Quantifying lumbar mobility using a single tri-axial accelerometer.

Background: Lumbar mobility is regarded as important for assessing and managing low back pain (LBP). Inertial Measurement Units (IMUs) are currently the most feasible technology for quantifying lumbar mobility in clinical and research settings. However, their gyroscopes are susceptible to drift errors, limiting their use for long-term remote monitoring. Research question: Can a single tri-axial accelerometer provide an accurate and feasible alternative to a multi-sensor IMU for quantifying lumbar flexion mobility and velocity? Methods: In this cross-sectional study, 18 healthy adults performed nine repetitions of full spinal flexion movements. Lumbar flexion mobility and velocity were quantified using a multi-sensor IMU and just the tri-axial accelerometer within the IMU. Correlations between the two methods were assessed for each percentile of the lumbar flexion movement cycle, and differences in measurements were modelled using a Generalised Additive Model (GAM). Results: Very high correlations (r > 0.90) in flexion angles and velocities were found between the two methods for most of the movement cycle. However, the accelerometer overestimated lumbar flexion angle at the start (-4.7° [95 % CI -7.6° to -1.8°]) and end (-4.8° [95 % CI -7.7° to -1.9°]) of movement cycles, but underestimated angles (maximal difference of 4.3° [95 % CI 1.4° to 7.2°]) between 7 % and 92 % of the movement cycle. For flexion velocity, the accelerometer underestimated at the start (16.6°/s [95%CI 16.0 to 17.2°/s]) and overestimated (-12.3°/s [95%CI -12.9 to -11.7°/s]) at the end of the movement, compared to the IMU. Significance: Despite the observed differences, the study suggests that a single tri-axial accelerometer could be a feasible tool for continuous remote monitoring of lumbar mobility and velocity. This finding has potential implications for the management of LBP, enabling more accessible and cost-effective monitoring of lumbar mobility in both clinical and research settings.

Quantifying lumbar sagittal plane kinematics using a wrist-worn inertial measurement unit.

Wearable sensors like inertial measurement units (IMUs), and those available as smartphone or smartwatch applications, are increasingly used to quantify lumbar mobility. Currently, wearable sensors have to be placed on the back to measure lumbar mobility, meaning it cannot be used in unsupervised environments. This study aims to compare lumbar sagittal plane angles quantified from a wrist-worn against that of a lumbar-worn sensor. Twenty healthy participants were recruited. An IMU was placed on the right wrist and the L3 spinal level. Participants had to position their right forearm on their abdomen, parallel to the floor. Three sets of three consecutive repetitions of flexion, and extension were formed. Linear mixed models were performed to quantify the effect of region (lumbar vs. wrist) on six outcomes [minimum, maximum, range of motion (ROM) of flexion and extension]. Only flexion ROM was significantly different between the wrist and lumbar sensors, with a mean of 4.54° (95% CI = 1.82°-7.27°). Across all outcomes, the maximal difference between a wrist-worn and lumbar-worn sensor was <8°. A wrist-worn IMU sensor could be used to measure gross lumbar sagittal plane mobility in place of a lumbar-worn IMU. This may be useful for remote monitoring during rehabilitation.

A modern way to teach and practice manual therapy.

BACKGROUND: Musculoskeletal conditions are the leading contributor to global disability and health burden. Manual therapy (MT) interventions are commonly recommended in clinical guidelines and used in the management of musculoskeletal conditions. Traditional systems of manual therapy (TMT), including physiotherapy, osteopathy, chiropractic, and soft tissue therapy have been built on principles such as clinician-centred assessment, patho-anatomical reasoning, and technique specificity. These historical principles are not supported by current evidence. However, data from clinical trials support the clinical and cost effectiveness of manual therapy as an intervention for musculoskeletal conditions, when used as part of a package of care. PURPOSE: The purpose of this paper is to propose a modern evidence-guided framework for the teaching and practice of MT which avoids reference to and reliance on the outdated principles of TMT. This framework is based on three fundamental humanistic dimensions common in all aspects of healthcare: safety, comfort, and efficiency. These practical elements are contextualised by positive communication, a collaborative context, and person-centred care. The framework facilitates best-practice, reasoning, and communication and is exemplified here with two case studies. METHODS: A literature review stimulated by a new method of teaching manual therapy, reflecting contemporary evidence, being trialled at a United Kingdom education institute. A group of experienced, internationally-based academics, clinicians, and researchers from across the spectrum of manual therapy was convened. Perspectives were elicited through reviews of contemporary literature and discussions in an iterative process. Public presentations were made to multidisciplinary groups and feedback was incorporated. Consensus was achieved through repeated discussion of relevant elements. CONCLUSIONS: Manual therapy interventions should include both passive and active, person-empowering interventions such as exercise, education, and lifestyle adaptations. These should be delivered in a contextualised healing environment with a well-developed person-practitioner therapeutic alliance. Teaching manual therapy should follow this model.

Rethinking narratives about youth experiencing homelessness: The influence of self-determined motivation and peer relations on coping.

Using the cognitive appraisal theory of coping and the self-determination theory of motivation, we examined the shared variance of motivational orientations, attachment relationships, and gender on adaptive and maladaptive coping among youth experiencing homelessness. Several scales including The Global Motivation Scale (assessing motivational orientations; i.e., autonomous and controlled motivation), the Brief Cope (adaptive and maladaptive coping strategies), and the Inventory of Parent and Peer Attachment (self-perceptions of relationships with mothers, fathers, and peers) were administered to 102 youth aged between 16 and 24 (Mage = 20, SD = 2.07) years recruited from an evening program for youth experiencing homelessness in Montreal, Canada. Autonomous motivation was positively associated with engagement in effective coping strategies, while controlled motivation was positively linked to maladaptive coping. Moderation analyses were used to examine whether gender and relationships with attachment figures moderated the relationship between motivation and coping. A significant main effect of peer attachment on adaptive coping emerged, in which greater peer attachment was related to more adaptive coping among the youth. No interaction effects resulted. Although no significant moderating effects were associated with essential relationships and gender, further research implementing a more nuanced approach to assessing the interaction between these constructs may be warranted. Overall, the findings highlight the importance of intervention programs for youth experiencing homelessness, that focus on enhancing autonomous motivation and utilizing peer support to optimize the use of adaptive coping strategies.

Reliability of the Commonly Used and Newly-Developed Autism Measures.

PURPOSE: The aim of the present study was to compare scale and conditional reliability derived from item response theory analyses among the most commonly used, as well as several newly developed, observation, interview, and parent-report autism instruments. METHODS: When available, data sets were combined to facilitate large sample evaluation. Scale reliability (internal consistency, average corrected item-total correlations, and model reliability) and conditional reliability estimates were computed for total scores and for measure subscales. RESULTS: Generally good to excellent scale reliability was observed for total scores for all measures, scale reliability was weaker for RRB subscales of the ADOS and ADI-R, reflecting the relatively small number of items for these measures. For diagnostic measures, conditional reliability tended to be very good (> 0.80) in the regions of the latent trait where ASD and non-ASD developmental disability cases would be differentiated. For parent-report scales, conditional reliability of total scores tended to be excellent (> 0.90) across very wide ranges of autism symptom levels, with a few notable exceptions. CONCLUSIONS: These findings support the use of all of the clinical observation, interview, and parent-report autism symptom measures examined, but also suggest specific limitations that warrant consideration when choosing measures for specific clinical or research applications.

What is manipulation? A new definition.

BACKGROUND: Definitions are important in healthcare. Unfortunately, problems can be found withall existing definitions of manipulation. METHODS: This paper derives a set of eligibility criteria from prior definitions of manipulation to inform what should (and should not) be incorporated within a valid definition. These criteria were then used to select components from currently available empirical data to create a new definition. RESULTS: The resulting definition of manipulation is: "Separation (gapping) of opposing articular surfaces of a synovial joint, caused by a force applied perpendicularly to those articular surfaces, that results in cavitation within the synovial fluid of that joint." The corresponding definition for the mechanical response of a manipulation is: "Separation (gapping) of opposing articular surfaces of a synovial joint that results in cavitation within the synovial fluid of that joint." In turn, the action of a manipulation can be defined as: "A force applied perpendicularly to the articular surfaces." CONCLUSIONS: We believe these definitions to be valid (derived from and consistent with all available empirical data), complete (containing all necessary components), minimally sufficient (minimal redundancy, and sufficient to distinguish manipulation from other physical interventions), and robust (able to withstand important limitations embodied within sensible eligibility criteria). It is hoped that the simplicity and clarity of these definitions, and the transparency of their formation, will encourage their wide adoption in clinical, research, educational and professional settings.

The role of post-trauma stress symptoms in the development of chronic musculoskeletal pain and disability: A systematic review.

BACKGROUND AND OBJECTIVE: Traumatic injuries are amongst the leading causes of death and disability in the world across all age groups. This systematic review aimed to (1) describe the role of post-traumatic stress symptoms (PTSS) on the development of chronic pain and/or pain-related disability following musculoskeletal trauma and (2) report pain and or pain-related disability by injury severity/type. DATABASE AND DATA TREATMENT: Electronic databases were searched, from inception to 31 November 2021 and updated on 10 May 2022, to identify studies in which: participants were adults aged ≥16 years sustaining any traumatic event that resulted in one or more musculoskeletal injuries; an outcome measure of PTSS was used within 3 months of a traumatic event; the presence of pain and/or pain-related disability was recorded at a follow-up of 3 months or more. Two reviewers independently screened papers and assessed the quality of included studies. RESULTS: Eight studies were included. Owing to between-study heterogeneity, the results were synthesized using a narrative approach. Five studies investigated the relationship between PTSS and pain. Participants with PTSS were more likely to develop persistent pain for at least 12 months post-injury. Six studies assessed the relationship between PTSS and pain-related disability. The results suggest that patients with PTSS had significantly higher disability levels for at least 12 months post-injury. CONCLUSION: Findings from this comprehensive systematic review support a clear relationship between PTSS post-injury and future pain/disability, with the potential importance of certain PTSS clusters (hyper-arousal and numbing). SIGNIFICANCE: The findings of this systematic review indicate an association between PTSS reported within 3 months of a traumatic musculoskeletal injury and the development of longer-term pain and disability. The PTSS clusters of 'hyper-arousal' and 'numbing' appear to be of particular importance in this relationship. PROSPERO REGISTRATION NUMBER: CRD42021285243.

Why is the prevailing model of joint manipulation (still) incorrect?

For manipulation, this paper addresses arguably the most fundamental question that can be asked about any therapeutic intervention: what is it? In answering this question, this paper presents the prevailing model of joint manipulation (of Sandoz) and explains why this influential model is fundamentally flawed. The early research on 'joint cracking' that led to the development of this model is described in chronological order, alongside how this research was misinterpreted, which gave rise to the model's flaw. Of concern, the flaw in this model makes worrying predictions that could lead to dangerous clinical decisions. Understandably, these predictions have attracted criticism over the use of manipulation as a therapeutic intervention. A corrected model, first published by Evans and Breen more than 15 years ago, is then presented and explained. Unlike the flawed model, this corrected model makes predictions in line with all available empirical data and additionally provides reassuring answers to critics. Many current definitions of manipulation have inherited the flaw from Sandoz's model. Hence, a better, empirically derived definition, consistent with the corrected model, is now required.

Pain-related fear of movement dynamics in individuals with and without low back pain participating in weightlifting and/or powerlifting training.

PURPOSE: Pain-free adults in the general population have been shown to possess unhelpful beliefs that certain movements and postures are harmful to the spine, potentially reinforcing fear-avoidance behaviour. Whether such beliefs occur in individuals undertaking regular powerlifting (PL) and Olympic weightlifting (OWL) training is unclear. METHODS: In a cross-sectional study design, 67 individuals who participate in OWL and PL training completed an online survey. Demographic characteristics, training history, and self-reported perceptions of harm, on the 40-item Photograph Series of Daily Activities shortened electronic version (PHODA-SeV), were collected. After removing collinear variables, 13 items were entered into a network analysis, in which the adjusted correlations between items, and the centrality indices of each item (i.e., the degree of connection with other symptoms in the network) were quantified. RESULTS: Twenty-one (31.3%) participants had LBP symptoms. The pairwise correlations with the greatest magnitudes were between images of 'leg stretch' and 'jumping' (0.32 [95%CI 0.08 to 0.45]) and two images depicting ironing (0.32 [95%CI 0.05 to 0.54]) respectively. The three most Central (connected) items were 'stair ascend', 'walking with groceries', and 'mopping with spine flexion'. CONCLUSIONS: For individuals training in OWL and PL, images reflecting walking, rather than those depicting high spinal flexion angle, had greater connectivity to other activity items. In addition, the strongest correlations were not between items reflecting high spinal flexion angle. Future studies that investigate the relationship between different intensities of OWL and PL training and the dynamics of pain-related fear are warranted.

Is exercise/physical activity effective at reducing symptoms of post-traumatic stress disorder in adults - A systematic review.

Background: Exercise has been used to manage symptoms of post-traumatic stress disorder (PTSD). The effect of exercise on PTSD outcomes has been previously explored in several studies. However, it still remains unclear what type of exercise/physical activity, intensity and duration is most effective for reducing symptoms of PTSD. A systematic review was conducted to determine which forms of exercise or physical activity have the greatest effect on PTSD outcome scores including an evaluation of exercise frequency and volume. Methods: The following electronic databases were systematically searched from January 1980 to June 2021: MEDLINE, PsycINFO, PubMed and Web of Science. Inclusion criteria were studies investigating adults aged 18 or over, reporting the effect of exercise and physical activities on PTSD symptom outcome scores. Two reviewers independently extracted information on study characteristics, exposure and outcomes. In total of 3,217 articles were screened and 23 full text articles further assessed, with 13 RCT's included in the review, covering seven exercise/physical activity interventions. The study protocol was registered prospectively with PROSPERO (CRD42021255131). Results: Thirteen studies from four countries involving a total of 531 patients were selected for inclusion. Individual forms of exercise/physical activity examined showed some effect on reducing PTSD symptoms but combined exercises (resistance training, aerobic, strength and yoga) administered over a 12 week period, three times a week for 30-60 min showed greater effects on PTSD symptoms. Conclusion: The limited evidence suggests that a combined exercise intervention has the best evidence for a having a beneficial effect on PTSD symptoms. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=255131.

Estimating Risk of Chronic Pain and Disability Following Musculoskeletal Trauma in the United Kingdom.

Importance: Serious traumatic injury is a leading cause of death and disability globally, with most survivors known to develop chronic pain. Objective: To describe early variables associated with poor long-term outcome for posttrauma pain and create a clinical screening tool for this purpose. Design, Setting, and Participants: This was a prospective cohort study at a major trauma center hospital in England. Recruitment commenced in December 2018 and ceased in March 2020. Participants were followed up for 12 months. Patients aged 16 years or older who were hospitalized because of acute musculoskeletal trauma within the preceding 14 days were included. Data were analyzed from March to December 2021. Exposure: Acute musculoskeletal trauma requiring admittance to a major trauma center hospital. Main Outcomes and Measures: A poor outcome was defined as Chronic Pain Grade II or higher and measured at both 6 months (primary time point) and 12 months. A broad range of candidate variables potentially associated with outcomes were used, including surrogates for pain mechanisms, quantitative sensory testing, and psychosocial factors. Univariable models were used to identify the variables most likely to be associated with poor outcome, which were entered into multivariable models. A clinical screening tool (nomogram) was derived from 6-month results. Results: In total, 1590 consecutive patients were assessed for eligibility, of whom 772 were deemed eligible and 124 (80 male [64.5%]; mean [SD] age, 48.9 [18.8] years) were recruited. At 6 months, 19 of 82 respondents (23.2%) reported a good outcome, whereas at 12 months 27 of 44 respondents (61.4%) reported a good outcome. At 6 months on univariable analysis, an increase in total posttraumatic stress symptoms (odds ratio [OR], 2.09; 95% CI, 1.33-3.28), pain intensity average (OR, 2.87; 95% CI, 1.37-6.00), number of fractures (OR, 2.79; 95% CI, 1.02-7.64), and pain extent (OR, 4.67; 95% CI, 1.57-13.87) were associated with worse outcomes. A multivariable model including those variables had a sensitivity of 0.93, a specificity of 0.54, and C-index of 0.92. Conclusions and Relevance: A poor long-term pain outcome from musculoskeletal traumatic injuries may be estimated by measures recorded within days of injury. These findings suggest that posttraumatic stress symptoms, pain spatial distribution, perceived average pain intensity, and number of fractures are good candidates for a sensitive multivariable model and derived clinical screening tool.

How to gain evidence for causation in disease and therapeutic intervention: from Koch's postulates to counter-counterfactuals.

Researchers, clinicians, and patients have good reasons for wanting answers to causal questions of disease and therapeutic intervention. This paper uses microbiologist Robert Koch's pioneering work and famous postulates to extrapolate a logical sequence of evidence for confirming the causes of disease: association between individuals with and without a disease; isolation of causal agents; and the creation of a counterfactual (demonstrating that an agent is sufficient to reproduce the disease anew). This paper formally introduces counter-counterfactuals, which appear to have been used, perhaps intuitively, since the time of Koch and possibly earlier. An argument is presented that counter-counterfactuals (disease-preventers) are a useful tool for identifying necessary causes of disease, and sometimes must be used in place of isolation which is not always possible. In addition, a logical sequence of causal evidence for a therapeutic intervention is presented: creating a counterfactual (demonstrating that the intervention is sufficient to change the natural course of a disease), comparisons between subjects in receipt of treatment versus those who are not (typically within a randomised controlled trial, which can quantify effects of intervention), and counter-counterfactuals (treatment-preventers, which can identify the intervention's mechanisms of action).

Does Pain Extent Predict Ongoing Pain and Disability in Patients with Chronic Whiplash-Associated Disorders?

This study investigates whether baseline pain extent, extracted from an electronic pain drawing, is an independent predictive factor of pain and disability measured 1 year and 2 years later in people with chronic WAD. Participants completed questionnaires assessing neck pain intensity, disability via the Neck Disability Index (NDI), psychological features, and work ability. Participants also completed electronic pain drawings from which their pain extent was extracted. A two-step modelling approach was undertaken to identify the crude and adjusted association between pain extent and NDI measured at 1-year and 2-year follow-ups. A total of 205 participants were included in the analysis. The univariate analysis showed that pain extent was significantly associated with the NDI score at the 1-year (p = 0.006, 95% CI: 0.159-0.909) and 2-year (p = 0.029, 0.057-0.914) follow-ups. These associations were not maintained when we introduced perceived disability, psychological health, and work ability into the model after 1 year (p = 0.56, 95%CI: -0.28-0.499) and 2 years (p = 0.401, -0.226-0.544). Pain extent, as an independent factor, was significantly associated with perceived pain and disability in patients with chronic WAD for up to 2 years. This association was masked by neck disability, psychological health, and work ability.

The science of humanity and the humanity of science: Perspectives on Ed Zigler's contributions to developmental psychopathology and the study of all children.

We present this article as a testament to Ed Zigler's commitment to science in the service of humanity and to policy based on conceptually compelling theory and methodologically rigorous science. In doing so, we highlight ways that Ed's universal and inclusive developmental world view, early training as a behaviorist, exacting scientific standards, concern for others, and appreciation of his own roots and upbringing all transformed the way that many different groups of people of all ages and backgrounds are studied, viewed, and intervened with by researchers, policy makers, and society at large. Ed's narrative of development rather than defect, universality rather than difference, and holistic rather than reductionist continues to compel us in the quest for a kinder, more inclusive, and enabling society. Conversely, Ed's behaviorist training as a graduate student also influenced him throughout his career and was essential to his career-long commitment to systemic action in the service of improving the lives of others. We cite the lessons that we, as his descendants, learned from Ed and apply them to our own areas of research with populations that Ed did not study, but had considerable interest in - persons with autism spectrum disorder and Indigenous youth.

A novel metric of reliability in pressure pain threshold measurement.

The inter-session Intraclass Correlation Coefficient (ICC) is a commonly investigated and clinically important metric of reliability for pressure pain threshold (PPT) measurement. However, current investigations do not account for inter-repetition variability when calculating inter-session ICC, even though a PPT measurement taken at different sessions must also imply different repetitions. The primary aim was to evaluate and report a novel metric of reliability in PPT measurement: the inter-session-repetition ICC. One rater recorded ten repetitions of PPT measurement over the lumbar region bilaterally at two sessions in twenty healthy adults using a pressure algometer. Variance components were computed using linear mixed-models and used to construct ICCs; most notably inter-session ICC and inter-session-repetition ICC. At 70.1% of the total variance, the source of greatest variability was between subjects ([Formula: see text] = 222.28 N2), whereas the source of least variability (1.5% total variance) was between sessions ([Formula: see text] = 4.83 N2). Derived inter-session and inter-session-repetition ICCs were 0.88 (95%CI: 0.77 to 0.94) and 0.73 (95%CI: 0.53 to 0.84) respectively. Inter-session-repetition ICC provides a more conservative estimate of reliability than inter-session ICC, with the magnitude of difference being clinically meaningful. Quantifying individual sources of variability enables ICC construction to be reflective of individual testing protocols.

Developmental Perspectives on the Study of Persons with Intellectual Disability.

Developmental approaches provide inclusive, universal, and methodologically rigorous frameworks for studying persons with intellectual disability (ID). This is an exceptionally heterogeneous group with regard to etiology, genotype, and phenotype that simply shares the traditional diagnostic criteria, typically a score of two standard deviations below the population mean of 100 on standardized IQ tests and deficits in adaptive behavior. We trace the foundational, conceptual, and methodological roots of developmental approaches and highlight ways that these and more recent iterations continue to be central to advances in the increasingly nuanced study of persons with ID. This work is premised on the consideration of specific etiological groupings and subgroupings across and between different domains of functioning within the context of familial and complex environments throughout the life span. We highlight the potential contributions of advances in behavioral methodologies, genomics, and neuroscience when considered within universal and hierarchic frameworks based on development.

A Review of the Default Mode Network in Autism Spectrum Disorders and Attention Deficit Hyperactivity Disorder.

Functional magnetic resonance imaging (fMRI) has been widely used to examine the relationships between brain function and phenotypic features in neurodevelopmental disorders. Techniques such as resting-state functional connectivity (FC) have enabled the identification of the primary networks of the brain. One fMRI network, in particular, the default mode network (DMN), has been implicated in social-cognitive deficits in autism spectrum disorders (ASD) and attentional deficits in attention deficit hyperactivity disorder (ADHD). Given the significant clinical and genetic overlap between ASD and ADHD, surprisingly, no reviews have compared the clinical, developmental, and genetic correlates of DMN in ASD and ADHD and here we address this knowledge gap. We find that, compared with matched controls, ASD studies show a mixed pattern of both stronger and weaker FC in the DMN and ADHD studies mostly show stronger FC. Factors such as age, intelligence quotient, medication status, and heredity affect DMN FC in both ASD and ADHD. We also note that most DMN studies make ASD versus ADHD group comparisons and fail to consider ASD+ADHD comorbidity. We conclude, by identifying areas for improvement and by discussing the importance of using transdiagnostic approaches such as the Research Domain Criteria (RDoC) to fully account for the phenotypic and genotypic heterogeneity and overlap of ASD and ADHD.

Domains of the autism phenotype, cognitive control, and rumination as transdiagnostic predictors of DSM-5 suicide risk.

Suicide is a global health problem affecting both normative and clinical populations. Theoretical models that examine mechanisms underlying suicide risk across heterogeneous samples are needed. The present study explored core characteristics associated with autism spectrum disorder (ASD), a sub-population at high risk of suicide, as well as two dimensional cognitive constructs, as potential transdiagnostic predictors of suicidal ideation in a clinically diverse sample. Participants (n = 1851, 62% female) aged 18 to 89 years completed online questionnaires assessing: social communication difficulties; insistence on sameness; cognitive control; and rumination. Forty-three percent of participants reported the presence of at least one neurodevelopmental or neuropsychiatric disorder. One third of the sample reported some suicidal ideation (SI), and 40 percent met the threshold for concern for depression. All hypothesized constructs were associated with SI and depression and, with the exception of rumination, contributed significantly to SI. Participants reporting SI returned significantly higher social communication difficulties and insistence on sameness, and lower levels of cognitive control than those reporting no-SI. The study was limited by the use of a cross-sectional sample assessed with self-report measures. All diagnoses were self-reported and the study was additionally limited by the use of a single item indicator of suicidal ideation. These findings support a role for constructs associated with the ASD phenotype and associated broad cognitive domains as potential risk factors underlying suicidal ideation in a large clinically diverse sample. Our findings suggest directions for future longitudinal research studies, along with specific targets for suicide prevention and clinical practice.

Visual Function and Macular Carotenoid Changes in Eyes with Retinal Drusen-An Open Label Randomized Controlled Trial to Compare a Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula.

PURPOSE: To compare the changes in visual and ocular parameters in individuals with retinal drusen who were treated with two commercially available nutritional supplements. METHODS: An open-label, single-center, randomized, parallel-treatment with an observational control group design was utilized. The treatment groups included individuals with fine retinal drusen sub-clinical age-related macular degeneration (AMD), while the control group consisted of ocular normal individuals. The treatment groups were randomly assigned to the micronized lipid-based carotenoid supplement, Lumega-Z (LM), or the PreserVision Age-Related Eye Disease Study 2 (AREDS-2) soft gel (PV). Visual performance was evaluated using the techniques of visual acuity, dark adaptation recovery and contrast sensitivity, at baseline, three months, and six months. Additionally, the macular pigment optical density (MPOD) was measured. The control group was not assigned any carotenoid supplement. The right eye and left eye results were analyzed separately. RESULTS: Seventy-nine participants were recruited for this study, of which 68 qualified and 56 participants had useable reliable data. Of the individuals who completed this study, 25 participants belonged to the LM group, 16 belonged to the PV group, and 15 to the control group. The LM group demonstrated statistically significant improvements in contrast sensitivity function (CSF) in both eyes at six months (p < 0.001). The LM group displayed a positive linear trend with treatment time in CSF (p < 0.001), with benefits visible after just three months of supplementation. Although there was a trend showing improvement in CSF in the PV group, the change was not significant after a Bonferroni-corrected p-value of p < 0.00625. Visual acuity, dark adaptation recovery and MPOD did not significantly improve in either treatment groups. CONCLUSION: The LM group demonstrated greater and faster benefits in visual performance as measured by CSF when compared to the PV group. This trial has been registered at clinicaltrials.gov (NCT03946085).