Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction.

BACKGROUND: Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. MATERIALS AND METHODS: In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's "EQ-5D-5L" index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. RESULTS: At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (-4.9; 95% CI, -5.3 to -4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (-22.7; 95% CI, -25.4 to -20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195-0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. CONCLUSION: Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).

Growth performance, meat quality and hematological parameters of broiler chickens fed safflower seed.

The aim of the current study was to determine the effects of dietary supplementation of safflower seed (SS) on the growth performance and hematological parameters of broiler birds along with the physicochemical, textural and sensory attributes of chicken meat. A total of 200 male chickens (7-days-old) were distributed into 5 groups (40 chickens in each) with 5 replicates of 8 chicks in a 42-day experiment. Each group was allocated to one of 5 dietary treatments, i.e., 0, 2.5, 5, 7.5, and 10% SS. The experimental diets were formulated for starter (7 to 21 days) and finisher (22 to 42 days) phases. Inclusion of SS in the diet improved growth performances in treatment groups between 7 and 42 days. The highest and lowest body weights were observed at the 5% SS and 0% SS levels, respectively. The physicochemical attributes of breast and thigh meat were found (P > 0.05) except for crude fat. The crude fat was significantly (P < 0.05) increased with increasing levels of SS in the diet. The inclusion of SS in the diet did not negatively impact the textural properties, i.e., hardness, cohesiveness, springiness, gumminess, chewiness, and shear force of breast and thigh meat. There was no significant difference in the sensory parameters of cooked chicken meat with increasing levels of SS in the diet. The results demonstrated a significant (P < 0.01) improvement in hematological parameters in the blood samples of broiler chickens fed diet supplemented with various levels of SS for five weeks. These findings suggest that, SS may be used as an oil seed for broiler chicken feed.

Trends in atmospheric water vapour over the Thar Desert during Indian Summer Monsoon period of 2003-2020.

The Thar is the most densely populated desert in the world, which supports diverse ecosystems and human endeavours such as agriculture and socioeconomic activities. Water demand and supply in the Thar play an essential role in regulating the socioeconomic activities of the region. Inland water and precipitation aid the movement of water in the Thar Desert. Precipitation in the Thar is governed by the Indian Summer Monsoon (ISM), during which the winds distribute water vapour to regulate precipitation across the region. Therefore, we analyse the water vapour, its sources and its relation with precipitation using satellite measurements and reanalysis data in the Thar during ISM. Like other regions, a clear seasonal cycle of water vapour is observed in the Thar, with very high values (> 45 kg/m2) during ISM and low in winter (< 15 kg/m2). Evapotranspiration and moisture transport have significant effects on the amount of water vapour during ISM. There is a significant increase in water vapour in the troposphere, with high trends at the surface (0.032 g/kg/year) and small at the tropopause (0.00002 g/kg/year). A significant increase in column water vapour is also estimated in the Thar during ISM, with high trends in the eastern and southern areas, at about 0.15-0.35 kg/m2/year. The rise in water vapour in the Thar can be attributed to the increase in evapotranspiration (0.03-0.07 mm/day/year) and water vapour transport (> 0.5 kg/m/s/year) from the Arabian Sea and Indian Ocean. The rise in water vapour can lead to an increase in precipitation in the Thar, as it shows significant positive trends (0.05-0.1 mm/day/year) in the eastern areas during ISM. The increase in precipitation and water vapour in the arid Thar Desert can have significant implications for the regional environment and agriculture.

Increased global cropland greening as a response to the unusual reduction in atmospheric PM2.5 concentrations during the COVID-19 lockdown period.

The devastating effects of COVID-19 pandemic have widely affected human lives and economy across the globe. There were significant changes in the global environmental conditions in response to the lockdown (LD) restrictions made due to COVID-19. The direct impact of LD on environment is analysed widely across the latitudes, but its secondary effect remains largely unexplored. Therefore, we examine the changes in particulate matter (PM2.5) during LD, and its impact on the global croplands. Our analysis finds that there is a substantial decline in the global PM2.5 concentrations during LD (2020) compared to pre-lockdown (PreLD: 2017-2019) in India (10-20%), East China (EC, 10%), Western Europe (WE, 10%) and Nigeria (10%), which are also the cropland dominated regions. Partial correlation analysis reveals that the decline in PM2.5 positively affects the cropland greening when the influence of temperature, precipitation and soil moisture are limited. Croplands in India, EC, Nigeria and WE became more greener as a result of the improvement in air quality by the reduction in particulates such as PM2.5 during LD, with an increase in the Enhanced Vegetation Index (EVI) of about 0.05-0.1, 0.05, 0.05 and 0.05-0.1, respectively. As a result of cropland greening, increase in the total above ground biomass production (TAGP) and crop yield (TWSO) is also found in EC, India and Europe. In addition, the improvement in PM2.5 pollution and associated changes in meteorology also influenced the cropland phenology, where the crop development stage has prolonged in India for wet-rice (1-20%) and maize (1-10%). Therefore, this study sheds light on the response of global croplands to LD-induced improvements in PM2.5 pollution. These finding have implications for addressing issues of air pollution, global warming, climate change, environmental conservation and food security to achieve the Sustainable Development Goals (SDGs).

Reference Data for Diagnosis of Spondylolisthesis and Disc Space Narrowing Based on NHANES-II X-rays.

Robust reference data, representing a large and diverse population, are needed to objectively classify measurements of spondylolisthesis and disc space narrowing as normal or abnormal. The reference data should be open access to drive standardization across technology developers. The large collection of radiographs from the 2nd National Health and Nutrition Examination Survey was used to establish reference data. A pipeline of neural networks and coded logic was used to place landmarks on the corners of all vertebrae, and these landmarks were used to calculate multiple disc space metrics. Descriptive statistics for nine SPO and disc metrics were tabulated and used to identify normal discs, and data for only the normal discs were used to arrive at reference data. A spondylolisthesis index was developed that accounts for important variables. These reference data facilitate simplified and standardized reporting of multiple intervertebral disc metrics.

Effects of Different Types of Physical Activity on Respiratory Health Parameters in Elderly Males: A Cross-Sectional Study.

Background Population aging is a global phenomenon associated with declines in muscle mass, physical activity levels, and respiratory health among elderly individuals. Despite evidence suggesting the benefits of physical activity on respiratory function, there is limited research examining its effects on lung function in the Indian elderly population. Materials and methods This cross-sectional study aimed to investigate the impact of different intensities of physical activity on respiratory health parameters among apparently healthy elderly males aged 60-80 years. Participants were categorized into walking, swimming, and sedentary groups based on their level of physical activity. Anthropometric measurements, cardiovascular parameters, respiratory endurance tests, and spirometry were conducted to assess lung function. Statistical analysis included nonparametric tests to compare the groups. Results Age, height, weight, BMI, waist circumference, and hip circumference were similar across groups, but the waist-to-hip ratio was higher in the sedentary group. Systolic and diastolic blood pressure did not differ significantly, while the pulse rate was lower in the swimming group. The sedentary group exhibited lower respiratory endurance, with a significantly reduced 40 mmHg endurance test and maximum expiratory pressure compared to the walking and swimming groups. Spirometry results showed significant improvements in various parameters, including forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), peak expiratory flow rate (PEFR), forced expiratory flow 25% (FEF-25), and maximum voluntary ventilation (MVV) in the walking and swimming groups compared to the sedentary group. Conclusion Regular physical activity, particularly walking and swimming, appears to positively influence respiratory health parameters among elderly males. Engaging in these activities may enhance respiratory muscle strength and lung function, potentially mitigating age-related declines in pulmonary function and promoting overall well-being.

Apoptosis induction capability of silver nanoparticles capped with Acorus calamus L. and Dalbergia sissoo Roxb. Ex DC. against lung carcinoma cells.

Silver nanoparticles (AgNPs) were prepared using a one-step reduction of silver nitrate (AgNO3) with sodium borohydride (NaBH4) in the presence of polyvinylpyrrolidone (PVP) as a capping agent. Plant extracts from D. sissoo (DS) and A. calamus L. (AC) leaves were incorporated during the synthesis process. The crystalline nature of the AgNPs was confirmed through X-ray diffraction (XRD), confirming the face-centered cubic structure, with a lattice constant of 4.08 Å and a crystallite size of 18 nm. Field Emission Gun Transmission Electron Microscopy (FEG-TEM) revealed spherical AgNPs (10-20 nm) with evident PVP adsorption, leading to size changes and agglomeration. UV-Vis spectra showed a surface plasmon resonance (SPR) band at 417 nm for AgNPs and a redshift to 420 nm for PVP-coated AgNPs, indicating successful synthesis. Fourier Transform Infrared Spectroscopy (FTIR) identified functional groups and drug-loaded samples exhibited characteristic peaks, confirming effective drug loading. The anti-cancer potential of synthesized NPs was assessed by MTT assay in human adenocarcinoma lung cancer (A549) and lung normal cells (WI-38) cells. IC50 values for all three NPs (AgPVP NPs, DS@AgPVP NPs, and AC@AgPVP NPs) were 41.60 ± 2.35, 14.25 ± 1.85, and 21.75 ± 0.498 µg/ml on A549 cells, and 420.69 ± 2.87, 408.20 ± 3.41, and 391.80 ± 1.55 µg/ml respectively. Furthermore, the NPs generated Reactive Oxygen Species (ROS) and altered the mitochondrial membrane potential (MMP). Differential staining techniques were used to investigate the apoptosis-inducing properties of the three synthesized NPs. The colony formation assay indicated that nanoparticle therapy prevented cancer cell invasion. Finally, Real-Time PCR (RT-PCR) analysis predicted the expression pattern of many apoptosis-related genes (Caspase 3, 9, and 8).

Adjunctive Use of Bone Growth Stimulation Increases Cervical Spine Fusion Rates in Patients at Risk for Pseudarthrosis.

STUDY DESIGN: A prospective multicenter clinical trial (NCT03177473) was conducted with a retrospective cohort used as a control arm. OBJECTIVE: The purpose of this study was to evaluate cervical spine fusion rates in subjects with risk factors for pseudarthrosis who received pulsed electromagnetic field (PEMF) treatment. SUMMARY OF BACKGROUND DATA: Certain risk factors predispose patients to pseudarthrosis, which is associated with prolonged pain, reduced function, and decreased quality of life. METHODS: Subjects in the PEMF group were treated with PEMF for 6 months postoperatively. The primary outcome measure was fusion status at the 12-month follow-up period. Fusion status was determined using anterior/posterior, lateral, and flexion/extension radiographs and computed tomography (without contrast). RESULTS: A total of 213 patients were evaluated (PEMF, n=160; Control, n=53). At baseline, the PEMF group had a higher percentage of subjects who used nicotine ( P =0.01), had osteoporosis ( P <0.05), multi-level disease ( P <0.0001), and were >65 years of age ( P =0.01). The PEMF group showed over two-fold higher percentage of subjects that had ≥3 risk factors (n=92/160, 57.5%) compared with the control group (n=14/53, 26.4%). At the 12-month follow-up, the PEMF group demonstrated significantly higher fusion rates compared with the control (90.0% vs. 60.4%, P <0.05). A statistically significant improvement in fusion rate was observed in PEMF subjects with multi-level surgery ( P <0.0001) and high BMI (>30 kg/m 2 ; P =0.0021) when compared with the control group. No significant safety concerns were observed. CONCLUSIONS: Adjunctive use of PEMF stimulation provides significant improvements in cervical spine fusion rates in subjects having risk factors for pseudarthrosis. When compared with control subjects that did not use PEMF stimulation, treated subjects showed improved fusion outcomes despite being older, having more risk factors for pseudarthrosis, and undergoing more complex surgeries.

Diagnosis of spine pseudoarthrosis based on the biomechanical properties of bone.

BACKGROUND CONTEXT: Failure to fuse following anterior cervical discectomy and fusion (ACDF) may result in symptomatic pseudoarthrosis. Traditional diagnosis involves computerized tomography to detect bridging bone and/or flexion-extension radiographs to assess whether segmental motion is above specific thresholds; however, there are currently no well-validated diagnostic tests. We propose a biomechanically rational approach to achieve a reliable diagnostic test for pseudoarthrosis. PURPOSE: Develop and test a biomechanically based approach to the diagnosis of pseudoarthrosis. STUDY DESIGN: Literature review, development of theory, re-analysis of a previously published study with surgical exploration as the gold-standard, and retrospective analysis of pooled studies to understand time to fusion. METHODS: Fully automated methods were used to measure disc space strains (change in disc space height divided by initial height). Measurement error combined with the reported failure strain of trabecular bone led to a proposed strain threshold for diagnosis of pseudoarthrosis following ACDF. We reanalyzed previously reported flexion-extension radiographs for asymptomatic volunteers to assess whether flexion-extension radiographs, in the absence of fusion surgery, can be expected to provide sufficient stress on motion segments to allow for reliable strain-based fusion assessment. The sensitivity and specificity of strain- and rotation-based pseudoarthrosis diagnosis were assessed by reanalysis of previously reported post-ACDF flexion-extension radiographs, where intraoperative fusion assessments were also available. Finally, we assessed changes in strain over time using 9,869 flexion-extension radiographs obtained 6 weeks to 84 months post-ACDF surgery from 1,369 patients. RESULTS: The estimated error in automated measurement of disc space strain from radiographs was approximately 3%, and the reported failure strain of bridging bone was less than 2.5%. On that basis, we propose a 5% strain threshold for pseudoarthrosis diagnosis. Reanalysis of a study in which intraoperative fusion assessments were available revealed 67% sensitivity and 82% specificity for strain-based diagnosis of pseudoarthrosis, which was comparable to rotation-based diagnosis. Analysis of post-ACDF flexion-extension radiographs revealed rapid strain reduction for up to 24 months, followed by a slower decrease for up to 84 months. When rotation is less than 2 degrees, the strain-based diagnosis differed from the rotation-based diagnosis in approximately 14% of the cases. CONCLUSIONS: We propose steps for standardizing diagnosis of pseudoarthrosis based on the failure strain of bone, measurement error, and retrospective data. These steps include obtaining high-quality flexion-extension studies, the application of proposed diagnostic thresholds, and the use of image stabilization for conclusive diagnosis, when motion is near thresholds. The necessity for an accurate diagnosis with minimal radiation exposure underscores the need for further optimization and standardization in diagnosing pseudoarthrosis following ACDF surgery. CLINICAL SIGNIFICANCE: In a symptomatic post-spine fusion patient, it is important to diagnose or rule-out pseudoarthrosis. There are currently no well-validated diagnostic tests for this condition. Incorporating strain-based intervertebral motion analysis into the diagnosis could lead to a standardized and validated test for detecting spine pseudoarthrosis.