Pediatric selective mutism therapy: a randomized controlled trial.

BACKGROUND: Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. AIM: The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. DESIGN: Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). SETTING: University third level Centre (Child and Adolescent Neuropsychiatry Clinic). POPULATION: Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). METHODS: Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. RESULTS: After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (P<0.001), Withdrawn (P=0.007) and Internalizing problems (P=0.020). Regarding SM severity according to SMQ assessment, children of group A showed a reduction of SM symptoms in all situations (school, P=0.003; family, P=0.018; and social, P=0.030 situations) and in SMQ total score (P<0.001). CONCLUSIONS: Our preliminary results suggest the positive effect of the psychomotor treatment in rehabilitative program for children affected by selective mutism, even if further studies are needed. CLINICAL REHABILITATION IMPACT: The present study identifies in psychomotricity a safe and efficacy therapy for pediatric selective mutism.

Headache, low back pain, other nociceptive and mixed pain conditions in neurorehabilitation. Evidence and recommendations from the Italian Consensus Conference on Pain in Neurorehabilitation.

Pain is a disabling symptom and is often the foremost symptom of conditions for which patients undergo neurorehabilitation. We systematically searched the PubMed and Embase electronic databases for current evidence on the frequency, evolution, predictors, assessment, and pharmacological and non-pharmacological treatment of pain in patients with headache, craniofacial pain, low back pain, failed back surgery syndrome, osteoarticular pain, myofascial pain syndrome, fibromyalgia, and chronic pelvic pain. Despite the heterogeneity of published data, consensus was reached on pain assessment and management of patients with these conditions and on the utility of a multidisciplinary approach to pain therapy that combines the benefits of pharmacological therapy, physiotherapy, neurorehabilitation, and psychotherapy. We of the Italian Consensus Conference on Pain in Neurorehabilitation (ICCPN) suggest a need to conduct randomized controlled trials on the efficacy of pain treatments and their risk-benefit profile for the conditions we have reviewed.

Back pain-related disability and quality of life in patients affected by vertebral fractures: data from baseline characteristics of population enrolled in Denosumab In Real Practice (DIRP).

BACKGROUND: Spine fragility fractures lead to a significant acute and/or chronic pain and worsening of quality of life. Denosumab is effective in reducing the risk of new vertebral fractures, but its effectiveness on pain relief and improvement of the quality of life in patients with spine fractures are not well known. AIM: The aim of this paper is to describe the baseline demographic and clinical characteristics, back pain-related disability and quality of life of the Denosumab In Real Practice (DIRP) study population. METHODS: DIRP is a multicenter prospective observational study evaluating the effectiveness of denosumab in reducing back pain-related disability and Health-Related Quality of Life (HRQoL) of women with postmenopausal osteoporosis who had already experienced at least one vertebral fragility fracture. Our evaluation protocol includes history of fractures, Spine Pain Index (SPI), HRQoL, bone mineral density (BMD) and radiological assessment of vertebral fragility fractures. RESULTS: Two hundred and twenty-three post-menopausal women, who received a prescription for denosumab, were enrolled. The mean SPI score was 58.6 ± 21.4 SD, and 187 (83.86%) women experienced a moderate-severe pain. The mean HRQoL health state value was 0.54 ± 0.27 SD using EQ-5D index, whereas the mean Physical and Mental Health Composite Scale scores derived from the SF-12 were 31.06 ± 7.77 SD and 39.20 ± 11.03 SD. DISCUSSION AND CONCLUSIONS: Baseline characteristics of DIRP study cohort indicate that patients who received a prescription of denosumab in Campania region are affected by severe osteoporosis with highly prevalent vertebral fractures, disabling back pain and poor health-related quality of life. This is in contradiction with what it is expected by a front-line drug for osteoporosis.

Hypovitaminosis D is associated with a reduction in upper and lower limb muscle strength and physical performance in post-menopausal women: a retrospective study.

BACKGROUND: Elderly people experience a gradual loss of muscle strength and a reduction of serum levels of vitamin D and of vitamin D receptor expression in skeletal muscle cells. AIMS: The aim of our study was to evaluate the association among serum levels of 25-hydroxy-vitamin D [25(OH)D3], muscle strength, and physical performance in post-menopausal women. METHODS: In our retrospective case-control study, we analyzed data from medical records of post-menopausal women aged ≥ 50 years. We compared subjects with hypovitaminosis D [25(OH)D3 <30 ng/ml] vs. those with normal levels [25(OH)D3 ≥ 30 ng/ml]. Outcome measures were: Hand Grip Strength Test (HGS) and Knee Extension Strength Test (KES) to evaluate upper and lower limb muscle strength, respectively; Short Physical Performance Battery (SPPB) and usual 4-m gait speed (4 MGS) to evaluate physical performance. RESULTS: We examined 80 patients (mean aged 65.92 ± 7.69 years): forty-six subjects with hypovitaminosis D (mean aged 66.09 ± 7.71 years) and 34 with normal levels of vitamin D (mean aged 65.71 ± 7.78 years). There was a statistically significant difference between hypovitaminosis D group and subjects with normal levels of vitamin D in HGS (12.13 ± 4.34 vs. 19.14 ± 5.59; p < 0.001), KES (11.99 ± 4.04 vs. 16.98 ± 8.43; p = 0.003), SPPB score [8 (5.75-10.25) vs. 12 (10-12); p < 0.001], and proportion of patients with usual 4 MGS ≤ 0.8 m/s [29 (63.0%) vs. 9 (26.5%); p = 0.002]. DISCUSSION: In literature, there is no agreement on the association among serum vitamin D levels and muscle function. Our data showed that post-menopausal women with hypovitaminosis D had worse upper and lower limb muscle strength and physical performance than subjects with normal levels of 25(OH)D3. CONCLUSIONS: Our results support the hypothesis that there is a significant positive association among serum 25(OH)D3 levels and upper and lower limb muscle functioning.

Incidence and costs of hip fractures vs strokes and acute myocardial infarction in Italy: comparative analysis based on national hospitalization records.

OBJECTIVES: As osteoporotic fractures are becoming a major health care problem in countries characterized by an increasing number of older adults, in this study we aimed to compare the incidence and costs of hip fragility fractures in Italian elderly people versus those of major cardiovascular diseases (strokes and acute myocardial infarctions [AMI]) occurring in the whole adult population. METHODS: We analyzed hospitalization records maintained at the national level by the Italian Ministry of Health for the diagnosis of hip fractures (ICD-9-CM codes 820-821), AMI (code 410), hemorrhagic (codes 430, 431, 432) and ischemic strokes (codes 433-434), and TIA (code 435) between 2001-2005. Cost analyses were based on diagnosis-related groups. RESULTS: The incidence of hip fractures in elderly people has increased (+12.9% between 2001 and 2005), as well as that of AMI (+20.2%) and strokes (hemorrhagic: +9.6%; ischemic: +14.7) occurring in the whole adult population; conversely, hospitalization due to TIA decreased by a rate of 13.6% between 2001 and 2005. In 2005, the hospital costs across the national health care system that were associated with hip fragility fractures in the elderly were comparable to those of strokes (both hemorrhagic and ischemic), which occurred in the whole Italian adult population. Moreover, these costs were higher than those generated by AMI and TIA. Rehabilitation costs following strokes reached about 3 billion Euros in 2005, but rehabilitative costs of hip fractures and AMI were comparable (about 530 million Euros in 2005). CONCLUSION: The burden of hip fragility fractures in Italy is comparable to that of AMI and strokes.

Does robotic gait training improve balance in Parkinson's disease? A randomized controlled trial.

BACKGROUND: Treadmill training (with or without robotic assistance) has been reported to improve balance skills in patients with Parkinson's disease (PD). However, its effectiveness on postural instability has been evaluated mainly in patients with mild to moderate PD (Hoehn & Yahr stage ≤3). Patients with more severe disease may benefit from robot-assisted gait training performed by the Gait-Trainer GT1, as a harness supports them with their feet placed on motor-driven footplates. The aim of this study was to determine whether robot-assisted gait training could have a positive influence on postural stability in patients with PD at Hoehn & Yahr stage 3-4. METHODS: Thirty-four patients with PD at Hoehn & Yahr stage 3-4 were randomly assigned into two groups. All patients received twelve, 40-min treatment sessions, three days/week, for four consecutive weeks. The Robotic Training group (n = 17) underwent robot-assisted gait training, while the Physical Therapy group (n = 17) underwent a training program not specifically aimed at improving postural stability. Patients were evaluated before, immediately after and 1-month post-treatment. Primary outcomes were: Berg Balance scale; Nutt's rating. RESULTS: A significant improvement was found after treatment on the Berg Balance Scale and the Nutt's rating in favor of the Robotic Training group (Berg: 43.44 ± 2.73; Nutt: 1.38 ± 0.50) compared to the Physical Therapy group (Berg: 37.27 ± 5.68; Nutt: 2.07 ± 0.59). All improvements were maintained at the 1-month follow-up evaluation. CONCLUSIONS: Robot-assisted gait training may improve postural instability in patients with PD at Hoehn & Yahr stage 3-4.

Accuracy of botulinum toxin type A injection into the gastrocnemius muscle of adults with spastic equinus: manual needle placement and electrical stimulation guidance compared using ultrasonography.

OBJECTIVE: To investigate the accuracy of manual needle placement and electrical stimulation guidance, compared using ultrasonography, for injection of botulinum toxin type A into the gastrocnemius muscle of adults with spastic equinus. DESIGN: Prospective clinical study. SUBJECTS: A total of 81 adults with stroke who were scheduled to receive botulinum toxin type A injection into the gastrocnemius muscle. METHODS: After randomization into two groups, each patient was injected into two sites at each head of the gastrocnemius muscle. The manual needle placement group (n = 42) underwent injections using anatomical landmarks and palpation. The electrical stimulation guidance group (n = 39) underwent injections under electrical stimulation guidance. The accuracy of needle placement and muscle thickness at each injection site were compared by means of ultrasonography. RESULTS: The overall accuracy of manual needle placement and electrical stimulation guidance, measured using ultrasonography, was significantly higher for the gastrocnemius medialis than for the lateralis (92.0% vs 79.0%). The gastrocnemius medialis was significantly thicker than the lateralis (mean 13.25 mm (standard deviation (SD) 1.86 mm) vs 10.84 mm (SD 1.52 mm). CONCLUSION: Electrical stimulation guidance may be useful for injections into the gastrocnemius lateralis of adults with spastic equinus. However, neither manual needle placement nor electrical stimulation guidance showed complete accuracy, when measured using ultrasonography.

Is spastic muscle echo intensity related to the response to botulinum toxin type A in patients with stroke? A cohort study.

OBJECTIVE: To investigate the relationship between gastrocnemius muscle echo intensity and response to botulinum toxin type A (BoNT-A) in patients with spastic equinus foot resulting from stroke. DESIGN: Cohort study. SETTING: University hospital. PARTICIPANTS: Adult patients (N=56) with spastic equinus foot resulting from stroke scheduled to receive BoNT-A injection into the gastrocnemius muscle. INTERVENTIONS: All patients were injected with BoNT-A (abobotulinumtoxinA) into the gastrocnemius muscle with an ultrasonography-guided, multisite injection technique. The toxin dose was 250U for the gastrocnemius medialis and 250U for the gastrocnemius lateralis (dilution 500U/2mL) in each patient. All patients were evaluated before and 4 weeks after BoNT-A injection. MAIN OUTCOME MEASURES: Spastic gastrocnemius muscle echo intensity visually graded with the Heckmatt scale. Clinical assessment of the spastic gastrocnemius with the Modified Ashworth Scale, Tardieu Scale, and ankle passive range of motion. RESULTS: Postintervention testing at 4 weeks showed overall significant improvements in the clinical assessment of the spastic gastrocnemius muscle. No significant change was observed in the echo muscle intensity of the spastic gastrocnemius after BoNT-A injection. Post hoc comparisons showed that all clinical outcomes were significantly better in those patients with echo muscle intensity of the spastic gastrocnemius graded II on the Heckmatt scale than those with grades III (P<.001) and IV (P<.001) after botulinum toxin injection. CONCLUSIONS: These findings support the hypothesis that patients with higher spastic muscle echo intensity have a reduced response to BoNT-A.

Effectiveness of teriparatide treatment on back pain-related functional limitations in individuals affected by severe osteoporosis: a prospective pilot study.

INTRODUCTION: Vertebral fractures have been associated with back pain, functional limitations and reduced health-related quality of life (HRQoL). Teriparatide is the first effective anabolic agent that demonstrated to significantly reduce the risk of vertebral fracture by 65%, as compared to placebo. The aims of this study were to evaluate the effectiveness of teriparatide treatment on back pain-related functional limitations and to investigate on patients HRQoL. MATERIALS AND METHODS: In this prospective observational pilot study osteoporotic patients, who were prescribed teriparatide therapy and a supplementation of calcium and vitamin D, were asked to answer to two self-administered questionnaires: the Spine Pain Index (SPI) and the SF-12 (at the recruitment, after 6, 12, and 18 months). RESULTS: Fifty-two women were evaluated (mean age of 70.58 yrs). The mean SPI score passed from 50.01 at baseline to 32.20 at 18 months. The mean SF-12 PCS score passed from 30.00 at baseline to 36.79 at 18 months, while the mean SF-12 MCS score was already within the normality range at baseline, constantly improving during the 18 months. CONCLUSION: In conclusion, 18 months of treatment with teriparatide has to be considered an effective therapeutic option for women with severe osteoporosis and vertebral fractures, in a real-life clinical setting, to improve both back pain related disability and quality of life.

Development of knowledge about osteoporosis in the world of orthopedics and traumatology.

The development of Orthopedics and Traumatology in the last 50 years have been characterized by the concurrence of several milestone events, such as the disappearance of polio and osteoarticular tuberculosis, the progress of some disciplines such as Anesthesia and Intensive Care, Diagnostic Imaging and technology development. As for other common diseases, also for osteoporosis the evolution of knowledge about pathophysiology and treatment represents a "must" to know for the orthopaedic surgeons.

Prevention of falls and role of calcium and vitamin D.

Falls in the elderly are very common and represent a serious cause of morbidity, severe disability and death. Impairments of the mechanisms of postural stability with age and the presence of acute and chronic diseases may favour the occurrence of falls in the elderly. Together with the adoption of non-pharmacological measures, supplementation of calcium and vitamin D demonstrated to reduce hip fracture risk, particularly in institutionalized people.

Neuropsychiatric disorders in hip fracture.

Hip fractures most frequently occur in the elderly population. They are mainly caused by falls from standing position. The presence of several comorbidities, in particular neuropsychiatric disorders, are related to high percentages of falls, disability and mortality rates. Delirium and depression are the two most common mental disorders in this population.Delirium is strongly related to an increase of functional limitation in activities of daily living, a decline in walking autonomy, and a higher rate of nursing home placement or death. A multi-factorial intervention program, consisting of oxygen supplementation, intravenous fluid supplementation and extra-nutrition, accurate monitoring of vital signs, adequate pain treatment, daily delirium screening, reduction in drug use, and modification in peri-operative management, should always be performed in good clinical practice.Patients who undergo surgery frequently experience depression that can worsening functional outcome. An early detection and an adequate intervention based on psychological support and pharmacological treatment can give good results.We propose a simple flow chart for the management of elderly hip fracture patients that should be used in both Orthopaedics and Rehabilitative settings.

The occurrence of acute myocardial infarction in Italy: a five-year analysis of hospital discharge records.

BACKGROUND: The incidence and costs of acute myocardial infarction (AMI) in Europe represent a substantial problem due to population aging. METHODS: Between 2001 and 2005, Italian hospitalization records were examined to evaluate hospital admissions and costs of AMI in adults aged ≥ 45 and in elderly people ≥ 65 or ≥ 75. Hospital costs were calculated on the basis of Diagnosis Related Groups (DRGs). RESULTS: 75,586 men and 43,164 women were hospitalized because of AMI in 2005, showing respectively increases of 17.2% and 29.2% across five years. In the youngest age group (45-64), 29,925 hospitalizations in men and 6443 in women due to AMI were registered during 2005. In the subgroup of patients aged 65-74, 21,621 men and 10,145 women were hospitalized for AMI; in the oldest group (≥ 75) 24,040 and 26,576 hospitalizations were recorded. The increasing rates across the five examined years were 8.3% and 22.0% in the first age group, 14.3% and 17.4% in people aged 65-74, and 31.8% and 36.3% in the oldest subgroup, respectively in men and women. Among AMI patients aged ≥ 75, the number of women was always higher than that of men. Overall hospitalization costs due to AMI in Italy were 305 million Euros in 2001 and 370 million in 2005, with an average cost of 3115 Euros per patient in the latter year. CONCLUSION: Our findings confirm AMI as a leading health problem and a leading cause of health care costs.

Risedronate's efficacy: from randomized clinical trials to real clinical practice.

Osteoporosis represents the most common human bone disorder with a large medical and economical burden on the Health Care System. Bisphosphonates are the major drugs used for the treatment of osteoporosis. Differences in their chemical structures and pharmacokinetic actions can explain the different clinical efficacy among these molecules. Risedronate is a potent inhibitor of farnesyl pyrophosphate synthase, but does not bind strongly to mineral; this lower mineral binding may enable risedronate to have a wider distribution in bone. Its antifracture efficacy has been established in several randomized phase III controlled studies that showed its value in the reduction of vertebral, non vertebral and hip fractures. Randomized controlled trials and observational studies demonstrated risedronate efficacy and safety in different subsets of patients, therefore risedronate is configured, among oral therapies currently available for osteoporosis, as a drug of first choice.

Pharmaco-economic issues in the treatment of severe osteoporosis.

INTRODUCTION: clinical guidelines recommend to identify and treat people at high risk of fracture. METHODS: we have carried out a simulation concerning pharmaco-economic issues in the treatment of severe osteoporosis and particularly those people with previous femoral fragility fractures, assuming that only 13.1% of hip fractured patients had started a proper antifracture therapy, as shown by the analysis of the Tuscany regional database. RESULTS: Annual costs sustained by the Italian healthcare system for treating hip fractured patients all over Italy have been estimated to range from 2 560 000 in year 2000 to 3 291 750 in year 2005, representing only 0,3% of the overall costs sustained because of hip fractures in Italy. CONCLUSIONS: Sixty percent of the pharmacological costs can be considered as ineffective from a therapeutic point of view because patients were assuming their drugs only for 6 months. There is a need for specific codification of osteoporotic fragility fractures at hospital admissions and for implementing regional strategies aimed to reduce hip re-fractures by increasing the number of patients on treatment and incrementing adherence to treatment.

Rehabilitative treatment in flexible flatfoot: a perspective cohort study.

Paediatric valgus flexible flatfoot is a common childhood paramorphism. Its treatment options consist of rehabilitation, corrective footwear and, if necessary, surgical intervention. The aim of our study was to compare a group of children who followed a rehabilitative programme versus a historical group of children who had been treated with insoles and orthopaedic footwear. Over a 2 year period (1995-1997), 300 children (mean age was 3.4-184 male, 116 female) with bilateral flexible flatfoot (600 feet) were recruited and underwent a rehabilitative programme for a mean period of 2.75 years. The feet were classified according to Viladot's method: 386 feet presented a type III degree deformity and 214 feet presented a type II degree deformity. The rehabilitative programme consisted of simple therapeutic exercises, which could be easily learnt by both patients and their caregivers. These children were compared to a historical group of children (674 feet) who had been treated in our department for infantile flexible flatfoot with the use of orthosis. In these groups, 396 feet presented a type III degree deformity and 278 feet presented a type II degree deformity. In the group of children who underwent the rehabilitative protocol, during follow-up at the age of eight, 352 of the 386 type III degree feet could be classified as normal and 210 of the 214 type II degree cases became normal. In the historical cohort of children treated with orthosis, at the age of eight, 214 of the 396 type III degree feet could be classified as normal; and 248 of the 278 type II degree cases became normal. Our results show that comparing the percentage of success (changing from type III or II degree to type I or N) in the two groups (children treated with rehabilitation and children treated with orthosis), the rehabilitative approach seems to be more effective. Probably it has a marginal influence on the natural history of paediatric valgus flexible flatfoot even though it plays a role in maintaining good flexibility of the flatfoot thus limiting functional impairment.

Incidence of breast cancer in Italy: mastectomies and quadrantectomies performed between 2000 and 2005.

OBJECTIVES: We aimed to determine the incidence of women's breast cancer in Italy without using statistical approximations. METHODS: We analyzed the national hospitalizations database at the Ministry of Health to calculate the number of major surgeries in Italian women (mastectomies and quadrantectomies) due to breast cancer between 2000 and 2005, overall and by age groups (<44, 45-64, 65-74 and >or= 75 years old). RESULTS: Over the six years examined, an overall number of 100,745 mastectomies and 168,147 quadrantectomies were performed. A total of 41,608 major surgeries due to breast cancer were performed in the year 2000 and this number rose to 47,200 in 2005, with a 13.4% increase over six years. CONCLUSION: by analyzing the hospitalizations database concerning major breast surgery, incidence of breast cancer in Italy was found to be 26.5% higher than the official estimations which have been computed using statistical models (namely 47,200 vs. 37,300 cases in year 2005).

Rehabilitation in esophageal cancer.

Cancer of the esophagus has an unfavorable prognosis with a five-year survival rate after radical surgery of less than 10%; early diagnosis is difficult. The appearance of symptoms, particulary dysphagia, is due to more than 2/3 tumor involvement of the esophageal circumference, already present in 2/3 of patients at diagnosis. Symptoms can be local and/or systemic; they can be physical, psychic, iatrogenic and evolutive. A careful rehabilitation program should follow these patients during the entire course of their disease The rehabilitation approach intends to define areas of intervention, short-term goals, possible achievements, role of health operators and overall verifications. Common problems of patients with esophageal cancer, are analyzed. A rehabilitation program including the patient care throughout the hospitalization period to improve his/her autonomy with respect to his/her social and familial activities, is illustrated.