Changes In Visual Analog Scale Scores Research Articles

Effect of age of gravida on post-cesarean section pain: An observational study

Objective: Preoperative identification of women at greater risk of post-cesarean pain might allow more intensive analgesic interventions. This study aimed to assess the effect of age of a parturient on post-cesarean section (CS) pain. Methods: 100 pregnant females were enrolled and divided into 4 groups: group A (age 18–24 years), group B (25–30 years), group C (31–35 years), and group D (≥36 years). Patient-controlled epidural analgesia was started postoperatively in all patients. Pain on a 0- to 10-point visual analog scale (VAS), a number of attempts tried for patient-activated dose delivery of ropivacaine, and successful delivery of patient-activated dose of ropivacaine were recorded for 72 hours. Breastfeeding was initiated as early as possible. The effect of breastfeeding on post-CS pain was observed for 72 hours in terms of increase, decrease, or no change in VAS scores with breastfeeding. Results: The peak VAS scores over 72 hours were 4.10 ± 0.60, 4.00 ± 0.67, 3.75 ± 0.45, and 3.42 ± 0.67, respectively, in groups A, B, C, and D, showing a significant declining trend (P = 0.007). The mean VAS scores decreased from 4.08 to 1.69 (group A, P < 0.0001), from 4.00 to 1.64 (group B, P < 0.0001), from 3.67 to 1.25 (group C, P < 0.0001), and from 3.33 to 1.50 (group D, P < 0.0001) over 72 hours. A statistically significant decline in patient-activated rescue drug delivery attempts, the number of times the rescue analgesic was delivered, and 24-h cumulative ropivacaine dose requirement was seen. Conclusions: In this study, it was found that post-cesarean pain decreases significantly with increasing age, as evidenced by reduced pain scores, reduced attempts at rescue drug delivery, and reduced rescue analgesic requirements.

Effectiveness of extracorporeal shock wave therapy according to plantar calcaneal spur types

Objective: The aim of this study is to group patients with plantar heel pain and calcaneal spurs detected via lateral foot x-rays based on the angle between the spur and the calcaneus and compare the efficacy of an Extracorporeal shock wave therapy (ESWT) treatment between these groups. Materials and Methods: The patients were divided into three groups based on the measurement the angle between the plantar calcaneal spur and the calcaneus. Those with a measured angle of &lt;30° were classified as Group 1, ranging between 30–60° as Group 2, and &gt;60° as Group 3. Demographic characteristics, spur length, visual analog scale (VAS) and foot function index score (FFI), and pain and function evaluation were used as the pre-and posttreatment data in each group. Results: Out of the 170 patients, 96 (56.5%) were included in Group 1, 65 (38.2%) were in Group 2, and 9 (5.3%) in Group 3. The posttreatment VAS and FFI scores of the patients were significantly lower than the pretreatment scores (p &lt; 0,001). It was determined that the highest and lowest VAS and FFI score changes in the posttreatment period was in Group 3 and Group 1, respectively. In the correlation analysis, a positive correlation was found between the measured angle value and pretreatment VAS and FFI scores, age, and spur length. Conclusion: ESWT is an effective treatment method for calcaneal spurs, but further studies are needed on PCS classifications and the efficacy of the treatment selected based on these classifications.

Efficacy of Ultrasound-Guided Pericapsular Nerve Group (PENG) Block Combined With Local Infiltration Analgesia on Postoperative Pain After Total Hip Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial

BackgroundThis study examined whether pericapsular nerve group (PENG) block combined with local infiltration analgesia (LIA) could improve pain management and functional recovery after total hip arthroplasty. MethodsAll patients were randomly assigned to receive PENG block combined with LIA (PENG group) or sham PENG block and LIA (Sham group). The primary outcome was cumulative morphine consumption within 24 hours after surgery. Secondary outcomes were pain scores on a visual analog scale (VAS); time to first rescue analgesia; cumulative morphine consumption during hospitalization; intraoperative consumption of opioids; postoperative recovery; and postoperative complications. ResultsPENG patients consumed significantly less morphine within the first 24 hours and throughout hospitalization and smaller amounts of intraoperative opioids. There were significantly lower pain scores at rest and during motion within 24 hours in PENG patients. PENG patients took significantly longer until the first rescue analgesia and showed significantly better postoperative rehabilitation. However, the absolute change in morphine consumption and VAS scores did not exceed the reported minimal clinically important differences (morphine consumption: 10 mg; VAS scores: 1.5 at rest and 1.8 during movement). The two groups showed no difference in quadriceps muscle strength and postoperative complications. ConclusionPENG block combined with LIA could improve postoperative pain relief, reduce opioid use, and enhance recovery in total hip arthroplasty patients, without weakening the quadriceps muscle strength. This work justifies further trials to examine the safety and efficacy of this block and to explore maximal effective volume of local anesthetic for motor-sparing PENG block.

Trigger point injections followed by immediate myofascial release in the treatment of pelvic floor tension myalgia.

Pelvic floor physical therapy (PFPT) is first-line therapy for treatment of pelvic floor tension myalgia (PFTM). Pelvic floor trigger point injections (PFTPI) are added if symptoms are refractive to conservative therapy or if patients experience a flare. The primary objective was to determine if a session of physical therapy with myofascial release immediately following PFTPI provides improved pain relief compared to trigger point injection alone. This was a retrospective cohort analysis of 87 female patients with PFTM who underwent PFTPI alone or PFTPI immediately followed by PFPT. Visual analog scale (VAS) pain scores were recorded pre-treatment and 2weeks post-treatment. The primary outcome was the change in VAS between patients who received PFTPI alone and those who received PFTPI followed by myofascial release. Of the 87 patients in this study, 22 received PFTPI alone and 65 patients received PFTPI followed by PFPT. The median pre-treatment VAS score was 8 for both groups. The median post-treatment score was 6 for the PFTPI only group and 4 for the PFTPI followed by PFPT group, showing a median change in VAS score of 2 and 4, respectively (p = 0.042). Seventy-seven percent of patients in the PFTPI followed by PFPT group had a VAS score improvement of 3 or more, while 45% of patients in the PFTPI only group had a VAS score improvement greater than 3 (p = 0.008). PFTPI immediately followed by PFPT offered more improvement in pain for patients with PFTM. This may be due to greater tolerance of myofascial release immediately following injections.

Efficacy of Tailor-Made Notched Music Training Versus Tinnitus Retraining Therapy in Adults With Chronic Subjective Tinnitus: A Randomized Controlled Clinical Trial.

Chronic subjective tinnitus can have a serious effect on daily life, even causing serious psychological disorders. Currently there are no specific effective solutions or cures. Tailor-made notched music training (TMNMT) is a recently proposed sound therapy that has simpler processes and a higher compliance rate than tinnitus retraining therapy (TRT), a widely used treatment for chronic subjective tinnitus. This study explores the therapeutic effect of TMNMT in comparison to TRT to highlight its clinical value. The study was a randomized controlled, single-blinded clinical trial. One hundred twenty eligible participants were randomly assigned to receive TMNMT (n = 60) or TRT (n = 60) for 3 mo with concurrent follow-up. It should be noted that the duration of sound treatment in TRT was modified to 2 hr per day for better feasibility in practice. The primary outcome was mean change in tinnitus handicap inventory (THI) measured at baseline ( T0 ), 1 mo ( T1 ) and 3 mo ( T2 ) after intervention. Change in visual analog scale (VAS) was measured as a secondary outcome. A comparison of therapeutic effectiveness between TMNMT and TRT was evaluated by repeated measure analysis of variance. One hundred and twelve (93%) of participants took part in the study, of which 64 were men and 48 women. Mean (SD) age was 42.80 (12.91) years. Fifty-eight were allocated to receive TMNMT and 54 to receive TRT. The between-group difference in primary outcome was -6.90 points (95% confidence interval [CI], -13.53 to -0.27) at T1 and -6.17 points (95% CI, -13.04 to 0.71) at T2 . These results closely reached to clinical significance of tinnitus-related effective relief. For the secondary outcome, the mean value in the TMNMT group was 0.83 points (95% CI, 0.12 to 1.54), significantly lower than the mean value of the TRT group. The differences in THI and VAS between the two groups were statistically significant after intervention. Further analysis showed that age and baseline THI and VAS scores were associated with change in THI and VAS scores after interventions. Both TMNMT and TRT were able to alleviate chronic subjective tinnitus effectively after a 3 month intervention. When the two forms of therapy were compared TMNMT appeared to be more effective and consequently potentially superior to TRT for reducing tinnitus loudness and functional and emotional disturbance associated with chronic subjective tinnitus.

A Prospective, Randomized Single-Blind Crossover Study Comparing High-Frequency 10,000 Hz and Burst Spinal Cord Stimulation

ObjectivesAlthough both high-frequency and burst spinal cord stimulation (SCS) have shown improved efficacy and patient satisfaction compared with conventional tonic stimulation, there are limited data directly comparing the two. This study aimed to compare both high-frequency 10,000 Hz and burst SCS in the same patients in terms of pain relief and satisfaction in those with axial back pain with or without leg pain. Materials and MethodsThis prospective, single-blind, randomized controlled trial was conducted at an outpatient pain clinic within an academic medical center. Participants were randomly allocated to one of two groups in which they trialed either burst or high-frequency 10,000 Hz SCS over five days, followed by a 24- to 48-hour washout period with no stimulation, and the alternative therapy over the remaining four days. Visual analog scale (VAS) scores were collected immediately before and after both therapy trials. Secondary end points included percentage change in VAS score and patient preference. ResultsOf 25 participants, those receiving burst followed by high-frequency SCS (n = 11) had a mean VAS difference of 4.73 after the first trial period and 2.86 after the second. Of those receiving high-frequency followed by burst SCS (n = 14), mean VAS difference after the first trial period was 4.00 and 1.93 after the second trial period. Four participants were withdrawn owing to lead migration. Both therapies showed statistically significant differences in pre- minus post-VAS scores and percent relief. There were no significant differences in carryover or treatment effects between the two groups. There was a statistically significant association between trial sequence and stimulator type implanted because the first stimulator trialed was more likely to be chosen. ConclusionsThere were no observed differences in VAS pain score decrease when comparing burst and high-frequency 10,000 Hz SCS programming therapies. Patient preference followed an order effect, favoring the first programming therapy in the trial sequence.

Post-COVID-19 Menstrual Symptom Disorders Relating to Anxiety and Long COVID-19 Symptoms

Objectives: Coronavirus disease 2019 (COVID-19) can affect the menstrual cycle and menstrual flow. To examine changes in menstrual symptoms of women recovering from COVID-19 and to identify factors that influence these changes. Materials and Methods: A questionnaire, prepared using Google Forms, was completed by 180 women (26.08±6.62 years) recovered from COVID-19. The menstrual symptoms, menstrual pain, fatigue severity and anxiety level of the participants were evaluated respectively with the Menstrual Symptom Questionnaire (MSQ), visual analogue scale (VAS), fatigue severity scale (FSS), and coronavirus anxiety scale (CAS). Results: Post-COVID-19 individuals’ MSQ totals, subgroup scores, FSS scores and menstrual pain levels showed significant increase compared to pre-COVID-19. Regression analysis identified that age at menarche, changes in FSS and VAS scores as contributors to 38.4% of the variance explained in the significant regression for change in MSQ score. Individuals with prolonged fatigue, muscle– joint pain and dyspnea symptoms showed increase in MSQ total scores (P=0.006, P=0.009, P=0.046 respectively) and MSQ negative effects/somatic complaints scores (P=0.004, P=0.002, P=0.017 respectively). Individuals with prolonged gastrointestinal symptoms showed increase in MSQ pain symptoms (P=0.029) and MSQ coping methods scores (P=0.002), while those with prolonged muscle and joint pain showed increase in MSQ coping methods (P=0.022) scores. Conclusions: The results of this study indicated that menstrual symptoms, fatigue, and menstrual pain severity are deteriorated in women recovered from COVID-19. Age at menarche, changes in fatigue and menstrual pain after COVID-19 were determiners of the deteriorated menstrual symptoms. Menstrual symptoms were more severe in those who have prolonged fatigue, dyspnea, muscle– joint pain and gastrointestinal symptoms.

Laparoscopic Adenomyomectomy under Real-Time Intraoperative Ultrasound Elastography Guidance: A Case Series and Feasibility Study.

This study aimed to examine the clinical characteristics of 11 patients undergoing laparoscopic adenomyomectomy guided by intraoperative ultrasound elastography and this technique's feasibility. Eleven patients undergoing laparoscopic adenomyomectomy using ultrasound elastography for adenomyosis at Kawasaki Medical School Hospital in Okayama, Japan between March 2020 and February 2021 were enrolled. Operative outcomes included operative time, operative bleeding, resected weight, operation complications, percent change in hemoglobin (Hb) values, and uterine volume pre- and postoperatively. Dysmenorrhea improvement was evaluated by changes in visual analog scale (VAS) scores pre- and 6- and 12-months postoperatively. The median operative time and bleeding volume was 125 min (range, 88-188 min) and 150 mL (10-450 mL), respectively. The median resected weight was 5.0 g (1.5-180 g). No intraoperative or postoperative blood transfusions or perioperative complications were observed. The median changes in uterine volume, Hb value, and VAS score were -49% (-65 to -28%), -3% (-11 to 35%), and -80% (-100 to -50%), respectively. The median follow-up period post-surgery was 14 months (7-30 months). Adenomyosis recurrence was not observed in the patients during the follow-up period. Laparoscopic adenomyomectomy using ultrasound elastography guidance is minimally invasive and resects as many adenomyotic lesions as possible.

Evaluating the Utility of EQ5D-5L in Patients with Brain Metastases: Secondary Analysis of NRG-CC001

<h3>Purpose/Objective(s)</h3> EuroQoL EQ5D has become the preferred preference-based tool used in oncology clinical trials to assess patient health states following different interventions. It allows for an efficient measure of patient quality-of-life (QoL) that can be used to calculate quality-adjusted life years required to perform cost-effectiveness analyses. NRG-CC001 established the neuroprotective effect of hippocampal avoidant-whole brain radiotherapy (HA-WBRT) plus memantine over WBRT plus memantine in patients with brain metastases. EQ5D results, collected as part of patient reported outcomes, demonstrated no differences between study arms. Although EQ5D was used in this trial, it is unknown if this tool is sensitive to QoL changes experienced by patients with brain metastases. The primary objective of this study was to assess the utility of EQ5D in reflecting neurocognitive function (NCF) changes in this patient population. <h3>Materials/Methods</h3> We performed a post hoc analysis of NRG-CC001 trial data, focusing on EuroQoL EQ5D measures. We used independent sample t-tests to assess mean differences of EQ5D index and visual analog scale (VAS) score changes from baseline (at 2, 4, and 6 months) between patients who experienced NCF failure and those who did not. We also compared mean changes in EQ5D for patients who experienced intracranial progression to those without intracranial progression. <h3>Results</h3> EQ5D index score and VAS score changes between those patients who had NCF failure and those that had intact NCF showed no statistically significant differences at 2, 4, and 6 months (Table). When stratifying by age (<=61, >61), education (<= high school, >high school), and KPS (70, >70), there was no significant EQ5D difference by treatment arm or by NCF change. There was a trend towards significance when assessing changes in EQ5D index and VAS score at 4 months (p=0.06 and 0.05, respectively), and a significant correlation at 6 months for VAS score change (p=0.04) based on progression of disease versus not. <h3>Conclusion</h3> EQ5D was not sensitive to changes in NCF following whole brain radiation therapy for patients with brain metastases, but was sensitive to changes in intracranial progression. Given that NCF is well-established as a patient-centric outcome measure following brain radiation, the results of this study challenge the routine use of EQ5D in brain metastases clinical trials that are focused on preventing NCF failure. There is an urgent need to identify preference-based health status measures that are sensitive to changes in NCF and can be utilized in clinical trials for patients with brain metastases.

Glomus Tumour of Hand--A Commonly Misdiagnosed Pathology: A Case Series.

Glomus tumours are benign neoplasms arising from the glomus body, a network of specialized neuromyoarterial structures containing arteriovenous anastomosis and regulating temperature. It is often misdiagnosed as paronychia, arthritis, traumatic sequelae, and many other conditions including psychiatric misdiagnosis. A typical triad of paroxysmal pain, point tenderness, and cold intolerance characterize it. Surgical excision is the treatment of choice, either by transungual or lateral approaches. We carried out a retrospective study of cases operated in our department in the last 4 years. Patients are evaluated based on either clinical parameters (Love test, Hildreth test, and cold insensitivity) or radiological parameters (X-ray and magnetic resonance imaging). Parameters such as age, gender, tumour side, presenting complaints, duration of symptoms, diagnostic modality, follow-up duration, recurrence, and postoperative nail deformity were analysed. Visual analogue scale (VAS) score was the primary statistical parameter, and the change in VAS score following surgery was analysed with paired t test. Mean preoperative VAS was 7.75 ± 0.5; in a total of four patients, and following surgery, VAS was reduced to a mean of 1 ± 1.5. Paired t test on the change of VAS score following surgery showed a significant difference in the VAS score (P = 0.002838). The average age was 39.25. The male-to-female ratio was 1:3, and the mean follow-up was 16 months (range 2-48 months). The mean duration of symptoms was 5.75 years (range 2-10 years). Two cases were in the right-hand side, and two cases were on the left-hand side; the thumb was most commonly involved with 50% (n = 2) incidence. Glomus tumours are often misdiagnosed and are intervened with different treatment options before being surgically intervened. With complete surgical excision, recurrence is nil but postoperative nail growth requires nearly 10 months. Level IV.

Assessment of outcomes in consecutive patients undergoing dorsal scapular nerve decompression.

Periscapular pain has a broad differential diagnosis. Dorsal scapular neuropathy is part of that differential diagnosis but is often forgotten by clinicians, leading to delayed diagnosis, chronic pain, and potentially worse outcomes. The objective of this study was to describe our method for diagnosis, surgical technique, intraoperative findings, and outcomes in consecutive patients undergoing dorsal scapular nerve (DSN) decompression. A retrospective cohort study was performed to compile and describe outcomes for consecutive patients (n = 21) who underwent DSN decompression by a single surgeon during the period between August 2018 and February 2021. The primary outcome was change in visual analog scale (VAS) score for periscapular pain between baseline and 6 months postoperatively. Secondary outcomes included change in VAS score for overall pain, change in Disabilities of the Arm, Shoulder, and Hand (DASH) score, and change in the Zung Self-Rating Depression Scale (Zung SDS) between baseline and 6 and 12 months postoperatively. Patients undergoing DSN decompression showed significant improvement in VAS score for periscapular pain between baseline and 6 months postoperatively (mean score 54.0 vs 26.8, respectively; p < 0.001). Fifteen of 21 patients (71%) had a good outcome (score improvement ≥ 20). Disability (as determined by DASH scores) was significantly improved at 6 and 12 months postoperatively. The only factor that was predictive of outcome was symptom duration, with longer symptom duration predicting a poor outcome. Surgical treatment of dorsal scapular neuropathy is associated with significant improvements in pain and disability, and these improvements are durable. Morbidity associated with surgical treatment is low.

Immediate Improvement in Subjective Visual Vertical and Disequilibrium Predicts Resolution of Benign Paroxysmal Positional Vertigo Following Single Canalith Repositioning Maneuver.

To evaluate whether immediate post-canalith repositioning maneuver (CRM) vestibular changes are predictive of benign paroxysmal positional vertigo (BPPV) resolution. Retrospective cohort study. Tertiary referral center. Adults (n = 27) with posterior canal BPPV. Single CRM with Frenzel goggles. The Visual Analog Scale (VAS) for disequilibrium, the subjective visual vertical (SVV), the subjective visual horizontal (SVH), and the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) were administered pre- and immediately following single CRM. Dix-Hallpike was performed 1-3 weeks after CRM to assess for BPPV resolution. Pre- and post-treatment vestibular assessments were compared between groups to determine if post-CRM vestibular changes could predict BPPV resolution. The change in VAS score following CRM treatment was statistically different between patients who responded to CRM treatment (n = 15) and those who did not (n = 12), (-0.07 points versus -2.40 points, respectively; P = 0.03). Likewise, a significantly greater improvement in SVV score was observed for CRM responders compared with CRM nonresponders (0.92° versus -0.06°, respectively; P = 0.02). Change in SVH and mCTSIB scores did not differ significantly between groups. Additionally, patient age was found to predict outcome of CRM treatment, with older patients more likely to experience persistent BPPV (P ≤ 0.01). Immediate improvement in VAS and SVV scores following CRM may be useful in predicting resolution of BPPV and may assist in directing the timing and need for future interventions. Younger age may have a favorable predictive value for improvement following single CRM.

P122. Comparing long term deformity correction and other outcomes between single level circumferential XLIF and MI-TLIF: a retrospective review with 5-year minimum follow up

<h3>BACKGROUND CONTEXT</h3> XLIF with percutaneous pedicle screw fixation (circumferential XLIF) and MI-TLIF are two commonly used minimally invasive approaches to the lumbar spine. Because of its lateral approach, traditional XLIF is blocked to the L5-S1 disc space by the iliac crest. Studies that have compared these two techniques typically do not account for this limitation and, furthermore, tend to not restrict their analysis by number of levels operated on. Additionally, studies evaluating long term (>5-year) outcomes of these techniques are less numerous. Therefore, this study aims to compare the clinical and radiological outcomes of single level circumferential XLIF and MI-TLIF exclusively at the L4-L5 disc space. <h3>PURPOSE</h3> To compare the clinical and radiological outcomes of single level XLIF and MI-TLIF at L4-L5. <h3>STUDY DESIGN/SETTING</h3> Retrospective comparative study. <h3>PATIENT SAMPLE</h3> A total of 108 total patients (75 MI-TLIF and 33 circumferential XLIF) that underwent single level surgery at L4-L5 at a single institution from 2008 to 2015 with a minimum of 5-year follow up. <h3>OUTCOME MEASURES</h3> 1) Patient demographics: age, sex, BMI, length of follow up; 2) rate of complications requiring a return to the OR (RTO); 3) Radiographic outcomes: graft subsidence, final anterior and posterior disc height (ADH and PDH); 4) Patient outcome scores: Oswestry Disability Index (ODI), Visual Analogue Scale (VAS). <h3>METHODS</h3> A retrospective review was performed to identify all patients between 2008-2015 who underwent circumferential XLIF or MI-TLIF with a minimum followup of 5 years. Demographic data, complication-related data, radiographic outcomes and patient outcome scores were recorded and compared between cohorts. Standard binominal and categorical comparative analyses were performed. <h3>RESULTS</h3> A total of 108 patients were included for analysis (75 MI-TLIF and 33 circumferential XLIF). Mean age (53.5 MI-TLIF and 53.9 XLIF), BMI (32.3 MI-TLIF and 31.4 XLIF), and length of follow up (90 months MI-TLIF and 103 months XLIF) were similar between cohorts. Overall RTO rate was found to be statistically similar between groups at 16.0% (95% CI, 9.24-26.07) in the MI-TLIF group and 6.1% (95% CI, 0.68-20.60) in the XLIF group. Final ADH was 9.03±1.10 mm in the MI-TLIF group and 12.3±2.60 mm in the XLIF group (p < 0.0001). Final PDH was 9.97±1.96 mm for MI-TLIF and 7.12±2.2 mm for XLIF (p < 0.0001). Average DH was 9.50±1.59 mm and 9.71±2.41 mm for the MI-TLIF and XLIF groups, respectively (p=0.593). Change in ODI and VAS scores at final follow up were similar between MI-TLIF and XLIF groups (p=0.629 for ODI and p=0.322 for VAS). <h3>CONCLUSIONS</h3> This long-term comparative study demonstrates similar clinical and radiological outcomes between single level MI-TLIF and circumferential XLIF at the L4-L5 level. As expected, MI-TLIF had significantly greater long-term improvement in posterior disc height and XLIF had significantly greater improvement in anterior disc height. However, average disc height was found to be similar between groups. This suggests that although MI-TLIF and circumferential XLIF lead to equivalent long-term improvement at the L4-L5 level, choosing one's approach based on the anterior versus posterior disc anatomy of the patient may enhance patient outcome. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Relationship between changes in physical function parameters and Roland-Morris disability questionnaire score after decompression surgery for lumbar spinal canal stenosis.

ABSTRACTAlthough decompression surgery for lumbar spinal canal stenosis (LSS) improves leg symptoms, low back pain (LBP), and disability, the factors related to the improvement of subjective disability have not been studied sufficiently. The purpose of the study was to clarify the relationship between subjective disability and objective physical function parameters. A total of 51 patients who underwent decompression were included and evaluated preoperatively and 6 and 12 months postoperatively. Patient-reported outcomes related to activity limitation due to LBP were evaluated using Roland–Morris disability questionnaire (RDQ) and VAS (Visual Analog Scale). Physical function was assessed using 6-min walk distance (6MWD) and trunk muscle strength. Univariate analysis and multivariable linear regression analysis were performed to identify significant factors for RDQ score change. The 6- and 12-month postoperative RDQ scores, VAS scores, and trunk extensor strength significantly improved relative to the preoperative values. In the univariate analysis, age, changes in VAS (LBP, leg pain, and numbness) scores, and change in 6MWD were associated with the RDQ score change (p < 0.05). Multivariable linear regression showed that 6MWD changes were significantly associated with RDQ score changes, explaining 41% of the variance in the RDQ score change. This study showed the change in 6MWD was significantly associated with the RDQ score change. Our results suggest that improving 6MWD may reduce disability in activities of daily living.

Efficacy of Benzodiazepines or Antihistamines for Patients With Acute Vertigo

Acute vertigo can be disabling. Antihistamines and benzodiazepines are frequently prescribed as "vestibular suppressants," but their efficacy is unclear. To assess the efficacy of antihistamines and benzodiazepines in the treatment of acute vertigo from any underlying cause. We searched the PubMed, CENTRAL, EMBASE, CINAHL, Scopus, and ClinicalTrials.gov databases from inception to January 14, 2019, without language restrictions. Bibliographies of the included studies and relevant reviews were also screened. We included randomized clinical trials (RCTs) comparing antihistamine or benzodiazepine use with another comparator, placebo, or no intervention for patients with a duration of acute vertigo for 2 weeks or less. Studies of healthy volunteers, prophylactic treatment, or induced vertigo were excluded, as were studies that compared 2 medications from the same class. Following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, data were extracted and risk of bias was assessed by 2 authors independently for each study. Data were pooled using a random-effects model. The predefined primary outcome was change in 10- or 100-point vertigo or dizziness visual analog scale (VAS) scores at 2 hours after treatment. Secondary outcomes included change in nausea VAS scores at 2 hours, use of rescue medication at 2 hours, and improvement or resolution of vertigo at 1 week or 1 month. Of the 27 trials identified in the systematic review, 17 contributed to the quantitative meta-analysis and involved a total of 1586 participants. Seven trials with a total of 802 participants evaluated the primary outcome of interest: single-dose antihistamines resulted in significantly more improvement on 100-point VAS scores compared with benzodiazepines (difference, 16.1 [95% CI, 7.2 to 25.0]) but not compared with other active comparators (difference, 2.7 [95% CI, -6.1 to 11.5]). At 1 week and 1 month, neither daily benzodiazepines nor antihistamines were reported to be superior to placebo. RCTs comparing the immediate effects of medications (at 2 hours) after a single dose generally had a low risk of bias, but those evaluating 1-week and 1-month outcomes had a high risk of bias. Moderately strong evidence suggests that single-dose antihistamines provide greater vertigo relief at 2 hours than single-dose benzodiazepines. Furthermore, the available evidence did not support an association of benzodiazepine use with improvement in any outcomes for acute vertigo. Other evidence suggested that daily antihistamine use may not benefit patients with acute vertigo. Larger randomized trials comparing both antihistamines and benzodiazepines with placebo could better clarify the relative efficacy of these medications.

Psychometric Validation of the Haemo-QOL-A in Participants with Hemophilia A Treated with Gene Therapy.

PurposeThe hemophilia-specific health-related quality of life (HRQOL) questionnaire (Haemo-QOL-A) is validated for detecting QOL changes following standard therapy for hemophilia A, but has not been rigorously evaluated after gene therapy. This post hoc analysis evaluated the psychometric properties of Haemo-QOL-A in adult people with severe hemophilia A (PWSHA) receiving valoctocogene roxaparvovec (AAV5-hFVIII-SQ) in 2 clinical trials (phase 1/2, NCT02576795; phase 3, NCT03370913).Patients and MethodsAdult PWSHA (factor VIII levels ≤1 IU/dL) received 1 AAV5-hFVIII-SQ infusion (6×1013 vg/kg). Participants were assessed using the Haemo-QOL-A and the EuroQOL (EQ)-5D-5L and visual analog scale (VAS) questionnaires pre- and post-infusion. Psychometric analyses included convergent and discriminant validity, internal consistency, and reliability. Clinically important difference (CID) was estimated using 3-point change in EQ-5D-5L VAS as anchor.ResultsHaemo-QOL-A data were analyzed from 7 (phase 1/2, 3-year follow-up) and 16 participants (phase 3, 26-week analysis). Change in Haemo-QOL-A Total Scores correlated with EQ-5D-5L VAS score change at 26 weeks (Pearson’s correlation 0.77). At 26 weeks, increased Haemo-QOL-A Physical Functioning was associated with decreased EQ-5D-5L Pain and Discomfort and decreased Anxiety and Depression (Spearman’s Rank correlations −0.73 and −0.62, respectively, P <0.01). Internal consistency analysis showed good reliability for all domains (Cronbach’s alpha >0.7) except Treatment Concern (Cronbach’s alpha = 0.31). Anchor-based CID estimates were met for Haemo-QOL-A Total Score (≥5.5) and domain scores (≥6) for Consequences of Bleeding, Physical Functioning, Role Functioning, and Worry.ConclusionOur preliminary results suggest that the Haemo‐QOL‐A is a valid, reliable instrument for HRQOL assessment in PWSHA undergoing gene therapy. Future research should be undertaken to confirm these findings in a larger number of participants.

Health-related quality of life (HRQoL) for patients with advanced/metastatic urothelial carcinoma (UC) enrolled in KEYNOTE-052 who are potentially platinum ineligible.

4561 Background: Frontline cisplatin-based chemotherapy improves survival in patients (pts) with UC, but ̃50% are cisplatin-ineligible owing to poor performance status or comorbidity. The definition of platinum ineligibility is not standardized; hence, treatment decisions are almost solely made by clinical judgment. Pembrolizumab (pembro) showed antitumor activity and manageable toxicity as frontline therapy in 370 cisplatin-ineligible pts in the single arm, phase 2 KEYNOTE-052 trial (NCT02335424). We present effects of pembro on HRQoL of pts in KEYNOTE-052 who were potentially platinum ineligible in this exploratory analysis. Methods: Eligible pts for KEYNOTE-052 were adults with no prior systemic chemotherapy for advanced/metastatic UC, ECOG PS ≤2, and measurable disease per RECIST v1.1 by blinded independent central review. Pembro 200 mg IV was administered Q3W for up to 2 y. Clinical characteristics of frail pts (platinum ineligible) were identified by extensive review of real-world treatment patterns and relevant literature. Consequently, platinum ineligibility was defined as having an ECOG PS ≥2 plus ≥1 of the following: visceral disease, creatinine clearance &lt; 60 mL/min, or age ≥80 y. HRQoL was assessed using the EORTC QLQ-C30 and EQ-5D-3L during the first 4 cycles, then every 2 cycles for 1 year or until treatment discontinuation (whichever occurred first), and at least 30 days after treatment discontinuation. Key end points were change from baseline per the QLQ-C30 global health status (GHS)/QoL score, QLQ-C30 physical functioning subscale, and EQ-5D visual analog scale (VAS). The minimum important difference (MID) was 10 for QLQ-C30 score change (improved: ≥10; stable: –10 to 10; deteriorated: –10 or less); MID for VAS score change was 7 (improved: ≥7; stable: –7 to 7; deteriorated: –7 or less). Results: Median age for 143 pts was 75 y (range, 34-91); 129 pts (90.2%) had visceral disease; 142 (99.3%) had ECOG PS 2; 1 had ECOG PS 3 (enrolled in error). Compliance rate for HRQoL questionnaires was 93.7% at baseline. At the prespecified analysis time of week 9, 77.6% of pts had improved (n = 51) or stable (n = 60) QLQ-C30 GHS/QoL scores, 64.3% had improved (n = 35) or stable (n = 57) QLQ-C30 physical functioning scores, and 62.2% had improved (n = 56) or stable (n = 33) EQ-5D VAS scores. These scores were stable throughout the HRQoL assessment period for pts who continued pembro. Conclusions: In this exploratory analysis, pembro maintained HRQoL for pts with advanced/metastatic UC in KEYNOTE-052 who were potentially platinum-ineligible per the above criteria. Together with the efficacy and safety data from KEYNOTE-052, these data suggest that pembro monotherapy is a valuable treatment option for select pts with advanced UC who are more senior and/or deemed medically frail. Clinical trial information: NCT02335424.

Randomized Controlled Trial of the Effects of Repetitive Transcranial Magnetic Stimulation and Mirror Therapy on Phantom Limb Pain in Amputees

To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) on phantom limb pain (PLP) in amputees, and to compare the therapeutic effect with that of mirror therapy (MT). The study was designed as a randomized controlled trial. The evaluators were blinded, while the subjects and the therapists were unblinded. Subjects were randomly assigned to either the rTMS group or the MT group with a computer-generated random number table. From June 2018 to December 2020, from out of 45 amputee patients screened for the study, 30 who met the inclusion criteria were recruited for the study. All patients were recruited from the Rehabilitation Medicine Center, West China Hospital, Sichuan University. In the end, 4 patients withdrew from the study and 26 patients (12 in the rTMS group and 14 in the MT group) completed the prescribed treatment and evaluation. The rTMS group was given rTMS (1 Hz, 15 min, 5 d/week) for 2 weeks in addition to conventional rehabilitation therapy, while the MT group received MT (corresponding movements of limbs, 15 min, 5 d/week) for 2 weeks in addition to conventional rehabilitation therapy. PLP was evaluated by the Visual Analogue Scale (VAS) and Douleur Neuropathique 4 Questions (DN-4). Subjects were assessed before treatment ( t 0), immediately after the completion of the treatment ( t 1) and 3 months after the completion of the treatment ( t 2). The mean age of the 26 patients was 39.73±12.64. There were 15 males and 11 females. According to the reported description of the characteristics of the PLP by the patients, the characteristics with the highest incidence were tingling, stabbing, numbing, electric shocks and burning in descending order. There was no significant difference in the incidence of PLP characteristics between the two groups ( P>0.05). The two groups had comparable baseline data, showing no significant difference in VAS and DN-4 between the two groups at t 0 ( P>0.05). At t 1 and t 2, the VAS and DN-4 scores were decreased from those of t 0, showing statistically significant difference in both groups ( P<0.01 for both scores). In the rTMS group, there was no significant difference between VAS and DN-4 scores at t 1 and those at t 2 ( P>0.05). In the MT group, the VAS and DN-4 scores at t 2 were significantly lower than those of t 1 ( P<0.05). There was no statistically significant difference between the rTMS group and MT group in the changes in pain measurements, i.e., VAS and DN-4 scores, before and after the intervention ( P>0.05). The 26 patients who completed the experiment showed no dizziness, headache, or other abnormalities during the study. The results of this study indicate that repetitive transcranial magnetic stimulation could improve PLP in amputees, and the improvement effect was comparable to that of mirror therapy.

The Effect of Music on Preoperative Anxiety in an Operating Room: a Single-Blind Randomized Controlled Trial.

This study aimed to determine the effect of music as an intervention on relieving preoperative anxiety in patients with dental fear in an outpatient operating room (OR) before intravenous sedation (IVS). Sixty adult patients with dental fear undergoing dental surgery under IVS were divided into 2 groups (music and nonmusic). The music group listened to music in the waiting room until immediately before the initiation of IVS whereas the nonmusic group did not. Patient anxiety was objectively measured using heart rate variability (HRV) analysis to assess the low-frequency/high-frequency ratio as an indication of sympathetic or parasympathetic nervous system activity. Subjective preoperative anxiety was evaluated with a visual analog scale (VAS). Heart rate variability analysis failed to demonstrate any significant difference between the 2 groups from baseline to start of IVS. There were also no significant differences between the 2 groups regarding changes in VAS scores. Music intervention was not found to reduce preoperative anxiety in patients with dental fear before IVS in the dental outpatient OR as determined by HRV analysis or VAS scores.

Association between perceived distress and salivary cortisol in veterans with mTBI

Mild traumatic brain injury (mTBI) is one of the most common injuries experienced by Veterans and can frequently result in a variety of post-concussive symptoms. Post-concussive headaches (PCH), one of the most common symptoms, can persist for years after the injury occurred. The long-lasting impacts of PCH can be extremely distressing for Veterans, thus necessitating the need to find reliable biomarkers that directly relate to subjective feelings of distress. Yoga-based interventions have been shown to improve both subjective and objective markers of stress. Techniques used in yoga, such as the focus on releasing muscular tension, are also recommended as strategies for treating PCH. Thus, yoga-based interventions provide a unique context for the comparison of subjective and objective measures of distress in Veterans with PCH. In this secondary, exploratory analysis, we examined the relationship between perceived distress and cortisol in sixteen Veterans with mTBI and long-term PCH within the context of a yoga intervention feasibility study. The Visual Analogue Scale (VAS), a validated tool for measuring subjective distress, was administered to participants immediately before and after 75-min yoga classes, which occurred twice weekly over eight weeks. Participants also provided salivary cortisol (pre- and post-yoga) at in-person sessions (eight) to compare to changes in VAS scores. We found that VAS scores were significantly reduced within five of the eight assessed yoga classes, but there were no significant changes in cortisol levels. No significant correlations were found between VAS scores and salivary cortisol levels. When looking at how cortisol levels changed over time (i.e., over the series of eight yoga sessions), there was a significant downward trajectory in post-yoga cortisol, but not after taking pre-class cortisol into account (i.e., within yoga session cortisol change over time). Taken together, we found that subjective distress, but not cortisol was reduced by yoga classes. These data suggest that salivary cortisol did not match changes in perceived distress, thus emphasizing the ongoing challenges of relating subjective and objective measures.