Clinical Anthropometrics and Body Composition from 3-Dimensional Optical Imaging.

The body size and composition assessment is commonly included in the routine management of healthy athletes as well as of different types of patients to personalize the training or rehabilitation strategy. The digital anthropometric analyses described in the following protocol can be performed with recently introduced systems. These new tools and approaches have the potential to be widely used in clinical settings because they are very simple to operate and enable the rapid collection of accurate and reproducible data. One system consists of a rotating platform with a weight measurement plate, three infrared cameras, and a tablet built into a tower, while the other system consists of a tablet mounted on a holder. After image capture, the software of both systems generates a de-identified three-dimensional humanoid avatar with associated anthropometric and body composition variables. The measurement procedures are simple: a subject can be tested in a few minutes and a comprehensive report (including the three-dimensional scan and body size, shape, and composition measurements) is automatically generated.

Epidemiology of Non-Contact Muscle Injuries in the Italian Male Elite Under-19 Football (Soccer) Championship.

BACKGROUND: While extensive research exists on muscle injuries among adult football players, a notable gap persists in studies concerning younger footballers. The aim of the current study is to provide epidemiological data on the characteristics of time-loss muscle injuries in young football players participating in the Italian Under-19 male elite Championship ("Primavera 1"). RESULTS: Conducted as a multicentre, prospective, observational cohort study, this research gathered injury data from the 2022-23 season across 14 of the 18 Clubs in the first Italian Under-19 championship. The cohort comprised 391 players with a mean age (± standard deviation) of 18.0 ± 0.4 years. A total of 479 injuries were reported, resulting in 14,231 days of activity lost. Of these, muscle injuries were 209 (44%), accounting for 4,519 (32%) days lost. Overall muscle injuries incidence was 1.82/1000 hours, with a mean injury burden of 39.4 days lost/1000 hours. Almost all muscle injuries (206 out of 209: 98.5%) occurred in hamstrings, quadriceps, adductors, calf and iliopsoas. Hamstrings injuries were the most burdensome (18.8 days lost/1000 hours) accounting for nearly half of all days lost due to muscle injuries. Incidence and burden of adductors injuries (0.25 injuries and 4.1 days lost/1000 hours, respectively) were found to be comparable to calf injuries (0.24 injuries and 4.7 days lost/1000 hours, respectively). Iliopsoas injuries accounted for a noteworthy portion of the total, with an injury incidence of 0.16/1000 hours and a burden of 3.3 days lost/1000 hours. Injuries with myo-tendinous or myo-aponeurotic involvement demonstrated delayed return-to-football compared to those without such involvement (35.6 vs. 18.5 days, p < 0.0001). CONCLUSIONS: The study highlighted a peculiar distribution of non-contact muscle injuries among elite young football players. While hamstring injuries were confirmed as the most burdensome, incidence and burden of adductors and calf injuries were found to be similar. A significant incidence and burden of iliopsoas injuries were observed. These findings suggest potential implementations for targeted injury prevention strategies in the Italian male elite Under-19 football Championship.

Equations for smartphone prediction of adiposity and appendicular lean mass in youth soccer players.

Digital anthropometry by three-dimensional optical imaging systems and smartphones has recently been shown to provide non-invasive, precise, and accurate anthropometric and body composition measurements. To our knowledge, no previous study performed smartphone-based digital anthropometric assessments in young athletes. The aim of this study was to investigate the reproducibly and validity of smartphone-based estimation of anthropometric and body composition parameters in youth soccer players. A convenience sample of 124 male players and 69 female players (median ages of 16.2 and 15.5 years, respectively) was recruited. Measurements of body weight and height, one whole-body Dual-Energy X-ray Absorptiometry (DXA) scan, and acquisition of optical images (performed in duplicate by the Mobile Fit app to obtain two avatars for each player) were performed. The reproducibility analysis showed percent standard error of measurement values < 10% for all anthropometric and body composition measurements, thus indicating high agreement between the measurements obtained for the two avatars. Mobile Fit app overestimated the body fat percentage with respect to DXA (average overestimation of + 3.7% in males and + 4.6% in females), while it underestimated the total lean mass (- 2.6 kg in males and - 2.5 kg in females) and the appendicular lean mass (- 10.5 kg in males and - 5.5 kg in females). Using data of the soccer players, we reparameterized the equations previously proposed to estimate the body fat percentage and the appendicular lean mass and we obtained new equations that can be used in youth athletes for body composition assessment through conventional anthropometrics-based prediction models.

Cytomegalovirus colitis unmasking human immunodeficiency virus infection as a cause of IgA vasculitis.

BACKGROUND: Human immunodeficiency virus (HIV) has a protean clinical picture, in rare instances manifesting as systemic autoimmune disorders such as vasculitides. HIV-induced autoimmune diseases often do not respond well to systemic immunosuppressive therapy. Opportunistic infections may occur in patients with either acquired immunodeficiency syndrome (AIDS) or heavy immunosuppressive treatment, and can further complicate the clinical presentation. CASE PRESENTATION: A patient presenting with immunoglobulin A (IgA) vasculitis (IgAV) with treatment-refractory purpuric skin rash and suspect intestinal vasculitis was discovered to have AIDS. HIV was the trigger of IgAV, and cytomegalovirus (CMV) colitis mimicked intestinal vasculitis. Antiretroviral treatment improved both CMV colitis and the control of the autoimmune disease. CONCLUSIONS: An autoimmune disease relapsing despite adequate immunosuppressive treatment and/or the presence of recurrent severe opportunistic infections may be clues to an underlying HIV infection.

Reproducibility and Accuracy of the Radiofrequency Echographic Multi-Spectrometry for Femoral Mineral Density Estimation and Discriminative Power of the Femoral Fragility Score in Patients with Primary and Disuse-Related Osteoporosis.

We aimed to investigate the reproducibility and accuracy of Radiofrequency Echographic Multi-Spectrometry (REMS) for femoral BMD estimation and the reproducibility and discriminative power of the REMS-derived femoral fragility score. 175 patients with primary and disuse-related osteoporosis were recruited: one femoral Dual-energy X-ray Absorptiometry (DXA) scan and two femoral REMS scans were acquired. No significant test-retest differences were observed for all REMS-derived variables. The diagnostic concordance between DXA and REMS was 63% (Cohen's kappa = 0.31) in patients with primary osteoporosis and 13% (Cohen's kappa: -0.04) in patients with disuse-related osteoporosis. No significant difference was observed between REMS and DXA for either femoral neck BMD (mean difference between REMS and DXA: -0.015 g/cm2) or total femur BMD (mean difference: -0.004 g/cm2) in patients with primary osteoporosis. Significant differences between the two techniques were observed in patients with disuse-related osteoporosis (femoral neck BMD difference: 0.136 g/cm2; total femur BMD difference: 0.236 g/cm2). Statistically significant differences in the fragility score were obtained between the fractured and non-fractured patients for both populations. In conclusion, REMS showed excellent test-retest reproducibility, but the diagnostic concordance between DXA and REMS was between minimal and poor. Further studies are required to improve the REMS-derived estimation of femoral BMD.

Digital Anthropometry for Body Circumference Measurements: European Phenotypic Variations throughout the Decades.

This review summarizes body circumference-based anthropometrics that are in common use for research and in some cases clinical application. These include waist and hip circumference-based central body indices to predict cardiometabolic risk: waist circumference, waist-to-hip ratio, waist-to-height ratio, waist-to-thigh ratio, body adiposity index, a body shape index (ABSI), hip index (HI), and body roundness index (BRI). Limb circumference measurements are most often used to assess sarcopenia and include: thigh circumference, calf circumference, and mid-arm circumference. Additionally, this review presents fascinating recent developments in optic-based imaging technologies that have elucidated changes over the last decades in average body size and shape in European populations. The classical apple and pear shape concepts of body shape difference remain useful, but novel and exciting 3-D optical "e-taper" measurements provide a potentially powerful new future vista in anthropometrics.

DXA-Based Detection of Low Muscle Mass Using the Total Body Muscularity Assessment Index (TB-MAXI): A New Index with Cutoff Values from the NHANES 1999-2004.

The aims of this study were to investigate age-related changes in total body skeletal muscle mass (TBSMM) and the between-limb asymmetry in lean mass in a large sample of adults. Demographic, anthropometric, and DXA-derived data of National Health and Nutrition Examination Survey participants were considered. The sample included 10,014 participants of two ethnic groups (Caucasians and African Americans). The age-related decline of TBSMM absolute values was between 5% and 6% per decade in males and between 4.5% and 5.0% per decade in females. The adjustment of TBSMM for body surface area (TB-MAXI) showed that muscle mass peaked in the second decade and decreased progressively during the subsequent decades. The following thresholds were identified to distinguish between low and normal TB-MAXI: (i) 10.0 kg/m2 and 11.0 kg/m2 in Caucasian and African American females; and (ii) 12.5 kg/m2 and 14.5 kg/m2 in Caucasian and African American males. The lean asymmetry indices were higher for the lower limbs compared with the upper limbs and were higher for males compared with females. In conclusion, the present study proposes the TB-MAXI and lean asymmetry index, which can be used (and included in DXA reports) as clinically relevant markers for muscle amount and lean distribution.

Preoperative Physical Activity Predicts Surgical Outcomes Following Lung Cancer Resection.

OBJECTIVES: To assess whether preoperative levels of physical activity predict the incidence of post-operative complications following anatomical lung resection. METHODS: Levels of physical activity (daily steps) were measured for 15 consecutive days using pedometers in 90 consecutive patients (prior to admission). Outcomes measured were cardiac and respiratory complications, length of stay, and 30-day re-admission rate. RESULTS: A total of 78 patients' datasets were analysed (12 patients were excluded due to non-compliance). Based on steps performed they were divided into quartiles; 1 (low physical activity) to 4 (high physical activity). There were no significant differences in age, smoking history, COPD, BMI, percentage predicted FEV1 and KCO and cardiovascular risk factors between the groups. There were significantly fewer total complications in quartiles 3 and 4 (high physical activity) compared to quartiles 1 and 2 (low physical activity) (8 vs 22; P = .01). There was a trend (P > .05) towards shorter hospital length of stay in quartiles 3 and 4 (median values of 4 and 5 days, respectively) compared to quartiles 1 and 2 (6 days for both groups). CONCLUSIONS: Preoperative physical activity can help to predict postoperative outcome and can be used to stratify risk of postoperative complications and to monitor impact of preoperative interventions, ultimately improving short term outcomes.

Quantitative assessment of volumetric muscle loss: Dual-energy X-ray absorptiometry and ultrasonography.

The generalized skeletal muscle disorder that involves (in elderly subjects) the progressive loss of muscle mass and function has been defined sarcopenia, whereas the rapid-onset (traumatic or surgical) and focal (unilateral) loss of skeletal muscle with resultant functional impairment has been defined volumetric muscle loss. Different tools and approaches are commonly used in the clinical settings to quantify the loss of muscle or lean mass and to assess the consequent motor impairment. This review describes the technical principles and provides a summary of the main parameters that can be obtained to assess lean mass (and its distribution) or muscle size (and its structure) through the two imaging techniques most easily accessible and therefore frequently adopted in the clinical practice: dual-energy X-ray absorptiometry and muscle ultrasonography.

Effects of neuromuscular electrical stimulation therapy on physical function in patients with COVID-19 associated pneumonia: Study protocol of a randomized controlled trial.

PURPOSE: Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients during and/or after intensive care unit (ICU) stay. The overall objective of this study is to evaluate the NMES effectiveness to counteract the post-ICU impairment in physical function of COVID-19 patients. The specific aim of this manuscript is to describe the study design, protocol, content of interventions, primary and secondary outcomes and to discuss the clinical rehabilitation impact of the expected experimental results. METHODS: This prospective, randomized, controlled, parallel-group, single-blind trial will include 80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure. Patients are randomized to a control group (routine physical therapy for 3 weeks) or a NMES group (routine physical therapy plus NMES of quadriceps and gastrocnemius muscles for 3 weeks). The primary outcome is physical performance assessed through the Short Physical Performance Battery (SPPB). Secondary outcomes include independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance. The SPBB and walking performance are assessed once (after the intervention), while all other outcomes are assessed twice (before and after the intervention). CONCLUSION: NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive. Therefore, proving the effectiveness of NMES therapy for physical and muscle function in COVID-19 patients could support its systematic incorporation in post-ICU rehabilitation protocols of patients presenting with post-intensive care syndrome.

DXA-Derived Adiposity and Lean Indices for Management of Cardiometabolic and Musculoskeletal Frailty: Data Interpretation Tricks and Reporting Tips.

The proper assessment and follow-up of obesity and sarcopenia are relevant for the proper management of the complications of cardiometabolic and musculoskeletal frailty. A total body dual-energy X-ray absorptiometry (DXA) scan should be systematically incorporated in the rehabilitative routine management of patients with obesity and sarcopenia. In the former patients, the total body DXA can be used to assess the fat tissue amount and distribution, while in the latter patients, it can be used to quantify the reduction of appendicular lean mass and to investigate the inter-limb lean mass asymmetry. This tutorial article provides an overview of different DXA-derived fat and lean indices and describes a step-by-step procedure on how to produce a complete DXA report. We suggest that the systematic incorporation of these indices into routine examinations of the patients with obesity and sarcopenia can be useful for identifying the patients at risk for cardiometabolic and neuromuscular impairment-related comorbidities and for evaluating the effectiveness of pharmacological and rehabilitative interventions.

Diagnostic performance of the Strength and Pain Assessment (SPA) score for non-contact muscle injury screening in male soccer players.

OBJECTIVES: The aims of this study were to develop a clinical-feature based scoring system for muscle injury screening and to assess its diagnostic accuracy when large number of injuries are suspected. METHODS: A prospective diagnostic accuracy study was performed according to the Standards for Reporting of Diagnostic Accuracy (STARD) criteria. The diagnostic accuracy of the Strength and Pain Assessment (SPA) score (index test) was assessed in relation to muscle ultrasonography (reference standard). A large (n = 175) number of male soccer players met the inclusion/exclusion criteria: clinical assessment (i.e., evaluation of pain onset modality, location, distribution, impact on performance, and manual muscle strength testing) and ultrasonography were performed in all players after 48 hours from the sudden or progressive onset of muscle pain during or after a soccer competition. RESULTS: 91 of 175 cases (52%) were classified as functional muscle disorders, while signs of muscle tear were observed in the remaining 84 of 175 (48%) cases that were classified as structural muscle injuries. The median (1st - 3rd quartile) value of the SPA score was significantly (P < 0.001) lower in the functional disorder group [9 (9-10)] compared to the structural injury group [12 (12-13)]. The area under the Receiver Operating Characteristic curve for different cutoff points of the SPA score was 0.977 (95% confidence intervals: 0.957-0.998) and the optimal cutoff value of the SPA score providing the greatest sensitivity and specificity (respectively, 99% and 89%) was 11. CONCLUSION: This study found that the SPA score has high diagnostic accuracy for structural muscle injuries and could be used as a valid screening tool in soccer players presenting with sudden or progressive onset of muscle pain during or after a competition.

Characterization of the stimulation output of four devices for focal muscle vibration.

Different devices for mechano-acoustic muscle vibration became available on the market in the last ten years. Although the use of these vibrators is increasing in research and clinical settings, the features of their stimulation output were never described in literature. In this study we aimed to quantify and compare the stimulation output of the four most widespread pneumatic devices for focal muscle vibration available on the market. A piezoelectric pressure sensor was used to measure the pressure profile generated by the four selected devices in the following experimental conditions: i) measurement of the output changes associated with variations of the stimulation amplitude for three stimulation frequencies (100 Hz, 200 Hz, and 300 Hz); ii) measurement of the output changes during a 20-min long stimulation at constant frequency (300 Hz) and amplitude; iii) measurement of the output changes associated with the progressive activation of all stimulation channels at constant frequency (200 Hz) for different amplitudes. The maximum peak-to-peak amplitudes of the pressure waves were in the range 102 mbar - 369 mbar (below the maximum values declared by the different manufacturers). The shape of the pressure waves generated by the four devices was quasi-sinusoidal and asymmetric with respect to the atmospheric pressure. All output features had a remarkable intra- and inter-device variability. Further studies are required to support the technological improvement of the currently available devices and to focus the issues of vibration effectiveness, limitations, proper protocols, modalities of its application and assessment in neuromuscular training and rehabilitation.

Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial.

BACKGROUND: The demand for total hip arthroplasty (THA) is quickly rising given the escalating global incidence of hip osteoarthritis, and it is widely accepted that the post-surgery rehabilitation is key to optimize outcomes. The overall objective of this study is to evaluate the effectiveness of a new telerehabilitation solution, ReHub, for the physical function and clinical outcome improvement following THA. The specific aims of this manuscript are to describe the study design, protocol, content of interventions, and primary and secondary outcomes and to discuss the clinical rehabilitation impact of the expected experimental results. METHODS/DESIGN: This prospective, randomized, controlled, parallel-group trial will include 56 patients who had undergone primary THA. Patients are randomized to a control group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3 weeks of unsupervised home-based rehabilitation) or an experimental group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3 weeks of home-based ReHub-assisted telerehabilitation). The primary outcome is physical performance assessed through the Timed Up-and-Go (TUG) test. Secondary outcomes include independence level, pain intensity, hip disability, hip range of motion, muscle strength, and patient's perception of clinical improvement. DISCUSSION: Proving the clinical and cost-effectiveness of a home-based telerehabilitation program for physical and muscle function following THA could support its systematic incorporation in post-surgical rehabilitation protocols, which should be tailored to the individual and collective needs. TRIAL REGISTRATION: ClinicalTrial.gov NCT04176315 . Registered on 22 November 2019.

Architectural Changes in Superficial and Deep Compartments of the Tibialis Anterior During Electrical Stimulation Over Different Sites.

Electrical stimulation is widely used in rehabilitation to prevent muscle weakness and to assist the functional recovery of neural deficits. Its application is however limited by the rapid development of muscle fatigue due to the non-physiological motor unit (MU) recruitment. This issue can be mitigated by interleaving muscle belly (mStim) and nerve stimulation (nStim) to distribute the temporal recruitment among different MU groups. To be effective, this approach requires the two stimulation modalities to activate minimally-overlapped groups of MUs. In this manuscript, we investigated spatial differences between mStim and nStim MU recruitment through the study of architectural changes of superficial and deep compartments of tibialis anterior (TA). We used ultrasound imaging to measure variations in muscle thickness, pennation angle, and fiber length during mStim, nStim, and voluntary (Vol) contractions at 15% and 25% of the maximal force. For both contraction levels, architectural changes induced by nStim in the deep and superficial compartments were similar to those observed during Vol. Instead, during mStim superficial fascicles underwent a greater change compared to those observed during nStim and Vol, both in absolute magnitude and in their relative differences between compartments. These observations suggest that nStim results in a distributed MU recruitment over the entire muscle volume, similarly to Vol, whereas mStim preferentially activates the superficial muscle layer. The diversity between spatial recruitment of nStim and mStim suggests the involvement of different MU populations, which justifies strategies based on interleaved nerve/muscle stimulation to reduce muscle fatigue during electrically-induced contractions of TA.

Algo-Functional Indexes and Spatiotemporal Parameters of Gait after Sacroiliac Joint Arthrodesis.

Aims of the study were to evaluate the reliability and validity of the Italian version of the Majeed and Iowa questionnaires and to investigate the long-term surgical outcomes following sacroiliac joint arthrodesis. Twenty one patients who underwent a sacroiliac joint arthrodesis and 21 healthy subjects were evaluated. The experimental procedure consisted of gait analysis and a physical activity assessment (in both groups) and of administration of outcome questionnaires and pain assessment (in the patient group). The Majeed and Iowa questionnaires showed excellent reliability, excellent (for the Majeed questionnaire) and good (for the Iowa questionnaire) construct validity, and poor convergent validity (for both questionnaires) relative to walking speed. Most of the patients reported no pain and minimum pain-related disability and their physical activity profile was comparable to healthy controls. Patients showed an impaired walking performance (i.e., they walked slower and using shorter steps) compared with healthy controls. Long-term walking pattern abnormalities following sacroiliac joint arthrodesis may occur despite excellent clinical results. Given their excellent reliability and construct validity, the Majeed and Iowa questionnaires can be used in combination with the assessment of spatiotemporal gait parameters for the prognostic assessment and/or follow-up of surgical patients.

Rectus Femoris Characteristics in Post Stroke Spasticity: Clinical Implications from Ultrasonographic Evaluation.

In stroke survivors, rectus femoris (RF) spasticity is often implicated in gait pattern alterations such as stiff knee gait (SKG). Botulinum toxin type A (BoNT-A) is considered the gold standard for focal spasticity treatment. However-even if the accuracy of injection is crucial for BoNT-A efficacy-instrumented guidance for BoNT-A injection is not routinely applied in clinical settings. In order to investigate the possible implications of an inadequate BoNT-A injection on patients' clinical outcome, we evaluated the ultrasound-derived RF characteristics (muscle depth, muscle thickness, cross-sectional area and mean echo intensity) in 47 stroke survivors. In our sample, we observed wide variability of RF depth in both hemiparetic and unaffected side of included patients (0.44 and 3.54 cm and between 0.25 and 3.16 cm, respectively). Moreover, our analysis did not show significant differences between treated and non-treated RF in stroke survivors. These results suggest that considering the inter-individual variability in RF muscle depth and thickness, injection guidance should be considered for BoNT-A treatment in order to optimize the clinical outcome of treated patients. In particular, ultrasound guidance may help the clinicians in the long-term follow-up of muscle quality.

Cross-cultural adaptation and validation of the Victorian Institute of Sports Assessment for gluteal tendinopathy questionnaire in Italian and investigation of the association between tendinopathy-related disability and pain.

BACKGROUND: The Victorian Institute of Sports Assessment for gluteal tendinopathy (VISA-G) questionnaire has recently been proposed as a condition-specific patient reported outcome measurement tool to assess the tendinopathy-related disability. AIM: The aim was to evaluate the reliability of the Italian version of the VISA-G questionnaire and its construct validity and to investigate the association between tendinopathy-related disability and pain. DESIGN: It consists in a cross-sectional study. SETTING: The location of the study was a university laboratory. POPULATION: We evaluated patients with gluteal tendinopathy (N.=38) and healthy controls (N.=38). METHODS: Subjects were asked to fill the VISA-G questionnaire twice to evaluate its reliability. The construct validity was evaluated by comparing the VISA score with the Oswestry Disability Index score. Moreover, pain intensity, extent and location were also investigated. RESULTS: The VISA-G scores showed non-significant changes in the median values and the values of intraclass correlation coefficient showed very high correlation between the first and second administration (ICC>0.90 in both populations). No significant correlations were found between VISA-G score and either pain extent (R=-0.05, P=0.76), or resting pain intensity (R=-0.13, P=0.45), or palpation pain intensity (R= 0.01, P=0.97). Conversely, a high (and significant) negative correlation was obtained between VISA-G score and Oswestry Disability Index score (R=-0.80, P<0.0001). CONCLUSIONS: These results indicated that the VISA-G Italian version presents excellent test-retest reliability. CLINICAL REHABILITATION IMPACT: The evaluation of gluteal tendinopathy-related disability through VISA-G can be useful for the prognostic assessment and/or follow-up of tendinopathy patients in combination with the pain drawing assessment of pain extent.

Common Musculoskeletal Disorders in the Elderly: The Star Triad.

Musculoskeletal disorders are debilitating conditions that significantly impair the state of health, especially in elderly subjects. A pathological triad of inter-related disorders that are highly prevalent in the elderly consists of the following main "components": sarcopenia, tendinopathies, and arthritis. The aim of this review is to critically appraise the literature relative to the different disorders of this triad, in order to highlight the pathophysiological common denominator and propose strategies for personalized clinical management of patients presenting with this combination of musculoskeletal disorders. Their pathophysiological common denominator is represented by progressive loss of (focal or generalized) neuromuscular performance with a risk of adverse outcomes such as pain, mobility disorders, increased risk of falls and fractures, and impaired ability or disability to perform activities of daily living. The precise management of these disorders requires not only the use of available tools and recently proposed operational definitions, but also the development of new tools and approaches for prediction, diagnosis, monitoring, and prognosis of the three disorders and their combination.

Long-term effects of intra-articular oxygen-ozone therapy versus hyaluronic acid in older people affected by knee osteoarthritis: A randomized single-blind extension study.

BACKGROUND: There is little evidence on intra-articular (IA) treatment in knee osteoarthritis (KOA) and there is a lack of long-term follow-up studies. OBJECTIVE: To assess the long-term effectiveness and safety of IA oxygen-ozone (O2O3) and hyaluronic acid (HA) in terms of functioning in KOA patients over a 31-week period. METHODS: Patients aged ⩾ 60 years with KOA were randomly allocated to receive 4 IA knee injections (1/week) of O2O3 or HA (T0-T3) and a follow-up visit 4 weeks after the fourth injection (T4). In this extension study we assessed VAS and safety in patients with Visual Analogue Scale (VAS) ⩾ 4 at the at 6-month follow-up visit (T5), undergoing a second treatment cycle (T5-T8) and 1-month follow-up visit (T9). RESULTS: Forty-two patients (aged 70.5 ± 5.8 years) were randomly allocated to O2O3 (n= 22) or HA group (n= 20). Twenty-three underwent another IA cycle: 12 (54.6%) in the O2O3 group and 11 (55.0%) in the HA group. Both groups showed significant reduction in VAS (p< 0.013) compared to baseline during both cycles. At follow-up visits (T4 and T9), VAS was significantly lower in the HA group (p< 0.013). There were no differences in adverse events occurrence between groups. CONCLUSIONS: IA O2O3 might be comparable to HA in terms of effectiveness and safety in reducing pain in KOA patients, although at both follow-up visits (T4 and T9) VAS was significantly lower in the HA group.