Baseline Numerical Rating Scale Research Articles

Pain reduction after lumbar epidural injections using particulate versus non-particulate steroids: intensity of the baseline pain matters.

To compare pain relief after CT-guided lumbar epidural steroid injections (ESI) using particulate (triamcinolone) and non-particulate (dexamethasone) steroids, and to explore factors affecting the effectiveness of both steroid types. This retrospective observational study included 806 patients with lumbar radiculopathy and corresponding MRI or CT abnormalities of the lumbar spine, who were matched using the propensity score method, yielding two cohorts of 209 patients each. Pain intensity was evaluated prior to the procedure using a pain numerical rating scale (NRS) with range 0-10. Reevaluation took place 1day and 4weeks post-injection. Logistic regression analysis and cubic splines applied to generalized additive models were implemented to assess the differences in pain reduction after ESI in the analyzed patient groups. Four weeks post-injection, the overall chance of ≥ 50% pain reduction was lower in the dexamethasone group than that in the triamcinolone group (odds ratio [OR] = 0.55; p < 0.012). In the dexamethasone cohort, the intensity of baseline pain and the presence of a herniated intervertebral disc in the infiltrated segment were both significant and independent predictors of ≥ 50% pain relief. Patients with baseline NRS score ≥ 7 points had markedly less chance of ≥ 50% pain relief than patients with NRS score < 7 (OR = 0.53; p < 0.032), whereas disc herniation increased the chances more than twofold (OR = 2.29; p < 0.044). There was no significant correlation between the effectiveness of triamcinolone and any analyzed concomitant variables. Triamcinolone was superior for lumbar radiculopathy of severe intensity. For mild to moderate pain, no benefit of using triamcinolone over dexamethasone was found. The effectiveness of dexamethasone was lower for stenotic spinal lesions than for disc herniation. • Triamcinolone is superior to dexamethasone for epidural treatment of severe lumbar radiculopathy. • For mild to moderate pain, dexamethasone could be equally effective. • Dexamethasone reduces pain caused by disc herniation much better than it does to pain caused by fixed stenotic spinal lesions.

Intravenous metoclopramide in the treatment of acute migraines: A randomized, placebo-controlled trial.

The present study aimed to evaluate the efficacy and safety of intravenous metoclopramide for acute migraine treatment. A double-blind, randomized, parallel-group, placebo-controlled trial was carried out in an academic emergency department. After the patients were assessed for eligibility via the International Headache Society criteria for migraines, they were randomized into 10mg intravenous metoclopramide and normal saline groups. The headache intensity was evaluated using an 11-point numeric rating scale (NRS) score. The primary outcome measure was determined as the median between-group change in the score at the 30thminute. The secondary outcome measures were rescue medication needs, adverse events, and emergency department (ED) revisits after discharge. A total of 148 patients were randomized into two equal groups with similar baseline characteristics, including the baseline NRS scores (8 points). The median reduction in the NRS scores at the 30thminute was 4 [interquartile range (IQR): 2-6)] in the metoclopramide group and 3 (IQR: 1-4) in the normal saline group [median difference: -1.0, 95% confidence interval (CI): -2.1 to 0.1]. No serious adverse events were observed, and the rescue medication needs were similar in both groups. No difference was found between intravenous metoclopramide and placebo regarding efficacy and safety in patients with acute migraines.

2189 Scrambler therapy: Potential new treatment for central neuropathic pain?

OBJECTIVES/SPECIFIC AIMS: Central neuropathic pain is a severely disabling consequence of conditions that cause tissue damage in the central nervous system (CNS) such as multiple sclerosis (MS) and neuromyelitis optica (NMO). It impacts mood, mobility and quality of life, but is often refractory to common treatments. Scrambler Therapy is an emerging non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways. It has been examined for treatment of peripheral neuropathy with favorable safety and efficacy outcomes, but its use in central neuropathic pain has not been reported. We aim to explore acceptability and safety of Scrambler Therapy through a Phase II sham-controlled trial in NMO, and describe its use to date in central neuropathic pain. METHODS/STUDY POPULATION: Two patients with longstanding central neuropathic pain who failed multiple drug trials were treated as proof-of-concept, supporting the recent launch of a Phase II randomized controlled trial in NMO where patients receive 10 daily Scrambler treatments versus sham. Safety and acceptability from those recruited to date will be reported. Acceptability is measured by adherence and responses to patient surveys. RESULTS/ANTICIPATED RESULTS: We plan to recruit 22 patients, randomized 1:1 into experimental and sham arms. We will present acceptability and safety data for Scrambler use in patients with NMO who have been recruited by the time of this conference, as well as effectiveness data from two cases that have been completed outside of the trial. One case involved a 65-year-old woman with a 4-year history of central neuropathic pain following a C3-C5 TM. Her numerical rating scale (NRS) pain score was reduced to 0/10 from a baseline score of 5/10. The second case involved a 52-year-old woman with a 13-year history of pain following a medullary cavernoma bleed. Her baseline NRS pain score was 9/10, which was reduced to 0.5/10 post-treatment. No adverse events were reported. Pain relief was sustained at 30 days’ post-treatment. DISCUSSION/SIGNIFICANCE OF IMPACT: We are investigating the acceptability and efficacy of Scrambler Therapy for central neuropathic pain treatment in NMO. Proof-of-concept was supported by two patients whose pain scores improved considerably more in response to this treatment than with previous pharmacologic and non-pharmacologic interventions. Results from this trial may support future investigation in other disorders that cause damage in the CNS, including MS and TM.

Characteristics and status of Korean medicine use in whiplash-associated disorder patients

BackgroundPatients are free to choose conventional or Korean medicine treatment under the dual medical system in Korea, and the prevalence of patients who choose Korean medicine treatment for whiplash-associated disorders (WADs) is high. This study analyzed the sociodemographic characteristics and medical service use in this population to provide healthcare providers with basic usage information of complementary and alternative medicine for WAD.MethodsA total of 8291 outpatients who registered under automobile insurance coverage and visited the main branch of Jaseng Hospital of Korean Medicine from April 1, 2014 to August 10, 2016 were included. Data on sociodemographic characteristics, symptoms, and accident and treatment-related details were collected from electronic medical records. Univariate and multivariate regression analyses were performed to identify baseline factors predictive of total treatment duration.ResultsThe most prevalent demographic of patients who chose Korean medicine for WAD treatment was males in their thirties whose initial visit to the hospital was 16.1 ± 94.1 days from the accident. Neck pain accompanied by low back pain (57.0%) was the most common complaint, and for singular pain, neck pain (13.5%) was the most prevalent. Baseline numeric rating scale (NRS) pain levels were generally moderate (4–6) regardless of area. Patients received 7.2 ± 10.2 sessions of treatment for 32.6 ± 55.3 days. The most commonly prescribed treatment modalities in order of highest frequency were acupuncture, cupping, pharmacopuncture, and herbal medicine, which collectively accounted for > 90% of treatments. Acupuncture was administered 29.0 ± 40.8 times, and cupping 14.0 ± 18.7 times as the two highest frequency treatments. In multivariate regression analysis, longer treatment periods were found to be associated with higher NRS, older age, and delayed initial visits at baseline.ConclusionsThis study highlights the characteristics and Korean medicine use of WAD patients. These results are particularly relevant and informative for consideration of personal preferences and effective prioritization in further insurance coverage.

Experimental Low Back Pain Decreased Trunk Muscle Activity in Currently Asymptomatic Recurrent Low Back Pain Patients During Step Tasks

Low back pain (LBP) patients show reorganized trunk muscle activity but if similar changes are manifest in recurrent LBP (R-LBP) patients during asymptomatic periods remains unknown. In 26 healthy and 27 currently asymptomatic R-LBP participants electromyographic activity (EMG) was recorded from trunk and gluteal muscles during series of stepping up and down on a step bench before and during experimentally intramuscular induced unilateral and bilateral LBP. Pain intensity was assessed using numeric rating scale (NRS) scores. Root mean square EMG (RMS-EMG) normalized to maximal voluntary contraction EMG and pain-evoked differences from baseline (ΔRMS-EMG) were analyzed. Step task duration was calculated from foot sensors. R-LBP compared with controls showed higher baseline RMS-EMG and NRS scores of experimental pain (P < .05). In both groups, bilateral compared with unilateral experimental NRS scores were higher (P < .001) and patients compared with controls reported higher NRS scores during both pain conditions (P < .04). In patients, unilateral pain decreased ΔRMS-EMG in the Iliocostalis muscle and bilateral pain decreased ΔRMS-EMG in all back and gluteal muscles during step tasks (P < .05) compared with controls. In controls, bilateral versus unilateral experimental pain induced increased step task duration and trunk RMS-EMG whereas both pain conditions decreased step task duration and trunk RMS-EMG in R-LBP patients compared with controls (P < .05). PerspectiveTask duration and trunk muscle activity increased in controls and decreased in R-LBP patients during experimental muscle LBP. These results indicate protective strategies in controls during acute pain whereas R-LBP patients showed higher pain intensity and altered strategies that may be caused by the higher pain intensity, but the long-term consequence remains unknown.

Treatment of Low Back Pain with a Digital Multidisciplinary Pain Treatment App: Short-Term Results.

BackgroundEven though modern concepts of disease management of unspecific low back pain (LBP) postulate active participation of patients, this strategy is difficult to adapt unless multidisciplinary pain therapy is applied. Recently, mobile health solutions have proven to be effective aides to foster self-management of many diseases.ObjectiveThe objective of this paper was to report on the retrospective short-term results of a digital multidisciplinary pain app for the treatment of LBP.MethodsKaia is a mobile app that digitalizes multidisciplinary pain treatment and is in the market as a medical product class I. For the current study, the data of anonymized Kaia users was retrospectively analyzed. User data were evaluated for 12 weeks regarding duration of use and effect on in-app user reported pain levels, using the numerical rating scale (NRS), depending on whether LBP was classified as acute, subacute, or chronic back pain according to current guidelines.ResultsData of 180 users were available. The mean age of the users was 33.9 years (SD 10.9). Pain levels decreased from baseline NRS 4.8 to 3.75 for all users at the end of the observation period. Users who completed 4, 8, or 12 weeks showed an even more pronounced decrease in pain level NRS (baseline 4.9 [SD 1.7] versus 3.6 [SD 1.5] at 4 weeks; baseline 4.7 [SD 1.8] versus 3.2 [SD [2.0] at 8 weeks; baseline 4.6 [SD 2.2] versus 2.6 [SD 2.0] at 12 weeks). In addition, subgroup analysis of acute, subacute, or chronic classification revealed no significant main effect of group (P>.30) on the reduction of pain. Conclusions: This retrospective study showed that in a pre-selected population of app users, an app digitalizing multidisciplinary rehabilitation for the self-management of LBP reduced user-reported pain levels significantly. The observed effect size was clinically relevant. Ongoing prospective randomized controlled trials (RCTs) will adjust for potential bias and selection effects.ConclusionsThis retrospective study showed that in a pre-selected population of app users, an app digitalizing multidisciplinary rehabilitation for the self-management of LBP reduced user-reported pain levels significantly. The observed effect size was clinically relevant. Ongoing prospective RCTs will adjust for potential bias and selection effects.

Effectiveness of Percutaneous Lumbar Extraforaminotomy in Patients with Lumbar Foraminal Spinal Stenosis: A Prospective, Single-Armed, Observational Pilot Study.

In lumbar foraminal spinal stenosis (LFSS), numerous ligaments may play an important role in causing radiculopathy by narrowing the exit of the nerve root. In order to achieve effective decompression of lumbar foraminal ligaments, a specially designed instrument for percutaneous lumbar extraforaminotomy (PLEF) was invented. The purpose of this study was to evaluate the effectiveness of PLEF in patients with intractable radiculopathy from LFSS. A prospective, single-armed, observational pilot study. A pain center in a tertiary university-based hospital. The PLEF was performed in patients who suffered from radiculopathy with concordant imaging evidence of a mild to severe degree of LFSS. For each patient, an 11-point numerical rating scale (NRS) pain score, the Oswestry Disability Index (ODI), the Roland Morris Disability Questionnaire (RMDQ) score, and any adverse events were evaluated at three-month follow-ups. Successful responder percentage defined as 40% or greater reduction from baseline NRS score with no increase in ODI, and the RMDQ score was assessed at three months. Among 26 patients who underwent PLEF, 20 patients completed the study protocol. PLEF was successful in 12 patients (60%). The overall mean pain reduction at three months was 36.3%. Patients who responded well also showed improvement in the ODI (-20%) and RMDQ score (-8.4) at their three-month follow-up. No serious complications were reported in the study. The PLEF can be an effective and safe treatment option, as well as a minimally invasive procedure, for the management of patients suffering from refractory radiculopathy caused by LFSS.

Predicting morphine related side effects in the ED: An international cohort study

Study objectivesMorphine is the reference treatment for severe acute pain in an emergency department. The purpose of this study was to describe and analyse opioid-related ADRs (adverse drug reactions) in a large cohort of emergency department patients, and to identify predictive factors for those ADRs. MethodsIn this prospective, observational, pharmaco-epidemiological international cohort study, all patients aged 18years or older who were treated with morphine were enrolled. The study was done in 23 emergency departments in the US and France. Baseline numerical rating scale score and initial and total doses of morphine titration were recorded. Logistic regression analysis was used to study the effects of demographic, clinical and medical history covariates on the occurrence of opioid-induced ADRs within 6h after treatment. ResultsA total of 1128 patients were included over 10months. Median baseline initial pain scores were 8/10 (7–10) versus 3/10 (1–4) after morphine administration. Median titration duration was 10min (IQR, 1–30). The occurrence of opioid-induced ADRs was 25% and 2% were serious. Patients experienced mainly nausea and drowsiness. Medical history of travel sickness (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.01–2.86) and history of nausea or vomiting post morphine (OR, 3.86; 95% CI, 2.29–6.51) were independent predictors of morphine related ADRs. ConclusionSerious morphine related ADRs are rare and unpredictable. Prophylactic antiemetic therapy could be proposed to patients with history of travel sickness and history of nausea or vomiting in a postoperative setting or after morphine administration.

Predictors of responses to corticosteroids for anorexia in advanced cancer patients: a multicenter prospective observational study.

Although corticosteroids are widely used to relieve anorexia, information regarding the factors predicting responses to corticosteroids remains limited. The purpose of the study is to identify potential factors predicting responses to corticosteroids for anorexia in advanced cancer patients. Inclusion criteria for this multicenter prospective observational study were patients who had metastatic or locally advanced cancer and had an anorexia intensity score of 4 or more on a 0-10 Numerical Rating Scale (NRS). Univariate and multivariate analyses were conducted to identify the factors predicting ≥2-point reduction in NRS on day 3. Among 180 patients who received corticosteroids, 99 (55%; 95% confidence interval [CI], 47-62%) had a response with ≥2-point reduction. Factors that significantly predicted responses were Palliative Performance Scale (PPS)>40 and absence of drowsiness. In addition, factors that tended to be associated with ≥2-point reduction in NRS included PS 0-3, absence of diabetes mellitus, absence of peripheral edema, presence of lung metastasis, absence of peritoneal metastasis, baseline anorexia NRS of >6, presence of pain, and presence of constipation. A multivariate analysis showed that the independent factors predicting responses were PPS of >40 (odds ratio=2.7 [95% CI=1.4-5.2]), absence of drowsiness (2.6 [1.3-5.0]), and baseline NRS of >6 (2.4 [1.1-4.8]). Treatment responses to corticosteroids for anorexia may be predicted by PPS, drowsiness, and baseline symptom intensity. Larger prospective studies are needed to confirm these results.

Predictors of Responses to Corticosteroids for Cancer-Related Fatigue in Advanced Cancer Patients: A Multicenter, Prospective, Observational Study

ContextAlthough corticosteroids are widely used to relieve cancer-related fatigue (CRF), information regarding the factors predicting responses to corticosteroids remains limited. ObjectivesThe aim of this study was to identify potential factors predicting responses to corticosteroids for CRF in advanced cancer patients. MethodsInclusion criteria for this multicenter, prospective, observational study were patients who had metastatic or locally advanced cancer and had a fatigue intensity score of 4 or more on a 0–10 Numerical Rating Scale (NRS). Univariate and multivariate analyses were conducted to identify the factors predicting two-point reduction or more in NRS on day 3. ResultsAmong 179 patients who received corticosteroids, 86 (48%; 95% CI 41%–56%) had a response with two-point reduction or more. Factors that significantly predicted responses were performance status score of 3 or more, Palliative Performance Scale score more than 40, absence of ascites, absence of drowsiness, absence of depression, serum albumin level greater than 3 mg/dL, serum sodium level greater than 135 mEq/L, and baseline NRS score greater than 5. A multivariate analysis showed that the independent factors predicting responses were baseline NRS score greater than 5 (odds ratio [OR] 6.6, 95% CI 2.8–15.4), Palliative Performance Scale score more than 40 (OR 4.4, 95% CI 2.1–9.3), absence of drowsiness (OR 3.4, 95% CI 1.7–6.9), absence of ascites (OR 2.3, 95% CI 1.1–4.7), and absence of pleural effusion (OR 2.2, 95% CI 1.0–5.0). ConclusionTreatment responses to corticosteroids for CRF may be predicted by baseline symptom intensity, performance status, drowsiness, and severity of fluid retention symptoms. Larger prospective studies are needed to confirm these results.

Symptomatic, Magnetic Resonance Imaging–Confirmed Cervical Disk Herniation Patients: A Comparative-Effectiveness Prospective Observational Study of 2 Age- and Sex-Matched Cohorts Treated With Either Imaging-Guided Indirect Cervical Nerve Root Injections or Spinal Manipulative Therapy

ObjectiveThe purpose of this study was to compare the outcomes of overall improvement, pain reduction, and treatment costs in matched patients with symptomatic, magnetic resonance imaging–confirmed cervical disk herniations treated with either spinal manipulative therapy (SMT) or imaging-guided cervical nerve root injection blocks (CNRI). MethodsThis prospective cohort comparative-effectiveness study included 104 patients with magnetic resonance imaging–confirmed symptomatic cervical disk herniation. Fifty-two patients treated with CNRI were age and sex matched with 52 patients treated with SMT. Baseline numerical rating scale (NRS) pain data were collected. Three months after treatment, NRS pain levels were recorded and overall “improvement” was assessed using the Patient Global Impression of Change scale. Only responses “much better” or “better” were considered “improved.” The proportion of patients “improved” was calculated for each treatment method and compared using the χ2 test. The NRS and NRS change scores for the 2 groups were compared at baseline and 3 months using the unpaired t test. Acute and subacute/chronic patients in the 2 groups were compared for “improvement” using the χ2 test. Results“Improvement” was reported in 86.5% of SMT patients and 49.0% of CNRI patients (P = .0001). Significantly more CNRI patients were in the subacute/chronic category (77%) compared with SMT patients (46%). A significant difference between the proportion of subacute/chronic CNRI patients (37.5%) and SMT patients (78.3%) reporting “improvement” was noted (P = .002). ConclusionSubacute/chronic patients treated with SMT were significantly more likely to report relevant “improvement” compared with CNRI patients. There was no difference in outcomes when comparing acute patients only.

Vertebral Bone Drilling (Puncture) Attenuates the Intractable Pain Due to Vertebral Fractures without Collapse

Purpose: Osteoporotic vertebral fractures with no sign of vertebral collapse on initial radiographs, which is so-called occult vertebral fractures (VFs), exist. Occult VFs have a high rate of missed diagnosis, and the treatment of these fractures has rarely been discussed in the literature. We evaluated the effects of vertebral bone drilling for the pain due to occults VFs. Materials and Methods: Eighteen patients with painful osteoporotic occult VFs underwent the vertebral bone drilling. We evaluated the clinical outcome by comparing numerical rating scale (NRS) and activity of daily life (ADL) values between before and after the vertebral bone drilling. Comparisons were made by using Wilcoxon signed rank test. Results: The mean baseline NRS and ADL score, and the mean NRS and ALD score after the bone drilling were 8.4 ± 0.8, 2.2 ± 0.6, 2.4 ± 1.0, 4.6 ± 0.5, respectively. Among the patients, we detected significant improvements in NRS pain score and ADL score after the drilling compared with baseline score (p < 0.0002). Conclusion: Vertebral bone drilling at the site of painful vertebral compression fractures alleviated the intractable pain due to osteoporotic occult VFs.

Long-Term Data of Efficacy, Safety, and Tolerability in a Real-Life Setting of THC/CBD Oromucosal Spray-Treated Multiple Sclerosis Patients.

Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was approved as add-on therapy for spasticity in patients with multiple sclerosis (MS). We show our 40-week postmarketing experience regarding efficacy and safety of THC/CBD spray in an Italian cohort of 102 MS patients. Patients were evaluated using the Expanded Disability Status Scale (EDSS) score, the Numerical Rating Scale (NRS) for spasticity, the Ambulation Index (AI), and Timed 25-Foot Walk (T25-FW) at the beginning of treatment and then every 3 months. After 4 weeks, if a clinically significant improvement in spasticity (at least 20% of baseline NRS score) was not seen, administration of the drug was stopped. In our cohort, patients received an average of 6.5 ± 1.6 sprays each day. The mean reduction to the NRS spasticity score was 2.5 ± 1.2 points (P < .0001). Thirty-seven patients (36.2%) discontinued the treatment. The incidence of adverse events (AEs) was 40.2%. Fifty-eight patients (56.9%) were also assessed using the NRS for pain, and 46 patients (45.1%) with bladder dysfunction were assessed for the IPSS (International Prostatic Symptoms Score) score, showing a significant improvement in these scales (P = .011 and P = .001, respectively). In conclusion, treatment with THC/CBD spray appears to be a valid answer to some of the unmet needs in MS patients, such as spasticity and other refractory-to-treatment symptoms.

Comparative Analgesic Efficacy of Oxycodone/Acetaminophen vs Codeine/Acetaminophen for Short-Term Pain Management Following ED Discharge.

To test the hypothesis that oxycodone/acetaminophen provides analgesia superior to codeine/acetaminophen following emergency department (ED) discharge. Prospective, randomized, double-blind, trial. Adult inner city ED. ED patients with acute extremity pain who were discharged home. Patients randomized to oxycodone/acetaminophen (5 mg/325 mg) or codeine/acetaminophen (30 mg/300 mg). The primary outcome, obtained via telephone one day after ED discharge, was the between-group difference in improvement in numerical rating scale (NRS) pain scores over a 2-hour period following the most recent ingestion of study drug. Secondary outcomes included proportion of patients with >50% pain reduction, side-effect profile, and patient satisfaction. Two hundred and forty patients were enrolled. Mean baseline NRS scores were 7.9 in both groups. Mean decrease over 2 hours was 4.5 NRS units in the oxycodone/acetaminophen group vs 4.2 NRS units in the codeine/acetaminophen group, for a clinically and statistically nonsignificant difference of 0.2 NRS units (95% CI -0.4-0.9 NRS units). Similarly, 66% vs 61% achieved >50% pain relief for a nonsignificant difference of 5% (95% CI -8% to 17%). Side-effect profile and patient satisfaction were similar. Our hypothesis that oxycodone/acetaminophen provides analgesia superior to codeine/acetaminophen was rejected. Although pain within each group was reduced by more than half, the between-group difference was not significant. Pending independent validation, these unexpected findings suggest that codeine/acetaminophen, a Schedule III agent, may be a clinically reasonable outpatient opioid alternative to oxycodone/acetaminophen, a more tightly restricted Schedule II agent thought to be more prone to misuse.

Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study

Background: The prospective, non-interventional Mobility Improvement (MOVE) 2 study was designed to provide real life data on clinical outcomes of patients with treatment-resistant multiple sclerosis (MS) spasticity receiving routine treatment with tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex®), subsequent to its approval in European countries. Methods: This interim analysis reports on MOVE 2 patients from Italy. Results: Interim data from 322 patients (58.3% female; mean age 51.1 ± 10.2 years) were analyzed. From baseline to month 3 of treatment (Visit 3), the mean 0-10 Numerical Rating Scale (NRS) score decreased by -19.1% (-1.6 points, p < 0.0001) and the mean modified Ashworth score decreased from 2.6 to 2.3 points (p < 0.0001). At Visit 3, 24.6% of 203 patients with available data were clinically relevant responders (≥30% improvement from baseline NRS score; p < 0.001 vs. baseline). The mean reported dose of THC:CBD oromucosal spray was 6.1 ± 2.5 sprays/day at Visit 1 (1 month) and 5.1 ± 2.6 sprays/day at Visit 3 (range 1-12 sprays/day at both timepoints). Forty-one (13.1%) patients reported at least one adverse event (AE), which included 3 serious AEs (1 unrelated). AEs with an incidence ≥1% were dizziness (5.6%), confusion (2.5%), nausea (1.25%) and somnolence (1.25%). Conclusion: In everyday clinical practice in Italy, THC:CBD oromucosal spray provided symptomatic relief of MS spasticity with good tolerability in a relevant number of previously resistant patients.

Clinical outcome and predictors of treatment response in foam sodium tetradecyl sulfate sclerotherapy of venous malformations.

To evaluate clinical outcomes and their predictors in patients with venous malformation (VM) treated with foam sodium tetradecyl sulfate (STS) sclerotherapy. We retrospectively evaluated clinical outcomes of foam STS sclerotherapy in 86 patients with 91 VMs to assess reduction in pain and mass after treatment. Univariate and multivariate analysis was performed to determine possible predictors of clinical outcome with foam STS sclerotherapy. A positive response of 49.5% in pain reduction and 52.7% in mass reduction was observed. The numerical rating scale (NRS) score improved from 4.36 ± 2.64 to 1.74 ± 1.57, and VM mass volume decreased to 41.7 ± 35.52% of the initial size. On multivariate analysis, a high baseline NRS score (odds ratio: 1.12, 95% confidence interval: 1.09-1.15) and VM location in the trunk versus the head and neck (odds ratio: 1.30, 95% confidence interval: 1.00-1.69) were positive predictors of pain improvement. Minor complications occurred in 11 (12.1%) patients and recurrence in 12 (13.2%) patients. Foam STS sclerotherapy is an effective treatment in venous malformation, with low complication risk. A high baseline NRS score and location in the trunk versus the head and neck were positive predictors in improvement of pain. • Foam STS sclerotherapy is effective in VM, with low risk of complications. • Relief of pain tends to be dramatic in patients with severe pain. • Location of VM is a predictor of pain improvement. • The presence of a draining vein does not affect foam sclerotherapy.

Low-dose ketamine vs morphine for acute pain in the ED: a randomized controlled trial

ObjectivesTo compare the maximum change in numeric rating scale (NRS) pain scores, in patients receiving low-dose ketamine (LDK) or morphine (MOR) for acute pain in the emergency department. MethodsWe performed an institutional review board–approved, randomized, prospective, double-blinded trial at a tertiary, level 1 trauma center. A convenience sample of patients aged 18 to 59 years with acute abdominal, flank, low back, or extremity pain were enrolled. Subjects were consented and randomized to intravenous LDK (0.3mg/kg) or intravenous MOR (0.1mg/kg). Our primary outcome was the maximum change in NRS scores. A sample size of 20 subjects per group was calculated based on an 80% power to detect a 2-point change in NRS scores between treatment groups with estimated SDs of 2 and an α of .05, using a repeated-measures linear model. ResultsForty-five subjects were enrolled (MOR 21, LDK 24). Demographic variables and baseline NRS scores (7.1 vs 7.1) were similar. Ketamine was not superior to MOR in the maximum change of NRS pain scores, MOR=5 (confidence interval, 6.6-3.5) and LDK=4.9 (confidence interval, 5.8-4). The time to achieve maximum reduction in NRS pain scores was at 5minutes for LDK and 100minutes for MOR. Vital signs, adverse events, provider, and nurse satisfaction scores were similar between groups. ConclusionLow-dose ketamine did not produce a greater reduction in NRS pain scores compared with MOR for acute pain in the emergency department. However, LDK induced a significant analgesic effect within 5 minutes and provided a moderate reduction in pain for 2 hours.

Novel continuous passive motion device for self-treatment of chronic lower back pain: a randomised controlled study

ObjectiveTo evaluate the efficacy of a novel, angular, continuous passive motion device for self-treatment at home in patients with mild-to-moderate, non-specific, chronic low back pain (LBP). DesignProspective, randomised, waiting-list-controlled (WLC) trial. SettingRecruitment and assessment were conducted at the Koren Centre for Physical Therapy. Self-treatment was performed at home. ParticipantsThirty-six patients with a score ≤6 on the numeric rating scale (NRS) for pain were enrolled. Twenty-eight patients completed treatment. InterventionsParticipants were randomised to receive the Kyrobak (Radiancy, Hod-hasharon, Israel) at enrolment [immediate treatment (IT) group] or 3 weeks later (WLC group). Self-treatment was prescribed for 10minutes, one to three times per day, for 3 weeks. The treatment period was followed by a 3-week follow-up period. Main outcome measuresPrimary outcome was self-reported pain level (NRS). ResultsThree weeks of self-treatment with the Kyrobak reduced pain levels significantly in the IT group compared with the WLC group {mean [standard deviation (SD)] ΔNRS score from baseline to post-treatment: IT group, 1.4 (1.5), 95% confidence interval (CI) 0.5 to 2.3; WLC group, −0.1 (2.2), 95% CI −1.1 to 1.2; effect mean difference 1.5}. This benefit was maintained over the follow-up period [from baseline to end of follow-up, mean (SD) ΔNRS score 1.1 (1.8), 95% CI 0.4 to 1.8]. Multi-linear regression analysis found that higher baseline pain resulted in greater pain reduction (P=0.003). Eighty-three percent of participants with a baseline NRS score >4.35 (threshold determined by logistic regression, P=0.01) achieved the minimal important change criterion of ΔNRS score ≥2. Daily NRS score reduced gradually over the treatment period [regression slope −0.052 (0.01), 95% CI −0.07 to −0.03]. ConclusionsPreliminary evidence suggests that the Kyrobak may be beneficial for short-term relief of non-specific, chronic LBP, particularly in participants with a moderate level of pain. A longer treatment period may lead to a further reduction in pain.

Comparison of the therapeutic efficacy of intravenous dimenhydrinate and intravenous piracetam in patients with vertigo: a randomised clinical trial

BackgroundThe present study aimed to compare the therapeutic efficacy of dimenhydrinate and piracetam in patients with vertigo.MethodsA blinded, parallel group, superiority, randomised clinical trial was carried out on patients who...

Are Modic changes related to outcomes in lumbar disc herniation patients treated with imaging-guided lumbar nerve root blocks?

ObjectiveTo compare outcomes after imaging-guided transforaminal lumbar nerve root blocks in MRI confirmed symptomatic disc herniation patients with and without Modic changes (MC). MethodsConsecutive adult patients with MRI confirmed symptomatic lumbar disc herniations and an imaging-guided lumbar nerve root block injection who returned an outcomes questionnaire are included. Numerical rating scale (NRS) pain data was collected prior to injection and 20–30min after injection. NRS and overall improvement were assessed using the patient's global impression of change (PGIC) scale at 1 day, 1 week and 1 month post injection. The proportion of patients with and without MC on MRI as well as Modic I and Modic II was calculated. These groups were compared for clinically relevant ‘improvement’ using the Chi-squared test. Baseline and follow-up NRS scores were compared for the groups using the unpaired t-test. Results346 patients are included with MC present in 57%. A higher percentage of patients without MC reported ‘improvement’ and a higher percentage of patients with MC reported ‘worsening’ but this did not reach statistical significance. The numerical scores on the PGIC and NRS scales showed that patients with MC had significantly higher pain and worse overall improvement scores at 1 month (p=0.048 and p=0.03) and a significantly lower 1 month NRS change score (p=0.04). ConclusionsPatients with MRI confirmed symptomatic lumbar disc herniations and MC report significantly lower levels of pain reduction after a lumbar nerve root block compared to patients without MC.