Hyperbaric Oxygen for Lower Limb Trauma (HOLLT): an international multi-centre randomised clinical trial.

INTRODUCTION: Hyperbaric oxygen treatment (HBOT) is sometimes used in the management of open fractures and severe soft tissue crush injury, aiming to reduce complications and improve outcomes. METHODS: Patients with open tibial fractures were randomly assigned within 48 hours of injury to receive standard trauma care or standard care plus 12 sessions of HBOT. The primary outcome was the incidence of necrosis or infection or both occurring within 14 days of injury. RESULTS: One-hundred and twenty patients were enrolled. Intention to treat primary outcome occurred in 25/58 HBOT assigned patients and 34/59 controls (43% vs 58%, odds ratio (OR) 0.55, 95% confidence interval (CI) 0.25 to 1.18, P = 0.12). Tissue necrosis occurred in 29% of HBOT patients and 53% of controls (OR 0.35, 95% CI 0.16 to 0.78, P = 0.01). There were fewer late complications in patients receiving HBOT (6/53 vs 18/52, OR 0.22, 95% CI 0.08 to 0.64, P = 0.007) including delayed fracture union (5/53 vs 13/52, OR 0.31, 95% CI 0.10 to 0.95, P = 0.04). Quality of life measures at one and two years were superior in HBOT patients. The mean score difference in short form 36 was 2.90, 95% CI 1.03 to 4.77, P = 0.002, in the short musculoskeletal function assessment (SMFA) was 2.54, 95% CI 0.62 to 4.46, P = 0.01; and in SMFA daily activities was 19.51, 95% CI 0.06 to 21.08, P = 0.05. CONCLUSIONS: In severe lower limb trauma, early HBOT reduces tissue necrosis and the likelihood of long-term complications, and improves functional outcomes. Future research should focus on optimal dosage and whether HBOT has benefits for other injury types.

Features and methods to discriminate between mechanism-based categories of pain experienced in the musculoskeletal system: a Delphi expert consensus study.

ABSTRACT: Classification of musculoskeletal pain based on underlying pain mechanisms (nociceptive, neuropathic, and nociplastic pain) is challenging. In the absence of a gold standard, verification of features that could aid in discrimination between these mechanisms in clinical practice and research depends on expert consensus. This Delphi expert consensus study aimed to: (1) identify features and assessment findings that are unique to a pain mechanism category or shared between no more than 2 categories and (2) develop a ranked list of candidate features that could potentially discriminate between pain mechanisms. A group of international experts were recruited based on their expertise in the field of pain. The Delphi process involved 2 rounds: round 1 assessed expert opinion on features that are unique to a pain mechanism category or shared between 2 (based on a 40% agreement threshold); and round 2 reviewed features that failed to reach consensus, evaluated additional features, and considered wording changes. Forty-nine international experts representing a wide range of disciplines participated. Consensus was reached for 196 of 292 features presented to the panel (clinical examination-134 features, quantitative sensory testing-34, imaging and diagnostic testing-14, and pain-type questionnaires-14). From the 196 features, consensus was reached for 76 features as unique to nociceptive (17), neuropathic (37), or nociplastic (22) pain mechanisms and 120 features as shared between pairs of pain mechanism categories (78 for neuropathic and nociplastic pain). This consensus study generated a list of potential candidate features that are likely to aid in discrimination between types of musculoskeletal pain.

Impact of the Opioid Epidemic and Associated Prescribing Restrictions on People Who Live With Chronic Noncancer Pain in Canada.

OBJECTIVES: Little is known about the consequences of the opioid epidemic on people living with chronic noncancer pain (CNCP). This study examined this issue in people who lived in the most impacted province by opioid overdoses in Canada (British Columbia [BC]) or one of the least impacted (Quebec [QC]), and examined the factors associated with opioid use. MATERIALS AND METHODS: This cross-sectional study was carried out in adults living in BC (N=304) and QC (N=1071) who reported CNCP (≥3 months) and completed an online questionnaire that was tailored to their opioid status. RESULTS: Almost twice as many participants in BC as in QC were proposed to cease their opioid medication in the past year (P<0.001). The proportion who reported having hoarded opioids in fear of not being able to get more in the future was also significantly higher in BC (P<0.001) compared with QC. In addition, they were significantly more likely to have had their opioid dose decreased than those in QC (P=0.001). No significant association was found between opioid discontinuation and province of residence. Two-thirds of the BC participants felt that the media coverage of the opioid crisis was very to extremely detrimental to CNCP patients in general, this percentage being significantly higher than in QC (P<0.001). DISCUSSION: The opioid epidemic and associated prescribing restrictions have had harmful effects on Canadians with CNCP. The clinical community, the general public, and the media need to be aware of these negative consequences to decrease patients' stigmatization and minimize inadequate treatment of CNCP.

COVID-19 impact and response by Canadian pain clinics: A national survey of adult pain clinics.

Background: As the result of public health authority responses to the COVID-19 pandemic, pain clinics have had to cease providing in-person appointments to reduce contact between patients and staff. Over the past decade, Canadians living with chronic pain have faced long waiting times for care within multidisciplinary pain clinics. We are concerned that ceasing in-person pain services exacerbates the daily hardships already faced by Canadians living with chronic pain. Aims: The aim of this study was to evaluate the impact of the COVID-19 pandemic on Canadian pain clinics, their responses, and changes to clinic practices that might be maintained when the pandemic is over. Methods: A survey of Canadian adult multidisciplinary pain clinics was conducted to determine impacts on medical and allied health care services and the strategies used to deliver care to patients during the COVID-19 pandemic. Results: Responses received from 17 adult pain clinics across Canada showed that adult multidisciplinary pain clinics had to cease or significantly reduce in-person patient contacts during the COVID-19 pandemic and responded by offering telehealth options. Despite their efforts, patients are waiting longer and have lost access to usual care. Increased levels of pain, stress, and medication use, particularly opioids and cannabinoids, were reported. Conclusions: Access to adaptable and innovative technologies, such as telehealth, can assist in the care of the one in five Canadians living with chronic pain during times of crises and must be included as a vital component of a comprehensive Canadian pain strategy.

Contexte: Suite aux mesures prises par les autorités de santé publique en réponse à la pandémie de COVID-19, les cliniques antidouleur ont dû cesser de proposer des rendez-vous en personne afin de réduire les contacts entre les patients et le personnel. Au cours de la dernière décennie, les Canadiens vivant avec la douleur chronique ont dû faire face à de longs délais d'attente pour obtenir des soins dans les cliniques antidouleur multidisciplinaires. Nous sommes préoccupés par le fait que l'arrêt des services antidouleur en personne exacerbe les difficultés quotidiennes auxquelles sont déjà confrontés les Canadiens qui vivent avec la douleur chronique.Objectifs: Cette étude visait à évaluer les repercussions de la pandémie de COVID-19 sur les cliniques antidouleur au Canada, leurs réactions et les changements dans leurs pratiques qui pourraient être maintenus en raison de la pandémie.Méthodes: Une enquête a été menée auprès des cliniques antidouleur multidisciplinaires pour adultes au Canada afin de determiner les répercussions sur les services médicaux et les services paramédicaux, ainsi que les strategies utilisées pout fournir des soins de santé aux patients pendant la pandémie de COVID-19.Résultats: Les réponses reçues de 17 cliniques antidouleur pour adultes au Canada ont montré que les cliniques antidouleur multidisciplinaires pour adultes avaient dû cesser ou réduire considérablement les contacts en personne avec les patients pendant la COVID-19 et qu'elles ont réagi en proposant des options de télésanté. Malgré leurs efforts, les patients attendent plus longtemps et n'ont plus accès aux soins habituels. L'augmentation des niveaux de douleur, de stress et de médication, en particulier les opioïdes et les cannabioïdes, a été signalée.Conclusion: L'accès à des technologies adaptables et innovantes, telles que la télésanté, peut contribuer aux soins des 20 % de Canadiens vivant avecla douleur chronique en période de crise et doit constituer un élément essentiel d'une stratégie canadienne globale de lutte contre la douleur.

Evidence-Based Recommendations on the Pharmacological Management of Osteoarthritis and Chronic Low Back Pain: An Asian Consensus

The overall burden of chronic musculoskeletal pain in Asian countries will continue to increase as the population ages, as will the demand for safe and effective pain management. Currently available Asian guidelines are mostly outdated and targeted only to primary care. Implementation of international guidelines may be unsuitable for Asian patients due to cultural, local economic and regulatory factors. With the aim of developing Asian-specifi c consensus recommendations for the pharmacological management of osteoarthritis (OA) pain and chronic low back pain (cLBP), we convened to review and discuss recent available evidence for pharmacotherapy, clinical experiences, and current practice challenges they face in the region, including challenges in opioid use. Taking these into consideration, we provided general recommendations for the overall assessment and management of OA pain and cLBP. The strength of the recommendations regarding the use of pharmacological agents was assessed using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system. Where evidence is confl icting or limited, we made no recommendation pending the availability of further evidence. We recommend topical non-steroidal anti-infl ammatory drugs (NSAIDs) as a fi rst-line pharmacological treatment of OA pain, while oral NSAIDs should be considered as a fi rst-line pharmacological treatment of cLBP. Acetaminophen has been commonly used as the fi rst-line treatment for OA pain and cLBP, but its long-term use is not recommended based on recent evidence. These consensus recommendations are not prescriptive, and serve as a guide for decision-making in clinical practice. The optimal management of OA pain and cLBP should ultimately be individualized to each patient.

Pharmacological management of chronic neuropathic pain: revised consensus statement from the Canadian Pain Society.

BACKGROUND: Neuropathic pain (NeP), redefined as pain caused by a lesion or a disease of the somatosensory system, is a disabling condition that affects approximately two million Canadians. OBJECTIVE: To review the randomized controlled trials (RCTs) and systematic reviews related to the pharmacological management of NeP to develop a revised evidence-based consensus statement on its management. METHODS: RCTs, systematic reviews and existing guidelines on the pharmacological management of NeP were evaluated at a consensus meeting in May 2012 and updated until September 2013. Medications were recommended in the consensus statement if their analgesic efficacy was supported by at least one methodologically sound RCT (class I or class II) showing significant benefit relative to placebo or another relevant control group. Recommendations for treatment were based on the degree of evidence of analgesic efficacy, safety and ease of use. RESULTS: Analgesic agents recommended for first-line treatments are gabapentinoids (gabapentin and pregabalin), tricyclic antidepressants and serotonin noradrenaline reuptake inhibitors. Tramadol and controlled-release opioid analgesics are recommended as second-line treatments for moderate to severe pain. Cannabinoids are now recommended as third-line treatments. Recommended fourth-line treatments include methadone, anticonvulsants with lesser evidence of efficacy (eg, lamotrigine, lacosamide), tapentadol and botulinum toxin. There is support for some analgesic combinations in selected NeP conditions. CONCLUSIONS: These guidelines provide an updated, stepwise approach to the pharmacological management of NeP. Treatment should be individualized for each patient based on efficacy, side-effect profile and drug accessibility, including cost. Additional studies are required to examine head-to-head comparisons among analgesics, combinations of analgesics, long-term outcomes and treatment of pediatric, geriatric and central NeP.

Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials.

BACKGROUND: Knowing when to change pain-medication strategy is not well researched and remains a gap in treating chronic pain. OBJECTIVE: Our aim was to determine how long to treat osteoarthritis (OA) knee pain and chronic low back pain (CLBP) with duloxetine before considering a change in medication strategy. METHODS: We employed a post hoc analysis of changes in pain-severity data from placebo-controlled studies of duloxetine treatment in nondepressed patients with OA knee pain and CLBP. The studies were selected for inclusion in the analyses based on similarity of study design. Pain severity was recorded daily in patient diaries using an ordinal 11-point numerical rating scale (0 = no pain to 10 = most severe pain). The weekly means of the daily 24-hour average pain severity ratings from these diaries were pooled within disease states. Moderate response was defined as at least a 30% reduction from baseline in pain severity, and minimal improvement was defined as <10% reduction from baseline. The probability of achieving at least moderate pain reduction during 3 months treatment with duloxetine was estimated by Kaplan-Meier methods in patients with no or minimal improvement after 2, 4, and 6 weeks of treatment, as well as in all patients who had not yet achieved a moderate response (<30% reduction in pain severity). RESULTS: There were 239 OA patients and 541 CLBP patients who were randomly assigned to treatment with duloxetine 60/120 mg/d. OA and CLBP patients with minimal improvement at 2 weeks of treatment had <40% probability of achieving a moderate response, and at 4 weeks of treatment their chances were reduced to <30% in OA patients and <25% in CLBP patients. In patients showing <30% improvement at week 2 of treatment, OA patients had a 62% probability of achieving a moderate response, and CLBP patients had a 52% probability for a moderate response, and at 4 weeks of treatment, their chances were reduced to <50% in OA patients and <40% in CLBP patients. CONCLUSIONS: Patients taking duloxetine for OA or CLBP who have <10% reduction in pain after 4 weeks of treatment have limited possibility for eventually achieving even moderate pain reduction by the end of 12 weeks. ClinicalTrials.gov identifier: NCT00433290, NCT00408421, NCT00424593, NCT00408876, NCT00767806.

Antidepressants in the treatment for chronic low back pain: questioning the validity of meta-analyses.

OBJECTIVES: To contrast the analgesic effect of duloxetine with antidepressants reported in other published randomized clinical trials (RCTs) and review articles in patients with chronic low back pain (CLBP). METHODS: In this narrative review, the results of 13 RCTs and 5 systematic reviews examining the analgesic effect of various antidepressants in CLBP were contrasted with those of 3 placebo-controlled duloxetine RCTs. Treatment effects based on the Brief Pain Inventory (BPI) average score in the duloxetine RCTs were assessed in all completers (by study and overall) and in last-observation-carried-forward (LOCF) analyses (extracted from study reports). 30%- and 50%-reduction response rates were compared between duloxetine and placebo. RESULTS: Eleven different antidepressants were examined in 13 individual RCTs. Sample sizes, treatment durations, and analysis methods varied across studies. Reviews each included 5 to 9 of the RCTs and came to different conclusions regarding the analgesic effect of antidepressants: 2 found no evidence while 3 reported some evidence. The completer analysis showed greater improvements in BPI average scores with duloxetine vs. placebo (significant in 2 studies). Overall, the least square mean (standard error) difference between treatments was - 0.7 (0.15) (P < 0.0001). Overall response rates were significantly larger with duloxetine than with placebo. CONCLUSIONS: Due to the diversity of previous studies and the pooling methods used, the conclusions regarding the analgesic effect of antidepressants in CLBP drawn from systematic reviews must be interpreted with caution. Appropriately designed and powered studies similar to recently published duloxetine studies are recommended to demonstrate the analgesic effect of antidepressants.

Does recall of preinjury disability change over time?

BACKGROUND: Pre-injury disability must be determined when assessing whether treatment programs return people to pre-injury status, however there is little empirical evidence to support recommendations that this be done as soon as possible after injury to prevent recall bias. OBJECTIVES: To determine disagreement between recall of pre-injury disability at different time points post-injury and bias towards under- or overestimating pre-injury disability. METHODS: Self-reported pre-injury global disability was assessed within days, 6 months and 12 months post-injury in patients admitted to two level 1 adult trauma centres. Kappa statistics and multiple logistic regression models identified predictors of disagreement between time-points. RESULTS: Pre-injury disability was measured at all time-points in 801 patients. Pre-injury disability at baseline was rated as none, mild, moderate, marked and severe in 80%, 12%, 5.1%, 1.9% and 1.0% respectively. Absolute agreement between baseline and 6 and 12 months respectively, was 79% and 80%. Corresponding kappa values (95% confidence intervals) were 0.33 (0.26-0.40) and 0.32 (0-25-0.38). Patients over 65 years or not completing high school were more likely to report less pre-injury disability at 6 and 12 months than at baseline with adjusted odds ratios (95% confidence intervals) for these groups being 8.24 (4.32-15.72) and 1.93 (1.03-3.64) respectively. CONCLUSIONS: There was little evidence of recall bias in an adult trauma population if self-reported global pre-injury disability was assessed 6 months post-injury. The recall of pre-injury disability up to 6 months post-injury can be used to determine return to pre-injury status, if assessment is not feasible shortly after injury.

Oblique axis body fracture--pitfalls in management.

BACKGROUND: Transverse fractures through the body of the axis, rather than at the base of the odontoid are uncommon and management with an external orthosis is usually recommended. Oblique fractures through the body of the axis accompanying a hangman's fracture have not been reported and are not described as part of any classification system. Such fractures may be at high risk for treatment failure in an external orthosis. CASE DESCRIPTION: We report on a case of an oblique axis fracture that failed treatment with external orthosis. Posterior instrumented fusion was employed successfully using a C1-C3 and C4 poly axial screw rod construct. Frameless stereotaxy and a biomodel were useful surgical adjuncts. Twelve month follow up revealed bony union in an asymptomatic patient. CONCLUSIONS: Oblique fractures of the body of the axis can displace in a halo-thoracic orthosis. Serial radiological review is required to detect displacement prior to fracture union. Oblique fractures of the body of the axis can be managed surgically with preservation of atlanto-occipital motion, resulting in satisfactory clinical and radiological outcomes.

Cervical spine magnetic resonance imaging in alert, neurologically intact trauma patients with persistent midline tenderness and negative computed tomography results.

STUDY OBJECTIVE: We aim to determine the prevalence and factors associated with cervical discoligamentous injuries detected on magnetic resonance imaging (MRI) in acute, alert, neurologically intact trauma patients with computed tomography (CT) imaging negative for acute injury and persistent midline cervical spine tenderness. We present the cross-sectional analysis of baseline information collected as a component of a prospective observational study. METHODS: Alert, neurologically intact trauma patients presenting to a Level I trauma center with CT negative for acute injury, who underwent MRI for investigation of persistent midline cervical tenderness, were prospectively recruited. Deidentified images were assessed, and injuries were identified and graded. Outcome measures included the presence and extent of MRI-detected injury of the cervical ligaments, intervertebral discs, spinal cord and associated soft tissues. RESULTS: There were 178 patients recruited during a 2-year period to January 2009. Of these, 78 patients (44%) had acute cervical injury detected on MRI. There were 48 single-column injuries, 15 two-column injuries, and 5 three-column injuries. Of the remaining 10 patients, 6 had isolated posterior muscle edema, 2 had alar ligamentous edema, 1 had epidural hematoma, and 1 had atlanto-occipital edema. The injuries to 38 patients (21%) were managed clinically; 33 patients were treated in cervical collars for 2 to 12 weeks, and 5 patients (2.8%) underwent operative management, 1 of whom had delayed instability. Ordinal logistic regression revealed that factors associated with a higher number of spinal columns injured included advanced CT-detected cervical spondylosis (odds ratio [OR] 11.6; 95% confidence interval [CI] 3.9 to 34.3), minor isolated thoracolumbar fractures (OR 5.4; 95% CI 1.5 to 19.7), and multidirectional cervical spine forces (OR 2.5; 95% CI 1.2 to 5.2). CONCLUSION: In patients with cervical midline tenderness and negative acute CT findings, we found that a subset of patients had MRI-detected cervical discoligamentous injuries and that advanced cervical spine degeneration evident on CT, minor thoracolumbar fracture, and multidirectional cervical spine forces were associated with increased injury extent. However, a larger study is required to validate which variables may reliably predict clinically important injury in such patients, thereby indicating the need for further radiographic assessment.

Validity of outcome measures used to assess one and six month outcomes in orthopaedic trauma patients.

INTRODUCTION: To evaluate the validity of the 12-item Short Form Health Survey (SF-12), Sickness Impact Profile (SIP) and the Short Musculoskeletal Functional Assessment Questionnaire (SMFA) for use in an orthopaedic trauma population. MATERIALS AND METHODS: A prospective validation trial was completed at a Level 1 adult trauma centre in Melbourne, Australia. One hundred and fifty four patients with orthopaedic trauma managed or followed-up by an orthopaedic unit were prospectively recruited. Patients with pathological fractures related to metastatic disease and/or an isolated orthopaedic injury, a documented history of mental illness or dementia or those for whom follow-up was likely to be difficult were excluded. The SF-12, SIP and SMFA were administered by a trained interviewer at one and six months. Each questionnaire was scored for the physical and mental components and then compared for content and construct validity at each time point. RESULTS: Complete data were collected for 134 patients at one and six months. The one and six month component scores correlated strongly between the SF-12 physical, SIP physical (r=0.513-0.669) and SMFA dysfunction (r=0.529-0.778); the SF-12 mental, SIP mental (r=0.643-0.719) and SMFA bother (r=0.564-0.602) components. The strength of association was greater for the six month time point compared to the one month measure. The SF-12 demonstrated no ceiling or floor effects, and provided a lower time burden on participants and researchers when compared to the SIP and SMFA. CONCLUSIONS: For large population-based surveillance research into orthopaedic injury the SF-12 provides a valid and versatile tool.

Comparing the responsiveness of functional outcome assessment measures for trauma registries.

BACKGROUND: Measuring long-term disability and functional outcomes after major trauma is not standardized across trauma registries. An ideal measure would be responsive to change but not have significant ceiling effects. The aim of this study was to compare the responsiveness of the Glasgow Outcome Scale (GOS), GOS-Extended (GOSE), Functional Independence Measure (FIM), and modified FIM in major trauma patients, with and without significant head injuries. METHODS: Patients admitted to two adult Level I trauma centers in Victoria, Australia, who survived to discharge from hospital, were aged 15 years to 80 years with a blunt mechanism of injury, and had an estimated Injury Severity Score >15 on admission, were recruited for this prospective study. The instruments were administered at baseline (hospital discharge) and by telephone interview 6 months after injury. Measures of responsiveness, including effect sizes, were calculated. Bootstrapping techniques, and floor and ceiling effects, were used to compare the measures. RESULTS: Two hundred forty-three patients participated, of which 234 patients (96%) completed the study. The GOSE and GOS were the most responsive instruments in this major trauma population with effect sizes of 5.3 and 4.4, respectively. The GOSE had the lowest ceiling effect (17%). CONCLUSIONS: The GOSE was the instrument with greatest responsiveness and the lowest ceiling effect in a major trauma population with and without significant head injuries and is recommended for use by trauma registries for monitoring functional outcomes and benchmarking care. The results of this study do not support the use of the modified FIM for this purpose.

Functional and health-related quality of life outcomes after pediatric trauma.

BACKGROUND: Pediatric trauma results in lower mortality than adults and a high potential for lifelong functional impairment and reduced health-related quality of life (HRQL). There is no consensus regarding the best approach to measuring outcomes in this group. METHODS: One hundred and fifty injured children admitted to a pediatric trauma center participated in this study. The Pediatric Quality of Life Inventory (PedsQL), Child Health Questionnaire (CHQ-PF28), King's Outcome Scale for Childhood Head Injury (KOSCHI), modified Glasgow Outcome Scale (mGOS), and the Functional Independence Measure (FIM) were administered at 1 month, 6 months, and 12 months after injury by telephone. Change in instrument scores was assessed using multilevel mixed effects models. Mean HRQL scores were compared with population norms for the CHQ-PF28 and with healthy children for the PedsQL. RESULTS: Follow-up at all time points was completed for 144 (96%) cases. The median injury severity score was 10, and 65% of the patients enrolled were men. At 12 months, the percentage of cases with ongoing disability was 14% for the FIM, 61% using the mGOS, and 58% for the KOSCHI. CHQ-PF28 physical and PedsQL psychosocial health scores were below healthy child norms at 12 months. Improvement across all time points was demonstrated for the KOSCHI, mGOS, CHQ-PF28 physical, and PedsQL psychosocial summary scores. CONCLUSIONS: Seriously injured children showed ongoing disability and reduced HRQL 12 months after injury. The CHQ-PF28 and PedsQL, and the mGOS and KOSCHI, performed comparably. The FIM demonstrated considerable ceiling effects, and improvement over time was not shown. The results inform the methodology of pediatric outcomes studies and protocol development for the routine follow-up of pediatric trauma patients.