both groups (p = 0.6857). All patients  gave similar results (very good/good/not so good/ bad: 43/54/3/0.1%). Specific AEs based on handwritten notes include 1 case each of trembling, heart racing, stomach pain, dizziness, and worsened neck pain. One participant reported in the handwritten notes to have taken IbuCaff for the indication of fever, which is an off-label use.Perceived efficacy did not differ relevantly between the two groups and with top ratings (very good/good) in about 90% of subjects ” . PharmacAnother limitation results from relying on self-diagnosis of NSP and headache and, within headache, whether this was migraine or not. Previous research had shown that a large fraction of patients can adequately self-diagnose their type of headache, but some cannot . TherefoFinally, questionnaires directed at patients must use patient-friendly language and should be kept short to ensure maximum participation by the users. For this reason, the questionnaire-mentioned symptoms and triggers in layperson language, e.g., awkward position, but did not provide formal definitions of what these terms mean. This raises the possibility that some participants misinterpreted some terms, which creates a potential limitation for the interpretation of their responses. However, we feel that this is a necessary and useful compromise in the setting of a pharmacy-based patient survey.About 64% of the survey participants suffering from headache also reported NSP. Subjects with and without concomitant NSP were similar in age and gender distribution. However, a greater fraction of participants with NSP reported to mainly work in sedentary positions and had more severe pain on more days per month, with less quality of life. Thus, NSP can be considered an aggravating co-factor for the burden of headache.Not surprisingly, perceived  tension/poor posture was rated as the most frequent trigger of headache and most strongly differentiated subjects with NSP from those without. Other perceived triggers were reported more often by subjects not suffering from NSP, suggesting that tension/poor posture exceeds the importance of other factors in headache sufferers with NSP.In line with the treatments reported by a larger sample of German headache sufferers , patientThe addition of caffeine to analgesics has been recommended for enhanced pain relief  and is gThe onset of pain relief was reported within 15 min in 34–38% and within 30 min in the vast majority of patients (about 78%). This corresponded well with the assessment of the onset of action, which was perceived by 75% (without NSP) and 84% (with NSP) as “very fast” or “fast.” Similar results were reported in a pharmacy-based survey on another caffeine-containing fixed-dose combination  (In general, satisfaction with IbuCaff onset of action, efficacy, and tolerability was rather high. Only very few AEs were reported, and about 97% of participants reported tolerability to be “very good” or “good.” This corresponds well with data from a RCT, where 91% of IbuCaff-treated patients reported tolerability to be “excellent,” “very good,” or “good” [ and dataIn conclusion, the present data confirm the frequent comorbidity between headache and migraine and NSP. They expand our knowledge by demonstrating that concomitant NSP is associated with a worse headache but also that the efficacy of IbuCaff in the treatment of headache is largely maintained in those with NSP. This investigation adds useful information on the perceived effects in patients treating headache with or without NSP in a day-to-day setting. However, several questions remain open that need addressing in future studies. This includes studies in which the type of headache has been confirmed by a healthcare professional and studies on chronic headache. Moreover, it remains to be investigated whether the maintained therapeutic efficacy of IbuCaff in headache/migraine with NSP can be extrapolated to headache/migraine treatments that are not expected to have direct effects on NSP, such as triptans. A third relevant task would be to better understand how headache and NSP are related mechanistically, for instance, the interplay between nociceptive afferents and sensitization of trigeminocervical neurons . FinallyThe raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.Ethical review and approval was not required for the study on human participants in accordance with the local legislation and institutional requirements. The patients/participants provided their written informed consent to participate in this study.CG supported the preparation of the survey, analyzed, and interpreted the data and read, commented, and approved the manuscript. HG was involved in the conceptualization of the work, implemented the project, such as collection, analysis, and interpretation of the data, and revised and approved the manuscript. TW was involved in the conceptualization of the work, the analysis and interpretation of the data, contributed to the manuscript concept, and revised and approved the manuscript. MM developed the statistical analysis plan and drafted the manuscript. AL was involved in the conceptualization of the work, interpretation of the data, and revised and approved the manuscript. MP was involved in the conceptualization of the work, contributed to the primary manuscript concept, and had the overall supervision of the project. SF supported the preparation of the survey, analyzed, and interpreted the data and read, commented, and approved the manuscript. All authors have contributed to the manuscript draft for critical intellectual content and read and approved the final manuscript version.The underlying survey had been funded by Sanofi-Aventis Germany GmbH.CG has received honoraria for consulting and lectures within the past 3 years from Allergan, Eli Lilly, Grünenthal, Hormosan, Lundbeck Perfood, Novartis Pharma, Sanofi-Aventis, TEVA, and Weber & Weber; he is honorary secretary of the German Migraine and Headache Society. HG, TW, AL, and MP are employees of Sanofi-Aventis Deutschland GmbH. MM is a consultant for Sanofi-Aventis Deutschland GmbH. SF received consultant, speaker, and/or advisory board member honoraria from Eli Lilly, Hormosan, Lundbeck, Novartis, Sanofi-Aventis, and Teva.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Adjacent-segment disease (ASD) is common in patients undergone previous lumbar fusion. A typical revision treatment from posterior approach requires management of postoperative scar tissue and previously implanted instrumentation. An oblique lumbar interbody fusion (OLIF) approach allows surgeon to reduce the potential risk of posterior approach. This study aimed to analyze the clinical and radiographic efficacy of stand-alone OLIF for the treatment of lumbar adjacent-segment disease.A total of 13 consecutive patients who underwent stand-alone OLIF for the treatment of adjacent-segment disease from December 2016 to January 2019 were reviewed. Visual analog scale (VAS) of back pain and leg pain and the Oswestry Disability Index (ODI) before surgery and at last postoperative clinic visits were obtained. Radiography, CT and MRI before and at last follow-up after surgery was evaluated in all patients.P < 0.01), and the leg pain VAS improved from 7.0 ± 1.9 to 1.0 ± 0.9 (P < 0.01). ODI improved from 28.0 ± 7.5 to 10.8 ± 4.0 (P < 0.01). The disc height (DH) increased from 9 ± 2 to 12 ± 2 mm (P < 0.01), the cross-sectional area (CSA) of spinal canal increased from 85 ± 26 to 132 ± 24 mm2 (P < 0.01), the foraminal height increased from 17 ± 2 to 21 ± 3 mm (P < 0.01) and the CSA of foramen increased from 95 ± 25 to 155 ± 36 mm2 (P < 0.01). Cage subsidence was observed in 2 cases.During the study period, 13 cases were successfully treated with stand-alone OLIF. The mean follow-up was 17.7 ± 8.3 months. The back pain VAS improved from 6.2 ± 1.0 to 2.0 ± 1.1 (Stand-alone OLIF provides a safe and effective alternative way to treat ASD. Adjacent-segment disease (ASD) is a common phenomenon following lumbar spinal fusion . The devOperative management to achieve decompression and stabilization for symptomatic ASD should be considered after failure of non-operative management . TraditiHere, we report a consecutive series of patients who had undergone stand-alone OLIF without additional instrumentation to achieve indirect decompression and stabilization for ASD and evaluate the clinical and radiographic efficacy of this approach.This is a retrospective study. A total of 13 consecutive patients who had undergone stand-alone OLIF for ASD after lumbar fusion in Xuanwu Hospital between December 2016 and January 2019 were included in this study based on the following inclusion criteria: (I) clinical and radiographic findings as reported by Cheh et al. were consistent with progressive degeneration at the adjacent spinal level with associated new back and/or leg symptoms , as similarly described in previous reports . The patBack and leg pain was evaluated according to the visual analog scale (VAS). The Oswestry Disability Index (ODI) before surgery and at last routine postoperative clinic visits were also compared. Achievement of minimum clinically important difference (MCID) was evaluated using following thresholds: ODI 10, back pain VAS 2.1, leg pain VAS 2.8. Radio , 23 grap2. All of the cases were successfully treated with stand-alone OLIF. The mean operation time was 64.9 ± 18.9 mins. The mean blood loss was 22.3 ± 8.6 mL. Hospital stay post operation was 3.8 ± 0.8 days. The mean follow-up was 17.7 ± 8.3 months. The mean follow-up time after operation was 17.7 ± 8.3 months. Demographic and operative characteristics of the patients was shown in The 13 consecutive patients were included in this study. The mean patient age was 68.5 ± 8.7 years. The mean BMI (Body Mass Index) was 26.5 ± 3.2 Kg/mP < 0.01, P < 0.01, Low back pain, leg pain evaluated by VAS were significantly improved at last follow-up after surgery compared with before surgery  between the preoperative and final follow-up radiographs. Global lumbar lordosis (L1–S1) increased from 34.8° ± 13.5° to 40.8° ± 10.0° (P < 0.05) comparing preoperative and last follow-up radiographs  may be performed. However, this approach risks iatrogenic destabilization adjacent to a fused construct and increases the risk of recurrent ASD . A more The standard of care in ASD remains structural stabilization, or extension of the construct, and decompression , 35. ThuZhu et al. compared stand-alone oblique lumbar interbody fusion with posterior lumbar interbody fusion for revision of rostral adjacent segment disease and concluded that OLIF was effective and safe for the treatment of rostral ASD following prior posterior lumbar fusion, and is superior to PLIF in terms of perioperative parameters, short-term clinical outcomes, and DH restoration, with similar fusion and reduction rates . In our A major concern regarding the use of stand-alone OLIF is that the construct may not be strong enough to promote fusion, and prevent the interbody cages from subsidence. As we all know, indirect neural decompression in OLIF was achieved by reduction of disc bulging and elongation of the hypertrophied ligamentum flavum through the restoration of DH . Cage suThere are several limitations to this study. With regard to the relief of neurological symptoms of stenosis, the OLIF approach relies entirely on indirect decompression by elevating intervertebral disc height, which expands the neuroforamen and tensions the ligaments to open the central canal. While we found excellent clinical and radiographic results, one might expect this approach to be occasionally inadequate in cases of severe stenosis, as well as in cases without severe disc collapse. A larger study with a wider variety of specific pathologies would be helpful to validate this technique across the broad spectrum of ASD. Another limitation relates to our ability to ascertain definitive fusion. In this series, we used reconstructed CT scans to identify bridging bone between the treated vertebral bodies as the determinant of fusion. However, a follow-up longer than 2 years would also be helpful as well, as an osseous nonunion would likely become more apparent clinically or radiographically over more protracted periods of time.This limited study suggests that OLIF using a stand-alone construct may be a safe and effective alternative way in treating ASD following a previous lumbar fusion. The approach can achieve adequate indirect neural decompression, satisfied clinical outcome as well as solid arthrodesis without supplemental fixation.The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s.The studies involving human participants were reviewed and approved by the Ethics Committee of Xuanwu Hospital of Capital Medical University. The patients/participants provided their written informed consent to participate in this study. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.WK is responsible for the writing of the paper. CC is responsible for the search for data and the inclusion of cases. QY is responsible for the design of the study. CZ is responsible for the evaluation of the results. FJ is responsible for the statistics of the data. HW is the instructor of the entire study. All authors contributed to the article and approved the submitted version.This research was supported by the Beijing Natural Science Foundation of China, the Beijing Natural Science Foundation of China Joint Project (KZ20191025028).The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Medical cannabis is becoming an acceptable treatment modality in medicine, especially for pain relief. Concurrently, cannabis use is becoming more prevalent worldwide, a public demand-driven trend despite the lack of established scientific basis. This observational open-label study sought to investigate the effectiveness of cannabis therapy for alleviating low back pain symptoms.9-tetrahydrocannabinol (THC)-rich smoked inflorescence (whole dried cannabis flowers) was administered for 12 months.Two types of cannabis treatment modalities were sequentially administered to chronic low back pain patients. After an initial 1-month washout period (WO1), the first modality was cannabidiol (CBD)-rich sublingual extract treatment administered for 10 months. Following another washout period, the second modality, ΔEnrolled in the study were 24 patients whose advanced imaging studies (i.e. computerized tomography or magnetic resonance imaging of the lumbar spine) revealed disc herniation or spinal stenosis. Three patients dropped out of extract therapy treatment but resumed study participation to receive THC-rich smoking therapy. After a minimum of 2 years, cannabis therapy had reduced lower back pain symptoms, as assessed by Oswestry Disability Index, the SF-12 patient-reported outcome questionnaire, and the visual analogue scale. Pain reduction was not significant during the extract treatment part of the study; however, pain reduction was significant during the inhaled therapy part of the study.Our findings indicate that inhaled THC-rich therapy is more effective than CBD-rich sublingual extract therapy for treating low back pain and that cannabis therapy is safe and effective for chronic low back pain. Medical cannabis is rapidly becoming an acceptable treatment modality,9-tetrahydrocannabinol (THC)-dominant and 17% were cannabidiol (CBD)-dominant. Despite unchanged pain intensities, there was a reported decrease in analgesic medication consumption and an increased quality of life, which coincided with higher doses of THC and the alpha-pinene terpene.Positive anecdotal outcomes reported by cannabis self-medicating individuals have propelled further studies of cannabinoid effect(s) on pain.n=3,544) that reported reduced medications use at six months, among which opioid use was reduced by 52.5%, analgesics by 39.2%, antipsychotics by 36.9%, antiepileptics by 35.7%, and hypnotics and sedatives were reduced by 35.3%.13Additionally, the interactions among (intra-entourage effect) and between (inter-entourage effect) the phytoconstituents of cannabis cultivars  may interfere with desired treatment outcomes, and therefore should be studied for each clinical indication.Cannabis can be administered in multiple ways. In Israel, inhaled cannabis is the dominant consumption modality. An alternative modality is extract administered sublingually. Oral consumption as edibles is reserved for children and was not relevant to the current study population.n=1,087) found that 58% of those surveyed used it to mitigate back pain, 36.1% used inhalation therapy, 45.1% used both inhalation and non-inhalation therapy, and 18.8% used non-inhalation therapy only.Treating pain with sublingually administered cannabis extracts is preferred by many physicians, as it may be regarded as easier to obtain from the pharmacy, and to consume. Sublingual administration might also have the benefit of a more consistent dosing regimen while avoiding the adverse effects of smoking. The authors’ real-world clinical experience indicates a relative lack of efficiency of sublingual extract treatments compared to smoking. Most patients seem to prefer smoking cannabis to extract consumption for pain relief. This preference seems to be supported by recent data released by the Medical Cannabis Unit of the IMOH for January and February 2022. In reporting the total number of licenses issued for medical cannabis products, they noted that 89.5% and 89.7% of the licenses were for dried inflorescences in January and February, respectively, while only 10.3% and 10.1% were for extracts, respectively.Currently, clinical trials data that compare administration methods are sparse. The current study was performed to assess the effect(s) of sublingual cannabis extract on low-back pain (LBP) as opposed to inhalation by smoking.This observational open-label study was conducted from 2017 to 2019 at the orthopedic clinic of Rabin Medical Center Golda Hasharon Campus, Petah Tikva, Israel. This study was conducted in full compliance and following the ICH-GCP standards and the ISO14155 Declaration of Helsinki ethical standard requirements .Patients considered eligible for the study signed a consent form to receive cannabis extract therapy (high CBD-to-THC ratio) and possibly, if clinically indicated, to receive dried inflorescence (high THC-to-CBD ratio) in the second phase of the study.Inclusion and exclusion criteria for the study were aligned with the IMOH regulations and requirements for receiving CB therapy . All patAfter study enrollment, all patients underwent an initial one-month washout period (WO1) to ensure they were in a cannabis-free symptom steady state. During WO1, analgesic medication regimens were continued as before, but all cannabis use was prohibited. After WO1, phase 1 (P1) of the study was initiated and sublingual cannabis extract was administered for 10 months using a personally adjusted slow titration protocol for each participant, based on clinical evaluations. At the end of 10 months, all participants underwent a second one-month washout period (WO2), after which phase 2 (P2) was initiated and patients were switched to smoked cannabis. This latter treatment continued indefinitely, with subsequent evaluations performed every six months .Study participants were allowed to use pain rescue medications as follows: tramadol (up to 300 mg per day), oxycodone , or acetaminophen .Cannabis-based products were supplied by an IMOH-approved medical cannabis manufacturer; this ensured administration of products similar to those available in Israeli pharmacies serving medical cannabis patients for all approved indications. It should be noted that, in Israel, manufacturers are required to label THC, CBD, and cannabinol content and the dates of manufacture, packaging, and expiration. No other labeling regarding other phytoconstituents is currently required by law, despite their bioactive activity and effects.2 extract of CBD-rich cultivar (CBD 16%: THC 0%), to which a supracritical CO2 extract from a THC-rich hybrid cultivar was added , for a final CBD:THC ratio mix of 6:1. The initial concentration was 30 mg CBD and 5 mg THC per milliliter (20 drops per mL).The cannabis extract used for P1 was a supracritical CODuring P2, the initial inhaled cannabis dosage was 20 g dried inflorescences per month (~600 mg/day), as balanced mixed cultivars with a final concentration of 10%±4% THC:10%±4% CBD . Two inflorescence brands were initially recommended to study participants: Argaman  or Paris .At one month after inflorescence-use initiation, the concentration was modified, when clinically indicated, to 20%±4% THC:4%±4% CBD . Dose increase criterion was based on a Brief Pain Inventory (BPI) intensity score or interference score >6.The recommended regimen ranged between 10 g and 20 g of Indica chemovar and 10 g of Sativa chemovar. The recommended Sativa brands for Sativa were either Tchelet brand  or Alaska brand . The recommended Indica chemovars were either Erez brand  or Roma brand  was 5 mg CBD:0.833 mg THC. Every week, the total daily dose was increased, starting at 10 mg CBD:1.67 mg THC after one week, 20 mg CBD:3.4 mg THC after two weeks, and the maximal dose of 30 mg CBD:5 mg THC TID after three weeks. This last-mentioned dose was administered until the end of the 10-month cannabis extract treatment period.If a participant experienced side effects or intolerance, the dose was reduced to the previously tolerated level. When possible, and based on the physician’s evaluation of the participant, another dose escalation was tried after three days.Before beginning phase 2, patients were advised not to use cannabis with tobacco. The recommended dosage schedule was from TID up to four times a day. Participants were informed that Indica-based chemovars were preferred for use at night and hybrid/Sativa-weighted chemovars during the day.The initial smoked cannabis regimen comprised dried inflorescences conforming to IMOH class 10% CBD:10% THC dosage. Participants were provided information regarding the recommended chemovars.Therapy was initiated at 0.6 g per day per the IMOH guidelines, representing a theoretical daily dose of 100 mg CBD:100 mg THC. However, since only part of the smoked cannabis enters the lungs, the actual inhaled amount is less.An increased concentration was considered based on a pain questionnaire completed by each patient. After a minimum of 1 month, a dosage increase was considered for patients whose pain was unresponsive to inhaled therapy . According to clinical need, following three months of smoking therapy, the treatment concentration was changed to 20%±4% THC and 4%±4% CBD (30 g). At subsequent time-points, dosages were increased in 10-g increments every three months, up to a maximum dose of 60 g inflorescences per month (representing around 2 g per day). Dosage increase was considered only if clinically indicated according to BPI scores.Patients were assessed at study enrollment, at the end of WO1, and at 3, 6, 11 (before WO1), 12 (after WO1), 18, and 24 months thereafter. Participant assessment data included body weight, blood pressure, a general physical examination, and completion of the following questionnaires: (1) patient-reported outcome SF-12 version-1 questionnaire (SF-12v1), a health-related quality of life questionnaire that assessed health domains and evaluated both a physical component score (PCS) and the mental component score (MCS)During the study, analgesics consumption and changes in usage patterns were recorded and converted into morphine-equivalent units (MEU) per the Faculty of Pain Management of the Royal College of Anaesthetists guidelines.15Statistical analysis was performed using Analyse-it for Excel 5.90 2021) . Questionnaire scores were analyzed by analysis of variance (ANOVA) for repeated measures to determine any significant differences between data groups. The Tukey–Kramer all-pair comparison was used to ensure the significance of any particular-pair difference. Treatment of missing values was by the last observation carried forward (LOCF) method as described by Mavridis et al., . The participant sex distribution was 17 males and 7 females; body mass index averaged 27.9±5.1.n=8), hypertension (n=9), hypercholesterolemia (n=6), moderate chronic obstructive pulmonary disease (n=2), ischemic heart disease (n=6), and peripheral vascular disease (n=1); one patient was a cancer survivor .Participants had an average of 2±1 concomitant chronic disorders as follows: diabetes (n=24), herniated discs (n= 16), sequestered discs (n=2), spinal stenosis (n=7), degenerative facet disease (n=5), grade 1 spondylolisthesis (n=2); no participants had evidence of a spinal neoplasm.Advanced imaging studies confirmed possible pain-causing abnormalities in all participants, as follows: bulging discs . During the extract therapy phase, this decrease was not significant and averaged 12.3% . The change in VAS was significant at 12–24 months and 12–18 months . Although the ODI decrease during P1 was not significant and averaged 5.4% , the decrease became significant for months 12–24 and 12–18  to 36.9±19 at 24 months (ANOVA nd 12–18 .P<0.002). There was a significant difference between months 0, 18, and 24. Additionally, a trend for significance was found for the difference between 0–6 and 0–12 months (P>0.09)  . The PCS(P>0.09) . Again, The 21 patients who completed P1 reached the maximal planned extract dosage (30 mg CBD:5 mg THC) . This waP<0.007)  decline in analgesic usage patterns. However, during P2, a significant decline of 65.8±18.1 MEU (95% CI 11.7–117.1) was observed (P<0.007) .While all 24 patients reported experiencing “red eyes,” no serious adverse events were recorded. No patient underwent surgery or had required spinal injections during the study period. Reported minor adverse events were: nausea, dizziness, and fatigue during the extract phase; sore throat during the inhalation phase; and drowsiness during both phases .The results of this study suggest that CB therapy is an efficacious treatment for LBP. First et al. reviewed 124 research papers and noted a sparsity of information regarding the effect of cannabis therapy on LBP symptomatology.23Our results also indicated that THC-rich smoked-cannabis inflorescence was more effective than CBD-rich cannabis-extracts for inducing symptom relief in LBP. However, due to the study design, it was impossible to rule out the possible clinical benefit of the extracts, which may have required a longer treatment duration. In addition, since the P2 smoked-cannabis therapy followed P1 extract therapy, it is possible that the longer duration of P2 treatment led to the eventual improvement in LBP symptoms.The dried inflorescences dispensed to patients in our study had a higher THC concentration and lower CBD concentration; hence, our results suggest that THC has a positive effect in alleviating pain when consumed in accordance with the study protocol. Furthermore, the results of this study suggest that a high THC:CBD ratio is more advantageous for a therapeutic effect in LBP. Interestingly, a meta-analysis of 33 orthopedic studies suggested that results appeared to be efficacious in non-controlled studies, while appearing mixed in controlled randomized studies24A retrospective study of cannabis extracts demonstrated anecdotal evidence of decreased pain levels and improved sleep using THC-rich cannabis extract preparations (up to 82% THC)n=127) of its patients who reported using CBG-predominant CB products to treat chronic pain had significantly less withdrawal symptoms compared to non-CBG-predominant products.With regard to pain, one study has suggested further investigation of cannabigerol (CBG)-predominant CB treatments (>50% CBG), also unavailable in Israel, since 40.9% n=1 of its pThis current study included 7 (29%) females and 17 males (71%). The most commonly reported adverse events during P1 were nausea, sore throat, drowsiness, dizziness, and fatigue, all of which were transient and disappeared after dose tolerance was achieved. Most of these adverse effects were noted in female patients. Interestingly, females have been reported to have more adverse effects than males, despite presenting with pain intensities similar to those of males.13Cannabidiol was also evaluated with regard to LBP. Two recent reviews noted that patients had reported a beneficial effect on chronic pain after CBD treatments; both reviews also noted that studies of CBD-rich treatments for pain were both scarce and limited, since dosing, dosing frequency, or dose combinations were not fully explored.23The results of our study showed a significant improvement in LBP, as demonstrated by VAS, ODI, MCS, and PCS scores at 24 months. When comparing our results to those of other studies, it is important to note that some of the results were non-significant at the 12-month time-point. Nevertheless, another study with 4,166 participants receiving various cannabis treatments for different indications demonstrated that the pain intensity at six months was improved for 74.7% of their cohort and did not change for 17.8%. Moreover, of their 1,580 patients treated for CNNCP, 85.9% experienced a ≥30% improvement on the VAS pain scale, and 59.3% a >50% improvement.13The high variability existing between and among cannabis strains and chemovars complicates defining the “ideal” strain in a specific clinical situation.28n= 4,364) in which patients had limited CB product options from which to choose also demonstrates the complex multiplicity of treatment options.13A recent six-month observational study (n=151) evaluating the benefits of 10 mg THC:10 mg CBD cannabis extract on chronic refractory pain over 3 months reported improved pain impact scores in 47.9% of participants, unchanged scores in 28.8%, and worse scores in 23.3%; pain intensity had improved for 32.9%, remained unchanged for 45.2%, and worsened for 21.9% of the participants. The authors suggested that the reduced pain intensity influenced the patients’ quality of life, which was not reflected in the pain intensity measurements.n=3,544) reported a reduction of pain medications at 6 months, including reduction in opioid use by 52.5%, in other analgesics by 39.2%, in anti-psychotics by 36.9%, in anti-epileptics by 35.7%, and in hypnotics and sedatives by 35.3%.13In our study, six months into P1, 21 participants had achieved the maximal dosage of 1 mL extract (30 mg CBD:5 mg THC), which had been titered up from 10 mg THC:10 mg CBD extracts; 3 participants  had dropped out due to insufficient pain relief . During The monthly CB dosage distribution of all patients in the current study  was rela3In Israel there is no actual control over CB product purchases, and patients may choose from a variety of approved CB products in accordance with their cannabis prescription, which can be filled by authorized pharmacies. A standard prescription specifies the product types, grams per month, and THC:CBD ratio permitted, but not the other bioactive phytoconstituents of cannabis such as terpenes or flavonoids, which may influence treatment outcomes. Patients in Israel are not required to report which product they purchase, and CB labeling does not provide data regarding phytoconstituents other than THC, CBD, and cannabinol. Similarly, our study did not analyze CB products for chemical or toxicological phytoconstituents; hence, the chemovar characteristics that may have been beneficial to participants could not be determined. To minimize potential participant dissatisfaction with specific chemovars, the authors recommended specific ones based on their previous experience with those chemovars in LBP patients. While Israeli patients are not bound by this recommendation, they do tend to adhere to the recommended chemovar when available at pharmacies. A patient’s freedom to choose any chemovar is a disadvantage of the current study; however, this study represents real-world experience as distinguished from participants being supplied with a single chemovar. While this created some undesirable treatment variability, it increased the likelihood of participant compliance.Another study limitation was the sample size. There are few studies that directly assess the effectiveness of CB treatments for LBP, and even fewer studies of two years’ duration and above. This study aimed to contribute to the growing knowledge in the field, and to support further studies involving larger numbers of patients for a longer duration, and with different cohorts to further elucidate knowledge regarding CB treatment modalities. With regard to sex distribution, although the male:female ratio in this study favored male patients, we do call for sex-balanced studies for the benefit of the general population.The current study is the first, to our knowledge, to indicate that THC-rich smoked therapy is more advantageous in ameliorating LBP, than low THC CBD-rich sublingual extracts. Despite the small number of patients, our data indicate that THC-rich smoked therapy is helpful in mitigating LBP. The relative strength of this study was its medium duration (up to 2 years), patient follow-ups, and multidimensional assessments that included physical and mental function, and pain and disability assessment. Further studies should be performed to assess the possible effect of THC-rich sublingual extracts compared with CBD-rich sublingual extracts for LBP treatment.