Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial.

OBJECTIVE: To assess whether percutaneous transforaminal endoscopic discectomy (PTED) is non-inferior to conventional open microdiscectomy in reduction of leg pain caused by lumbar disc herniation. DESIGN: Multicentre randomised controlled trial with non-inferiority design. SETTING: Four hospitals in the Netherlands. PARTICIPANTS: 613 patients aged 18-70 years with at least six weeks of radiating leg pain caused by lumbar disc herniation. The trial included a predetermined set of 125 patients receiving PTED who were the learning curve cases performed by surgeons who did not do PTED before the trial. INTERVENTIONS: PTED (n=179) compared with open microdiscectomy (n=309). MAIN OUTCOME MEASURES: The primary outcome was self-reported leg pain measured by a 0-100 visual analogue scale at 12 months, assuming a non-inferiority margin of 5.0. Secondary outcomes included complications, reoperations, self-reported functional status as measured with the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery. Outcomes were measured until one year after surgery and were longitudinally analysed according to the intention-to-treat principle. Patients belonging to the PTED learning curve were omitted from the primary analyses. RESULTS: At 12 months, patients who were randomised to PTED had a statistically significantly lower visual analogue scale score for leg pain (median 7.0, interquartile range 1.0-30.0) compared with patients randomised to open microdiscectomy (16.0, 2.0-53.5) (between group difference of 7.1, 95% confidence interval 2.8 to 11.3). Blood loss was less, length of hospital admission was shorter, and timing of postoperative mobilisation was earlier in the PTED group than in the open microdiscectomy group. Secondary patient reported outcomes such as the Oswestry Disability Index, visual analogue scale for back pain, health related quality of life, and self-perceived recovery, were similarly in favour of PTED. Within one year, nine (5%) in the PTED group compared with 14 (6%) in the open microdiscectomy group had repeated surgery. Per protocol analysis and sensitivity analyses including the patients of the learning curve resulted in similar outcomes to the primary analysis. CONCLUSIONS: PTED was non-inferior to open microdiscectomy in reduction of leg pain. PTED resulted in more favourable results for self-reported leg pain, back pain, functional status, quality of life, and recovery. These differences, however, were small and may not reach clinical relevance. PTED can be considered as an effective alternative to open microdiscectomy in treating sciatica. TRIAL REGISTRATION: NCT02602093ClinicalTrials.gov NCT02602093.

[Antalgic effects of socio-aesthetics in cancer patients]. / Effets antalgiques de la socio-esthétique chez les patients atteints de cancer.

INTRODUCTION: Socio-aesthetics is the delivery appropriate beauty care in a population weakened by a physical, psychological and/or social attack. It has found its place in indications in both medical (especially in oncology) and social settings. It offers many types of treatments including facials, foot beauty, make-up, wig tips, body massage, product advice, cosmetic manicure, varnishing… The main purpose of this study was to evaluate pain reduction as a result of socio-aesthetics. METHODS: One hundred and eighty patients were offered a socio-aesthetic session between 12/01/2018 and 11/30/2019. One hundred and fifty-seven (87,2%) accepted the care (56.7% of women/43.3% of men, regardless of the type of cancer) and all agreed to complete a questionnaire on the type of treatment received, the benefits felt and a Likert pain assessment scale before and after the treatment. RESULTS: No patient experienced an increase in pain after the socio-aesthetic care. In the general population, the mean pain evaluation was rated at 1.31/10 and 0.78/10 before and after the session respectively, p<10-5. By selecting patients experiencing pain before treatment (40 patients, 28.0% of the total population), the mean pain evaluation was 4.27/10 and 2.52/10 before and after the treatment respectively, p<10-5. Pain was significantly reduced by massage. No patient found the socio-aesthetic treatment unnecessary. CONCLUSION: Socio-aesthetics is definitely a supportive care in oncology as it is significantly analgesic. It is easily accepted by men and regardless of the type of cancer. Researchers should conduct more studies on its impact on the quality of life.

The efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) for postoperative pain in laparoscopy: A protocol for systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: With the promotion of the concept of "minimally invasive" surgery, the advantages of laparoscopic surgery are increasingly manifested. However, the postoperative pain of laparoscopic surgery brings difficulties and challenges to patients' rehabilitation. Transcutaneous electrical acupoint stimulation (TEAS) is a non-invasive treatment, which can exert the dual efficacy of acupuncture and electrical stimulation. The efficacy and safety of TEAS for postoperative pain after laparoscopy based on randomized controlled trials (RCTs) need to further evaluate. METHODS: A comprehensive and systematic literature searching will mainly perform on 7 electronic databases (PubMed, the Cochrane Library, Embase, China National Knowledge Infrastructure, Chongqing VIP Information, WanFang Data, and Chinese Biomedical Database) from their inception up to November 30, 2020. We will also search for ongoing or unpublished studies from other websites (eg, PROSPERO, ClinicalTrials.gov, and Chinese Clinical Trial Registry) and do manual retrieval for potential gray literature. Only the relevant RCTs published in English or Chinese were included. Two independent investigators will independently complete literature selection, assessment of risk bias, and data extraction, the disagreements will be discussed with the third party for final decisions. The primary outcome measures: the pain intensity (eg, VAS) and the consumption of postoperative analgesics. The secondary outcome measures: the postoperative quality of life, the duration of hospitalization, and the incidence of adverse reactions and serious events. Assessment of bias risk will follow the Cochrane risk of bias tool. Data processing will be conducted by Stata 15.0 software. RESULTS: We will evaluate the efficacy and safety of TEAS for postoperative pain after laparoscopy based on RCTs. CONCLUSION: This study can provide more comprehensive and strong evidence of whether TEAS is efficacy and safe for postoperative pain in laparoscopic surgery.

Clinical acupuncture therapy for femur head necrosis: A protocol for systematic review and meta analysis.

BACKGROUND: Femur Head Necrosis (FHN) is a common clinical joint orthopedic-related disease, and its incidence is increasing year by year. Symptoms include dull pain and dull pain in the affected hip joint or its surrounding joints. More severely, it can lead to limited joint movement and inability to walk autonomously. Surgical treatment has many sequelae. The high cost makes it unaffordable for patients, and the side effects of drug treatment are unknown. A large number of clinical studies have shown that acupuncture is effective in treating femoral head necrosis. Therefore, this systematic review aims to explore the safety and effectiveness of acupuncture in the treatment of femoral head necrosis. METHODS: We will conduct a comprehensive literature search in Medline, PubMed, Cochrane Database of Systematic Reviews, Embase, Chinese Biomedical Literatures Database (CBM), China National Knowledge Infrastructure (CNKI), Wang FangDatabase (WF), Chinese Scientific Journal Database (VIP) from inception to May 2021 without any language restriction. In addition, we will retrieve the unpublished studies and the references of initially included literature manually. The two reviewers will identify studies, extract data, and assess the quality independently. The outcomes of interest include: total effective rate; the total nasal symptom score; Hip function (Hip Harris joint score, WOMAC hip score, hip joint Lequesne index score, Merle D 'Aubigne and hip joint Postel score); Adverse events. Randomized clinical trials will be collected, methodological quality will be evaluated using the Cochrane risk-of-bias assessment tool, and the level of evidence will be rated using the Grading of Recommendations, Assessment, Development and Evaluation approach. Meta-analysis will be performed using RevMan 5.4.0 software. The heterogeneity test will be conducted between the studies, P < .1 and I2 > 50% are the thresholds for the tests. We will utilize the fixed effects model or the random effects model according to the size of heterogeneity. RESULTS: The meta-analysis program will systematically evaluate the efficacy and safety of acupuncture in the treatment of FHN patients. CONCLUSION: This study will investigate whether acupuncture can be used as one of the non-surgical and non-pharmacological therapies for the prevention or treatment of FHN. TRIAL REGISTRATION NUMBER: INPLASY202150035.

Classification of circadian pain rhythms and pain characteristics in chronic pain patients: An observational study.

ABSTRACT: This study aimed to perform cluster analysis in patients with chronic pain to extract groups with similar circadian rhythms and compare neuropathic pain and psychological factors among these groups to identify differences in pain-related outcomes. A total of 63 community-dwellers with pain lasting at least 3 months and Numerical Rating Scale scores of ≥2 were recruited from 3 medical institutions. Their pain circadian rhythms were evaluated over 7 days by measuring pain intensity at 6-time points per day using a 10-cm visual analog scale. Cluster analysis was performed using 6 variables with standardized visual analog scale values at 6-time points for individual participants to extract groups with similar pain circadian rhythms. The results of the Neuropathic Pain Symptom Inventory and psychological evaluations in each group were compared using the Kruskal-Wallis test. The results revealed 3 clusters with different circadian rhythms of pain. The total and evoked pain subscale Neuropathic Pain Symptom Inventory scores differed among the 3 clusters. The results suggest that a thorough understanding of circadian pain rhythms in chronic pain patients may facilitate the performance of activities of daily living and physical exercise from the perspective of pain management.

Acupuncture for blunt chest trauma: A protocol for a double-blind randomized control trial.

INTRODUCTION: Blunt chest trauma (BCT) accounts for up to 65% of polytrauma patients. In patients with 0 to 2 rib fractures, treatment interventions are typically limited to oral analgesics and breathing exercises. Patients suffering from BCT experience symptoms of severe pain, poor sleep, and inability to perform simple daily life activities for an extended period of time thereafter. In this trial, we aim to investigate the efficacy of acupuncture as a functional and reliable treatment option for blunt chest trauma patients. METHODS: The study is designed as a double-blind randomized control trial. We will include 72 patients divided into 2 groups; the acupuncture group (Acu) and placebo group (Con). The acupuncture group will receive true acupuncture using a uniquely designed press tack needle. The control group will receive placebo acupuncture treatment through the use of a similarly designed press tack needle without the needle element. The acupoints selected for both groups are GB 34, GB 36, LI 4, LU 7, ST 36, and TH 5. Both groups will receive 1 treatment only following the initial visit to the medical facility and upon diagnosis of BCT. Patient outcome measurements include: Numerical Rating Scale, Face Rating Scale, respiratory function flowmeter, Verran Snyder-Halpern sleep scale, and the total amount of allopathic medication used. Follow-up time will be scheduled at 4 days, 2 weeks, and lastly 3 months. EXPECTED OUTCOME: The results of this study can potentially provide a simple and cost-effective analgesic solution to blunt chest trauma patients. This novel study design can serve as supporting evidence for future double-blind studies within the field of acupuncture. OTHER INFORMATION: The study will be conducted in the thoracic surgical department and acupuncture department in China Medical University Hospital, Taichung, Taiwan. The study will be conducted on blunt chest trauma patients and is anticipated to have minimum risk of adverse events. Enrollment of the patients and data collection will start from March 2020. Study completion time is expected in March 2022. PROTOCOL REGISTRATION: (CMUH109-REC1-002), (NCT04318496).

Efficacy and safety of Biqi capsule in the treatment of knee osteoarthritis: A protocol of a randomized controlled trial.

BACKGROUND: Knee osteoarthritis (KOA) is a chronic and degenerative bone and joint disease, with KOA, cartilage degeneration, destruction and subchondral bone remodeling as the main pathological features. Its clinical symptoms are knee pain, swelling, limited activity, and long course of disease can cause joint deformities. At present, the early treatment of Western medicine is mainly the use of nonsteroidal drugs for anti-inflammation and removing pain, but because the efficacy of these drugs is unstable, the disease is easy to repeat after treatment, and the clinical effect is not good. Although Biqi capsule has advantages in the treatment of KOA, there is a lack of standard clinical studies to verify it, so the purpose of this randomized controlled study is to evaluate the efficacy and safety of Biqi capsule in the treatment of KOA. METHODS: This is a prospective randomized controlled trial to study the efficacy and safety of Biqi capsule in the treatment of KOA. The patients were randomly divided into a treatment group and a control group according to 1:1. Among them, treatment group: Biqi capsule combined with diclofenac sodium sustained release tablets; Control group: Diclofenac sodium sustained-release tablets alone. Both groups were treated with standard treatment for 2 weeks and were followed up for 30 days to pay attention to the efficacy and safety indexes. Observation indicators included: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Hospital for Special Surgery Knee Score (HSS), liver and kidney function, adverse reactions, and so on. SPSS 25.0 software is used for data analysis. DISCUSSION: This study will evaluate the efficacy and safety of Biqi capsule in the treatment of KOA, and the results of this experiment will provide a clinical basis for Biqi capsule in the treatment of KOA. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/6HB9D.

Effect of Foot Massages on Postpartum Comfort and Pain Level of Mothers After Vaginal Delivery: A Randomized Trial.

This study conducted on 66 mothers aimed to investigate the effect of foot massages postpartum using an introductory information form, the Postpartum Comfort Scale, the visual analog scale, and a drug follow-up card. It was concluded that foot massages positively improved comfort, reduced pain levels, and reduced unnecessary medications.

Fuzzy Logic Modeling of Factors Affecting Musculoskeletal Disorders in a Steel Factory in Iran: A Cross-Sectional Study.

OBJECTIVES: The aim of this study was to model associated factors affecting musculoskeletal disorders (MSDs), using fuzzy logic in a steel factory in Iran. METHODS: A cross-sectional study was conducted on steel industry workers. A 6-part questionnaire was used, consisting of demographic characteristics, occupational stress, work-family conflict, general health, occupational postures, and Nordic Musculoskeletal Questionnaire. Pearson correlation was used for statistical analysis. RESULTS: The prevalence of MSDs for 270 participants in the studied factory was 94.8%. Job stress, work-family conflict, general health, and work posture had a statistically significant relationship with MSDs (P < .05). The fuzzy model demonstrated 23.8% predictability for the actual data of the study. The defuzzification data had significant correlation with real data of MSDs. CONCLUSIONS: The results of this study provided a new perspective about associated factors affecting MSDs and demonstrate that fuzzy logic can be used as a possible tool for evaluating MSDs.

High Volume Liposuction in Tumescence Anesthesia in Lipedema Patients: A Retrospective Analysis.

BACKGROUND: Lipedema is a chronic, progressive disease that occurs almost exclusively in women and leads to pathological, painful fat growths at the extremities. Only symptomatic therapy can be offered since the etiology of the disease has not yet been clarified. Liposuction in tumescent anesthesia has established itself as a surgical treatment method of choice. The complication rate associated with the procedure and the pharmacological course and safety of treatment in patients with lipedema has not yet been sufficiently studied. The aim of the study was to broaden the evidence on the safety of ambulatory high-volume liposuction in tumescent anesthesia in lipedema patients. Influencing factors of patients (weight, fat content, comorbidities) or the process technique (drug administration, volume of aspirates) should be investigated on the safety and risks of tumescent anesthesia. This was a retrospective data analysis in which data from 27 patients (40 liposuction procedures) treated at the Sandhofer and Barsch lipedema center between 2016 and 2018 were evaluated. The liposuctions were carried out in tumescent anesthesia and using a Power-Assisted Liposuction system. Clinical examinations and regular blood samples were carried out before the procedure, intra- and postoperatively. The procedures lasted an average of 118 minutes and an average of 6111 ml of aspirate was removed. For tumescent anesthesia, patients were given an average lidocaine dose of 34.23 mg/kg body weight and an epinephrine dose of 0.11 mg/kg body weight. No relevant complications associated with drug side effects, hypovolemia or hypervolemia or blood loss were detected. Liposuction under high volume tumescent anesthesia for the treatment of lipedema patients is, even for major intervention, a safe procedure. J Drugs Dermatol. 2021;20(3):326-334. doi:10.36849/JDD.5828.

Efficacy and safety of acupuncture treatment as an adjunctive therapy after knee replacement: Single-center, pragmatic, randomized, assessor blinded, pilot study.

INTRODUCTION: Total knee replacement (TKR) is a surgical procedure that is being increasingly performed as a result of population aging and the increased average human life expectancy in South Korea. Consistent with the growing number of TKR procedures, the number of patients seeking acupuncture for relief from adverse effects, effective pain management, and the enhancement of rehabilitative therapy effects and bodily function after TKR has also been increasing. Thus, an objective examination of the evidence regarding the safety and efficacy of acupuncture treatments is essential. The aim of this study is to verify the hypothesis that the concurrent use of acupuncture treatment and usual care after TKR is more effective, safe, and cost-effective for the relief of TKR symptoms than usual care therapy alone. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded randomized controlled trial that includes 50 patients with TKR. After screening the patients and receiving informed consent, the patients are divided into two groups (usual care + acupuncture group and usual care group); the patients will then undergo TKR surgery and will be hospitalized for 2 weeks. The patients will receive a total of 8 acupuncture treatments over 2 weeks after surgery and will be followed up at 3, 4, and 12 weeks after the end of the intervention. The primary outcome is assessed using the Korean version of the Western Ontario and McMaster Universities Arthritis Index (K-WOMAC), and the secondary outcome is measured using the Numerical Rating Scale (NRS), Risk of Fall, and Range of Motion (ROM). Moreover, the cost per quality-adjusted life years (QALYs) is adopted as a primary economic outcome for economic evaluation, and the cost per NRS is adopted as a secondary economic outcome. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS17ENSS0063). We intend to submit the results to a peer-reviewed journal and/or conferences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03633097.

Effectiveness of electrophysical modalities in the sensorimotor rehabilitation of radial, ulnar, and median neuropathies: A meta-analysis.

INTRODUCTION: People with ulnar, radial or median nerve injuries can present significant impairment of their sensory and motor functions. The prescribed treatment for these conditions often includes electrophysical therapies, whose effectiveness in improving symptoms and function is a source of debate. Therefore, this systematic review aims to provide an integrative overview of the efficacy of these modalities in sensorimotor rehabilitation compared to placebo, manual therapy, or between them. METHODS: We conducted a systematic review according to PRISMA guidelines. We perform a literature review in the following databases: Biomed Central, Ebscohost, Lilacs, Ovid, PEDro, Sage, Scopus, Science Direct, Semantic Scholar, Taylor & Francis, and Web of Science, for the period 1980-2020. We include studies that discussed the sensorimotor rehabilitation of people with non-degenerative ulnar, radial, or median nerve injury. We assessed the quality of the included studies using the Risk of Bias Tool described in the Cochrane Handbook of Systematic Reviews of Interventions and the risk of bias across studies with the GRADE approach described in the GRADE Handbook. RESULTS: Thirty-eight studies were included in the systematic review and 34 in the meta-analysis. The overall quality of evidence was rated as low or very low according to GRADE criteria. Low-level laser therapy and ultrasound showed favourable results in improving symptom severity and functional status compared to manual therapy. In addition, the low level laser showed improvements in pinch strength compared to placebo and pain (VAS) compared to manual therapy. Splints showed superior results to electrophysical modalities. The clinical significance of the results was assessed by effect size estimation and comparison with the minimum clinically important difference (MCID). CONCLUSIONS: We found favourable results in pain relief, improvement of symptoms, functional status, and neurophysiological parameters for some electrophysical modalities, mainly when applied with a splint. Our results coincide with those obtained in some meta-analyses. However, none of these can be considered clinically significant. TRIAL REGISTRATION: PROSPERO registration number CRD42020168792; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=168792.

Influence of acute pain on valence rating of words.

Numerous studies showed the effect of negative affective and pain-related semantic primes enhancing the perceived intensity of successive painful stimuli. It remains unclear whether and how painful primes are able to influence semantic stimuli in a similar way. Therefore, we investigated the effects of noxious primes on the perception of the valence of subsequent semantic stimuli. In two experiments, 48 healthy subjects were asked to give their valence ratings regarding different semantic stimuli (pain-related, negative, positive, and neutral adjectives) after they were primed with noxious electrical stimuli of moderate intensity. Experiment 1 focused on the existence of the effect, experiment 2 focused on the length of the effect. Valence ratings of pain-related, negative, and positive words (not neutral words) became more negative after a painful electrical prime was applied in contrast to no prime. This effect was more pronounced for pain-related words compared to negative, pain-unrelated words. Furthermore, the priming effect continued to affect the valence ratings even some minutes after the painful priming had stopped. So, painful primes are influencing the perception of semantic stimuli as well as semantic primes are influencing the perception of painful stimuli.

Resultados de una cohorte de pacientes tratados con osteopatía en un hospital polivalente / Results of a cohort of patients treated with osteopathy in a polivalent hospital

Introducción: la osteopatía aborda al paciente de manera global y aplica técnicas de tratamiento manual. Se realizó una evaluación retrospectiva sobre 447 pacientes para conocer los resultados del tratamiento del dolor lumbar y cervical. Material y métodos: fueron incluidos en este estudio 447 pacientes con diagnóstico de lumbalgia y cervicalgia (77,4% de sexo femenino). Los pacientes atendidos ya habían realizado tratamientos convencionales sin haber conseguido resultados satisfactorios. Se evaluó a los pacientes con la escala de valor numérico de dolor (EVN), y los puntajes (scores) de Oswestry (ODI) y el índice de discapacidad de la región cervical (NDI). Los 4 osteópatas intervinientes son profesionales certificados en esta disciplina. Resultados: el 42,8% de los pacientes fueron derivados por el Servicio de Traumatología y el 41,3% por el Servicio de Medicina Familiar. El 34,2% tuvieron diagnóstico de dolor lumbar y al 20,81% se le diagnosticó dolor cervical. Tanto en la valoración del dolor como en los scores utilizados se encontraron diferencias estadísticamente significativas entre la primera y la última sesión. Discusión: en pacientes con diagnóstico de lumbalgia y cervicalgia que no habían obtenido resultados satisfactorios con tratamientos convencionales previos, el tratamiento osteopático derivó en mejoras significativas en todos los parámetros estudiados. (AU)

Introduction: osteopathy addresses the patient globally and applies manual treatment techniques. A retrospective evaluation was carried out on 447 patients to know the results of the treatment of lumbar and cervical pain. Material and methods: 447 patients with a diagnosis of low back pain and cervical pain (77.4% female) were included in this study. The patients already had undergone conventional treatments without having achieved satisfactory results. The patients were evaluated with the numerical value of pain scale (VNS), and Oswestry scores (ODI) and the index of disability of the cervical region (NDI). The 4 intervening osteopaths are certified professionals in this discipline. Results: 42.8% of the patients were referred by the Traumatology Service and 41.3% by the Family Medicine Service. 34.2% had a diagnosis of lumbar pain and 20.8% were diagnosed with neck pain. Statistically significant differences were found between the first and last sessions in both the pain assessment and the scores used. Discussion: in patients with low back pain and neck pain who had not obtained satisfactory results with previous conventional treatments, osteopathic treatment resulted in significant improvements in all the parameters evaluated. (AU)

TCM nonpharmacological interventions for ankylosing spondylitis: A protocol for systematic review and network meta-analysis.

BACKGROUND: Ankylosing spondylitis (AS) is a common infammatory rheumatic disease that affects the axial skeleton. Traditional Chinese medicine (TCM) nonpharmacological interventions are gaining an increasing popularity for AS. Nevertheless, the evidence of efficacy and safety of random controlled trials (RCTs) remains controversial. This study aims to evaluate the efficacy and acceptability of different TCM nonpharmacological therapies by systematic review and network meta-analysis. METHODS: According to the strategy, the authors will retrieve a total of 7 electronic databases by December 2020, including PubMed, the Cochrane Library, EMbase, China National Knowledge Infrastructure, China Biological Medicine, Chongqing VIP, and Wan-fang databases After a series of screening, 2 researchers will use Aggregate Data Drug Information System and Stata software to analyze the data extracted from the randomized controlled trials of TCM nonpharmacological interventions for AS. The primary outcome will be the improvement of Pain intensity and functional status/disability and the secondary outcomes will include lobal improvement, health-related quality of life, satisfaction with treatment, and adverse events. Both classical meta-analysis and network meta-analysis will be implemented to investigate direct and indirect evidences on this topic. The quality of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation instrument. RESULTS: This study will provide a reliable evidence for the selection of TCM nonpharmacological therapies in the treatment of AS. CONCLUSION: This study will generate evidence for different TCM nonpharmacological therapies for AS and provide a decision-making reference for clinical research. ETHICS AND DISSEMINATION: This study does not require ethical approval. The results will be disseminated through a peer-reviewed publication. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/FHD2U.

Transcutaneous Electrical Nerve Stimulation for Pain Management for Women in Labor.

PURPOSE: To determine effectiveness of a transcutaneous electrical nerve stimulation (TENS) unit to improve labor pain management and patient satisfaction with overall labor experience among women in labor at term. STUDY DESIGN: Prospective, exploratory design using convenience sampling. METHODS: Pregnant women at term, anticipating a vaginal birth at our tertiary care hospital, were invited to participate in the TENS study to help manage early labor pain. Pain level was assessed on entry into the study and 2 hours post-TENS application using the Wong-Baker FACES® Pain Rating Scale. A TENS satisfaction survey was conducted during postpartum. Pain scores were analyzed using a matched Wilcoxon signed-rank test. RESULTS: There were 272 women enrolled in the study; 255 completed the patient satisfaction survey and 263 had measured pain assessments pre- and post-TENS application. There was a significant reduction in pain scores after application of TENS, (7.09 vs. 6.74, p = 0.02). Most women 78% (199/255) agreed that TENS helped manage early labor pain, 80% (203/255) would recommend TENS for management of early labor pain, and 72% (183/255) would use TENS again. CLINICAL IMPLICATIONS: TENS therapy provides nurses with an opportunity to offer women a low-cost, low-intervention treatment for managing early labor. TENS provides a distraction from contractions and generates a sense of control to help women manage the discomforts of labor and possibly remain home longer.

Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial.

BACKGROUND: Epidemiological studies have shown that young women often suffer from primary dysmenorrhea (PD) which is a common cause that affects their routine work and quality of life. Chinese herbal medicine has been widely used for PD in China. A systematic review found that Xuefu Zhuyu (XFZY) has a promising effect on PD management, yet there is a dearth of high-quality evidence in support of this claim. We want to conduct a randomized controlled trial to evaluate the efficacy and safety of XFZY for PD patients. METHODS: This is a protocol for a multicenter, randomized, placebo-controlled trial. A total of 248 participants with PD will be recruited at 6 centers and randomized into two groups-a herbal treatment group and a placebo group. The participants will receive either XFZY or placebo, three times per day, for 3 menstrual cycles, with a 12-week follow-up. The primary outcome will be the mean change in pain intensity as measured by VAS, while the change in menstrual pain duration, the change in peak pain intensity as measured by VAS, the Cox Menstrual Symptom Scale (CMSS), quality of life EQ-5D-5L, cumulative painkiller consumption, and health economics will be included as secondary outcomes. Adverse events will also be reported. DISCUSSION: This protocol describes a multicenter, double-blind, randomized, placebo-controlled trial that investigates the efficacy and safety of XFZY for primary dysmenorrhea. Validated evaluation tools will assess dysmenorrhea severity. We believe that this research will provide important evidence regarding the use of XFZY to treat dysmenorrhea. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900026819 . Registered on 23 October 2019.

Pain Experience and Tolerance of Awake In-Office Upper Airway Procedures: Influencing Factors.

OBJECTIVES/HYPOTHESIS: Awake, unsedated in-office upper airway procedures are performed frequently and have high completion rates, yet less is known about the patients' pain experience and potentially influencing factors. It is also unclear if patients' pain experiences become worse with repeated procedures. We identified procedure- and patient-related factors that might influence procedural completion and pain scores. STUDY DESIGN: Retrospective chart review. METHODS: Pre-, intra-, and post-procedure pain scores were collected prospectively for awake unsedated upper airway procedures performed at a single institution over a 5-year period. Patient factors reviewed were demographics, body mass index, psychiatric and/or pain diagnosis, and related medications. Procedure factors reviewed were procedure type, route, side, and performance of the same procedure multiple times. Patients reported their pain level before, during, and after the procedure using a standard 0 to 10 scale. Maximum pain score change (PΔmax), or the difference between highest and lowest reported pain levels, was calculated. Descriptive and multivariate analyses were performed. RESULTS: Procedure completion was 98.7% for 609 first time patients and 99.0% in 60 patients undergoing 292 repeat procedures. PΔmax did not covary with age, gender, or BMI. PΔmax covaried with pain and psychiatric conditions and associated medications. PΔmax was highest for injection medialization and lowest for tracheoscopy. PΔmax decreased over time for those undergoing multiple identical procedures. CONCLUSIONS: Procedures were performed with a very high completion rate and low pain scores. Age, sex, and BMI did not affect pain experience. A combination of pain and psychiatric conditions did. Injection medialization had the highest PΔmax and tracheoscopy the lowest. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E1580-E1588, 2021.

The clinical efficacy and safety of traditional Chinese medicine in the treatment of recurrent aphthous stomatitis: A protocol of systematic review and meta-analysis.

BACKGROUND: The objective of this meta-analysis was to summarize and identify the available evidence from studies to estimate the clinical value of traditional Chinese medicine (TCM) in the treatment of recurrent aphthous stomatitis (RAS) and provides clinicians with evidence on which to base their clinical decision making. METHODS: This review will include all studies comparing clinical efficacy of TCM in the treatment of RAS. The search strategy will be performed in 9 databases. We will not establish any limitations to language and publication status, published from inception to the August 2020. Two reviewers will screen, select studies, extract data, and assess quality independently. Outcome is clinical efficacy, pain relief, duration of wound healing, effect on wound healing, rate of recurrence, adverse events, and safety. The methodological quality including the risk of bias of the included studies will be evaluated. We will carry out statistical analysis using RevMan 5.3 software. RESULTS: This study will summarize current evidence to assess the efficacy and safety of TCM in the treatment of RAS. CONCLUSION: The findings of this study will provide helpful evidence for the clinician, and will promote further studies, as well as studying the value of TCM. REGISTRATION NUMBER: INPLASY202080126 (DOI number: 10.37766/inplasy2020.8.0126).