Long-term results of the SOFTGRIP trial: TIPP versus ProGrip Lichtenstein's inguinal hernia repair.

PURPOSE: In preventing Chronic Postoperative Inguinal Pain (CPIP) after inguinal herniorrhaphy, mesh position and mesh fixation seem important factors. The SOFTGRIP trial compared the TransInguinal PrePeritoneal (TIPP) repair to Polysoft mesh, to the Open anterior repair (Lichtenstein) using the self-gripping ProGrip mesh. Since CPIP might resolve and recurrence rate increase, this study reports the SOFTGRIP trial's long-term results (with a minimal follow-up of 5 years). METHODS: All patients initially randomized in the SOFTGRIP trial were contacted if not deceased. Patients were invited for an interview and physical examination. The procedures and methodology of this randomized clinical trial have been published together with the short-term results. The main outcomes for this long-term follow-up study were chronic pain, recurrences, re-operations and numbness. RESULTS: A total of 193 patients (81.4% of the initially randomized patients) were included for long-term follow-up analyses, 96 after TIPP, 97 after ProGrip Lichtenstein. After a median follow-up of 74 months (range 60-80) there were no significant differences between the two groups. Overall, chronic pain drastically decreased. Fourteen patients reported CPIP at long-term follow-up (overall 7.3%, 7 after TIPP and 7 after ProGrip Lichtenstein, any form, frequency and intensity of pain included). Recurrence rate increased from 2.6% (n = 6) at one-year follow-up, to 8.3% (n = 16) at 5-year's follow-up. CONCLUSION: The SOFTGRIP trial´s long-term outcomes show that after both TIPP and ProGrip Lichtenstein, recurrence rate increases and CPIP mostly disappears. These findings aid in better informing patients on the benefits and harms of inguinal hernia repair. The findings of accumulating recurrences and fading of chronic pain, confirms the need for long-term follow-up studies. High-quality long-term data on TIPP, ProGrip Lichtenstein and other types of herniorrhaphy are scarce and complication rates vary widely. Further long-term studies are needed to reveal the true spectrum of benefits and harms of the different inguinal hernia repair techniques. TRIAL REGISTRATION: Registered on August 25, 2009 at the Dutch Trial Registry ( www.trialregister.nl ) NTR1853.

Direct application of an ECG-based sleep staging algorithm on reflective photoplethysmography data decreases performance.

OBJECTIVE: The maturation of neural network-based techniques in combination with the availability of large sleep datasets has increased the interest in alternative methods of sleep monitoring. For unobtrusive sleep staging, the most promising algorithms are based on heart rate variability computed from inter-beat intervals (IBIs) derived from ECG-data. The practical application of these algorithms is even more promising when alternative ways of obtaining IBIs, such as wrist-worn photoplethysmography (PPG) can be used. However, studies validating sleep staging algorithms directly on PPG-based data are limited. RESULTS: We applied an automatic sleep staging algorithm trained and validated on ECG-data directly on inter-beat intervals derived from a wrist-worn PPG sensor, in 389 polysomnographic recordings of patients with a variety of sleep disorders. While the algorithm reached moderate agreement with gold standard polysomnography, the performance was significantly lower when applied on PPG- versus ECG-derived heart rate variability data (kappa 0.56 versus 0.60, p < 0.001; accuracy 73.0% versus 75.9% p < 0.001). These results show that direct application of an algorithm on a different source of data may negatively affect performance. Algorithms need to be validated using each data source and re-training should be considered whenever possible.

Effects of vibration-induced fatigue on the H-reflex.

Vibration exercise (VE) has been suggested as an effective training for improving muscle strength and coordination. However, the underlying physiological adaptation processes are not yet fully understood, limiting the development of safe and effective exercise protocols. To better understand the neuromuscular responses elicited by VE, we aimed at investigating the acute effects of superimposed vibration on the Hoffmann reflex (H-reflex), measured after fatiguing exercise. Twenty-five volunteers performed four isometric contractions of the right Flexor Carpi Radialis (FCR) with baseline load at 80% of their maximal voluntary contraction (MVC), both with no vibration and with superimposed vibration at 15, 30, and 45 Hz. Fatigue was estimated by MVC test and estimation of electromyographic spectral compression. H-reflex suppression was estimated as the relative decrease after exercise. Our results show that fatiguing exercise determined a decrease in H-reflex amplitude compared to rest condition while vibration determined a lower H-reflex suppression as compared to no vibration. The superimposition of 30-Hz vibration determined the largest acute reduction in force generating capacity (36 N, p < 0.05) and the lowest H-reflex suppression (20%, p < 0.05). These results suggest VE to be particularly suitable in rehabilitation programs for rapid restoration of muscle form and function after immobilization periods.

The transinguinal preperitoneal technique (TIPP) in inguinal hernia repair does not cause less chronic pain in relation to the ProGrip technique: a prospective double-blind randomized clinical trial comparing the TIPP technique, using the PolySoft mesh, with the ProGrip self-fixing semi-resorbable mesh.

BACKGROUND: Position of the mesh and the method of fixation are important in the occurrence of chronic pain in inguinal herniorrhaphy. An RCT was conducted to evaluate chronic pain after transinguinal preperitoneal (TIPP) repair compared with a Lichtenstein-like repair with a semi-resorbable self-fixing mesh (ProGrip). METHODS: Patients with a primary unilateral inguinal hernia were randomized either to the TIPP (PolySoft mesh) or to repair with a ProGrip mesh. Primary objective was the occurrence of chronic pain after surgery. Secondary objectives were, i.e., recurrences, complications, and quality of life. Follow-up occurred after 2 weeks, 3 months, and 1 year. Patients and physicians were blinded. RESULTS: Two hundred and fifty-eight patients were randomized to TIPP or ProGrip mesh repair. Two hundred and thirty-eight were included in the analysis: 122 in the TIPP group and 116 in the ProGrip group. Baseline characteristics were compatible. After 2 weeks and 3 months, there was significantly more moderate and severe pain in the ProGrip group on different pain scores. Median pain scores were very low in both groups after 3 months and 1 year (0-0.5 on a scale of 0-10). There was no difference in pain scores between both groups after 1 year. Recurrence rates were low; three patients in each group (2.6 % ProGrip and 2.5 % TIPP). CONCLUSION: There was no significant difference in chronic pain between the inguinal repairs with the use of a ProGrip mesh compared with a TIPP repair at 1 year after surgery. In both groups, the occurrence of chronic pain was low.

Motor unit activity within the depth of the masseter characterized by an adapted scanning EMG technique.

OBJECTIVE: To study motor unit activity in the medio-lateral extension of the masseter using an adapted scanning EMG technique that allows studying the territories of multiple motor units (MUs) in one scan. METHODS: We studied the m. masseter of 10 healthy volunteers in whom two scans were performed. A monopolar scanning needle and two pairs of fine-wire electrodes were inserted into the belly of the muscle. The signals of the fine wire electrodes were decomposed into the contribution of single MUs and used as a trigger for the scanning needle. In this manner multiple MU territory scans were obtained simultaneously. RESULTS: We determined 161 MU territories. The maximum number of territories obtained in one scan was 15. The median territory size was 4.0mm. Larger and smaller MU territories were found throughout the muscle. CONCLUSIONS: The presented technique showed its feasibility in obtaining multiple MU territories in one scan. MUs were active throughout the depth of the muscle. SIGNIFICANCE: The distribution of electrical and anatomical size of MUs substantiates the heterogeneous distribution of MUs throughout the muscle volume. This distributed activity may be of functional significance for the stabilization of the muscle during force generation.

The associations between fatigue, apathy, and depression in Parkinson's disease.

OBJECTIVES: Fatigue and apathy are two of the most common and most disabling non-motor symptoms of Parkinson's disease (PD). They have a high coincidence and can often be confused; moreover, their relationship is not fully understood. The aim of our study was to describe the coincidence of apathy with different fatigue domains in the presence/absence of depression and to separately describe the associations of different aspects of primary and secondary fatigue with apathy and other clinical and disease-related factors. MATERIALS AND METHODS: A total of 151 non-demented patients with PD were examined using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Starkstein Apathy Scale, Multidimensional Fatigue Inventory (MFI), Beck Depression Inventory-II, and Epworth Sleepiness Scale. RESULTS: The prevalence and severity of fatigue and apathy were significantly higher in depressed PD patients. However, our results show that depression, fatigue, and apathy can be clearly distinguished in PD. Apathy was associated with the MFI's-reduced motivation domain in both depressed and non-depressed patients. However, apathy was associated with mental fatigue aspects only in non-depressed patients, and it was not related to the physical aspects of fatigue in any of the studied groups. CONCLUSIONS: Although the pathophysiology of fatigue and apathy in PD is clearly multifactorial, in a proportion of PD patients, these symptoms are associated with depression, dopaminergic depletion in the mesocorticolimbic structures, and disruption of the prefrontal cortex-basal ganglia axis. Therefore, in some PD patients, adequate management of depression and optimal dopaminergic medication may improve both fatigue and apathy.

The clinical utility of botulinum toxin injections targeted at the motor endplate zone in cervical dystonia.

BACKGROUND AND PURPOSE: Cervical dystonia (CD) patients usually receive repeated botulinum neurotoxin (BoNT) injections. The aims of this study were to evaluate the feasibility of motor endplate zone (MEZ) detection of relevant cervical muscles in CD patients receiving chronic BoNT treatment and to compare the treatment effect of half-dosed, endplate-targeted injections to standard BoNT injections. METHODS: In study 1, high-density surface electromyography (HD-sEMG) was recorded from the sternocleidomastoid (SCM) and splenius capitis (SC) muscles in 18 CD patients with ongoing BoNT treatment, by which the location of the MEZ was determined. In study 2, nine additional patients with rotational-type CD participated in a treatment effect study where they received either half of their regular BoNT dose through endplate-targeted injections or their normal BoNT dose through standard injections (crossover design). Dystonia severity was recorded before and 4 weeks after each treatment session (Toronto Western Spasmodic Torticollis Rating Scale severity subscore). RESULTS: In the SCM muscle the MEZ was located at the lower border of the superior third part of the muscle, and in the SC muscle at half muscle length. Endplate-targeted, half-dosed BoNT injection resulted in a similar treatment effect to injecting the full dose in the standard technique. CONCLUSIONS: Half-dosed, endplate-targeted BoNT injections lead to a similar treatment effect to the standard BoNT injection protocol. MEZ detection confronts the clinician with some technical challenges, such as the ability of accurate and technically optimal placement of the electrode grid and correct interpretation of the HD-sEMG signal.

Localised task-dependent motor-unit recruitment in the masseter.

Localised motor-unit (MU) recruitment in the masseter was analysed in this study. We investigated whether differential activation behaviour, which has already been reported for distant masseter regions, can also be detected in small muscle subvolumes at the level of single MUs. Two bipolar fine-wire electrodes and an intra-oral 3D bite-force transmitter were used to record intra-muscular electromyograms (EMG) resulting from controlled bite-forces of 10 healthy human subjects (mean age 24.1 ± 1.2 years). Two-hundred and seventeen decomposed MUs were organised into localised MU task groups with different (P < 0.001) force-direction-specific behaviour. Proportions of MUs involved in one, two, three or four examined tasks were 46%, 31%, 18% and 5%, respectively. This study provides evidence of the ability of the neuromuscular system to modify the mechanical output of small masseter subvolumes by differential control of adjacent MUs belonging to distinct task groups. Localised differential activation behaviour of the masseter may be the crucial factor enabling highly flexible and efficient adjustment of the muscle activity in response to complex local biomechanical needs, for example, continually varying bite-forces during the demanding masticatory process.

Loss of motor unit size and quadriceps strength over 10 years in post-polio syndrome.

OBJECTIVE: To investigate whether strength decline in post-polio syndrome (PPS) results from excessive distal axonal degeneration of enlarged motor units. METHODS: We assessed changes over 10 years in isometric quadriceps strength, mean motor unit action potential (MUAP) size, root mean squared (RMS) amplitude, and level of interference (LOI) in 47 patients with PPS and 12 healthy controls, using high density surface EMG. At baseline, all patients had symptomatic quadriceps dysfunction, evidenced by transmission defects on single-fibre EMG. RESULTS: MU size and strength declined significantly by 20% and 15%, respectively in patients with PPS. Those with the largest initial MU sizes exhibited the greatest losses of mean MU size (27%) and proportional decreases in quadriceps strength (23%). Initial strength, change in LOI and change in RMS amplitude together explained 35% of the variability in strength changes in patients. MU size of controls did not change, although they lost 29% strength. CONCLUSIONS: MU size and strength declined concomitantly in a homogeneous cohort of patients with PPS and quadriceps dysfunction. SIGNIFICANCE: This long term follow-up study provides evidence that size diminution of enlarged MUs combined with a reduced number of active MUs contributes to the gradual strength decline in PPS.

Roma coronary heart disease patients have more medical risk factors and greater severity of coronary heart disease than non-Roma.

OBJECTIVES: Coronary heart disease (CHD) is the most common cause of mortality and morbidity world-wide. Evidence on ethnic differences between the Roma and non-Roma regarding medical risk factors is scarce. The aim of this study was to assess differences in medical risk factors and the severity of CHD in Roma compared with non-Roma CHD patients, adjusted for gender, age and education. METHODS: Six hundred seventy four patients were included in this cross-sectional study (132 Roma, 542 non-Roma). Data on medical risk factors, symptoms, medication and severity of CHD were obtained from medical records. After matching Roma and non-Roma according to education, linear and logistic regression analyses with adjustments for gender and age were used. RESULTS: Compared with non-Roma, Roma patients had significantly more risk factors and more severe types of CHD. They were treated less frequently with statins and beta-blockers, were more frequently left on pharmacotherapy and surgically revascularised. These differences remained after controlling for education, gender and age. CONCLUSIONS: Roma CHD patients have a worse risk profile at entry of care and seem to be undertreated compared with non-Roma CHD patients.

A survey of the outcome of prophylaxis, on-demand treatment or combined treatment in 18-35-year old men with severe haemophilia in six countries.

A number of studies have been published on the benefits of prophylactic treatment in adults with haemophilia. However, in many countries, it is considered as optional due to financial constraints. This survey was carried out to examine the long-term effects of prophylaxis and the continuing benefit of the treatment into adulthood. Self-assessed health-related data and the EQ-5D questionnaire measuring health utility were collected from 124 men (26.9 ± 4.6 years) from Canada (N = 40), France (N = 14), Ireland (N = 17), the Netherlands (N = 16), Poland (N = 24) and the UK (N = 13). The respondents were split into four groups: On-Demand, <50% life on prophylaxis, ≥ 50% life on prophylaxis, Prophylaxis. Overall, long-term prophylaxis results in lower presence of target joints (P ≤ 0.001), occurrence of serious bleeding episodes (P ≤ 0.05), recurring bleeding episodes (P ≤ 0.01) and requirement for surgical procedures (P ≤ 0.05). Furthermore, health utility (P ≤ 0.01) in the On-demand group was significantly lower (P ≤ 0.01) compared to the ≥ 50% life on prophylaxis and the Prophylaxis group. No significant differences between countries were found except between the Netherlands and Poland, with Poland showing the lowest health utility (P ≤ 0.01) and the most problems with mobility (P ≤ 0.05) and pain/discomfort (P ≤ 0.001). The Netherlands showed the highest health utility (0.915) followed by Canada (0.791), Ireland (0.786), UK (0.768), France (0.687) and Poland (0.629). The results demonstrate consistently higher quality of life of individuals who are on long-term prophylactic treatment when compared to on-demand treatment or intermittent prophylaxis and on -demand treatment.

Social support, hopelessness and life satisfaction among Roma and non-Roma adolescents in Slovakia.

OBJECTIVES: Evidence on the psychosocial determinants of health among Roma adolescents is completely lacking. Our aim was to compare social support, life satisfaction and hopelessness of Slovak Roma and non-Roma adolescents and to assess the impact of parental education and social desirability on these differences. METHODS: We conducted a cross-sectional study among Roma from settlements in the eastern part of Slovakia (N = 330; mean age = 14.50; interview) and non-Roma adolescents (N = 722; mean age = 14.86; questionnaire). The effect of ethnicity on social support, life satisfaction and hopelessness was analysed using linear regression, adjusted for gender, parental education and social desirability. RESULTS: Roma adolescents reported higher social support from parents, higher life satisfaction and higher hopelessness rates. Parental education explained part of the ethnic differences, as did social desirability. After adjustment for the aforementioned factors, differences by ethnicity remained statistically significant. CONCLUSIONS: Roma adolescents experience higher levels of social support, life satisfaction and hopelessness than non-Roma adolescents. Reduction of hopelessness feelings while maintaining levels of social support and life satisfaction among Roma adolescents should be a topic for both intervention and further research.

Skeletal muscle involvement in myotonic dystrophy type 2. A comparative muscle ultrasound study.

This study determines the presence and extent of muscle changes in 31 myotonic dystrophy type 2 (DM2) patients detected by muscle ultrasound. Results were compared to 31 adult-onset myotonic dystrophy type 1 patients (DM1) and healthy controls. Furthermore, we tested the hypothesis that structural muscle changes correlate with age, quantitative muscle force and serum creatine kinase in both disorders. In DM2 all seven examined muscles (right masseter muscle, right and left biceps brachii, right and left forearm flexors, right rectus femoris, and left tibialis anterior muscle) showed increased mean echo intensities (p ≤ 0.001). Atrophy of the masseter muscle and rectus femoris were both found in 23% of DM2 patients. Muscle thickness was significantly more decreased in the elbow flexors in DM2 compared to DM1. Echo intensity sum score correlated positively with age in DM2 (r=0.57, p=0.001) and negatively with muscle force (r=0.36, p=0.048). We conclude that all tested muscles are affected and structurally abnormal in DM2 patients. Proximal arm muscles are more affected in DM2 compared to DM1, which corresponds to clinical findings.

Unchanged muscle fiber conduction velocity relates to mild acidosis during exhaustive bicycling.

Muscle fiber conduction velocity (MFCV) has often been shown to decrease during standardized fatiguing isometric contractions. However, several studies have indicated that the MFCV may remain constant during fatiguing dynamic exercise. It was investigated if these observations can be related to the absence of a large decrease in pH and if MFCV can be considered as a good indicator of acidosis, also during dynamic bicycle exercise. High-density surface electromyography (HDsEMG) was combined with read-outs of muscle energetics recorded by in vivo (31)P magnetic resonance spectroscopy (MRS). Measurements were performed during serial exhausting bouts of bicycle exercise at three different workloads. The HDsEMG recordings revealed a small and incoherent variation of MFCV during all high-intensity exercise bouts. (31)P MRS spectra revealed a moderate decrease in pH at the end of exercise (~0.3 units down to 6.8) and a rapid ancillary drop to pH 6.5 during recovery 30 s post-exercise. This additional degree of acidification caused a significant decrease in MFCV during cycling immediately after the rest period. From the data a significant correlation between MFCV and [H(+)] ([H(+)] = 10(-pH)) was calculated (p < 0.001, Pearson's R = -0.87). Our results confirmed the previous observations of MFCV remaining constant during fatiguing dynamic exercise. A constant MFCV is in line with a low degree of acidification, considering the presence of a correlation between pH and MFCV after further increasing acidification.

Socio-economic status and physical activity among adolescents: the mediating role of self-esteem.

OBJECTIVES: Physical activity is an essential part of a healthy lifestyle in adolescence. Previous studies have shown physical activity to be associated with socio-economic status and self-esteem; the latter association may mediate the former, but evidence on this is lacking. The aim of this study was to explore the associations of socio-economic status and the self-esteem of adolescents with physical activity, and their joint effects. METHODS: A sample of 3694 elementary-school students from Slovakia (mean age 14.3 years, 49% boys) completed the Rosenberg Self-esteem Scale and answered questions about the frequency of their physical activity and their parents' educational level. RESULTS: Adolescents with higher socio-economic status were significantly more likely to report physical activity on ≥5 days/week and to report higher self-esteem. In logistic regression, the association between socio-economic status and physical activity decreased after including self-esteem, suggesting that at least a part of this association is mediated by self-esteem. CONCLUSIONS: To conclude, youths from lower socio-economic groups have already been identified as a target group, for intervention. These findings suggest that it is important for promotion programmes to focus not only on the enhancement of their physical activity, but also on their self-esteem as a possible mediator.

Botulinum toxin has an increased effect when targeted toward the muscle's endplate zone: a high-density surface EMG guided study.

OBJECTIVES: To compare the effect of endplate-targeted injections of a low Botulinum neurotoxin type A (BoNT-A) dose with that of injections at defined distances from the motor endplate zone. METHODS: In eight healthy volunteers, the main endplate zones of the right and left extensor digitorum brevis (EDB) muscles were localized using high-density surface EMG. On the study side BoNT-A was injected at fixed distances from the endplate zone. On the control side, BoNT-A was administered into the endplate zone. Compound muscle action potential (CMAP) prior to the injection and 2, 12, and 24 weeks later were recorded. RESULTS: On the control side, the mean CMAP reduction 2 weeks after BoNT-A injection was 79.3%. The difference in CMAP reduction between both EDB muscles was significantly related to the injection distance from the endplate zone. Increasing the injection distance by 1cm reduced the effect of BoNT-A by 46%. CONCLUSIONS: Guided injection of a reduced BoNT-A dose into the muscle's endplate zone(s) is a promising strategy for optimizing the therapeutic effectiveness of BoNT-A and for minimizing side-effects such as unwanted weakness of adjacent muscles. SIGNIFICANCE: Precise endplate-targeted injections increase the effect of BoNT-A and may thus prove to reduce required dosage and treatment costs.

Gender differences in adolescent health-related behaviour diminished between 1998 and 2006.

OBJECTIVES: Male teenagers used to smoke more than females, but this male:female ratio has reversed in several European countries over recent decades. The aim of this study was to assess whether a similar shift in gender differences in smoking and other health-related behaviours has occurred in Slovak adolescents over the last decade. STUDY DESIGN: Cross-sectional study. METHODS: Data were collected in 1998 (n=2616, 52.4% male, mean age 14.9±0.6 years, response rate 96.3%) and 2006 (n=1081, 47.0% male, mean age 14.3±0.6 years, response rate 93.0%). Changes in gender-specific prevalence rates for smoking, alcohol consumption and lack of physical activity were assessed for both cohorts overall and by socio-economic group using the highest educational level of the parents. RESULTS: Statistically significant changes occurred in the male:female ratios for smoking and lack of physical activity but not for alcohol consumption. The prevalence of smoking in males dropped below that in females, and the physical activity of females increased substantially. However, changes in gender ratios varied strongly by socio-economic group. The greatest shift in the gender ratio for smoking occurred in the middle socio-economic group, showing an increase in the entire sample. Changes in gender ratios over time among adolescents from the highest socio-economic group were much smaller. CONCLUSIONS: The behaviour of Slovak female adolescents has become similar to that of their male peers in terms of smoking and physical activity. This shift in the gender ratio in Slovakia over the last decade mimics the shift in Western Europe from approximately two decades ago.