Mean Change In Visual Analog Scale Research Articles

Effect of Xuefu zhuyu oral liquid on tension-type headache: A randomized clinical trial

BackgroundTension-type headache (TTH) is the most common neurological disorder worldwide, incurring immense social and economic costs and affecting quality of life. However, due to adverse reactions and inadequate effectiveness, there is still an unmet need for treatment. Xuefu zhuyu oral liquid (XZOL) is a Chinese patent medicine widely used for TTH in China, but evidence of its efficacy remains scant. PurposeThe aim of this study was to assess the efficacy and safety of XZOL for TTH patients. MethodsThis multicenter, double-blind, randomized placebo-controlled trial enrolled 174 patients with TTH in six centers in China from March 2020 to October 2021. Patients were randomly assigned to receive XZOL or a matched placebo for 4weeks. The primary outcome was the change in the mean headache intensity as measured by a visual analogue scale (VAS) from baseline to the end of treatment (Week 4). Secondary outcomes were the change in VAS from baseline to Week 12, the area-under-the-headache curve (AUC), response rate, number of headache days, average headache duration, rescue medication use proportion, etc. ResultsOf the 174 patients who were randomized, 160 completed the study. There was no significant difference in the mean change in VAS from baseline to the end of treatment between the XZOL group and the placebo group (-0.29; (95 % CI:0.81 to 0.23; p = 0.279) in the full analysis set (FAS), while there were statistically significant results (-0.9; 95 % CI:1.47 to -0.33; p = 0.002) in the per-protocol set (PPS). There were no significant differences in any of the secondary outcomes. The incidence of adverse events was similar in the two groups. ConclusionXZOL may be an alternative option to relieve pain for TTH patients with high compliance in clinical practice. However, XZOL did not improve headache measurements in the FAS population.

Imaging Findings, Fluoroscopic Time, and Results of the Lumbosacral Selective Nerve Root Block: Focus on the L5 Nerve Root Block.

Introduction Selective nerve root block (SNRB) is a valuable diagnostic and therapeutic tool. In some cases, intra-nerve root puncture is difficult and time-consuming, and radiation exposure time for the surgeon may be prolonged. The aim of this study is to examine the contrast findings, fluoroscopic time, and outcomes of SNRB. Methods A total of 139 cases of SNRB were included in the study. We investigated radiating pain presence, duration of fluoroscopic time, contrast types for nerve roots, and SNRB outcomes. Contrast patterns of nerve roots were categorized into three types, which were: type 1: the presence of contrast along the nerve roots; type 2: the presence of contrast within the intravertebral foramen but not in the nerve root; and type 3: the absence of both nerve root and intravertebral foramen contrast. Results The mean fluoroscopic time was 12.8 ± 15.3 seconds for type 1, 11.1 ± 8.9 seconds for type 2, and 23.6 ± 18.8 seconds for type 3. Statistically significant differences were found between the three groups (p = 0.007), and subsequent multiple comparisons showed significant differences between type 1 and type 2 (p = 0.010) and between type 2 and type 3 (p = 0.015). The visual analog scale (VAS) score before and 30 minutes after SNRB demonstrated a significant improvement in all patients. The mean change in VAS before and after nerve root block was 49.6 ± 21.7 mm for type 1 cases, 49.8 ± 25.2 mm for type 2 cases, and 37.8 ± 23.6 mm for type 3 cases, with no statistically significant difference between the three groups (p = 0.090). The proportion of patients with subjective symptomatic improvement before and after SNRB was 91.3% in type 1 cases, 88.5% in type 2 cases, and 85.7% in type 3 cases, with no statistically significant difference between the three groups (p = 0.641). Conclusions The above findings indicate that type 3 is beneficial for both diagnostic and therapeutic purposes.

P71. Should physical therapy be incorporated in patient care post 1-2 level lumbar fusions for degenerative lumbar instability? A comparative outcome analysis

BACKGROUND CONTEXT Fewer studies in the literature have examined the role of postoperative physical therapy (PT) after lumbar fusion. In the postoperative setting, much of the rehabilitation literature focuses on postdiscectomy patients. PURPOSE Evaluate and compare the changes in pain and functional scores between patients who completed physical therapy (PT) versus no-PT after their anterior or posterior 1-2 level lumbar fusions for degenerative lumbar instability. Our hypothesis was that the PT group may experience comparatively better functional and pain outcomes than their counterparts. STUDY DESIGN/SETTING Retrospective. PATIENT SAMPLE A total of 123 patients with degenerative lumbar instability. OUTCOME MEASURES Oswestry disability index (ODI) and visual analog scale (VAS). METHODS A database of patients undergoing 1-2 level lumbar fusion surgery for degenerative disease was assembled. Demographic and outcome scores such as oswestry disability index (ODI) and visual analog scale (VAS) in patients who participated in postoperative PT vs those that did not were compared. RESULTS There were 72 and 51 patients in PT and no-PT that met the inclusion criteria, respectively. There were higher numbers of females (63.8%) in PT group. No-PT group had similar numbers of males and females. Mean ages for PT and no-PT groups were 61.4(±14.7) and 59.5(±14.1) years, respectively. Both groups were similar with respective to body mass index. A majority of the cases in both groups involved posterior/posterolateral approach; 55.5% of patients in PT group and 50.9% in no-PT had 1 level lumbar fusion. Mean change (preoperative vs 1-year postoperative) in ODI between the two groups differed significantly (PT vs no-PT: 18.8±13.9 and 9.3±17.5; p=0.019). Similarly, mean change in VAS was significantly different between the two groups (PT vs. no-PT: 3.2±2.18 and 1.05±2.08; p=0.026). None of our PT patients reported any change in pre vs 1-year postoperative followup employment status (35% retired, 38% employed full-time, 11% unemployed and 16% homemaker). Ninety-eight percent of no-PT patients reported no change in employment status during the same timeframe (46% retired, 25% employed full-time, 13% unemployed and 15% homemaker). CONCLUSIONS PT group reported significant improvements in functional and pain scores than their counterparts. Post-lumbar fusion rehabilitation may benefit the majority of adult patients undergoing lumbar fusion surgery for a degenerative indication. Prospective studies with standardized PT approach, additional patients and greater statistical power are needed to further understand the effects of physical therapy on patients undergoing lumbar fusions for degenerative lumbar instability. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs. Fewer studies in the literature have examined the role of postoperative physical therapy (PT) after lumbar fusion. In the postoperative setting, much of the rehabilitation literature focuses on postdiscectomy patients. Evaluate and compare the changes in pain and functional scores between patients who completed physical therapy (PT) versus no-PT after their anterior or posterior 1-2 level lumbar fusions for degenerative lumbar instability. Our hypothesis was that the PT group may experience comparatively better functional and pain outcomes than their counterparts. Retrospective. A total of 123 patients with degenerative lumbar instability. Oswestry disability index (ODI) and visual analog scale (VAS). A database of patients undergoing 1-2 level lumbar fusion surgery for degenerative disease was assembled. Demographic and outcome scores such as oswestry disability index (ODI) and visual analog scale (VAS) in patients who participated in postoperative PT vs those that did not were compared. There were 72 and 51 patients in PT and no-PT that met the inclusion criteria, respectively. There were higher numbers of females (63.8%) in PT group. No-PT group had similar numbers of males and females. Mean ages for PT and no-PT groups were 61.4(±14.7) and 59.5(±14.1) years, respectively. Both groups were similar with respective to body mass index. A majority of the cases in both groups involved posterior/posterolateral approach; 55.5% of patients in PT group and 50.9% in no-PT had 1 level lumbar fusion. Mean change (preoperative vs 1-year postoperative) in ODI between the two groups differed significantly (PT vs no-PT: 18.8±13.9 and 9.3±17.5; p=0.019). Similarly, mean change in VAS was significantly different between the two groups (PT vs. no-PT: 3.2±2.18 and 1.05±2.08; p=0.026). None of our PT patients reported any change in pre vs 1-year postoperative followup employment status (35% retired, 38% employed full-time, 11% unemployed and 16% homemaker). Ninety-eight percent of no-PT patients reported no change in employment status during the same timeframe (46% retired, 25% employed full-time, 13% unemployed and 15% homemaker). PT group reported significant improvements in functional and pain scores than their counterparts. Post-lumbar fusion rehabilitation may benefit the majority of adult patients undergoing lumbar fusion surgery for a degenerative indication. Prospective studies with standardized PT approach, additional patients and greater statistical power are needed to further understand the effects of physical therapy on patients undergoing lumbar fusions for degenerative lumbar instability.

Clinical efficacy of nanohydroxyapatite-containing toothpaste at relieving dentin hypersensitivity: an 8 weeks randomized control trial

ObjectiveThe objective of this study was to investigate and compare the effectiveness of several toothpastes containing nanohydroxyapatite (nano-HAP) to relieve dentin hypersensitivity (DHS) with that of a commercial desensitizing dentifrice containing calcium sodium phosphosilicate (CSPS).Materials and methodsIn this double-blind, randomized, parallel-group clinical trial, patients diagnosed with DHS and qualified to participate were randomized into four groups: toothpaste containing 10% nano-HAP (10%nano-HAP), 15% nano-HAP (15%nano-HAP), 10% nano-HAP supplemented with potassium nitrate (KNO3) (10%nano-HAPKN), or CSPS. Subjects’ baseline and post-treatment sensitivities were assessed using visual analog scale (VAS) after the application of ice-cold and air stimuli. Subjects used their assigned toothpaste for routine toothbrushing twice daily. Post-treatment sensitivity was assessed every 2 or 8 weeks. Mean change in VAS (mm) from baseline at each time point were compared using random-intercept, mixed-model analysis and Duncan test (P < 0.05).ResultsWith either air or cold stimulus, VAS indicated a significant (P < 0.001) reduction from baseline DHS at each time point with all test toothpastes. Among the nano-HAP toothpastes, 15%nano-HAP and 10%nano-HAPKN were consistent in DHS reduction with both stimuli. With either stimuli, the CSPS did not significantly differ from 15%nano-HAP and 10%nano-HAPKN at any time point.ConclusionsToothpaste containing nano-HAP (10 or 15%) alone or supplemented with KNO3 was as effective as CSPS for relief of DHS symptoms when used at least twice daily.

Symptoms, Health-Related Quality of Life, and Tolerability of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Introduction In the ongoing single-arm, open-label phase 2 ADCT-402-201 study (LOTIS 2, NCT03589469), loncastuximab tesirine has shown substantial antitumor activity with a manageable toxicity profile in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who had failed ≥ 2 prior therapies, including activity in patients with high-risk disease characteristics. The overall response rate was 48.3% (based on positron emission tomography-computed tomography [PET-CT] assessed by independent review according to Lugano response criteria), and the median duration of response was 10.25 months. This analysis examined symptoms, health-related quality of life (HRQoL), and tolerability using validated patient-reported outcome instruments. Methods Enrolled patients aged ≥18 years received loncastuximab tesirine as an intravenous infusion on day 1 of each 3-week treatment cycle. Responders were defined as patients with a best overall response of complete or partial response. Patient-reported symptoms and HRQoL were measured using the Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) and EQ-5D 5 Levels (EQ-5D-5L) instruments at baseline, day 1 of each cycle while patients were treated, and at the end-of-treatment visit. Descriptive statistics for change from baseline scores and percentages of patients with improved, stable, or worsened symptoms were summarized by visit and clinical response. Analysis was conducted using data collected from study initiation (1 August 2018) through 6 April 2020. Results The 145 patients enrolled in this study had a median age of 66 years (range, 23-94). Patients were heavily pretreated, with a median of 3 (range, 2-7) prior systemic therapies. A baseline patient-reported outcome score and at least one post-baseline score were available for 130 patients. Completion rates among patients treated at each visit were ≥ 92% for EQ-5D-5L and ≥ 88% for FACT-Lym up to cycle 9, day 1 (24 weeks). After cycle 9, fewer than 20 patients had patient-reported outcome scores available for analysis. For symptoms assessed in the FACT-Lym lymphoma subscale, pain in certain parts of the body, lumps/swelling, trouble sleeping at night, and fatigue were the most frequently reported symptoms at baseline (34%-59% reported "somewhat" to "very much"). Most patients (≥ 80%) reported "not at all" or "a little bit" at baseline for fever, night sweats, losing weight, itching, and loss of appetite. During the course of treatment, higher percentages of patients reported improvement than worsening for pain and lumps/swelling for the majority of visits. Fever, night sweats, and losing weight did not change for most patients. Itching was the only symptom for which more patients experienced worsening than improvement. For other symptoms, similar percentages of patients reported improvement and worsening. The mean change from baseline in EQ-5D Visual Analog Scale (VAS) score showed a trend of improvement in overall health over time (see figure). The mean VAS change reached the minimally important difference of 7 points at cycle 8, day 1. This improvement was associated with clinical response. When patients were asked how much they were bothered by side effects of treatment, most patients (&amp;gt; 60%) reported "not at all" or "a little bit" for all visits throughout the treatment. Conclusions Results of this analysis suggest that patients who responded to treatment with loncastuximab tesirine generally had stable or improved symptoms and overall HRQoL. The treatment was well tolerated by patients. These findings further support the clinical use of loncastuximab tesirine for the treatment of relapsed or refractory DLBCL. Disclosures Spira: ADCT:Research Funding;Janssen:Consultancy;Incyte:Consultancy;BMS:Consultancy;Merck:Consultancy;Novartis:Consultancy;Takeda:Consultancy;Cardiff Oncology:Research Funding.Chen:ADCT:Current Employment, Current equity holder in publicly-traded company.Zhou:ADCT:Research Funding.Gnanasakthy:ADCT:Research Funding.Wang:ADC Therapeutics America, inc:Current Employment, Current equity holder in publicly-traded company.Ungar:ADC Therapeutics:Current Employment, Current equity holder in publicly-traded company.Curiel:ADCT:Current Employment, Current equity holder in publicly-traded company.Radford:GlaxoSmithKline:Current equity holder in publicly-traded company, Other: Spouse;AstraZeneca:Current equity holder in publicly-traded company, Other: Spouse;Takeda:Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau;Pfizer:Research Funding;ADCT:Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding;BMS:Consultancy, Honoraria, Speakers Bureau;Novartis:Consultancy, Honoraria;Seattle Genetics:Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.Kahl:AstraZeneca Pharmaceuticals LP:Consultancy, Membership on an entity's Board of Directors or advisory committees;Celgene Corporation:Consultancy;Genentech:Consultancy;Pharmacyclics LLC:Consultancy;Roche Laboratories Inc:Consultancy;BeiGene:Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding;Janssen:Consultancy, Membership on an entity's Board of Directors or advisory committees;Acerta:Consultancy, Research Funding;ADC Therapeutics:Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding;AbbVie:Consultancy.

Trigeminal endonasal perception - an outcome predictor for septoplasty.

No adequate test exists to predict outcome after septoplasty. Despite adequate surgery, patients still might experience nasal breathing impairment. The aim of this study was to determine if pre-operative trigeminal sensitivity can predict satisfaction after septoplasty. Single centre prospective cohort study in tertiary referral centre with follow-up time of 6 weeks postoperatively. Patients scheduled for septoplasty or septorhinoplasty with turbinoplasty were consecutively selected the day before surgery. Standard preoperative examinations (acoustic rhinometry and Sniffin’ Sticks 12 test), the evaluation of nasal obstruction on a visual analogue scale (VAS) and the trigeminal lateralisation task were performed before and 6 weeks after surgery. Biopsies were taken during surgery and TRPV1 mRNA expression was measured by PCR. Thirty patients were included with a median age of 29 years and equal gender distribution. Trigeminal perception and sensation of nasal obstruction showed a significant correlation: preoperative lateralisation test scores, representing endonasal trigeminal sensitivity, correlated significantly with the mean VAS change scores, which demonstrate subjective improvement. A lateralisation test score of 31.5 and more had a sensitivity of 88% to predict an improvement of more than 3 VAS points. Additionally, high TRPV1 mRNA expression was linked with good postoperative VAS scores. The preoperative evaluation of the trigeminal sensitivity could improve patients’ selection for septoplasty with a higher rate of satisfaction. Endonasal trigeminal sensitivity is directly linked with subjective outcome. Therefore, patients with low trigeminal sensitivity should undergo septoplasty only after thorough counselling.

Transforaminal Versus Lateral Parasagittal Versus Midline Interlaminar Lumbar Epidural Steroid Injection for Management of Unilateral Radicular Lumbar Pain: A Randomized DoubleBlind Trial

Background: Epidural steroid injections (ESIs) are commonly used for management of lumbosacral radicular pain. Midline interlaminar (MIL) or transforaminal (TF) routes are commonly used. The TF route, although associated with higher delivery of drug to the ventral epidural space, has serious complications including spinal cord injury and permanent paralysis reported in literature. Therefore, there is a search for a technically better route with fewer complications and greater drug delivery into the ventral epidural space. Recently, a parasagittal interlaminar (PIL) approach has been defined. Objectives: We conducted this study to compare therapeutic effectiveness of 3 techniques of ESIs in patients having unilateral lumbar radiculopathy. Further, effect of ESI on bone mineral density (BMD) and serum osteocalcin levels were studied. Study Design: Randomized double-blind trial. Setting: Pain clinic of a tertiary care hospital. Methods: Sixty-five patients were randomly allocated into group MIL, group PIL, and group TF to receive epidural injection with 80 mg of methylprednisolone and 2 mL of 2% lidocaine. Effective pain relief and improvement in disability were assessed using Visual Analog Scale (VAS) and Modified Oswestry Disability Questionnaire (MODQ) scores at 2 weeks, 4 weeks, 3 months, and 6 months, respectively. Patients with &lt; 50% relief received additional injection. Primary outcome of study was effective pain relief at 6 months. Mean change in VAS and MODQ scores, BMD, and serum osteocalcin levels were secondary outcome assessed. Results: Patients having effective pain relief were significantly higher in group PIL (16 of 20 [80%]) and group TF (15 of 20 [75%]) compared with group MIL. Patients receiving ESI in group PIL and group TF showed significantly lower VAS scores than group MIL (P = 0.02, P = 0.50 at 3 months and P = 0.00, P = 0.02 at 6 months, respectively). Mean MODQ scores in group PIL and group TF were significantly lower than group MIL. However, group PIL and group TF did not significantly differ in MODQ scores. There was no significant change in serum osteocalcin and BMD, as assessed by dual energy x-ray absorptiometry scan at 3 months. Limitations: The absence of a placebo control group, small sample size, and relatively short follow-up of 6 months were limitations. Conclusions: PIL approach is equivalent to TF and superior to MIL approach in terms of effective pain relief and decrease in disability in patients with unilateral lumbar radiculopathy. This study showed no deleterious effect on BMD. Key words: Epidural steroid, technique, efficacy, bone marrow density, serum osteocalcin

A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain

PurposeA prospective, single-arm, open-label study to evaluate the effectiveness of intraosseous radio frequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of vertebrogenic-related chronic low back pain (CLBP) in typical spine practice settings using permissive criteria for study inclusion.MethodsConsecutive patients with CLBP of at least 6 months duration and with Modic Type 1 or 2 vertebral endplate changes between L3 and S1 were treated with RF ablation of the BVN in up to four vertebral bodies. The primary endpoint was patient-reported change in Oswestry Disability Index (ODI) from baseline to 3 months post-procedure. Secondary outcome measures included change in visual analog scale (VAS), SF-36, EQ-5D-5L, and responder rates.ResultsMedian age was 45 years; baseline ODI was 48.5; VAS was 6.36. Seventy-five percent (75%) of the study patients reported LBP symptoms for ≥ 5 years; 25% were actively using opioids; and 61% were previously treated with injections. Mean change in ODI at 3 months posttreatment was − 30.07 +14.52 points (p < 0.0001); mean change in VAS was − 3.50 + 2.33 (p < 0.0001). Ninety-three percent (93%) of patients achieved a ≥ 10-point improvement in ODI, and 75% reported ≥ 20-point improvement.ConclusionsMinimally invasive RF ablation of the BVN demonstrated a significant improvement in pain and function in this population of real-world patients with chronic vertebrogenic-related LBP.Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.

Nalfurafine hydrochloride for refractory pruritus in peritoneal dialysis patients: a phase III, multi-institutional, non-controlled, open-label trial

BackgroundNalfurafine hydrochloride (“nalfurafine”), the world’s first selective oral κ-receptor agonist for improving pruritus, is approved in Japan for the treatment of pruritus resistant to existing treatments in hemodialysis (HD) or chronic liver disease patients. Peritoneal dialysis (PD) patients, like HD patients, suffer from end-stage renal disease (ESRD) and some experience refractory pruritus.MethodsWe investigated the efficacy and safety of nalfurafine in 37 ESRD patients who underwent PD and had refractory pruritus. Nalfurafine was given once daily for 4 weeks at 2.5 μg in weeks 1 and 2 of the treatment period and at 5 μg in weeks 3 and 4. The primary endpoint was visual analog scale (VAS) changes for pruritus (i.e., the value upon rising or before sleep in week 2, whichever larger).ResultsThe mean VAS change from baseline in week 2 of the treatment period was 24.93 mm [18.67, 31.19] (the point estimate of the mean [90% confidence interval (CI)]); the lower limit of CI exceeded the point estimate of the mean VAS change (15.24 mm) of the placebo group at the evaluation point (week 2) in a preceding confirmatory trial suggesting that had demonstrated nalfurafine efficacy for refractory pruritus in HD patients. The observed VAS change was comparable to that of the 2.5-μg group (week 2) in the preceding confirmatory trial, demonstrating that nalfurafine is as effective for treating pruritus in PD patients as in HD patients. Nalfurafine 5 μg was associated with a mean VAS change of 32.13 mm at week 4, i.e., the full length of the trial treatment period suggesting efficacy at the dose of 5 μg. The incidence of adverse drug reactions (ADR) was 45.9% (1/37 patients) with no serious ADRs observed. ADRs occurring in ≥ 5% of patients included insomnia (13.5%), increased blood prolactin (13.5%), somnolence (8.1%), lower blood testosterone free (8.1%), and vomiting (5.4%), all of which were mild.ConclusionsThis trial demonstrated the efficacy and safety of nalfurafine against refractory pruritus in PD, suggesting clinical benefit for treating pruritus in PD patients.Trial registrationJapan Pharmaceutical Information Center, JapicCTI-142565

Improved immediate postoperative pain following laparoscopic inguinal herniorrhaphy using self-adhering mesh.

Several synthetic meshes are available to reinforce the inguinal region following laparoscopic hernia reduction. We sought to compare postoperative pain of patients who underwent laparoscopic inguinal herniorrhaphy using self-adhering polyester mesh to those who had non-adhering, synthetic mesh implanted using absorbable tacks. This study is a retrospective review of patients who underwent primary laparoscopic inguinal herniorrhaphy at the Medical College of Wisconsin between October 2012 and July 2014. Clinical information and perioperative pain scores using the visual analog scale (VAS) were obtained to evaluate immediate pre and postoperative pain. A total of 98 patients (88 male) underwent laparoscopic inguinal herniorrhaphy during the study interval. Forty-two patients received self-adhering mesh and 56 patients received mesh secured with tacks. Patient demographics and comorbidities did not differ significantly between the two groups. There was no difference in preoperative VAS scores between groups. The self-adhering mesh patients had a lower mean VAS change score (less pain). Postoperative complications did not differ between groups apart from a higher observed incidence of seroma in the self-adhering mesh group (p=0.04). No hernias recurred in either group during the study interval. Self-adhering mesh in laparoscopic inguinal herniorrhaphy resulted in less immediate postoperative pain than tacked mesh as demonstrated by VAS score. Postoperative complications were similar between the two groups. The results of this study demonstrate that laparoscopic inguinal herniorrhaphy using self-adhering mesh is comparable to tacked mesh in regards to short-term complication rates, but show a favorable advantage in regards to immediate postoperative pain.

Do antiemetic drugs benefit adult emergency department patients with nausea? The literature says no, but is it right?

Nausea is a common problem in ED patients. Antiemetic drugs have been used in the ED for decades, but a recent Cochrane review found no convincing evidence for the benefit of antiemetic drugs over placebo. This was largely based on three placebo-controlled trials, which found mean Visual Analog Scale (VAS) changes for various drugs and placebo, to be similar. However, reliance on mean VAS change as the primary outcome measure has probably been a mistake. It does not give information on the number of improved patients, so these cannot be compared between groups. Alternative primary outcome measures warrant further exploration. Use of a VAS cut-off level indicative of clinically significant symptom improvement would allow comparison of numbers of patients with improved nausea ratings. This is proposed as the best option currently available. Preliminary testing of this outcome measure suggests that the conclusions of past studies may be misleading, and that the question of antiemetic efficacy for ED patients is not yet answered.

Neurolysis with Amniotic Membrane Nerve Wrapping for Treatment of Secondary Wartenberg Syndrome: A Preliminary Report.

Entrapment of the superficial sensory branch of the radial nerve (SRN) commonly results in debilitating pain of the dorsoradial wrist. Symptom relief following SRN neurolysis is often incomplete or temporary due to recurrent perineural scarring. We performed a retrospective review with prospective follow-up of all patients with SRN neuropathy who were treated with neurolysis and nerve wrapping using an amnion-based allograft adhesion barrier over a one-year interval. Measured outcomes included pain rated by Visual Analog Scale (VAS) and Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional outcome scores. Three females satisfied inclusion. At mean follow-up of 28.9 months, all three patients exhibited improved pain (mean VAS change -4.7 ± 0.6), function (mean QuickDASH change -40 ± 5), and subjective satisfaction. No adverse events or reactions to the implanted tissue occurred. SRN entrapment neuropathy was safely and effectively treated with neurolysis and amnion nerve wrapping in this small series. Use of this technique for perineural scar prevention warrants additional study in larger groups of patients and in other upper extremity entrapment neuropathies.

Carbon dioxide versus room air insufflation during balloon-assisted enteroscopy: A systematic review with meta-analysis.

Background and study aims Carbon dioxide (CO2) insufflation has been suggested to be an ideal alternative to room air insufflation to reduce trapped air within the bowel lumen after balloon assisted enteroscopy (BAE). We performed a systematic review and meta-analysis to assess the safety and efficacy of utilizing CO2 insufflation as compared to room air during BAE. Patients and methods The primary outcome is mean change in visual analog scale (VAS; 10 cm) at 1, 3, and 6 hours to assess pain. Secondary outcomes include insertion depth (anterograde or retrograde), adverse events, total enteroscopy rate, diagnostic yield, mean anesthetic dosage, and PaCO2 at procedure completion. We searched MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception until May 2015. Multiple independent extractions were performed, the process was executed as per the standards of the Cochrane collaboration. Results Four randomized controlled trials (RCTs) were included in the meta-analysis. VAS at 6 hours favored CO2 over room air (MD 0.13; 95 % CI 0.01, 0.25; p = 0.03). Anterograde insertion depth (cm) was improved in the CO2 group (MD, 58.2; 95 % CI 17.17, 99.23; p = 0.005), with an improvement in total enteroscopy rate in the CO2 group (RR 1.91; 95 % CI 1.20, 3.06; p = 0.007). Mean dose of propofol (mg) favored CO2 compared to air (MD, – 70.53; 95 % CI – 115.07, – 25.98; P = 0.002). There were no differences in adverse events in either group. Conclusions Despite the ability of CO2 to improve insertion depth and decrease amount of anesthesia required, further randomized control trials are needed to determine the agent of choice for insufflation in balloon assisted enteroscopy.

A randomised controlled trial of paracetamol and ibuprofen with or without codeine or oxycodone as initial analgesia for adults with moderate pain from limb injury.

Compare pain relief from non-opioid, codeine and oxycodone analgesic regimens in adults with moderate pain from limb injury. Double-blind, randomised, controlled, non-inferiority trial. Three regimens of six tablets, each included 2×500mg paracetamol and 2×200mg ibuprofen with 2×100mg thiamine (non-opioid), 2×30mg codeine (codeine) or 2×5mg oxycodone tablets (oxycodone). difference in mean visual analogue scale (VAS) change between groups at 30min, with a limit of inferiority of 13. Secondary outcomes included mean change in VAS rating from baseline to 30min for each group, patient satisfaction, need for additional analgesia and adverse events. Pain ratings taken at 60 and 90min for patients still in ED are described. Of 182 patients randomised, non-opioid, codeine and oxycodone numbers were 61, 62 and 59. Differences (95% CI) between groups at 30min were as follows: non-opioid versus codeine -2.6 (-8.8 to 3.6); non-opioid versus oxycodone -2.7 (-9.3 to 3.9); codeine versus oxycodone 0.1 (-6.6 to 6.4). Mean VAS reductions for non-opioid, codeine and oxycodone were -13.5, -16.1 and -16.2mm, respectively. Satisfaction with analgesia was reported by 77.6% (64.7-87.5), 81.0% (67.2-89.0) and 73.6% (59.7-84.7) and adverse events by 3.3% (0.4-11.3), 1.6% (0.4-8.7) and 16.9% (8.4-29.0), respectively. Mean VAS reductions at 60 and 90min were as follows: -23.2 and -18.7mm for non-opioid; -30.7 and -33.3mm for codeine; and -26.1 and -31.7mm for oxycodone. At 30min, analgesic effects of non-opioid, codeine and oxycodone groups were non-inferior.

Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series.

IntroductionThis was a prospective case series designed to investigate treatment for anterior cruciate ligament (ACL) tears using an injection of autologous bone marrow concentrate.MethodsConsecutive adult patients presenting to a private outpatient interventional musculoskeletal and pain practice with knee pain, ACL laxity on exam, and magnetic resonance imaging (MRI) evidence of a grade 1, 2, or 3 ACL tears with less than 1 cm retraction were eligible for this study. Eligible patients were treated with an intraligamentous injection of autologous bone marrow concentrate, using fluoroscopic guidance. Pre- and postprocedural sagittal MRI images of the ACLs were analyzed using ImageJ software to objectively quantify changes between pre- and posttreatment scans. Five different types of measurement of ACL pixel intensity were examined as a proxy for ligament integrity. In addition pain visual analog scale (VAS) and Lower Extremity Functional Scale (LEFS) values were recorded at baseline and at 1 month, 3 months, 6 months, and annually postinjection. Objective outcomes measured were pre- to post-MRI measurement changes, as analyzed by the ImageJ software. Subjective outcomes measured were changes in the VAS and LEFS, and a self-rated percentage improvement.ResultsSeven of ten patients showed improvement in at least four of five objective measures of ACL integrity in their postprocedure MRIs. In the entire study group, the mean gray value, median, raw integrated density, and modal gray value all decreased toward low-signal ACLs (P=0.01, P=0.02, P=0.002, and P=0.08), indications of improved ligament integrity. Seven of ten patients responded to the self-rated metrics follow up. The mean VAS change was a decrease of 1.7 (P=0.25), the mean LEFS change was an increase of 23.3 (P=0.03), and mean reported improvement was 86.7%.ConclusionBased on this small case series, autologous bone marrow concentrate shows promise in the treatment of grade 1, 2, and possibly grade 3 ACL tears without retraction. Further investigation using a controlled study design is warranted.

An observational study to assess back pain in patients with severe osteoporosis treated with teriparatide versus antiresorptives: An Indian subpopulation analysis.

Background:One year, prospective, observational study in an Indian subpopulation to assess back pain in patients with severe osteoporosis treated with teriparatide or antiresorptives in a clinical setting.Materials and Methods:One hundred and nineteen teriparatide-naοve Indian men and postmenopausal women (mean age 68.0 years) with previous osteoporotic vertebral fracture participated. Patients were assessed at baseline, 6-and 12-months to evaluate relative risk (RR) of new/worsening back pain using the Back Pain Questionnaire. The incidence of back pain and changes in back pain severity were assessed using the visual analog scale (VAS); Health outcomes were assessed using the euroquol-5 dimensions (EQ-5D) questionnaire. All tests were conducted with a two-sided alpha of 0.05.Results:Of 562 overall patients, 57, 60, and 2 Indian patients received teriparatide, antiresorptive, or teriparatide and antiresorptive, respectively. Baseline disease characteristics were slightly worse for antiresorptive-treated patients, whereas teriparatide-treated patients were older with more comorbidities. At 6-months, the incidence of new/worsening back pain was 5.3% for teriparatide-treated patients versus 4.4% for antiresorptive-treated patients (RR: 1.00, 95% confidence interval: 0.68, 1.48); the incidence of severe back pain was 0% versus 12.5% (P = 0.017); in these treatment groups, respectively. Mean VAS change scores (mean ± standard deviation [SD]) were − 1.9 ± 1.73 versus − 1.4 ± 1.77, and mean EQ-5D change scores were 4.2 ± 27.20 versus 9.9 ± 26.23 at 6-months. At 6 months, more teriparatide-treated patients felt better (89% vs. 61%; P = 0.001) and were at least very satisfied with their treatment (30% vs. 9%; P = 0.011).Conclusion:Teriparatide-treated Indian patients had similar new/worsening back pain risk and minimal risk of severe back pain compared with antiresorptive-treated patients at 6-months.

Metronidazole Therapy for Treating Dientamoebiasis in Children Is Not Associated With Better Clinical Outcomes: A Randomized, Double-Blinded and Placebo-Controlled Clinical Trial

There is a paucity of evidence documenting the pathogenicity of Dientamoeba fragilis, an intestinal protozoan common in children. As case reports on successful treatment are numerous, many authors advocate treatment, despite no placebo-controlled trials being available. Metronidazole is often used for treatment, though eradication rates are relatively low (60%-80%). In the present study we determined the clinical and microbiological efficacy of metronidazole in Danish children. In this parallel placebo-controlled double-blinded trial, children aged 3-12 years with >4 weeks of gastrointestinal symptoms were allocated using block randomization in a 1:1 ratio to a 10-day course of oral metronidazole or placebo. Primary outcome was change in level of gastrointestinal symptoms, measured on a visual-analog-scale (VAS), and secondary outcome was eradication of D. fragilis infection. Participants, caregivers, investigators, and sponsor were all blinded to group assignment. The trial was registered with clinicaltrials.gov (NCT01314976) prior to start. Of 96 participants, 48 were allocated to the metronidazole and placebo group each. Mean VAS change from pre- to post-treatment did not differ significantly (P = .8) between the metronidazole (-1.8 CI, [-2.5, -1.1]) and the placebo group (-1.6 CI, [-2.3, -.9]). Eradication of D. fragilis was significantly greater in the metronidazole group, although it declined rapidly from 62.5% 2 weeks after end of treatment to 24.9% 8 weeks after end of treatment. These findings do not provide evidence to support routine metronidazole treatment of D. fragilis positive children with chronic gastrointestinal symptoms. Study funded by Statens Serum Institut. Trial was registered with clinicaltrials.gov (NCT01314976).

The effects of Panax notoginseng on delayed onset muscle soreness and muscle damage in well-trained males: A double blind randomised controlled trial

The aim of the study was to determine if Panax notoginseng is effective in reducing pain, indicators of inflammation and muscle damage, and in turn improve performance in well trained males who underwent a bout of eccentric exercise designed to induce delayed onset muscle soreness (DOMS). A double blind randomised placebo controlled trial. Twenty well trained male volunteers, matched by maximum aerobic capacity were randomly assigned to consume a regime of 4000 mg of P. notoginseng capsules or an indistinguishable placebo before and after a downhill treadmill running episode designed to induce DOMS. Performance measures (Kin-Com, counter movement and squat jump), pain assessments (visual analogue scale (VAS), algometer) and blood analyses (interleukin-1, interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF-α), C-reactive protein, myoglobin, creatine kinase) were assessed at 7 time points over 5 days (pre, post, 4, 24, 48, 72 and 96 h after the downhill run). The placebo group demonstrated a significant decrease in squat jump performance immediately post the downhill run, with a mean change ± 95% confidence interval (CI) of 0.8 cm (-3.53 to 1.93). The placebo group also experienced increased pain in the quadriceps 96 h after the downhill run, with a mean VAS change ± 95% CI of -0.32 cm (-0.34 to 0.98).The serum concentration of IL-6 and TNF-α were significantly lower in the placebo group 24h after the downhill run. Mean IL-6 change ± 95% CI of 0.50 pg/mL (-1.59 to 0.59), and mean TNF-α change ± 95% CI was 0.98 pg/mL (-2.04 to 0.09). No other significant differences were identified between the groups for any other outcome measure. Considering all data from this study, P. notoginseng did not convincingly have an effect on performance, muscular pain or assessed blood markers in well-trained males after an intense bout of eccentric exercise that induced DOMS.

Xylocaine Spray Reduces Patient Discomfort During Nasogastric Tube Insertion

Background: Nasogastric tube insertion is not tolerated well by patients especially after failed previous attempts. Atomised 1% Xylocaine spray may be used topically in the oropharynx and nasopharynx during endoscopy procedures. Aims: The authors assessed the efficacy of topical local anaesthetic in a cohort of patients undergoing nasogastric tube insertion. Methods: Patients in whom first attempt at tube insertion was unsuccessful were recruited to the study and consent obtained. Patient discomfort was assessed for the initial insertion attempt (VAS 1) and after use of the topical local anaesthetic (VAS 2) using a visual analogue scale. Results: All second attempts with Xylocaine spray topical local anaesthesia were successful. Mean score for VAS 1 was 74.5 and for VAS 2 was 52.5. The mean reduction in VAS was 22. Paired t test revealed a significant reduction in discomfort scores at the second attempt. Conclusion: The authors suggest that this technique should be used on all suitable patients to increase tolerance of the procedure. INTRODUCTION Nasogastric tubes are frequently used within the surgical specialties in order to decompress the upper gastrointestinal tract, measure fluid losses or administer enteral nutritional supplements. The procedure is not tolerated well by all patients and previous reports have suggested comforting strategies to aide placement1,2. Topical 1% Xylocaine spray is used in the oropharynx and nasopharynx by ENT surgeons for minor procedures and to aide examination (Figure one). The authors have previously used this topical anaesthetic to aide nasogastric placement with great success. METHODS The authors conducted a prospective study to examine the effect of atomised lignocaine spray on patient discomfort during nasogastric tube insertion. Inclusion criteria were any adult patient who had a failed first attempt at insertion by a senior surgical ward nurse, a GCS of 15, no contraindication to insertion and no impairment of swallowing reflex. Patients were consented for the study by the senior author. A visual analogue scale (VAS) was used to record the level of discomfort for the failed nasogastric tube insertion immediately after the attempt. The VAS was a 100mm linear scale with 0 marked as no discomfort, 50 as moderate discomfort and 100 as severe discomfort. Patients then received a single spray of lignocaine 1% to the patent nostril and a further spray to the posterior oropharynx. An identical nasogastric tube was inserted by the authors using a standard technique3,4. Correct placement was tested using aspiration, pH testing with litmus paper and air injection with auscultation over the gastric fundus. A second VAS was then completed together with a proforma with patient details, reason for insertion and whether the procedure had been successful. Results were statistically analysed using the paired t test. RESULTS Eleven patients met the inclusion criteria and all agreed to be included in the study (Table one). There were 5 males and 6 females. Mean age was 64 (range 32 to 85 years). Xylocaine Spray Reduces Patient Discomfort During Nasogastric Tube Insertion 2 of 3 Nasogastric tubes were successfully passed in all eleven patients during the second part of the study although five patients required second attempts due to coiling of the tube within the oropharynx. All patients recorded a decrease in their level of discomfort after lignocaine spray use. The mean VAS1 was 75 (range 50 to 92) and the mean VAS2 was 53 (range 35 to 82). The mean change in VAS (VAS1-VAS2) was 22 (range 6 to 36). Paired t test revealed a significant difference between the two groups: t = 7.246 (p < 0.0001).

Correlation of change in visual analog scale with pain relief in the ED

Objectives To evaluate the validity of change in visual analog Scale (VAS) as a measure of pain relief using a verbal descriptor Scale (VDS) of change in pain. Methods A prospective observational study of emergency department patients measured pain with VAS and recorded verbal report of change in pain. Results One thousand four hundred ninety patients yielded 1999 comparisons between change in VAS and VDS. Correlation of change in VAS and VDS of change in pain was ρ = 0.667 ( P < .001). A wide range of change in VAS, large standard deviations for the mean change in VAS, and discordance in the direction of change in VAS were present within each verbal descriptor category. Conclusions Change in VAS is moderately correlated with a VDS of change in pain. Wide variability in change in VAS and discordance with a VDS demonstrate that change in VAS is not a valid indicator of pain relief for individual patients.