Multicenter study evaluating factors associated with treatment outcome for low back pain injections.

BACKGROUND: There has been a worldwide surge in interventional procedures for low back pain (LBP), with studies yielding mixed results. These data support the need for identifying outcome predictors based on unique characteristics in a pragmatic setting. METHODS: We prospectively evaluated the association between over two dozen demographic, clinical and technical factors on treatment outcomes for three procedures: epidural steroid injections (ESIs) for sciatica, and sacroiliac joint (SIJ) injections and facet interventions for axial LBP. The primary outcome was change in patient-reported average pain intensity on a numerical rating scale (average NRS-PI) using linear regression. For SIJ injections and facet radiofrequency ablation, this was average LBP score at 1 and 3 months postprocedure, respectively. For ESI, it was average leg pain 1- month postinjection. Secondary outcomes included a binary indicator of treatment response (success). RESULTS: 346 patients were enrolled at seven hospitals. All groups experienced a decrease in average NRS-PI (p<0.0001; mean 1.8±2.6). There were no differences in change in average NRS-PI among procedural groups (p=0.50). Lower baseline pain score (adjusted coefficient -0.32, 95% CI -0.48 to -0.16, p<0.0001), depressive symptomatology (adjusted coefficient 0.076, 95% CI 0.039 to 0.113, p<0.0001) and obesity (adjusted coefficient 0.62, 95% CI 0.038 to 1.21, p=0.037) were associated with smaller pain reductions. For procedural outcome, depression (adjusted OR 0.94, 95% CI 0.91, 0.97, p<0.0001) and poorer baseline function (adjusted OR 0.59, 95% CI 0.36, 0.96, p=0.034) were associated with failure. Smoking, sleep dysfunction and non-organic signs were associated with negative outcomes in univariate but not multivariate analyses. CONCLUSIONS: Identifying treatment responders is a critical endeavor for the viability of procedures in LBP. Patients with greater disease burden, depression and obesity are more likely to fail interventions. Steps to address these should be considered before or concurrent with procedures as considerations dictate. TRIAL REGISTRATION NUMBER: NCT02329951.

Waddell (Nonorganic) Signs and Their Association With Interventional Treatment Outcomes for Low Back Pain.

BACKGROUND: The rising use of injections to treat low back pain (LBP) has led to efforts to improve selection. Nonorganic (Waddell) signs have been shown to portend treatment failure for surgery and other therapies but have not been studied for minimally invasive interventions. METHODS: We prospectively evaluated the association between Waddell signs and treatment outcome in 3 cohorts: epidural steroid injections (ESI) for leg pain and sacroiliac joint (SIJ) injections and facet interventions for LBP. Categories of Waddell signs included nonanatomic tenderness, pain during sham stimulation, discrepancy in physical examination, overreaction, and regional disturbances divulging from neuroanatomy. The primary outcome was change in patient-reported "average" numerical rating scale for pain intensity (average NRS-PI), modeled as a function of the number of Waddell signs using simple linear regression. Secondary outcomes included a binary indicator of treatment response. We conducted secondary and sensitivity analyses to account for potential confounders. RESULTS: We enrolled 318 patients: 152 in the ESI cohort, 102 in the facet cohort, and 64 in the SIJ cohort, having sufficient data for primary analysis on 308 patients. Among these, 62% (n = 192) had no Waddell signs, 18% (n = 54) had 1 sign, 11% (n = 33) had 2, 5% (n = 16) had 3, 2% (n = 7) had 4, and about 2% (n = 6) had all 5 signs. The mean change in average NRS-PI in each of these 6 groups was -1.6 ± 2.6, -1.1 ± 2.7, -1.5 ± 2.5, -1.6 ± 2.6, -1 ± 1.5, and 0.7 ± 2.1, respectively, and their corresponding treatment failure rates were 54% (102 of 192), 67% (36 of 54), 70% (23 of 33), 75% (12 of 16), 71% (5 of 7), and 83% (5 of 6). In the primary analysis, an increasing number of Waddell signs were not associated with a significant decrease in average NRS-PI (coefficient [Coef] = 0.19; 95% confidence interval [CI], -0.43 to 0.05; P = .12). A higher number of Waddell signs were associated with treatment failure, with a 1.35 increased odds of treatment failure per cumulative number of signs (P = .008). CONCLUSIONS: Whereas this study found no consistent relationship between Waddell signs and decreased mean pain scores, a significant relationship between the number of Waddell signs and treatment failure was observed.

Prognostic value of hypersensitivity reactions on epidural steroid injection outcomes: a phenotypic signature? A prospective cohort study.

BACKGROUND: Studies have found that diffuse pain, indicative of central sensitization, portends poor interventional outcomes. Multiple chemical sensitivities are associated with signs of central sensitization. We sought to prospectively determine whether hypersensitivity reactions (HR) were associated with epidural steroid injection (ESI) outcomes. METHODS: HR were classified as immune-related or non-immune-related and categorized by number (0=low, 1 or 2=intermediate, ≥3=high). The primary outcome measure was mean reduction in average leg pain score 1 month post-procedure. A positive outcome was defined as a two-point or greater decrease in average leg pain accompanied by satisfaction 1 month post-procedure. RESULTS: The mean number of immune-mediated and non-immune-mediated HR were 0.6±1.2 and 0.8±1.4, respectively. Individuals in the high (n=24) total HR group had a mean reduction in average leg pain of 0.1±2.7, compared with those in the low (n=61; 1.8±2.1, p=0.025) and intermediate groups (n=52; 1.6±3.1, p=0.060). For back pain and categorical successful outcome, those with fewer HR experienced greater benefit. There were no differences in outcomes when patients were stratified by immune-related HR. Among participants in the low, intermediate and high non-immune-mediated HR groups, the mean reductions in average leg pain scores were 1.7±2.5, 1.6±3.0, and -0.2±2.3, respectively (p = 0.002). 51%, 35%, and 12% of people with low, intermediate and high numbers of non-immune-mediated HR experienced a positive categorical outcome, respectively (p=0.007). CONCLUSIONS: Non-immune-related HR were inversely correlated with some ESI outcome measures.

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.

Compounded Topical Pain Creams to Treat Localized Chronic Pain: A Randomized Controlled Trial.

Background: The use of compounded topical pain creams has increased dramatically, yet their effectiveness has not been well evaluated. Objective: To determine the efficacy of compounded creams for chronic pain. Design: Randomized controlled trials of 3 interventions. (ClinicalTrials.gov: NCT02497066). Setting: Military treatment facility. Participants: 399 patients with localized pain classified by each patient's treating physician as neuropathic (n = 133), nociceptive (n = 133), or mixed (n = 133). Intervention: Pain creams compounded for neuropathic pain (ketamine, gabapentin, clonidine, and lidocaine), nociceptive pain (ketoprofen, baclofen, cyclobenzaprine, and lidocaine), or mixed pain (ketamine, gabapentin, diclofenac, baclofen, cyclobenzaprine, and lidocaine), or placebo. Measurements: The primary outcome measure was average pain score 1 month after treatment. A positive categorical response was a reduction in pain score of 2 or more points coupled with a score above 3 on a 5-point satisfaction scale. Secondary outcomes included Short Form-36 Health Survey scores, satisfaction, and categorical response. Participants with a positive outcome were followed through 3 months. Results: For the primary outcome, no differences were found in the mean reduction in average pain scores between the treatment and control groups for patients with neuropathic pain (-0.1 points [95% CI, -0.8 to 0.5 points]), nociceptive pain (-0.3 points [CI, -0.9 to 0.2 points]), or mixed pain (-0.3 points [CI, -0.9 to 0.2 points]), or for all patients (-0.3 points [CI, -0.6 to 0.1 points]). At 1 month, 72 participants (36%) in the treatment groups and 54 (28%) in the control group had a positive outcome (risk difference, 8% [CI, -1% to 17%]). Limitations: Generalizability is limited by heterogeneity among pain conditions and formulations of the study interventions. Randomized follow-up was only 1 month. Conclusion: Compounded pain creams were not better than placebo creams, and their higher costs compared with approved compounds should curtail routine use. Primary Funding Source: Centers for Rehabilitation Sciences Research, Defense Health Agency, U.S. Department of Defense.

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.

Acupuncture for the Treatment of Chronic Pain in the Military Population: Factors Associated With Treatment Outcomes.

OBJECTIVES: Acupuncture is characterized as an alternative or complementary medicine with a low complication rate and minimal side effects. There is a lack of robust evidence that shows acupuncture is an effective treatment for chronic pain. The purpose of this study was to determine which (if any) characteristics can predict successful response to acupuncture in chronic pain patients treated at military treatment facilities. METHODS: Data from 222 patients who received treatment for a chronic pain condition were collected from 2 medical centers. The patients underwent at least 4 acupuncture treatments and had an average pain score of 4 or higher on a 0- to 10-point numerical rating scale or visual analog scale in the week before treatment initiation. A successful outcome was defined to be a 2-point or greater reduction on the numerical rating scale or visual analog scale 12 weeks postinitial treatment. RESULTS: The overall treatment success rate was 42.3%. Multivariate logistic regression found a higher baseline pain rating and the use of stimulation needles to be associated with a positive outcome (odds ratio [OR]=1.26; 95% confidence interval [CI], 1.03-1.55; P=0.02 and OR=2.73; 95% CI, 1.39-5.32; P=0.03, respectively). Only the presence of one or more psychological comorbidities was found to be associated with treatment failure (OR=0.67; 95% CI, 0.49-0.92; P=0.01). DISCUSSION: The use of electrical stimulation and higher baseline pain score were associated with a positive treatment outcome, while the presence of a psychological comorbidity diminished the likelihood of treatment success. Practitioners should consider using electrical stimulation more frequently, and addressing psychopathology before or concurrent to treatment, when initiating acupuncture.

Classification and Treatment of Chronic Neck Pain: A Longitudinal Cohort Study.

BACKGROUND AND OBJECTIVES: Neck pain exerts a steep personal and socioeconomic toll, ranking as the fourth leading cause of disability. The principal determinant in treatment decisions is whether pain is neuropathic or nonneuropathic, as this affects treatment at all levels. Yet, no study has sought to classify neck pain in this manner. METHODS: One hundred participants referred to an urban, academic military treatment facility with a primary diagnosis of neck pain were enrolled and followed up for 6 months. Pain was classified as neuropathic, possible neuropathic, or nonneuropathic using painDETECT and as neuropathic, mixed, or nociceptive by s-LANSS (self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale) and physician designation. Based on previous studies, the intermediate possible neuropathic pain category was considered to be a mixed condition. The final classification was based on a metric combining all 3 systems, slightly weighted toward physician's judgment, which is considered the reference standard. RESULTS: Fifty percent of participants were classified as having possible neuropathic pain, 43% as having nonneuropathic pain, and 7% with primarily neuropathic pain. Concordance was high between the various classification schemes, ranging from a low of 62% between painDETECT and physician designation for possible neuropathic pain, to 83% concordance between s-LANSS and the 2 other systems for neuropathic pain. Individuals with neuropathic pain reported higher levels of baseline disability, were more likely to have a coexisting psychiatric illness, and underwent surgery more frequently than other pain categories, but were also more likely to report greater reductions in disability after 6 months. CONCLUSIONS: Although pure neuropathic pain comprised a small percentage of our cohort, 50% of our population consisted of mixed pain conditions containing a possible neuropathic component. There was significant overlap between the various classification schemes.

Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness.

Occipital neuralgia (ON) is characterized by lancinating pain and tenderness overlying the occipital nerves. Both steroid injections and pulsed radiofrequency (PRF) are used to treat ON, but few clinical trials have evaluated efficacy, and no study has compared treatments. We performed a multicenter, randomized, double-blind, comparative-effectiveness study in 81 participants with ON or migraine with occipital nerve tenderness whose aim was to determine which treatment is superior. Forty-two participants were randomized to receive local anesthetic and saline, and three 120 second cycles of PRF per targeted nerve, and 39 were randomized to receive local anesthetic mixed with deposteroid and 3 rounds of sham PRF. Patients, treating physicians, and evaluators were blinded to interventions. The PRF group experienced a greater reduction in the primary outcome measure, average occipital pain at 6 weeks (mean change from baseline -2.743 ± 2.487 vs -1.377 ± 1.970; P < 0.001), than the steroid group, which persisted through the 6-month follow-up. Comparable benefits favoring PRF were obtained for worst occipital pain through 3 months (mean change from baseline -1.925 ± 3.204 vs -0.541 ± 2.644; P = 0.043), and average overall headache pain through 6 weeks (mean change from baseline -2.738 ± 2.753 vs -1.120 ± 2.1; P = 0.037). Adverse events were similar between groups, and few significant differences were noted for nonpain outcomes. We conclude that although PRF can provide greater pain relief for ON and migraine with occipital nerve tenderness than steroid injections, the superior analgesia may not be accompanied by comparable improvement on other outcome measures.

Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy study.

OBJECTIVE: To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy. DESIGN: A multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes. SETTINGS: Eight military, Veterans Administration, and civilian hospitals. PARTICIPANTS: 145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain. INTERVENTIONS: Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin. MAIN OUTCOME MEASURES: Average leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥ 2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit. RESULTS: There were no significant differences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted difference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments. CONCLUSIONS: Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier: NCT01495923.

Predictive factors associated with success and failure for Calmare (Scrambler) therapy: a multicenter analysis.

OBJECTIVE: Calmare (Scrambler) therapy is a novel therapeutic modality that purports to provide pain relief by "scrambling" afferent pain signals and replacing them with "non-pain" information through conventional lines of neural transmission. The goal of this study is to identify which factors are associated with treatment outcome for Calmare therapy. METHODS: Data were garnered from 3 medical centers on 147 patients with various pain conditions who underwent a minimum of either 3 Calmare therapies on consecutive days or 5 therapies overall. A successful outcome was predefined as ≥50% pain relief on a 0 to 10 numerical rating scale that persisted for longer than 1 month after the last treatment. Variables evaluated for their association with outcome included age, sex, study site, baseline pain score, etiology, type of pain, diagnosis, treatment compliance, coexisting psychopathology, opioid use, antidepressant use, and membrane stabilizer use. RESULTS: Overall, the success rate was 38.1%. Variables found to be associated with a positive outcome in multivariate logistic regression included the presence of neuropathic (OR=24.78; 95% CI, 2.47-248.97; P=0.006) or mixed (OR=10.52; 95% CI, 1.09-101.28; P=0.042) pain, and treatment at either Walter Reed (OR=6.87; 95% CI, 1.60-29.51; P=0.010) or Seoul National University (OR=12.29; 95% CI, 1.73-87.43; P=0.012). Factors that correlated with treatment failure were disease (OR=0.04; 95% CI, 0.002-0.59; P=0.020) or traumatic/surgical etiologies (OR=0.05; 95% CI, 0.005-0.56; P=0.015) and antidepressant use (OR=0.47; 95% CI, 0.18-1.02; P=0.056). CONCLUSIONS: A neuropathic or mixed neuropathic-nociceptive pain condition was associated with a positive treatment outcome. Investigators should consider these findings when developing selection criteria in clinical trials designed to determine the efficacy of Calmare therapy.

Epidural steroid injections, conservative treatment, or combination treatment for cervical radicular pain: a multicenter, randomized, comparative-effectiveness study.

BACKGROUND: Cervical radicular pain is a major cause of disability. No studies have been published comparing different types of nonsurgical therapy. METHODS: A comparative-effectiveness study was performed in 169 patients with cervical radicular pain less than 4 yr in duration. Participants received nortriptyline and/or gabapentin plus physical therapies, up to three cervical epidural steroid injections (ESI) or combination treatment over 6 months. The primary outcome measure was average arm pain on a 0 to 10 scale at 1 month. RESULTS: One-month arm pain scores were 3.5 (95% CI, 2.8 to 4.2) in the combination group, 4.2 (CI, 2.8 to 4.2) in ESI patients, and 4.3 (CI, 2.8 to 4.2) in individuals treated conservatively (P = 0.26). Combination group patients experienced a mean reduction of -3.1 (95% CI, -3.8 to -2.3) in average arm pain at 1 month versus -1.8 (CI, -2.5 to -1.2) in the conservative group and -2.0 (CI, -2.7 to -1.3) in ESI patients (P = 0.035). For neck pain, a mean reduction of -2.2 (95% CI, -3.0 to -1.5) was noted in combination patients versus -1.2 (CI, -1.9 to -0.5) in conservative group patients and -1.1 (CI, -1.8 to -0.4) in those who received ESI; P = 0.064). Three-month posttreatment, 56.9% of patients treated with combination therapy experienced a positive outcome versus 26.8% in the conservative group and 36.7% in ESI patients (P = 0.006). CONCLUSIONS: For the primary outcome measure, no significant differences were found between treatments, although combination therapy provided better improvement than stand-alone treatment on some measures. Whereas these results suggest an interdisciplinary approach to neck pain may improve outcomes, confirmatory studies are needed.

Can changes in vital signs be used to predict the response to lumbar facet blocks and radiofrequency denervation? A prospective, correlational study.

BACKGROUND: Facet joint radiofrequency (RF) ablation is characterized by a high failure rate, which is partly due to the fact that pain relief after diagnostic blocks is inherently subjective. An area that has yet to be explored is whether more objective measures, such as changes in vital signs after blocks, might be used to predict treatment outcomes. METHODS: A multicenter, prospective study was performed in 223 patients who underwent diagnostic lumbar medial branch blocks, of whom 87 proceeded to RF denervation. Blood pressure (BP), heart rate (HR), and pain scores were recorded preblock and 20 minutes postblock. A positive vital sign response was designated as a decrease of less than 7.5 units in BP or HR, and a positive facet block as pain relief of 50% or greater based on 6-hour pain diary scores. RESULTS: Overall, 125 subjects (56.1%; 95% confidence interval, 49.3%-62.6%) experienced a positive facet block, and 71 had 3-month follow-up information after denervation. Correlations between changes in NRS scores and HR (r = -0.01, P = 0.893), systolic BP (r = 0.05, P = 0.47), diastolic BP (DBP) (r = 0.08, P = 0.22), and mean arterial pressure (r = 0.08, P = 0.21) were weak and nonsignificant. No associations were found between facet block results and any vital sign. Six (85.7%) of 7 patients who experienced a decrease in DBP of greater than 7.5 mm Hg after facet block had a positive RF denervation outcome at 3 months, compared with 43.8% who did not (odds ratio, 7.52; 95% confidence interval, 0.84-363.8; P = 0.049). A classification tree based on significant decrease in DBP, pain duration, and baseline NRS pain score showed a 76.7% (range, 65.8%-86.3%) accuracy rate. CONCLUSIONS: Although a decrease in DBP of more than 7.5 mm Hg had 97.3% specificity and 85.7% positive predictive value for predicting positive RF ablation outcomes, the low negative predictive value (56.3%) precludes its use as a solitary screening tool. An algorithm based on age, baseline NRS pain score, and a significant decrease in DBP was able to predict 76.7% (range, 65.8%-86.3%) of RF denervation outcomes.

The effect of sedation on the accuracy and treatment outcomes for diagnostic injections: a randomized, controlled, crossover study.

BACKGROUND AND OBJECTIVE: Diagnostic injections are used to diagnose myriad pain conditions, but are characterized by a high false-positive rate. One potential cause of inaccurate diagnostic blocks is the use of sedation. We sought to determine the effect of sedation on the validity of diagnostic injections. DESIGN: Randomized, crossover study in which 73 patients were allocated to receive a diagnostic sacroiliac joint or sympathetic nerve block performed either with or without sedation using midazolam and fentanyl. Those who obtained equivocal relief, good relief lasting less than 3 months, or who were otherwise deemed good candidates for a repeat injection, received a subsequent crossover injection within 3 months (N = 46). SETTING AND PATIENTS: A tertiary care teaching hospital and a military treatment facility. RESULTS: In the primary crossover analysis, blocks performed with sedation resulted in a larger mean reduction in pain diary score than those done without sedation (1.2 [2.6]; P = 0.006), less procedure-related pain (difference in means 2.3 [2.5]; P < 0.0001), and a higher proportion of patients who obtained > 50% pain relief on their pain diaries (70% vs. 54%; P = 0.039). The increased pain reduction was not accompanied by increased satisfaction (sedation mean 3.9 [1.1] vs. 3.7 [1.3]; P = 0.26). Similar findings were observed for the parallel group (N = 73) and omnibus (all sedation vs. no sedation blocks, N = 110) analyses. No differences in outcomes were noted between the use and non-use of sedation at 1-month. CONCLUSIONS: The use of sedation during diagnostic injections may increase the rate of false-positive blocks and lead to misdiagnoses and unnecessary procedures, but has no effect on satisfaction or outcomes at 1-month.

Does pain score in response to a standardized subcutaneous local anesthetic injection predict epidural steroid injection outcomes in patients with lumbosacral radiculopathy? A prospective correlational study.

OBJECTIVE: Epidural steroid injections (ESI) are the most commonly performed pain procedures. Despite numerous studies, controversy continues to surround their effectiveness. The purpose of this study is to determine whether a standard, clinical local anesthetic injection can predict outcomes for ESI. STUDY DESIGN: In this multicenter study, 103 patients received two ESI 2 weeks apart. Prior to their first injection, subjects rated the pain intensity of a standardized subcutaneous (SQ) injection of lidocaine prior to the full dose. Numerical rating scale pain scores were correlated with leg and back pain relief, and functional improvement, through 3-month follow-up. OUTCOME MEASURES: A composite successful outcome was predetermined to be a ≥2-point decrease in leg pain score, coupled with a positive global perceived effect. RESULTS: A small but significant relationship was found between SQ pain score and reduction in leg (r = -0.21, 95% CI -0.38 to -0.04; P = 0.03) and back pain (r = -0.22, 95% CI -0.36 to -0.07; P = 0.03). Subjects with a positive outcome at 1 month had a mean SQ pain score of 2.5 (SD 1.9) vs 4.1 (SD 2.7) in those with a negative outcome (P = 0.04). Subjects with SQ pain scores <4/10 had lower leg and back pain scores than those with pain scores ≥4 at 1-month (mean 3.2, SD 2.6 vs 5.1, SD 2.7 for leg, P < 0.01; mean 3.7, SD 2.6 vs 5.0, SD 3.0 for back, P = 0.02) and 3-month (mean 3.8, SD 2.7 vs 5.2, SD 3.1 for leg, P = 0.01; mean 4.0, SD 2.6 vs 4.9, SD 3.1 for back; P = 0.14) follow-up. CONCLUSIONS: The results of this study found a weak positive correlation between SQ pain scores and treatment results. Further research should consider whether pain perception in conjunction with other variables might prove to be a reliable predictor for ESI and other procedural outcomes.

A multicenter, randomized, controlled study evaluating preventive etanercept on postoperative pain after inguinal hernia repair.

BACKGROUND: Chronic postsurgical pain (CPSP) affects between 5% and 70% of surgical patients, depending on the surgery. There is no reliable treatment for CPSP, which has led to an increased emphasis on prevention. In this study, we sought to determine whether preventive etanercept can decrease the magnitude of postoperative pain and reduce the incidence of CPSP. METHODS: We performed a multicenter, randomized study in 77 patients comparing subcutaneous etanercept 50 mg administered 90 minutes before inguinal hernia surgery with saline. Patients, surgeons, anesthesiologists, the injecting physician, nursing staff, and evaluators were blinded. The primary outcome measure was a 24-hour numerical rating scale pain score. Secondary outcome measures were postanesthesia care unit pain scores, 24-hour opioid requirements, time to first analgesic, and pain scores recorded at 1 month, 3 months, 6 months, and 12 months. RESULTS: Mean 24-hour pain scores were 3.3 (95% confidence interval [CI], 3.2-4.6) in the etanercept and 3.9 (95% CI, 2.6-4.0) in the control group (P=0.22). The mean number of analgesic pills used in the first 24 hours was 4.0 (SD, 2.8) in the treatment versus 5.8 (SD, 4.2) in the control group (P=0.03). At 1 month, 10 patients (29%) in the treatment group reported pain versus 21 (49%) control patients (P=0.08). The presence of pain at 1 month was significantly associated with pain at 3 months (hazard ratio, 0.74; 99% CI, 0.52-0.97; P=0.03). CONCLUSION: Although preventive etanercept was superior to saline in reducing postoperative pain on some measures, the effect sizes were small, transient, and not statistically significant. Different dosing regimens in a larger population should be explored in future studies.

Establishing an optimal "cutoff" threshold for diagnostic lumbar facet blocks: a prospective correlational study.

OBJECTIVES: Diagnostic medial branch blocks (MBB) are considered the reference standard for diagnosing facetogenic pain and selecting patients for radiofrequency (RF) denervation. Great controversy exists regarding the ideal cutoff for designating a block as positive. The purpose of this study is to determine the optimal pain relief threshold for selecting patients for RF denervation after diagnostic MBB. METHODS: In this multicenter, prospective correlational study, 61 consecutive patients undergoing lumbar facet RF denervation after experiencing significant pain relief after MBB were enrolled. A positive outcome was defined as a ≥50% reduction in back pain at rest or with activity coupled with a positive satisfaction score lasting longer than 3 months. The relationship between pain relief after the blocks and denervation outcomes was evaluated by pairwise correlation matrix, receiver's operating characteristic curve, and stratifying outcomes based on 10- and 17-percentage point intervals for MBB. RESULTS: There were no significant differences in RF outcomes based on any MBB pain relief cutoff over 50%. A trend was noted whereby those patients who obtained <50% pain relief reported poorer outcomes. No optimal threshold for designating a diagnostic block as positive, above 50% pain relief, could be calculated. CONCLUSION: Employing more stringent selection criteria for lumbar facet RF is likely to result in withholding a beneficial procedure from a substantial number of patients, without improving success rates.

Epidural steroids, etanercept, or saline in subacute sciatica: a multicenter, randomized trial.

BACKGROUND: Perineural inhibitors of tumor necrosis factor have recently generated intense interest as an alternative to epidural steroid injections for lumbosacral radiculopathy. OBJECTIVE: To evaluate whether epidural steroids, etanercept, or saline better improves pain and function in adults with lumbosacral radiculopathy. DESIGN: A multicenter, 3-group, randomized, placebo-controlled trial conducted from 2008 to 2011. Randomization was computer-generated and stratified by site. Pharmacists prepared the syringes. Patients, treating physicians, and nurses assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00733096) SETTING: Military and civilian treatment centers. PATIENTS: 84 adults with lumbosacral radiculopathy of less than 6 months' duration. INTERVENTION: 2 epidural injections of steroids, etanercept, or saline, mixed with bupivacaine and separated by 2 weeks. MEASUREMENTS: The primary outcome measure was leg pain 1 month after the second injection. All patients had 1-month follow-up visits; patients whose condition improved remained blinded for the 6-month study period. RESULTS: The group that received epidural steroids had greater reductions in the primary outcome measure than those who received saline (mean difference, -1.26 [95% CI, -2.79 to 0.27]; P = 0.11) or etanercept (mean difference, -1.01 [CI, -2.60 to 0.58]; P = 0.21). For back pain, smaller differences favoring steroids compared with saline (mean difference, -0.52 [CI, -1.85 to 0.81]; P = 0.44) and etanercept (mean difference, -0.92 [CI,-2.28 to 0.44]; P = 0.18) were observed. The largest differences were noted for functional capacity, in which etanercept fared worse than the other treatments: steroids vs. etanercept (mean difference, -16.16 [CI, -26.05 to -6.27]; P = 0.002), steroids vs. saline (mean difference, -5.87 [CI, -15.59 to 3.85]; P = 0.23), and etanercept vs. saline (mean difference, 10.29 [CI, 0.55 to 20.04]; P = 0.04). More patients treated with epidural steroids (75%) reported 50% or greater leg pain relief and a positive global perceived effect at 1 month than those who received saline (50%) or etanercept (42%) (P = 0.09). LIMITATION: Short-term follow-up, small sample size, and a possibly subtherapeutic dose of etanercept. CONCLUSION: Epidural steroid injections may provide modest short-term pain relief for some adults with lumbosacral radiculopathy, but larger studies with longer follow-up are needed to confirm their benefits. PRIMARY FUNDING SOURCE: The John P. Murtha Neuroscience and Pain Institute, International Spinal Intervention Society, and Center for Rehabilitation Sciences Research.

Headaches during war: analysis of presentation, treatment, and factors associated with outcome.

BACKGROUND: Headache is often associated with physical trauma and psychological stress. The aim of this study is to evaluate the impact of headache on personnel deployed in war zones and to identify factors associated with return to duty (RTD). METHODS: Outcome data were prospectively collected on 985 personnel medically evacuated out of Operations Iraqi and Enduring Freedom for a primary diagnosis of headache between 2004 and 2009. Electronic medical records were reviewed to examine clinical and treatment patterns and the effect that myriad factors had on RTD. RESULTS: 33.6% of evacuees returned to duty. The most common headaches were post-concussion (34.1%) and migraine (30.0%). Headaches typically associated with trauma such as post-concussion (18.7%), occipital neuralgia (23.1%), and cervicogenic headache (29.7%) had the lowest RTD rates, whereas tension headache (49.6%) was associated with the best outcome. Other variables associated with negative outcome included presence of aura (OR 0.51, 95% CI 0.30-0.88; p = 0.02), traumatic brain injury (OR 0.50, 95% CI 0.29-0.87; p = 0.01), opioid (OR 0.41, 95% CI 0.26-0.63; p < 0.001), and beta-blocker (OR 0.26, 95% CI 0.12-0.61; p = 0.002) use, and co-existing psychopathology (p < 0.001 in univariable analysis). CONCLUSION: Headaches represent a significant cause of unit attrition in personnel deployed in military operations, with physical trauma and co-existing psychopathology associated with poorer outcomes.

Effect of MRI on treatment results or decision making in patients with lumbosacral radiculopathy referred for epidural steroid injections: a multicenter, randomized controlled trial.

BACKGROUND: Studies have shown that radiologic imaging does not improve outcomes in most patients with back pain, though guidelines endorse it before epidural steroid injections (ESIs). The objective of this study was to determine whether magnetic resonance imaging (MRI) improves outcomes or affects decision making in patients with lumbosacral radiculopathy referred for ESI. METHODS: In this multicenter randomized study, the treating physician in group 1 patients was blinded to the MRI results, while the physician for group 2 patients decided on treatment after reviewing the MRI findings. In group 1 subjects, an independent physician proposed a treatment plan after reviewing the MRI, which was compared with the treatment the patient received. RESULTS: Slightly lower leg pain scores were noted in the group 2 at 1 month compared with MRI-blinded patients in group 1 (mean scores, 3.6 vs 4.4) (P = .12). No differences were observed in pain scores or function at 3 months. Overall, the proportion of patients who experienced a positive outcome was similar at all time points (35.4% at 3 months in group 1 vs 40.7% in group 2). Among subjects in group 1 who received a different injection than that proposed by the independent physician, scores for both leg pain (4.8 vs 2.4) (P = .01) and function (38.7 vs 28.2) (P = .04) were inferior to patients whose injection correlated with imaging. Collectively, 6.8% of patients did not (group 2) or would not have (group 1) received an ESI after the MRI was reviewed. CONCLUSION: Magnetic resonance imaging does not improve outcomes in patients who are clinical candidates for ESI and has only a minor effect on decision making. Trial Registration clinicaltrials.gov Identifier: NCT00826124.