Painful Procedures Research Articles

The analgesic effect of non-nutritive sucking on neonates during invasive procedures

Background & objective: Neonates admitted and treated in the Neonatal Intensive Care Unit (NICU) often receive painful invasive procedures. In such situations, the treating physicians often find themselves in a fix regarding the use of analgesics to relieve their actual or potential pain. It has been observed that the sucking often distracts the neonates from their mild to moderate pain. We conducted this study to analyze the effectiveness of non-nutritive sucking as an analgesic for neonates who were to receive invasive procedures. Methodology: This experimental study implemented a post-test-only control group design, involving 64 neonates in the NICU, selected using a simple random sampling technique, who were then divided into two groups, with 32 neonates each in a treatment group and a control group. The treatment group was given non-nutritive sucking, while the control group was given standard intervention, then the pain response was measured in both groups. Next, the pain levels of the two groups were compared using the Mann-Whitney U test. Results: The measurement results showed that there was a difference in the mean scores of pain response between treatment and control group, respectively 1.53125 and 5.8125. The P-value of the difference test was 0.000000004252, so that it could be interpreted that there was a significant difference in pain levels between the two groups. Conclusion: On the basis of the results of our study, it is concluded that non-nutritive sucking is an effective method for reducing the pain response in neonates during invasive procedures. Keywords: Infant; Non-nutritive sucking; Neonatal Intensive Care UNIT; Pain; Pain management Citation: Ratnaningsih T, Peni T, Firdausiyah N, Nugroho HSW. The analgesic effect of non-nutritive sucking on neonates during invasive procedures. Anaesth. pain intensive care 2024;28(4):640−645; DOI: 10.35975/apic.v28i4.2511 Received: April 27, 2024; Reviewed: June 10, 2024; Accepted: June 19, 2024

Neonatal amygdala volumes, procedural pain and the association with social-emotional development in children born very preterm.

Very preterm birth (< 32 weeks' gestational age) is associated with later social and emotional impairments, which may result from enhanced vulnerability of the limbic system during this period of heightened vulnerability. Evidence suggests that early procedural pain may be a key moderator of early brain networks. In a prospective cohort study, neonates born very preterm (< 30 weeks' gestation) underwent MRI scanning at term-equivalent age (TEA) and clinical data were collected (mechanical ventilation, analgesics, sedatives). Procedural pain was operationalized as the number of skin breaking procedures. Amygdala volumes were automatically extracted. The Strengths and Difficulties questionnaire was used to assess social-emotional outcomes at 5 years of age (mean age 67.5 months). General linear models were employed to examine the association between neonatal amygdala volumes and social-emotional outcomes and the timing and amount of procedural pain exposure (early within the first weeks of life to TEA) as a moderator, adjusting for biological sex, gestational age, 5-year assessment age, days of mechanical ventilation and total cerebral volumes. A total of 42 preterm infants participated. Right amygdala volumes at TEA were associated with prosocial behaviour at age 5 (B = -0.010, p = 0.005). Procedural pain was found to moderate the relationship between right amygdala volumes in the neonatal period and conduct problems at 5 years, such that early skin breaking procedures experienced within the first few weeks of life strengthened the association between right amygdala volumes and conduct problems (B = 0.005, p = 0.047). Late skin breaking procedures, experienced near TEA, also strengthened the association between right amygdala volumes and conduct problems (B = 0.004, p = 0.048).

A Randomized Controlled Comparison of Guardian-Perceived Cosmetic Outcome of Simple Lacerations Repaired With Either Dermabond, Steri-Strips, or Absorbable Sutures.

The aim of this study was to compare the guardian-perceived 3-month cosmetic outcome for pediatric lacerations repaired with absorbable sutures, Dermabond, or Steri-Strips. Secondarily, pain and satisfaction with the procedure from both guardian and provider perspectives were compared. In this randomized controlled trial, we enrolled a convenience sample of children aged 0 to <18 years who presented with simple linear lacerations (≤5 cm in length, ≤0.5 cm in width, and <12 hours old) to a pediatric emergency department. Children were randomized to receive laceration repair with absorbable sutures, Dermabond, or Steri-Strips. Topical L.E.T. solution (lidocaine, epinephrine, tetracaine) was applied to wounds which were then closed by the primary team. Guardians and providers completed questionnaires regarding perceived pain and satisfaction with the procedure. Guardians were contacted 3 months after the repair and asked to email a picture of the scar with their perception of cosmesis rated on a visual analog scale from 0 to 100. Fifty-five patients were enrolled, of whom 30 completed 3-month follow-up (12 suture, 7 Dermabond, 11 Steri-strips). There was no statistical evidence of an association between scar appearance and closure method based on medians and interquartile ranges for cosmetic ratings of scar: suture median 70.5 (IQR 59.8-76.8), Dermabond median 85 (IQR 73-90), Steri-strips median 67 (IQR 55-78) (P = 0.254). Guardian satisfaction with length of stay, guardian and physician satisfaction with the procedure, and guardian and physician-perceived pain also showed no differences. No differences were observed in guardian-perceived cosmesis of simple lacerations repaired with sutures, Dermabond, or Steri-Strips when evaluated 3 months after intervention. In addition, there were no differences in guardian or physician-perceived pain or satisfaction with the closure methods. The results of this study suggest that all 3 closure methods appear to be clinically equivalent, which is largely consistent with other evidence. Further study should be expanded to a larger demographic.

Soothing venipuncture: Bubble blowing and ball squeezing in reducing anxiety, fear, and pain in children.

The objective of this study was to investigate the impact of bubble-blowing and ball-squeezing interventions on children's levels of anxiety, fear, and pain during venipuncture procedures. This study was designed as a randomized controlled trial. Out of 108 children aged 5-10 years, 72 were allocated to the two experimental groups, while 36 were assigned to the control group. The levels of anxiety, fear, and pain experienced by the children were assessed using the "Wong-Baker FACES® Pain Rating Scale," "Child Anxiety Scale-State," and "Child Fear Scale," respectively. Intergroup comparisons were analyzed using one-way ANOVA, while intragroup comparisons were conducted using Wilks' Lambda analysis. It was observed that 50% of the children in the control group, 47.2% in the bubble-blowing group, and 47.2% in the ball-queezing group did not receive information about the painful procedure. Anxiety, fear, and pain scores of all groups were statistically similar in the initial measurement without any intervention. Children in the bubble-blowing and ball-squeezing groups experienced lower anxiety, fear, and pain during and at the end of the painful procedures. The study discovered that interventions involving bubble blowing and ball squeezing significantly decreased children's levels of anxiety, fear, and pain both during and after intravenous procedures. Information on procedures, alongside interactive techniques like bubble blowing and ball squeezing, helps pediatric nurses calm children, easing anxiety, fear, and pain. Implementing these strategies enhances treatment experiences and confidence in healthcare.

Delphi study for developing a checklist of adverse events associated with acupotomy

BackgroundAcupotomy, a more invasive procedure than acupuncture, involves the use of a thicker needle with an integrated knife at the tip, necessitating safety research. We aimed to define relevant adverse events (AEs) and create a standardized form of the ACUPOtomy-related AEs CHECKlist (ACUPOCHECK). MethodsBefore conducting the Delphi process, a systematic review and pilot prospective study were conducted to gather information on previously reported AEs. Using these data, pilot versions of the ACUPOCHECK and Delphi questionnaires were developed. The Delphi questionnaire involved selecting types of AE for inclusion, establishing separate criteria for acupotomy-related AEs, and achieving a consensus on AE assessment. Thirteen Korean doctors with experience in acupotomy or AE research were recruited to participate in each Delphi round. Consensus was considered to have been reached if the critical value for the content validity ratio met or exceeded 0.538. ResultsThe final ACUPOCHECK was developed using four rounds of the Delphi method and one face-to-face consensus meeting. It included 12 local AEs (pain, hemorrhage, bruise, hematoma, edema, pruritus, rash, infection, nerve damage, dysesthesia, movement impairment, and pneumothorax) and 14 systemic AEs (disease aggravation, needle fatigue, sleepiness, procedural nausea, procedural vomiting, procedural headache, procedural dizziness, sweating, procedural shock, syncope, dyspnea, procedural pain, sleep disorder, and postprocedural infection). Separate criteria were established for pain, hemorrhage and bruising: pain was defined as pain that occurrs during daily activities and persists for longer than 72 h, hemorrhage as bleeding that continues for ≥ 3 min despite pressure application, and bruising as having a bruise with a diameter of ≥ 3 cm. Open-ended descriptions were allowed for AEs not covered by the checklist, and severity and causality were assessed using the Common Terminology Criteria for Adverse Events and modified World Health Organization-Uppsala Monitoring Center criteria. ConclusionACUPOCHECK provides a standardization framework that can help research on traditional practices as well as new tools and techniques that are more invasive and may cause more severe AEs. Subsequent studies will use ACUPOCHECK to develop rational safety guidelines for acupotomy techniques.Please cite this article as: Jun H, Lee H, Yoon SH, Kwon CY, Jeon D, Lee JH, Leem J. Delphi study for developing a checklist of adverse events associated with acupotomy. J Integr Med. 2024; 22(5): 579–587.

Utilizing Local Anesthesia Only for Penile and Scrotal Urologic Surgery: A Prospective Study on Patient Tolerability and Surgical Outcomes for a Sedation-free Option

ObjectiveTo prospectively assess surgical outcomes, complications, and patient-reported tolerability of invasive scrotal surgeries under local anesthesia (LA) alone, without sedation, compared to tolerability of penile procedures commonly performed in this manner. MethodsAdult patients undergoing penile and scrotal surgeries under LA only were enrolled from August 2022 to June 2023 (NCT05617261). Demographics, surgeon-perceived and patient-reported pain, and surgical variables were collected. Tolerability to the procedures and future anesthetic choice for a repeat procedure was assessed on follow-up. Complication data was collected, including recurrence, infection, excessive pain, and emergency room and family physician visits. Results107 patients were enrolled with a mean age ± SD of 42.2 ± 16.4 years. There was a 100% procedural success rate and no cases of perioperative complications or escalation of anesthetic. 92.4% (n=97) of patients indicated they would opt for LA only for a hypothetical repeat procedure. Of the minority opting for general anesthetic, most indicated discomfort or preferring an element of amnesia. No differences between intraoperative pain or tolerability scores of invasive scrotal procedures compared to penile procedures were observed. On univariate analysis, longer procedure duration (p=0.003), cannabis use (p=0.01), and higher intra-operative pain (p=0.005) was associated with lower tolerability. ConclusionLA alone in an office-based setting is promising for scrotal surgeries. It offers similarly high patient tolerability compared to procedures that are routinely performed under LA, with the preservation of outcomes. Adopting this method has the potential for substantial cost savings, reduced wait times, enhanced accessibility, and improved surgical efficiency.

Intravenous Sedation and Analgesia in a Pediatric Emergency Department: A Retrospective Descriptive Study.

Background Painful procedures in the pediatric emergency department often require the use of sedation and analgesia to ensure adequate pain control, a right of children and adolescents. This study aims to describe the procedural sedation and analgesia with intravenous medications performed in a pediatric emergency department. Methods This is a retrospective descriptive study of intravenous sedoanalgesia used in a pediatric emergency department of a level II district hospital in the Lisbon metropolitan area from October 2018 to December 2023. The type of intervention, drugs used, and adverse events were analyzed. Results A total of 615 patients were included in the study; 65.7% (n=404) were male with a median age of 6 years. The most frequently performed procedures were wound suturing (50.9%, n=313) and fracture reduction (36.3%, n=223). The drugs used for sedation and analgesia were ketamine (99.2%, n=610), midazolam (95.8%, n=589), propofol (1.6%, n=10), and morphine (0.5%, n=3). The majority of patients received midazolam and ketamine in association (93.8%, n=577). A total of 50 adverse events (8.1%) were recorded in 42 patients. The most frequent side effects were transient oxygen desaturation (2%, n=12), vomiting (1.5%, n=9), apnea/bradypnea (1%, n=6), and hallucinations (0.8%, n=5). The occurrence of adverse events was not dose-dependent (p >0.05). Respiratory complications resolved without requiring invasive interventions. Children were sedated by a pediatric intensivist in 68.1% (n=419), by a general pediatrician in 26.7% (n=164), and by a pediatric resident in 2% (n=12). Conclusions The results of this study demonstrate that intravenous sedoanalgesia, particularly the combination of ketamine and midazolam, is a safe method for sedation in pediatric patients, with a low rate of adverse events.

Unraveling the joints: a narrative review of osteoarthritis.

Osteoarthritis (OA) is a chronic and progressive degenerative disease that affects joint structures, such as the hips, knees, and hands, involving the articular cartilage, subchondral bone, ligaments, capsule, and synovium. OA is characterized by a progressive degeneration of the joint structures, resulting in pain and decreased quality of life. Local and systemic risk factors pave the way for OA development. Different phenotypes may be identified, but three main molecular mechanisms define the endotypes: the bone-driven endotype, the synovitis-driven endotype, and the cartilage-driven endotype. The hallmark of OA pathophysiology involves more than just mechanical degradation; it includes the release of pro-inflammatory mediators, such as interleukins and TNF-α, which elucidates the significant roles of metabolic syndrome, diabetes, and cellular senescence in its development. OA is distinguished by a clinical presentation that varies significantly between people and is marked by pain, stiffness, and functional impairments. The clinical course can be split into Pre-OA, Early OA, Evident OA, and End-Stage. Depending on the stage of the disease, OA diagnosis frequently necessitates a complex strategy that combines clinical evaluation to detect joint tenderness, range of motion, and joint swelling or abnormalities, medical history assessment, imaging modalities, and laboratory investigations. There is no known treatment for OA, and different therapies are usually evaluated based on the stage of the disease to minimize pain and stiffness while maintaining joint function. Treatments are divided into the reduction of modifiable risk factors, pharmacologic therapies, rehabilitation, complementary therapies, interventional pain procedures, and surgery. OA clinical heterogeneity underlines the importance of prevention, early diagnosis, and identifying the phenotype and endotype to tailor the treatment.

Health inequities, bias, and artificial intelligence

Musculoskeletal (MSK) pain leads to significant healthcare utilization, decreased productivity, and disability globally. Due to its complex etiology, MSK pain is often chronic and challenging to manage effectively. Disparities in pain management - influenced by provider implicit biases and patient race, gender, age, and socioeconomic status - contribute to inconsistent outcomes. Interventional radiology (IR) provides innovative solutions for MSK pain through minimally invasive procedures, which can alleviate symptoms and reduce reliance on opioids. However, IR services may be underutilized, especially due to current treatment paradigms, referral patterns, and in areas with limited access to care. Artificial intelligence (AI) presents a promising avenue to address these inequities by analyzing large datasets to identify disparities in pain management, recognizing implicit biases, improving cultural competence, and enhancing pain assessment through multimodal data analysis. Additionally, patients who may benefit from an IR pain procedure for their MSK pain may then receive more information through their providers after being identified as a candidate by AI sifting through the electronic medical record. By leveraging AI, healthcare providers can potentially mitigate their biases while ensuring more equitable pain management and better overall outcomes for patients.

PEACE-HYPNO – Management of procedural pain by multimodal sedation analgesia combining hypnosis in children with congenital heart disease: A randomized trial of non-inferiority

PEACE-HYPNO – Management of procedural pain by multimodal sedation analgesia combining hypnosis in children with congenital heart disease: A randomized trial of non-inferiority

Efficacy of intrauterine device procedural analgesics.

Nearly half of all pregnancies worldwide are unintended. Intrauterine devices are an effective, long-acting form of pregnancy prevention that require minimal maintenance, and also can be used in patients with menorrhagia. However, they are underused because of pain associated with their insertion. Topical and local anesthesia are good options for reducing procedural pain in select patients. IUD placement falls within the scope of practice for physician associates/assistants (PAs) practicing in family medicine, internal medicine, and women's health. PAs should be aware of these additional analgesia options available to patients in order to increase use of effective contraception.

The Effectiveness of Virtual and Augmented Reality in Surgical Pain Management: A Systematic Review of Randomized Controlled Trials.

Satisfactory management of postoperative pain remains challenging. Nonpharmacological modalities such as virtual and augmented reality (VR/AR) offer potential benefits and are becoming increasingly popular. This systematic review evaluates the effectiveness and safety of VR/AR interventions on postoperative pain and recovery. MEDLINE, Embase, CINAHL, Web of Science, and CENTRAL databases were searched from inception to July 27, 2023, for randomized controlled trials (RCTs), published in English, evaluating the use of VR/AR interventions for surgical pain relief. Study selection and data extraction were performed by pairs of reviewers independently and in duplicate, and potential risk of bias was determined using the Risk of Bias-version 2 (RoB 2) tool. Our outcomes included pain relief, reduction of anxiety, satisfaction, and adverse effects. Due to substantial heterogeneity, a narrative synthesis without meta-analysis was performed. We included 35 trials among 2257 citations, categorized as surgery (n = 12), minor procedures (n = 15), and postoperative physiotherapy (n = 8). Surgical group included various surgeries, with 11 using immersive VR predominantly in the postoperative period, and most reporting no differences in pain, but potential for reduced anxiety and sedation requirements. In the minor procedures group, most studies reported decreased pain and anxiety during the procedural performance. Two studies reported increased heart rate, while 2 others reported better hemodynamic stability. Home-based AR physiotherapy achieved (n = 6) similar pain and functional outcomes after knee replacement, with 1 large study (n = 306) reporting reduction of mean costs by $2745 for provision of 12 weeks physiotherapy. There were some concerns around potential bias for most studies, as the nature of interventions make it challenging to blind assessors and participants. No important adverse effects were noted using VR/AR technology. Evidence from RCTs indicates that the use of immersive VR during minor procedures may reduce procedural pain, decrease anxiety, and improve satisfaction. However, small studies, inconsistent effect, and variation in the application of interventions are important limitations. Evidence to support the application of AR/VR for major surgeries is limited and needs to be further investigated. Use of home-based physiotherapy with AR likely has economic advantages, and facilitates virtual care for appropriate patients who can access and use the technology safely.

Rectus Sheath Blocks for Umbilical Hernia Reductions in the Emergency Department: A Case Series.

Rectus sheath blocks have been used for decades in the operating room for analgesia following umbilical surgical procedures. We present the first reported case series of a rectus sheath block used in the emergency department (ED) for the reduction of an umbilical hernia. Four patients presented to the ED for painful, non-reducible umbilical hernias. An ultrasound-guided bilateral rectus sheath block was used in all four patients with complete pain relief and an easy hernia reduction. Rectus sheath blocks are an excellent addition to a multimodal analgesic regimen in periumbilical pain and painful procedures. This block is easy to perform and implement for pain control in umbilical hernias in an ED setting.

ASSESSMENT OF NEWBORN PAIN RELATED TO CARE

Pain in newborns is an issue we cannot ignore any longer. The health care providers should confirm that the baby is comfortable during any procedures as it is not only that it is ethically right for them to treat in pain the patients but can also have serious after-effects in newborns and can also lead to other diseases. This study aimed to evaluate pain induced by medical procedures, describe pain management practices, and improve pain management. Two surveys were conducted: the first one on the patients through the prospective descriptive observational study. This was carried out in the NICU in the department of neonatology in the CHU MOHAMED VI of Oujda over a period of 4 months, starting from February 26, 2024 until June 26, 2024. Pain was assessed by using the DAN scale in 98 newborns (female: 56%, sex ratio: 1.27, premature: 42%, and mean weight: 2538g). The median DAN score duringmedical procedures was 4.5, which dropped to 1 three minutes after the painful procedure. The second survey was conducted among a sample of 45 medical and paramedical workers of the neonatology department of the CHU MOHAMED VI Oujda. Eighteen percent of the medical and paramedical staff indicated that they had taken specific training in pain and palliative care. A specific training session was organized for enhancing pain management. Before the training, 44% of caregivers had never assessed the pain level of their patient whereas after the training 78% of them will always assess the pain, this improved significantly post training. Regarding pain management, before training, it was not done routinely, fifty-eight percent of caregivers reported that they rarely or never used any preventive strategies, whereas after training, 84% reported always or often using preventive measures. The majority of caregivers were against the presence of parents during invasive procedures.

Preprocedural Paracetamol Reduces Pain Scores in Patients Undergoing in-Office Laryngeal Procedures.

To investigate the utility of preprocedural paracetamol on reducing pain scores post office-based laryngeal procedures. Prospective, controlled before-after comparative study. Controlled prospective before-after study. A retrospective analysis was performed of 100 patients who underwent office-based laryngeal procedures without preprocedural analgesia at our center to establish a control group. Age, sex, procedure type, and amount of substance used were documented as well as postprocedural pain score. Pain scores were recorded every 5 minutes for 30 minutes following office-based laryngeal procedures. A prospective arm of this study was then performed in which every patient undergoing office-based laryngeal procedures at our center between September 2019 and December 2020 was administered 1000 mg of paracetamol prior to their procedure. The postprocedure pain scores of the 2 groups were then compared. A hundred patients were included in the retrospective arm and 75 patients were included in the prospective arm, receiving 1000 mg of paracetamol a median of 45 (interquartile range: 30-53) minutes prior to their procedure. The 2 groups were matched for age, sex, and type of laryngeal procedure. Both nonanalgesia and analgesia groups demonstrated a similar proportion of patients who experienced any pain (47% and 48%, respectively) postprocedurally. The prospective arm of this study however reported a statistically significant reduction in the magnitude of their pain scores at all points postprocedurally (P = .005). Paracetamol preprocedurally reduces the severity of pain in office-based laryngeal procedures and would be a useful consideration for patients who are likely to experience significant postprocedural pain. Level 3.

Comparison of curved and straight tip radiofrequency cannula deflection in a ballistic model

BackgroundPercutaneous pain and spine procedures play an important diagnostic and therapeutic role in the treatment of various pain diagnoses. Accurate placement of needles or cannulae during these procedures is paramount to the success of these procedures. ObjectiveThe purpose of this study is to examine and quantify the amount of deflection of radiofrequency cannulae based on curved tip versus no curved tip, using a ballistic gel tissue simulant. Materials and methodsSix different types of cannulae commonly used for spinal and peripheral nerve ablations were selected, including 18, 20, and 22 gauge curved and straight radiofrequency cannulae. Ballistic gel samples were made in molds of 40 mm and 80 mm. Each cannula was mounted in a drill press to ensure accurate trajectory. ResultsCurved RFA cannula had increased deflection when compared to straight cannula for 18-, 20-, and 22-gauge cannulae at a depth of 40 mm. Curved RFA cannula had increased deflection when compared to straight cannula for 20- and 22-gauge cannulae at a depth of 80 mm. Overall, the mean deflection for a curved cannula increased 1.9x for 20-gauge cannulae and 2.5x for 22-gauge cannulae when compared to a straight cannula. ConclusionsFor interventionalists, understanding the effects of needle or cannula shape is crucial for accurate placement. When a procedure requires additional steerability, additional deflection up to 2.5x obtained by placing a bend in the needle or cannula tip should be considered.

Evaluation of a novel blood collection set for venipuncture in oncology patients with difficult venous access: Impact on sample quality, phlebotomist satisfaction and patient pain perception

PurposeDifficult venous access (DVA), characterized by non-visible and non-palpable veins, is common in oncology patients. The objectives of this study were to compare the performances of two blood collection sets in an oncology phlebotomy setting: BD Vacutainer® UltraTouch™ Push Button (UT-PBBCS) and BD Vacutainer® Safety-Lok™ Blood Collection Set (SLBCS). The two sets were evaluated to assess whether use of a smaller gauge (G) needle (down-gauging) may reduce patient pain and improve peripheral venous access experience during phlebotomy in oncology patients. MethodsQuestionnaires were used to record patient data (age, gender), phlebotomy procedural observations (venipuncture site, number of collected tubes, blood flow, needle repositioning, underfilled tubes), patient pain perception and phlebotomist difficulty perception scores (0–10 points scale). Specimen quality was evaluated by hemolysis index (HI) on Roche Cobas® 6000. ResultsSubject groups showed no statistical difference. SLBCS (21/23G) or UT-PBBCS (23/25G) were used in 264 (45.8%) and 313 (54.2%) subjects respectively. Lower gauge was preferred for DVA (hand venipuncture), and DVA was associated with tube underfilling but no with type of blood collection set. For UT-PBBCS, pain perception, patients' anxiety level and phlebotomists’ difficulty grade were lower when compared to SLBCS (p < 0.001). Blood samples collected with UT-PBBCS showed less hemolysis compared to samples collected with SLBCS (p < 0.001). ConclusionProvision of a smaller gauge UT-PBBCS option during phlebotomy in oncology patients with DVA reduces procedural pain and anxiety and improved phlebotomist’ experience during sample collection. Despite the down-gauging, hemolysis was lower for UT-PBBCS, keeping sample quality while improving DVA patient comfort.

Interventional pain management practices in Pakistan: The role of Physical Medicine and Rehabilitation (PMR).

Chronic pain represents a complex, multifaceted challenge that surpasses the prevalence of commonly encountered disorders such as diabetes mellitus and hypertension. This condition exerts a substantial burden on healthcare systems due to its pervasive impact. While pain interventions and procedures constitute a crucial facet, they alone do not constitute a comprehensive solution. Nevertheless, the strategic and precise application of these procedures by well-trained and proficient physicians offers patients a swift route to resuming their normal activities, sparing them from protracted reliance on medications. Within the realm of Physical Medicine and Rehabilitation (PM&R), Interventional Pain Management (IPM) adopts a multidisciplinary rehabilitative approach, addressing all dimensions of pain syndromes. This approach culminates in enhanced functional outcomes and an improved quality of life. This concise review underscores the significance of this integrated approach, shedding light on various pain procedures routinely employed for diagnostic and therapeutic purposes. Within this context, we briefly explore the application of ultrasound and C-arm guided procedures. In conclusion, this review underscores the imperative nature of embracing a multidimensional approach to pain management, essential for seamlessly incorporating interventional pain management techniques into the broader domain of rehabilitation medicine.

Safety, tolerability, and pharmacokinetics of antisense oligonucleotide BIIB078 in adults with C9orf72-associated amyotrophic lateral sclerosis: a phase 1, randomised, double blinded, placebo-controlled, multiple ascending dose study

Hexanucleotide repeat expansion of C9orf72 is a common genetic cause of amyotrophic lateral sclerosis (ALS). No C9orf72-targeted treatments are available. BIIB078 is an investigational antisense oligonucleotide targeting C9orf72 sense RNA. We aimed to assess the safety, tolerability, and pharmacokinetics of BIIB078 in participants with C9orf72-associated ALS. This phase 1, randomised controlled trial was done at 22 sites in six countries (Canada, Ireland, Netherlands, Switzerland, UK, and USA). Adults with ALS and a pathogenic repeat expansion in C9orf72 were randomly assigned within six cohorts, via Interactive Response Technology in a 3:1 ratio per cohort, to receive BIIB078 (5 mg, 10 mg, 20 mg, 35 mg, 60 mg, or 90 mg in cohorts 1-6, respectively) or placebo, via an intrathecal bolus injection. The treatment period consisted of three loading doses of study treatment, administered approximately once every 2 weeks, followed by monthly maintenance doses during a treatment period of about 3 months for cohorts 1-3 and about 6 months for cohorts 4-6. Patients and investigators were masked to treatment assignment. The primary endpoint was the incidence of adverse events and serious adverse events. This trial was registered with ClinicalTrials.gov (NCT03626012) and is completed. Between Sept 10, 2018, and Nov 17, 2021, 124 patients were screened for inclusion in the study. 18 patients were excluded and 106 participants were enrolled and randomly assigned to receive 5 mg (n=6), 10 mg (n=9), 20 mg (n=9), 35 mg (n=19), 60 mg (n=18), or 90 mg (n=18) of BIIB078, or placebo (n=27). 58 (55%) of 106 patients were female. All patients received at least one dose of study treatment and were included in all analyses. All participants had at least one adverse event; most adverse events were mild or moderate in severity and did not lead to treatment discontinuation. The most common adverse events in BIIB078-treated participants were falls, procedural pain, headache, and post lumbar puncture syndrome. 14 (18%) of 79 patients who received any dose of BIIB078 reported serious adverse events, compared with nine (33%) of 27 patients who received placebo. Five participants who received BIIB078 and three participants who received placebo had fatal adverse events: respiratory failure in a participant who received 10 mg BIIB078, ALS worsening in two participants who received 35 mg BIIB078, traumatic intracerebral haemorrhage in one participant who received 35 mg BIIB078, pulmonary embolism in one participant who received 60 mg BIIB078, and respiratory failure in three participants who received placebo. All deaths were assessed as not related to the study treatment by the reporting investigator. On the basis of these phase 1 study results, including secondary and exploratory findings showing no reduction in neurofilament levels and no benefit on clinical outcomes relative to the placebo cohort, BIIB078 clinical development has been discontinued. However, these results will be informative in furthering our understanding of the complex pathobiology of C9orf72-associated ALS. Biogen.

Predicting the Diagnosis of Prostate Cancer with a Novel Blood-Based Biomarker: Comparison of Its Performance with Prostate-Specific Antigen.

The purpose of this study was to assess the efficacy, specificity, and predictive value of a newly discovered biomarker, Zinc finger-like1 protein (referred to as neuroendocrine marker, NEM) for the detection of prostate cancer (PCa). We retrospectively analyzed banked plasma samples from 508 men, with a median age of 67 years (range 48-97), to compare the performance of NEM and PSA in predicting subsequent histologic PCa. The cohort consisted of four groups of patients visiting a urology clinic: (1) patients not diagnosed with either benign prostatic disease or prostate cancer (PCa) were defined as normal; (2) patients diagnosed with benign hyperplasia (BPH) but not PCa; (3) patients with confirmed PCa; and (4) patients with cancer other than PCa. The normal men displayed a mean NEM plasma level of 0.948 ± 0.051 ng/mL, which increased to 1.813 ± 0.315 ng/mL in men with BPH, 86.49 ± 15.51 ng/mL in men with PCa, and 10.47 ± 1.029 ng/mL in men with other Ca. The corresponding concentrations of prostate-specific antigen (PSA) in these subjects were 1.787 ± 0.135, 5.405 ± 0.699, 35.77 ± 11.48 ng/mL, and 8.036 ± 0.518, respectively. Receiver operating characteristic (ROC) curve analysis was performed to compare NEM and PSA performance, and the Jouden Index for each biomarker was calculated to determine cut-off points for each biomarker. The area under the ROC curve to predict PCa was 0.99 for NEM and 0.81 for PSA (p < 0.0001). The cut-off for NEM was at 1.9 ng/mL, with sensitivity of 98% and specificity of 97%. The corresponding PSA values were 4.4 ng/mL, with sensitivity of 76% and specificity of 95%. The predictive value of each biomarker in a patient was matched with his pathologic data to determine the accuracy of each biomarker. NEM was more accurate than PSA in differentiating cancer from benign conditions, such as BPH or prostatitis. In conclusion, NEM was a better predictor of PCa than PSA in patients visiting urology clinics. NEM tests, either alone or in conjunction with other biomarkers, provide a reliable, non-invasive, and inexpensive test to remarkably reduce false positives and thereby reduce the number of diagnostic biopsies and associated painful procedures and the loss of quality of life.