Single-blind Pilot Study Research Articles

Effects of a Sorghum Beverage with Lacticaseibacillus paracasei on Body Composition, Lipid Profiles, and Intestinal Health in Overweight and Obese Adults: A Randomized Single-Blind Pilot Study.

(1) Background: This study aimed to evaluate the effect of an extruded whole-grain sorghum beverage containing L. paracasei on body composition, lipid profiles, and intestinal health in overweight and obese adults. (2) Methods: A chronic, single-blind randomized controlled pilot study was conducted with 30 volunteers allocated to three groups (n = 10/group): extruded sorghum beverage (ESB), extruded sorghum beverage with L. paracasei (ESPB), and control beverage (CB) (waxy maize starch). The chemical composition of the beverages was analyzed. Volunteers consumed the beverages for ten weeks at breakfast, along with individual dietary prescriptions. Body composition, biochemical markers, gastrointestinal symptoms, stool consistency, intestinal permeability, short-chain fatty acids, fecal pH, and stool L. paracasei DNA concentration were analyzed at the beginning and end of the intervention period. (3) Results: The ESB showed better composition than the CB, particularly in terms of resistant starch content, total phenolic compounds, condensed tannins, and antioxidant capacity. Both the ESB and the ESPB had an effect on body composition (estimated total visceral fat and waist volume), biochemical markers (Castelli index I), and intestinal health (Bristol scale, diarrhea score, valeric acid, and L. paracasei DNA concentration). No changes were observed in the CB group after the intervention. (4) Conclusions: Whole-grain sorghum beverages demonstrated good nutritional value, and consumption of these beverages, with or without L. paracasei, provided health benefits, including improvements in body composition, Castelli index I scores, and intestinal health, in overweight and obese adults.

Randomized, controlled, within-patient, single-blinded pilot study to evaluate the efficacy of 12-weeks of endermotherapy with adult burn survivors

BackgroundVacuum massage, or endermotherapy, is applied to scar tissue with the primary therapeutic goal of promoting structural or physiological changes. These changes are intended to enhance pliability, enabling the skin to possess the strength and elasticity required for normal mobility. The advantage of vacuum massage compared to therapist-generated manual massage is that it provides a standardized dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting its impact on post-burn hypertrophic scar is lacking. Thus, this study was designed to objectively characterize the changes in scar elasticity, erythema, melanin, thickness, and transepidermal water loss immediately after a vacuum massage session and after a 12-week course of treatment compared to intra-individual matched control scars. MethodsWe conducted a prospective, randomized, controlled, within-patient, single-blinded clinical trial, initially designed as a fully-powered study but limited to a pilot study due to COVID-19 restrictions. Nineteen burn survivors consented to participate and 16 completed the study. Two homogeneous, intra-individual scars were randomized to usual care control or vacuum massage therapy plus usual care. Vacuum massage interventions were provided by a certified massage therapist three times per week for 12 weeks. Scar characteristics were evaluated every four weeks immediately before and after mechanical massage treatment. The evaluations included measurements of elasticity (Cutometer), erythema and melanin (Mexameter), transepidermal water loss (TEWL) (Tewameter), and thickness (high-frequency ultrasound). Linear mixed-model analyses were performed to test for immediate and long-term treatment effects. ResultsThe ANOVA analyses revealed a non-significant time:treatment interaction for elasticity, erythema, melanin, thickness, or TEWL. There was a significant increase in elasticity and erythema and a decrease in TEWL in both the control and treatment sites over time with consistent standard care. However, there was no statistically significant immediate or long-term treatment effect for any of the skin characteristics. Nonetheless, the mean participant satisfaction was 4/5 (SD = 1.5) and the mean participant perception of effectiveness was 8/10 (SD = 1.9). ConclusionsThis pilot study did not find a treatment benefit of vacuum massage therapy for elasticity, erythema, melanin, thickness or TEWL, but it did find an improvement with time in elasticity, erythema and TEWL. Despite the lack of objective improvement of the treated scar site, participants were satisfied with the results and believed vacuum massage was very effective. Further high-quality research is required to better inform clinicians patient education and treatment decisions for this costly, burdensome treatment approach that has high participant satisfaction.

Changes in standing stability when wearing different colored glasses cannot be determined by participants’ subjective preference – A crossover randomized single-blinded pilot study

BackgroundThe use of individually preferred colored glasses has gained popularity with the expectation that it may improve balance control and sports performance, however, the results of previous studies remain inconclusive. Aim of the studyIn the present pilot study, we aimed to determine the association between participants’ subjective preference and standing balance performance when wearing five different colored glasses. MethodsThirteen participants stood on one or two legs on a pair of synchronized force platforms for 30 seconds with 60 seconds rest between the five-five randomized stance trials, while wearing red, blue, yellow, green, or transparent colored glasses. In addition to 7 CoP-related variables, we analyzed five features of EMG data from three lower limb muscles on both legs. ResultsNo significant effect of colored glasses was found. Some CoP (velocity: χ²(4, 13) = 10.086; p = 0.039; Kendall’s W = 0.194, root mean square [RMS]: χ²(4, 13) = 12.278; p = 0.015; Kendall’s W = 0.236) and EMG-related (RMS of biceps femoris: χ²(4, 13) = 13.006; p = 0.011; Kendall’s W = 0.250) variables showed differences between the colored glass conditions during dominant-leg stance, however, participants failed to consecutively determine these differences in standing stability. ConclusionsOverall, our results may suggest that lens color preference, irrespective of the color itself, may influence dominant leg standing balance most probably due to psychological factors, however, only subjective determination have no potential to determine the color of the glasses that would support the individual’s standing balance the most.

Efficacy and Safety of Two Chondroprotective Supplements in Patients With Knee Osteoarthritis: A Randomized, Single-Blind, Pilot Study.

Background: Hyaluronic acid (HA), glucosamine (Glc), and chondroitin sulfate (CS) are key ingredients commonly incorporated into dietary chondroprotective supplements for the management of osteoarthritis (OA). Despite their widespread use, there is a paucity of published data regarding their efficacy and safety, necessitating rigorous investigation in clinical settings. To address this knowledge gap, we conducted a randomized, single-blindpilot study to evaluate the effects of two commercially available multi-ingredient supplements on patients with mild-to-moderate knee OA. Methods: A total of 51 patients diagnosed with mild-to-moderate knee OA were enrolled in a four-week randomized study and allocated equally (1:1:1 ratio) into three groups: a control group (n = 17) that received no treatment, an HA group (n = 17) given Syalox® 300 Plus (1 tablet/day) containing HA (300 mg) and Boswellia serrata extract (100 mg), and a Glc + CS group (n = 17) given Cartijoint® Forte (1 tablet/day) containing Glc (415 mg), CS (400 mg), and curcuminoids from rhizomes of Curcuma longa L (50 mg).Physicians conducting evaluations were blinded to group assignments, whereas patients were not. All participants underwent assessments of pain relief, functional capacity improvement, and serum adropin levels, an emerging biomarker of knee OA, at baseline and after the four-week intervention period. Results: Both the HA and the Glc + CS groups exhibited improvements at the end of the study relative to baseline, with statistically significant differences (p < 0.05) observed in pain at rest, pain during movement, range of motion, and the overall Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, including its pain, stiffness, and physical function subscales. Notably, the HA group outperformed the Glc + CS group in the alleviation of pain at rest, pain during movement, and on the WOMAC pain subscale, with all differences being statistically significant (p < 0.05). Additionally, both groups showed a significant elevation in serum adropin levels from baseline (p < 0.05), with the HA group experiencing a more substantial increase when compared to the Glc + CS group (p < 0.05). Both supplements showed a limited number of treatment-emergent adverse events. Conclusion:Oral supplementation with either HA or Glc + CS demonstrated potential benefits for managing symptoms of mild-to-moderate knee OA. Notably, HA supplementation was associated with greater improvements in pain relief and higher elevations in serum adropin levels compared to Glc + CS supplementation. However, larger-scale and longer-term studies are necessary to further evaluate the safety and efficacy of these dietary supplements within the clinical management arsenal for knee OA.

Unilateral Magnetic Resonance Imaging-Guided Laser Interstitial Thermal Therapy Thalamotomy for Essential Tremor.

Essential tremor (ET) affects numerous adults, impacting quality of life (QOL) and often defying pharmacological treatment. Surgical interventions like deep brain stimulation (DBS) and lesional approaches, including radiofrequency, gamma-knife radiosurgery, and magnetic resonance imaging (MRI)-guided focused ultrasound, offer solutions but are not devoid of limitations. This retrospective, single-center, single-blinded pilot study aimed to assess the safety and efficacy of unilateral MRI-guided laser interstitial thermal therapy (MRIg-LITT) thalamotomy for medically intractable ET. Nine patients with ET, unresponsive to medications and unsuitable for DBS, underwent unilateral MRIg-LITT thalamotomy. We assessed tremor severity, QOL, cognitive function, and adverse events (AE) over a 12-month period. Tremor severity significantly improved, with a reduction of 83.37% at 12 months post-procedure. QOL scores improved by 74.60% at 12 months. Reported AEs predominantly included transient dysarthria, proprioceptive disturbances, and gait balance issues, which largely resolved within a month. At 3 months, 2 patients (22%) exhibited contralateral hemiparesis requiring physiotherapy, with 1 patient (11%) exhibiting persistent hemiparesis at 12 months. No significant cognitive impairment was detected post-procedure. Unilateral MRIg-LITT thalamotomy yielded substantial and enduring tremor alleviation and enhanced QOL in patients with ET that is resistant to medication. The AE profile was acceptable. Our findings support the need for additional research with expanded patient cohorts and extended follow-up to corroborate these outcomes and to refine the role of MRIg-LITT as a targeted and minimally invasive approach for ET management. © 2024 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Impact of Stationary Cycling on Clinical Outcomes in Patients with Tibiofemoral Osteoarthrosis: A Pilot Study

Introduction: Knee osteoarthrosis (tibiofemoral) is one of the most common forms of arthritis and a significant contributor to disability in the elderly. It has a notable impact on the muscle strength and lower limb biomechanics. The pain and stiffness associated with osteoarthrosis knee can significantly hinder daily activities and work potential in affected individuals. Aerobic exercises have demonstrated positive outcomes for these patients. Aim: To evaluate the effectiveness of forward and backward cycling with knee osteoarthrosis ranging from grade 1-3. Materials and Methods: A prospective, randomised clinical trial and single-blind pilot study was conducted in the Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India. The compared two groups: one adding static cycling to regular treatment, the other receiving only regular treatment. Both groups got treatment three times a week for four weeks. Quality of Life (QoL) and pain were assessed using the Comprehensive Knee Osteoarthritis Index (CKOAI) scale, while isokinetic strength was measured with an isokinetic dynamometer. Evaluation at both baseline and endpoint was conducted by the same assessor. Results: Significant improvements were shown at the 4-week follow up for QOL, pain and isokinetic strength (p&lt;0.02) with stationary cycling. The CKOAI, an indicator of pain intensity and QOL showed significant improvement (p=0.02). Conclusion: The research affirms the findings from the earlier Randomised Controlled Trials (RCTs) and indicated that engaging in stationary cycling leads to significant enhancement in individuals with osteoarthrosis knee. Participants expressed their appreciation for the program and proved to be safe, effective and feasible in primary care.

Lesion network guided delta frequency neuromodulation improves cognition in patients with psychosis spectrum disorders: A pilot study

BackgroundTranscranial electric stimulation (tES) may improve cognition in psychosis spectrum disorders. However, few studies have used novel tES approaches, such as high definition tES (HD-tES) to target specific brain circuits. Recently, the extrastriate visual cortex (V5/MT) has been causally linked to visual hallucinations through lesion network mapping and this may be a promising approach for improving cognition. ObjectiveWe aim to determine if causal lesion network guided HD-tES to V5/MT improves cognitive performance as measured by the Brief Assessment of Cognition in Schizophrenia (BACS). MethodsA single-blind pilot study with a within-subjects crossover design was performed to characterize the effect of cathodal HD-transcranial direct current stimulation (tDCS) and 2 Hz HD-transcranial alternating current stimulation (tACS) on cognition. Enrolled patients received 20 mins of HD-tES twice daily for 5 consecutive days applied bilaterally to V5/MT with a washout between conditions. BACS assessments were performed at baseline, day-5, and 1-month. Results6 participants with psychosis spectrum disorder were enrolled. 6 individuals received cathodal HD-tDCS. 4 individuals received 2 Hz HD-tACS. HD-tACS resulted in significant (p < 0.1 baseline to 1-month improvements for Digit Sequencing, Verbal Fluency, and Tower of London. HD-tDCS did not result in significant improvement on any task. ConclusionsHD-tACS targeting V5/MT may be a promising treatment to improve cognitive abilities in individuals with psychosis. By promoting delta oscillations, tACS may enhance cortico-cortico communications across brain networks to improve verbal working memory, processing speed, and executive function. Large-scale investigations are needed to replicate these results.

Low-load blood flow restriction strength training in patients with COPD: a randomised single-blind pilot study

ObjectiveThe objective of this study is to compare the effectiveness of lower limb low-load blood flow restriction training (LL-BFRT) with high-load strength training (HL-ST) as part of an outpatient pulmonary...

Breath-Hold-Triggered BOLD fMRI in Drug-Resistant Nonlesional Focal Epilepsy-APilot Study.

Individuals with drug-resistant epilepsy may benefit from epilepsy surgery. In nonlesional cases, where no epileptogenic lesion can be detected on structural magnetic resonance imaging, multimodal neuroimaging studies are required. Breath-hold-triggered BOLD fMRI (bh-fMRI) was developed to measure cerebrovascular reactivity in stroke or angiopathy and highlights regional network dysfunction by visualizing focal impaired flow increase after vasodilatory stimulus. This regional dysfunction may correlate with the epileptogenic zone. In this prospective single-center single-blind pilot study, we aimed to establish the feasibility and safety of bh-fMRI in individuals with drug-resistant non-lesional focal epilepsy undergoing presurgical evaluation. In this prospective study, 10consecutive individuals undergoing presurgical evaluation for drug-resistant focal epilepsy were recruited after case review at amultidisciplinary patient management conference. Electroclinical findings and results of other neuroimaging were used to establish the epileptogenic zone hypothesis. To calculate significant differences in cerebrovascular reactivity in comparison to the normal population, bh-fMRIs of 16healthy volunteers were analyzed. The relative flow change of each volume of interest (VOI) of the atlas was then calculated compared to the flow change of the whole brain resulting in an atlas of normal cerebral reactivity. Consequently, the mean flow change of every VOI of each patient was tested against the healthy volunteers group. Areas with significant impairment of cerebrovascular reactivity had decreased flow change and were compared to the epileptogenic zone localization hypothesis in asingle-blind design. Acquisition of bh-fMRI was feasible in 9/10cases, with one patient excluded due to noncompliance with breathing maneuvers. No adverse events were observed, and breath-hold for intermittent hypercapnia was well tolerated. On blinded review, we observed full or partial concordance of the local network dysfunction seen on bh-fMRI with the electroclinical hypothesis in 6/9cases, including cases with extratemporal lobe epilepsy and those with nonlocalizing 18F-fluorodeoxyglucose positron emission tomography (FDG-PET). This represents the first report of bh-fMRI in individuals with epilepsy undergoing presurgical evaluation. We found bh-fMRI to be feasible and safe, with apromising agreement to electroclinical findings. Thus, bh-fMRI may represent apotential modality in the presurgical evaluation of epilepsy. Further studies are needed to establish clinical utility.

Effects of a digital cognitive behavioral therapy for insomnia on sleep and alcohol consumption in heavy drinkers: A randomized pilot study.

Insomnia is a well-established, prospective risk factor for Alcohol Use Disorder. Thus, targeting sleep problems could serve as a novel and efficacious means of reducing problematic drinking. Here, we examined the potential utility of a well-validated, interactive, easy to use, self-paced digital cognitive behavioral therapy for insomnia program. In a randomized, single-blind pilot study, we examined the impact of treatment with Sleep Healthy Using the Internet (SHUTi) on drinking and sleep outcomes in a sample of heavy drinkers with insomnia. Heavy drinking men (n = 28) and women (n = 42) with insomnia were randomly assigned to complete either the SHUTi program or a control patient education program. Subjective measures of sleep and alcohol use were administered at baseline, immediately following completion of the intervention, 3 months post-intervention, and 6 months post-intervention. Sleep outcomes were assessed using the Insomnia Severity Index and Pittsburgh Sleep Quality Index. Drinking outcomes were assessed using the 30-Day Timeline Follow-Back calendar. We used linear mixed effects models to compare groups on both insomnia and drinking outcomes. Data from all 70 subjects (SHUTI: n = 40; control: n = 30) were analyzed. Linear mixed effects models showed that SHUTi significantly reduced insomnia symptoms (p = 0.01) and drinking outcomes (ps < 0.05) more than the control condition over time. Trend-level effects on sleep quality (p = 0.06) were also observed. No adverse events were reported. Improving sleep may be an effective treatment intervention for reducing hazardous drinking in at-risk individuals. Further, findings provide preliminary support for the implementation of an easily accessible health behavior intervention with significant public health impact in a high-risk population.

Feasibility of a novel neurofeedback system: a parallel randomized single-blinded pilot study

Neurocognitive assessment tools have been proposed to optimize, maintain, and improve perceptual-cognitive performance. Here, we investigated the feasibility and efficacy of a novel neurofeedback system, neuroMoon (nM), on cognitive abilities compared with one of the most popular perceptual-cognitive training (PCT) tools both in sports and rehabilitation called NeuroTracker (NT). Thirty-one young athletes performed a comprehensive battery of cognitive tests from the Vienna Test System before and after a 12-session computer-based cognitive training program using nM (n = 11, age 22.6 ± 3.8 years), nM sham (CON, n = 10, age 20.3 ± 1.2 years) or NT (n = 10, age 20.5 ± 1.7 years) device. A series of repeated-measures ANOVA was performed to detect changes in cognitive abilities in response to the training. Participants had faster median reaction time in both the color-naming and word-reading conditions of the Stroop test (all p < 0.005), regardless of group. Regarding the task switching test, statistical analysis indicated faster working time and mean reaction time of the incongruent stimuli, repetition task, and shifting task (all p < 0.005), nevertheless, these changes were also regardless of group. In addition, we found fewer omitted (pre: 17.5 ± 8.3, post: 6.4 ± 1.5, d = 1.311) and more correct (pre: 261.6 ± 36.1, post: 278.6 ± 38.7, d = − 1.020) post-intervention answers in the determination test, regardless of group. Finally, participants in each group performed the digit span backward test with larger post (6.42 ± 1.54) vs. pre (5.55 ± 1.43) scores following the PCT (d = − 0.801). Overall, PCT with nM as compared with NT induced similar results in cognitive abilities suggesting its potential to be used to achieve and maintain better mental performance. However, considering that the sham stimulation also induced similar improvements in cognitive abilities, future studies should clearly determine the cognitive measures that could benefit from NF training.

Effects of Stroke Rehabilitation Using Gait Robot-Assisted Training and Person-Centered Goal Setting: A Single Blinded Pilot Study

Many stroke survivors have difficulties due to the mobility and activities required in daily living. A walking impairment negatively affects the independent lifestyle of stroke patients, requiring intensive post-stroke rehabilitation. Therefore, the purpose of this study was to examine the effects of stroke rehabilitation using gait robot-assisted training and person-centered goal setting on mobility, the activities of daily living, stroke self-efficacy, and health-related QoL in stroke patients with hemiplegia. An assessor-blinded quasi-experimental study with a pre-posttest nonequivalent control group was used. Participants who were admitted to the hospital with a gait robot-assisted training system were assigned to the experimental group, and those without gait robots were assigned to the control group. Sixty stroke patients with hemiplegia from two hospitals specialized in post-stroke rehabilitation participated. Stroke rehabilitation using gait robot-assisted training and person-centered goal setting for stroke patients with hemiplegia was conducted for a total of six weeks. There were significant differences between the experimental group and control group in the Functional Ambulation Category (t = 2.89, p = 0.005), balance (t = 3.73, p < 0.001), Timed Up and Go (t = -2.27, p = 0.027), Korean Modified Barthel Index (t = 2.58, p = 0.012), 10 m Walking test (t = -2.27, p = 0.040), stroke self-efficacy (t = 2.23, p = 0.030), and health-related quality of life (t = 4.90, p < 0.001). A gait robot-assisted rehabilitation using goal setting for stroke patients with hemiplegia improved gait ability, balance ability, stroke self-efficacy, and health-related quality of life in stroke patients.

Effects of Individualised High Positive End-Expiratory Pressure and Crystalloid Administration on Postoperative Pulmonary Function in Patients Undergoing Robotic-Assisted Radical Prostatectomy: A Prospective Randomised Single-Blinded Pilot Study

Robotic-assisted laparoscopic prostatectomy (RALP) is typically conducted in steep Trendelenburg position (STP). The aim of the study was to evaluate whether crystalloid administration and individual management of positive end-expiratory pressure (PEEP) improve peri- and post-operative pulmonary function in patients undergoing RALP. Prospective randomised single-centre single-blinded explorative study. Patients were either allocated to a standard PEEP (5 cmH2O) group or an individualised high PEEP group. Furthermore, each group was divided into a liberal and a restrictive crystalloid group (8 vs. 4 mL/kg/h predicted body weight). Individualised PEEP levels were determined by means of preoperative recruitment manoeuvre and PEEP titration in STP. Informed consent was obtained from 98 patients scheduled for elective RALP. The following intraoperative parameters were analysed in each of the four study groups: ventilation setting (peak inspiratory pressure [PIP], plateau pressure, driving pressure [Pdriv], lung compliance [LC] and mechanical power [MP]) and postoperative pulmonary function (bed-side spirometry). The spirometric parameters Tiffeneau index (FEV1/FVC ratio) and mean forced expiratory flow (FEF25-75) were measured pre- and post-operatively. Data are shown as mean ± standard deviation (SD), and groups were compared with ANOVA. A p-value of <0.05 was considered significant. The two individualised high PEEP groups (mean PEEP 15.5 [±1.71 cmH2O]) showed intraoperative significantly higher PIP, plateau pressure and MP levels but significantly decreased Pdriv and increased LC. On the first and second postoperative day, patients with individualised high PEEP levels had a significantly higher mean Tiffeneau index and FEF25-75. Perioperative oxygenation and ventilation and postoperative spirometric parameters were not influenced by restrictive or liberal crystalloid infusion in either of the two respective PEEP groups. Individualised high PEEP levels (≥14 cmH2O) during RALP improved intraoperative blood oxygenation and resulted in more lung-protective ventilation. Furthermore, postoperative pulmonary function was improved for up to 48 h after surgery in the sum of the two individualised high PEEP groups. Restrictive crystalloid infusion during RALP seemed to have no effect on peri- and post-operative oxygenation and pulmonary function.

The Safety and Efficacy of Macrofocused Ultrasound without Visualization on Enlarged Facial Pores among Thai Patients: A Pilot Study

Introduction. Visibly enlarged facial pores are familiar dermatologic concerns. Macrofocused ultrasound energy without visualization (MaFU‐WV) showed efficacy in facial tightening and an improvement in skin textural irregularities which opened the potential of the positive effects in reducing the appearance of facial pores. This study aims to assess the safety and efficacy of MaFU‐WV in tightening facial pores. Methods. This was a prospective, single‐blinded pilot study. Thirty‐four Thai subjects with enlarged pores received a single treatment of MaFU‐WV using a 2.0 mm transducer on bilateral malar areas of the face. Primary outcome measures included the pore count, pore volume, and pore index measurements using an instrument with a camera for image acquisition and software for analysis of skin. Secondary outcome measures incorporated two blinded dermatologists’ evaluation of clinical photographs and the subjects’ perception of improvement in their facial pores using a 6‐point scale. Measurements were taken at baseline, 1 week, 1 month, 3 month, and 6 month after treatment. Results. The pore count significantly decreased from baseline to 6 month after treatment (p &lt; 0.001). Pore volume was significantly lowered from baseline to 1 week and 1, 3, and 6 months after treatment (p &lt; 0.05). The pore index was likewise significantly reduced from baseline in every visit (p &lt; 0.05). The majority of photographic evaluations by blinded dermatologists were scored as a 1–25% pore minimizing effect across nearly all follow‐up visits. On the other hand, patient satisfaction kept improving until the end of the study at 6 months. No adverse events occurred throughout the conduct of the study. Conclusion. Macrofocused ultrasound energy using a 2 mm transducer is a safe and effective treatment for facial pore tightening. The trial is registered with registration number: TCTR20220719001.

A Pilot Study on Presence of Parkinson’s Disease Risk Gene PARK7 in Population of West Bengal, India: A Preliminary Observation

Introduction: The neurodegenerative Parkinson’s Disease (PD) is associated with different risk genes along with some environmental factors. Till date, there are few identified genes which play a pivotal role in the early onset of PD among the general population. Aim: To screen the presence of different risk genes of Parkinson’s disease along with associated environmental factors among randomly selected 62 urban participants. Materials and Methods: The present randomised control trial single blind pilot study was conducted in the Department of Biotechnology, Heritage Institute of Technology, Kolkata, West Bengal, India, from March 2021 to June 2021. The study participants were informed about the study and blood was collected from them. The genomic Deoxyribonucleic Acid (DNA) extraction was carried out following phenol chloroform extraction protocol and Polymerase Chain Reaction (PCR) was done with specific primers of the risk genes namely, Parkinson Disease 1 (PARK1) Alpha-synuclein (α-synuclein), Parkinson Disease 2 (PARK2) (Parkin), Parkinson Disease Protein 7 (PARK7) or DJ -1 and PINK 1. Protein Deglycase-1 (DJ-1) and PTEN Induced Kinase 1 (PINK1). The statistical analysis of the findings was done using Statistical package for the Social Sciences (SPSS) software version 21.0. Results: Out of 62 particpants, 47 were males and 15 were females and the age distribution of the participants was in between 21 years to &gt;60 years. After obtaining specific band in agarose gel electrophoresis, 35 positive cases of PARK7 gene and 1 positive case of PARK2 gene were identified. Conclusion: There was a statistically significant association of different bacterial and viral infections with the PARK7 gene positive cases. PARK7 gene responsible for early onset of PD is significantly prevalent in the general population of West Bengal.

RETRACTED: Comparison of the effects of etomidate combined with sufentanil, fentanyl, or dezocine on the consciousness index and adverse reactions for painless gastroscopy: A randomized controlled single-blinded pilot study

ObjectiveTo use etomidate in combination with different opioids (sufentanil, fentanyl, and dezocine) to compare several anesthesia options from the aspects of the patient's index of consciousness (IoC). MethodsThis was a prospective pilot study of consecutive patients who were scheduled for elective painless gastroscopy at PLA Strategic Force Characteristic Medical Center, Beijing, China, between December 2020 and May 2022. The patients were randomized to control (etomidate), S (sufentanil ​+ ​etomidate), F (fentanyl ​+ ​etomidate), and D (dezocine ​+ ​etimidate). IoC was measured before anesthesia (T1), opioids (T2), etomidate (T3), the start of endoscopy (T4), drug withdrawal (T5), OAA/S ​> ​2 (T6), and OAA/S ​> ​4) (T7). The primary outcome was the observation of IoC at T6 and T7. The adverse reaction and recovery time were secondary outcomes. ResultsWith 20 patients in each group, there were no differences in the operation and awakening times among the four groups (P ​> ​0.05). Compared with group C, the IoC values of groups S and F at T5, T6, and T7 were increased after drug administration (P ​< ​0.05), with intragroup differences (P ​< ​0.001). Compared with group C, the IoC values of groups S, F, and D were higher at T6 and T7 (PS-T6 ​= ​0.003, PF-T6 ​= ​0.013, PD-T6 ​= ​0.015; PS-T7 ​= ​0.015, PF-T7 ​= ​0.040, PD-T7 ​= ​0.028). There were differences in nausea and vomiting between groups D and C (PD-C ​= ​0.044) and myoclonus (PS–CPF-C<0.001, and PD-C<0.001). SpO2 <90% (two cases in group S and one in group F) were observed. ConclusionIoC value has a good correlation with OAA/S score, which can accurately monitor the effect of etomidate combined with opioids on the depth of anesthesia of patients undergoing painless gastroscopic anesthesia. Trial registrationChiCTR, ChiCTR2000040927. Registered December 16, 2020 –Prospective registration, http://www.chictr.org.cn/ChiCTR2000040927.

Efficacy and Ease of Use of a Newly Designed Pencil-Point Epidural Needle Compared to Conventional Tuohy Epidural Needle: A Randomized Single-Blind Pilot Study.

Background and objectiveAccidental dural puncture (ADP) and consequent post-dural puncture headache (PDPH) related to epidural needle use have prompted the design of a pencil-point epidural needle. The aim of this prospective, randomized, single-blind pilot study was to assess the efficacy, ease of use, patient satisfaction, and adverse events associated with this newly designed pencil-point epidural needle compared to a Tuohy conventional epidural needle in parturients receiving combined spinal-epidural (CSE) anesthesia for labor.MethodsAfter obtaining the Institutional Research Board approval, 100 parturients were randomized to receive CSE anesthesia with either the new pencil-point epidural needle (Gertie Marx, IMD Inc., Huntsville, UT) (P group) or Tuohy needle (T group). We documented patients’ height, weight, loss of resistance (LOR), number of attempts required, onset time of spinal anesthesia, difficulties with insertion of spinal needle, difficulties with insertion of the epidural needle and catheter, duration of the procedure, overall satisfaction of the provider and patient, ADP, PDPH, paresthesia, and pain.ResultsThere was no difference in body mass index (BMI), LOR, number of attempts, and onset time of spinal anesthetic between the study groups. Success in obtaining cerebrospinal fluid (CSF) on the first attempt was 50/51 (98%) in the T group vs. 44/49 (89.8%) in the P group (p=0.108). The need for subsequent epidural needle readjustment to obtain CSF was higher in the P group (16/49, 32.7%) vs. the T group (3/51, 5.9%, p<0.001). Success on the first attempt with epidural catheter threading was lower with the pencil-point epidural needle compared to the Tuohy needle (69% vs. 98%, p<0.001). The anesthesiologist switched from the assigned pencil-point epidural needle to the Tuohy needle due to technical difficulties in 8/49 (16.3%) cases. The duration of the procedure was longer in the P group (16.43 ±6.33 minutes) compared to the T group (11.49 ±1.87 minutes) (p<0.001). User satisfaction was lower in the P group compared to the T group (34.7% vs. 90.2%, p<0.001). Patient satisfaction was lower with the pencil-point epidural needle compared to the Tuohy needle (75.5% vs. 92.2%, p=0.03). There was no difference in complication rates from the CSE procedure between groups (pain, paresthesia, ADP, and PDPH).ConclusionIn this pilot study, the use of the pencil-point epidural needle for CSE was associated with less successful epidural catheter placement as well as low user and patient satisfaction compared to the Tuohy epidural needle. Modifications in the pencil-point epidural needle design are needed to improve efficacy and enhance user acceptance before a larger study can be conducted to evaluate the rates of ADP and PDPH.

The Effect of Platelet-Rich Plasma Injection on Short Term Vocal Outcomes Following Phonosurgery-A Pilot Study.

Background and Objectives: The efficiency and optimal voice rest period following phonosurgery remains debatable. Platelet-rich plasma (PRP) is a safe and cheap alternative to many bioactive agents being studied on animal models, and is already in use in many medical areas. We investigate the short-term effects of PRP and voice rest on voice outcomes following phonosurgery as an alternative to voice rest alone. Materials and Methods: A prospective single-blinded pilot study was conducted. Sixteen patients with a diagnosis of vocal fold cyst and polyps were included, forming equal groups (PRP and voice rest vs. voice rest alone). Voice analysis was carried out on the preoperative day, day three, and week three following surgery. The measured parameters were fundamental frequency (F0), noise–signal ratio (NSR), harmonic poverty (HP), attack alteration (AL), pitch instability (PI), and amplitude instability (AI).VHI(Voice Handicap Index)-30 questionnaires were carried out before surgery and three weeks following surgery to assess the impact of subjective voice change on quality of life. PRP was obtained using commercial kits with separator gel. Results: An average 3.68-fold increase in platelets was obtained with PRP. No side effects were noted after injection. All voice parameters improved on day three and week three following surgery. Statistical significance was noted only in the fundamental frequency of male patients (p = 0.048) in favor of the PRP-voice rest group. In addition, the VHI- 30 questionnaire results between preoperative and postoperative assessments showed statistically significant differences in total VHI score (p = 0.02) as well as the physical (p = 0.05) and emotional (p = 0.02) scale in favor of the PRP-voice rest group. Conclusions: PRP presents short term safety in patients who undergo phonosurgery, although long-term outcomes are unknown. PRP and voice rest are superior to voice rest alone when considering subjective assessment of the voice. When analyzing acoustic parameters, PRP and voice rest are not superior to voice rest alone.

Usefulness of combined handheld ultrasound and fluoroscopy-guided injection in adhesive capsulitis of the shoulder: A prospective, randomized single blind-pilot study.

BACKGROUND: Ultrasound is increasingly being utilized in the diagnosis and treatment of adhesive capsulitis.OBJECTIVE: To compare the therapeutic effects and advantages of combined handheld ultrasound and fluoroscopy-guided intra-articular corticosteroid injection with those of conventional ultrasound-guided corticosteroid injection in adhesive capsulitis of the shoulder.METHODS: A total of 39 patients diagnosed with adhesive capsulitis of the shoulder were randomly assigned into two groups. Group A patients ( 19) underwent combined handheld ultrasound and fluoroscopy-guided corticosteroid injection and group B patients ( 20) underwent conventional ultrasound-guided corticosteroid injection to the intra-articular space of the shoulder twice. Treatment efficacy was assessed at 2 and 6 weeks after the final injection, based on the verbal numeric pain scale, Shoulder Pain and Disability Index, and range of motion. Secondary outcome measures were the accuracy and procedure time.RESULTS: Both injection methods were effective in the treatment of adhesive capsulitis. No significant differences in treatment efficacy and injection accuracy were observed between the two groups ( 0.05).CONCLUSIONS: This study showed no statistical differences in treatment efficacy between 2 groups. However, the combined use of ultrasound and fluoroscopy can increase the accuracy of injection compared with conventional ultrasound alone.

A randomised prospective single-blind pilot study to compare the analgesic efficacy of thoracic epidural block and erector spinae plane block in breast cancer surgery.

Background and Aims:Thoracic epidural analgesia (TEA) is an effective analgesic technique for breast surgery, although it has many associated complications. Ultrasound (US)–guided erector spinae plane (ESP) block requires less technical expertise, is safe and may be an alternative to TEA. We aimed to compare the efficacy of TEA with US-guided continuous ESP block for post-operative analgesia in patients undergoing modified radical mastectomy (MRM) surgeries.Methods:Sixty-six female patients of age group 18–65 years, and American Society of Anesthesiologists (ASA) physical status I and II, undergoing MRM surgeries were recruited. Patients received TEA in Group Ep and US-guided ESP block in Group Er, before induction of general anaesthesia. Both the groups received 0.2% ropivacaine 15 mL, followed by 5 mL.h-1 infusion for 24 h. The primary outcome was the duration of analgesia. Secondary outcomes were total doses of rescue analgesics in 24 hours and visual analogue scale (VAS) scores at 0 h, 1 h, 2 h, 4 h, 8 h, 12 h, and 24 h.Results:The mean duration of analgesia was 21.72 ± 4.73 hours in Ep group and 20.60 ± 5.77 hours in Er group (P = 0.39). The total dose of rescue analgesics in the postoperative period was comparable between both the groups. There was no significant difference in VAS scores between the groups over 24 h.Conclusion:US-guided ESP block can be used as safe and easy to perform alternative analgesic technique over thoracic epidural analgesia for peri-operative pain management in breast cancer surgeries.