Multicenter, Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine for Mechanical Cervical Pain.

BACKGROUND: There are few efficacious treatments for mechanical neck pain, with controlled trials suggesting efficacy for muscle relaxants and topical nonsteroidal anti-inflammatory drugs. Although studies evaluating topical lidocaine for back pain have been disappointing, the more superficial location of the cervical musculature suggests a possible role for topical local anesthetics. METHODS: This study was a randomized, double-blind, placebo-controlled crossover trial performed at four U.S. military, Veterans Administration, academic, and private practice sites, in which 76 patients were randomized to receive either placebo followed by lidocaine patch for 4-week intervals (group 1) or a lidocaine-then-placebo patch sequence. The primary outcome measure was mean reduction in average neck pain, with a positive categorical outcome designated as a reduction of at least 2 points in average neck pain coupled with at least a 5-point score of 7 points on the Patient Global Impression of Change scale at the 4-week endpoint. RESULTS: For the primary outcome, the median reduction in average neck pain score was -1.0 (interquartile range, -2.0, 0.0) for the lidocaine phase versus -0.5 (interquartile range, -2.0, 0.0) for placebo treatment (P = 0.17). During lidocaine treatment, 27.7% of patients experienced a positive outcome versus 14.9% during the placebo phase (P = 0.073). There were no significant differences between treatments for secondary outcomes, although a carryover effect on pain pressure threshold was observed for the lidocaine phase (P = 0.015). A total of 27.5% of patients in the lidocaine group and 20.5% in the placebo group experienced minor reactions, the most common of which was pruritis (P = 0.36). CONCLUSIONS: The differences favoring lidocaine were small and nonsignificant, but the trend toward superiority of lidocaine suggests more aggressive phenotyping and applying formulations with greater penetrance may provide clinically meaningful benefit.

Lateral Brain Displacement and Cerebral Autoregulation in Acutely Comatose Patients.

OBJECTIVES: Lateral displacement and impaired cerebral autoregulation are associated with worse outcomes following acute brain injury, but their effect on long-term clinical outcomes remains unclear. We assessed the relationship between lateral displacement, disturbances to cerebral autoregulation, and clinical outcomes in acutely comatose patients. DESIGN: Retrospective analysis of prospectively collected data. SETTING: Neurocritical care unit of the Johns Hopkins Hospital. PATIENTS: Acutely comatose patients (Glasgow Coma Score ≤ 8). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Cerebral oximetry index, derived from near-infrared spectroscopy multimodal monitoring, was used to evaluate cerebral autoregulation. Associations between lateral brain displacement, global cerebral autoregulation, and interhemispheric cerebral autoregulation asymmetry were assessed using mixed random effects models with random intercept. Patients were grouped by functional outcome, determined by the modified Rankin Scale. Associations between outcome group, lateral displacement, and cerebral oximetry index were assessed using multivariate linear regression. Increasing lateral brain displacement was associated with worsening global cerebral autoregulation (p = 0.01 septum; p = 0.05 pineal) and cerebral autoregulation asymmetry (both p < 0.001). Maximum lateral displacement during the first 3 days of coma was significantly different between functional outcome groups at hospital discharge (p = 0.019 pineal; p = 0.008 septum), 3 months (p = 0.026; p = 0.007), 6 months (p = 0.018; p = 0.010), and 12 months (p = 0.022; p = 0.012). Global cerebral oximetry index was associated with functional outcomes at 3 months (p = 0.019) and 6 months (p = 0.013). CONCLUSIONS: During the first 3 days of acute coma, increasing lateral brain displacement is associated with worsening global cerebral autoregulation and cerebral autoregulation asymmetry, and poor long-term clinical outcomes in acutely comatose patients. The impact of acute interventions on outcome needs to be explored.

Effect of Body Temperature on Cerebral Autoregulation in Acutely Comatose Neurocritically Ill Patients.

OBJECTIVES: Impaired cerebral autoregulation following neurologic injury is a predictor of poor clinical outcome. We aimed to assess the relationship between body temperature and cerebral autoregulation in comatose patients. DESIGN: Retrospective analysis of prospectively collected data. SETTING: Neurocritical care unit of the Johns Hopkins Hospital. PATIENTS: Eighty-five acutely comatose patients (Glasgow Coma Scale score of ≤ 8) admitted between 2013 and 2017. INTERVENTIONS: None. MEASUREMENT AND MAIN RESULTS: Cerebral autoregulation was monitored using multimodal monitoring with near-infrared spectroscopy-derived cerebral oximetry index. Cerebral oximetry index was calculated as a Pearson correlation coefficient between low-frequency changes in regional cerebral oxygenation saturation and mean arterial pressure. Patients were initially analyzed together, then stratified by temperature pattern over the monitoring period: no change (< 1°C difference between highest and lowest temperatures; n = 11), increasing (≥ 1°C; n = 9), decreasing (≥ 1°C; n = 9), and fluctuating (≥ 1°C difference but no sustained direction of change; n = 56). Mixed random effects models with random intercept and multivariable logistic regression analysis were used to assess the association between hourly temperature and cerebral oximetry index, as well as between temperature and clinical outcomes. Cerebral oximetry index showed a positive linear relationship with temperature (ß = 0.04 ± 0.10; p = 0.29). In patients where a continual increase or decrease in temperature was seen during the monitoring period, every 1°C change in temperature resulted in a cerebral oximetry index change in the same direction by 0.04 ± 0.01 (p < 0.001) and 0.02 ± 0.01 (p = 0.12), respectively, after adjusting for PaCO2, hemoglobin, mean arterial pressure, vasopressor and sedation use, and temperature probe location. There was no significant difference in mortality or poor outcome (modified Rankin Scale score of 4-6) between temperature pattern groups at discharge, 3, or 6 months. CONCLUSIONS: In acute coma patients, increasing body temperature is associated with worsening cerebral autoregulation as measured by cerebral oximetry index. More studies are needed to clarify the impact of increasing temperature on cerebral autoregulation in patients with acute brain injury.

Effectiveness of Lumbar Facet Joint Blocks and Predictive Value before Radiofrequency Denervation: The Facet Treatment Study (FACTS), a Randomized, Controlled Clinical Trial.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: With facet interventions under scrutiny, the authors' objectives were to determine the effectiveness of different lumbar facet blocks and their ability to predict radiofrequency ablation outcomes. METHODS: A total of 229 participants were randomized in a 2:2:1 ratio to receive intraarticular facet injections with bupivacaine and steroid, medial branch blocks, or saline. Those with a positive 1-month outcome (a 2-point or more reduction in average pain score) and score higher than 3 (positive satisfaction) on a 5-point satisfaction scale were followed up to 6 months. Participants in the intraarticular and medial branch block groups with a positive diagnostic block (50% or more relief) who experienced a negative outcome proceeded to the second phase and underwent radiofrequency ablation, while all saline group individuals underwent ablation. Coprimary outcome measures were average reduction in numerical rating scale pain score 1 month after the facet or saline blocks, and average numerical rating scale pain score 3 months after ablation. RESULTS: Mean reduction in average numerical rating scale pain score at 1 month was 0.7 ± 1.6 in the intraarticular group, 0.7 ± 1.8 in the medial branch block group, and 0.7 ± 1.5 in the placebo group; P = 0.993. The proportions of positive blocks were higher in the intraarticular (54%) and medial branch (55%) groups than in the placebo group (30%; P = 0.01). Radiofrequency ablation was performed on 135 patients (45, 48, and 42 patients from the intraarticular, medial branch, and saline groups, respectively). The average numerical rating scale pain score at 3 months was 3.0 ± 2.0 in the intraarticular, 3.2 ± 2.5 in the medial branch, and 3.5 ± 1.9 in the control group (P = 0.493). At 3 months, the proportions of positive responders in the intraarticular, medial branch block, and placebo groups were 51%, 56%, and 24% for the intraarticular, medial branch, and placebo groups, respectively (P = 0.005). CONCLUSIONS: This study establishes that facet blocks are not therapeutic. The higher responder rates in the treatment groups suggest a hypothesis that facet blocks might provide prognostic value before radiofrequency ablation.

Nonorganic (Behavioral) Signs and Their Association With Epidural Corticosteroid Injection Treatment Outcomes and Psychiatric Comorbidity in Cervical Radiculopathy: A Multicenter Study.

OBJECTIVE: To determine the association between cervical nonorganic pain signs and epidural corticosteroid injection outcomes and coexisting pain and psychiatric conditions. PATIENTS AND METHODS: Seventy-eight patients with cervical radiculopathy who received epidural corticosteroid injection were observed to determine the effects that nonorganic signs have on treatment outcome. A positive outcome was a decrease of 2 or more points in average arm pain, coupled with a score of 5 on a 7-point Patient Global Impression of Change scale 4 weeks after treatment. Nine tests in 5 categories (abnormal tenderness, regional disturbances deviating from normal anatomy, overreaction, discrepancies in examination findings with distraction, and pain during sham stimulation) were modified from previous studies and standardized. Other variables examined for their association with nonorganic signs and outcomes included disease burden, psychopathology, coexisting pain conditions, and somatization. RESULTS: Of the 78 patients, 29% (n=23) had no nonorganic signs, 21% (n=16) had signs in 1 category, 10% (n=8) had signs in 2 categories, 21% (n=16) had signs in 3 categories, 10% (n=8) had signs in 4 categories, and 9% (n=7) had signs in 5 categories. The most common nonorganic sign was superficial tenderness (44%; n=34). Mean number of positive nonorganic categories was higher in individuals with negative treatment outcomes (2.5±1.8; 95% CI, 2.0 to 3.1) compared with those with positive outcomes (1.1±1.3; 95% CI, 0.7 to 1.5; P=.0002). Negative treatment outcomes were most strongly associated with regional disturbances and overreaction. Positive associations were noted between nonorganic signs and multiple pain (P=.011) and multiple psychiatric (P=.028) conditions. CONCLUSION: Cervical nonorganic signs correlate with treatment outcome, pain, and psychiatric comorbidities. Screening for these signs and psychiatric symptoms may improve treatment outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04320836.

Fluoroscopically Guided vs Landmark-Guided Sacroiliac Joint Injections: A Randomized Controlled Study.

OBJECTIVES: To determine the prevalence of intra- and extra-articular sacroiliac joint (SIJ) pain, which injection is more beneficial, and whether fluoroscopy improves outcomes. PATIENTS AND METHODS: This patient- and evaluator-blinded comparative effectiveness study randomized 125 participants with SIJ pain from April 30, 2014, through December 12, 2017, to receive fluoroscopically guided injections into the joint capsule (group 1) or "blind" injections to the point of maximum tenderness using sham radiographs (group 2). The primary outcome was average pain on a 0 to 10 scale 1 month after injection. A positive outcome was defined as at least a 2-point decrease in average pain score coupled with positive (>3) satisfaction on a Likert scale from 1 to 5. RESULTS: For the primary outcome, no significant differences were observed between groups (mean ± SD change from baseline, -2.3±2.4 points in group 1 vs -1.7±2.3 points in group 2; 95% CI, -0.33 to 1.36 points for adjusted difference; P=.23), nor was there a difference in the proportions of positive blocks (61% vs 62%) or 1-month categorical outcome (48% vs 40% in groups 1 and 2, respectively; P=.33). At 3 months, the mean ± SD reductions in average pain (-1.8±2.1 vs -0.9 ± 2.0 points; 95% CI, 0.11 to 1.58 points for adjusted difference; P=.02) and worst pain (-2.2±2.5 vs -1.4±2.0 points; 95% CI, 0.01 to 1.66 points for adjusted difference; P=.049) were greater in group 1 than 2, with other outcome differences falling shy of statistical significance. CONCLUSION: Although fluoroscopically guided injections provide greater intermediate-term benefit in some patients, these differences are modest and accompanied by large cost differences. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02096653.