Combined Rehabilitation with Alpha Lipoic Acid, Acetyl-L-Carnitine, Resveratrol, and Cholecalciferolin Discogenic Sciatica in Young People: A Randomized Clinical Trial.

Background and Objectives: In the Western world, back pain and sciatica are among the main causes of disability and absence from work with significant personal, social, and economic costs. This prospective observational study aims to evaluate the effectiveness of a rehabilitation program combined with the administration of Alpha Lipoic Acid, Acetyl-L-Carnitine, Resveratrol, and Cholecalciferol in the treatment of sciatica due to herniated discs in young patients in terms of pain resolution, postural alterations, taking painkillers, and quality of life. Materials and Methods: A prospective observational study was conducted on 128 patients with sciatica. We divided the sample into 3 groups: the Combo group, which received a combination of rehabilitation protocol and daily therapy with 600 mg Alpha Lipoic Acid, 1000 mg Acetyl-L-Carnitine, 50 mg Resveratrol, and 800 UI Cholecalciferol for 30 days; the Reha group, which received only a rehabilitation protocol; and the Supplement group, which received only oral supplementation with 600 mg Alpha Lipoic Acid, 1000 mg Acetyl-L-Carnitine, 50 mg Resveratrol, and 800 UI Cholecalciferol. Clinical assessments were made at the time of recruitment (T0), 30 days after the start of treatment (T1), and 60 days after the end of treatment (T2). The rating scales were as follows: the Numeric Rating Scale (NRS); the Oswestry Disability Questionnaire (ODQ); and the 36-item Short Form Health Survey (SF-36). All patients also underwent an instrumental stabilometric evaluation. Results: At T1, the Combo group showed statistically superior results compared to the other groups for pain (p < 0.05), disability (p < 0.05), and quality of life (p < 0.05). At T2, the Combo group showed statistically superior results compared to the other groups only for pain (p < 0.05) and quality of life (p < 0.05). From the analysis of the stabilometric evaluation data, we only observed a statistically significant improvement at T2 in the Combo group for the average X (p < 0.05) compared to the other groups. Conclusions: The combined treatment of rehabilitation and supplements with anti-inflammatory, pain-relieving, and antioxidant action is effective in the treatment of sciatica and can be useful in improving postural stability.

Effectiveness of cryo plus ultrasound therapy versus diathermy in combination with high-intensity laser therapy for pain relief in footballers with muscle injuries: A prospective study.

BACKGROUND: Muscle injuries are common traumatic events in the clinical practice of the rehabilitation field. There is still a gap in the scientific literature on the effectiveness of physical agent modalities in the management of muscle injuries in athletes. OBJECTIVE: The aim of this study was to assess the effectiveness of cryo plus ultrasound therapy com-pared to diathermy in combination with high-intensity laser therapy (HILT) for pain relief in professional footballers with muscle injuries. METHODS: A case-control study was conducted on 31 professional footballers with a muscle injury of the lower limbs. Of these, 17 patients, assigned to a Group A (AG), were treated with HILT and cryoultrasound therapy; the remaining 14 patients, assigned to a Group B (BG), underwent HILT and diathermy. We assessed the extent of the pain, the size of the muscle injury, frequency of recurrence and number of days to recovery, at the time of recruitment, at the end of the rehabilitation and 3 months after the injury. RESULTS: Group A athletes had a greater benefit on pain (4.65 ± 0.61 vs 3.24 ± 0.63; p< 0.05) and muscle injury recurrence. The return to play in the athletes of group A took place 4.73 days earlier. CONCLUSION: HILT and cryo plus ultrasound therapy, in combination with therapeutic exercise, rep-resent a valid strategy in the treatment of muscle injuries in professional footballers.

Effect of Telerehabilitation and Outpatient Rehabilitation in Women with Breast Cancer.

Telemedicine was shown to be indispensable during the SARS-CoV-2 pandemic to ensure continuity of care for fragile patients. We compared a telerehabilitation program versus an outpatient rehabilitation program in women with breast cancer undergoing quadrantectomy surgery. There were 56 women with breast cancer divided into two groups: the treatment group (TG), made up of 24 patients undergoing a remote rehabilitation project program; and the control group (CG), composed of 32 patients subjected to the same rehabilitation project program in an outpatient setting. At the time of enrollment (T0) and the end of the 8 weeks of treatment (T1), the following questionnaire scores were considered: numerical rating scale (NRS), Disabilities of the Arm, Shoulder and Hand questionnaire (Quick-DASH), Piper fatigue scale (PFS)m and Breast Cancer Therapy Functional Rating Scale (FACT-B). We observed that the CG showed greater improvements than the TG in upper limb function (7.8 ± 4.2 vs. 10.9 ± 4.9; p < 0.05) and quality of life (27.9 ± 7.2 vs. 40.0 ± 3.3; p < 0.05). No difference in efficacy between the two groups was observed for pain (2.2 ± 0.6 vs. 2.3 ± 0.9; p = 0.64) and fatigue (3.2 ± 1.1 vs. 3.2 ± 0.6; p = 0.66). Telerehabilitation is a valid tool in the management of women with breast cancer in the postoperative phase. However, face-to-face rehabilitation treatment may be preferred because it is more effective as it allows the construction of a specific, personalized, and targeted rehabilitation program.

Immersion Ultrasound Therapy in Combination with Manual Therapy in the Treatment of Ischemic Digital Ulcers in Systemic Sclerosis.

Background and Objectives: Digital ulcers (DUs) are the most common complication in patients with Systemic Sclerosis (SSc). They cause pain with hand dysfunction and negatively impact activities of daily and working life. Our study aims to evaluate the efficacy of a combined treatment of manual therapy and ultrasound therapy in SSc patients with ischemic DU (IDU) compared to manual therapy alone. Materials and Methods: We conducted a before-and-after study (non-randomized study). We enrolled a consecutive series of IDU patients undergoing rehabilitation treatment and divided them into two groups: a treatment group consisting of patients undergoing a combination of manual therapy and US water immersion and a standard care group consisting of patients subjected to manual therapy alone. At the time of the first visit (T0) and at the end of the 4-week rehabilitation period (T1), we evaluated functional capacity, pain intensity, ulcer evolution, and quality of life. Results: In the treatment group, we observed a statistically significant improvement in the functional capacity of the hand (DHI: 28.15 ± 11.0 vs. 19.05 ± 8.83; p < 0.05), pain (NRS: 5.55 ± 1.2 vs. 2.9 ± 1.09; p < 0.05), and PSST score (24.4 ± 4.0 vs. 16.2 ± 2.36; p < 0.05). In the standard care group, we observed a statistically significant improvement only for the functional capacity of the hand (DHI: 28.85 ± 9.72 vs. 22.7 ± 7.68; p < 0.05). Finally, from the comparison between the treatment group and the standard care group, we observed statistically significant improvements in pain (2.9 ± 1.09 vs. 4.5 ± 1.07; p < 0.05) and in the PSST scale (16.2 ± 2.36 vs. 20.4 ± 4.02; p < 0.05). Furthermore, at the end of treatment in the treatment group, 15 ulcers (62.5%) were completely healed, while in the standard care group, only 3 ulcers were completely healed (14.3%). Conclusions: Combined treatment with manual therapy and ultrasound therapy appears to be useful in the management of IDU in patients with scleroderma.

Neck Pain in Fibromyalgia: Treatment with Exercise and Mesotherapy.

BACKGROUND AND OBJECTIVES: Fibromyalgia is a very common musculoskeletal disease. The purpose of this study is to assess, on a population of fibromyalgic patients, the clinical efficacy of antalgic mesotherapy with diclofenac and thiocolchicoside in the treatment of cervical pain reduction for improvement of the functional capacity and quality of life of these patients. MATERIALS AND METHODS: We conducted an observational study of 78 fibromyalgia patients recruited using our hospital database. Based on the different types of treatment received, the patients were divided into two groups: the treatment group (TG), who received antalgic mesotherapy with diclofenac, thiococolchicoside, and mepivacaina; and the placebo group (PG), who received mesotherapy with sodium chloride solution. Patients in both groups also received the same rehabilitation protocol of 20 sessions. The primary outcome evaluated was the extent of pain. The secondary outcomes were the functional capacity and quality of life. RESULTS: Pain improved both in the treatment group (7.4 ± 1.2 vs. 5.1 ± 1.1; p < 0.05) and placebo group (7.5 ± 1.4 vs. 6.1 ± 1.6; p < 0.05). The treatment group, compared to the placebo group, also showed significant statistical improvements in functional capacity (NDI: 35.6 ± 5.23 vs. 19.3 ± 3.41; p < 0.05) and quality of life (SF-12: 18.3 ± 4.11 vs. 33.1 ± 2.41; p < 0.05). CONCLUSIONS: Mesotherapy treatment with diclofenac and thiocolchicoside is a safe and effective procedure in the management of neck pain in fibromyalgia patients in the short term in terms of pain reduction, functional recovery and quality of life.

Intra-Articular Injection of Botulinum Toxin for the Treatment of Knee Osteoarthritis: A Systematic Review of Randomized Controlled Trials.

The purpose of the present paper was to review the available evidence on intra-articular botulinum toxin (BTX) injection in the treatment of knee osteoarthritis and to compare it to other conservative treatment options. A systematic review of the literature was performed on the PubMed, Scopus, Cochrane Library, Web of Science, Pedro and Research Gate databases with the following inclusion criteria: (1) randomized controlled trials (RCTs), (2) written in the English language, and (3) published on indexed journals in the last 20 years (2001-2021) dealing with the use of BTX intra-articular injection for the treatment of knee OA. The risk of bias was assessed using the Cochrane Risk of Bias tool for RCTs. Nine studies involving 811 patients in total were included. Patients in the control groups received different treatments: conventional physiotherapy, hyaluronic acid injection or prolotherapy or a combination thereof in 5 studies, steroid infiltrative therapy (triamcinolone) in 1 study, placebo in 2, and local anesthetic treatment in 1 study. Looking at the quality of the available literature, two of the included studies reached "Good quality" standard, three were ranked as "Fair", and the rest were considered "Poor". No major complications or serious adverse events were reported following intra-articular BTX, which provided encouraging pain relief, improved motor function, and quality of life. Based on the available data, no clear indication emerged from the comparison of BTX with other established treatments for knee OA. The analysis of the available RCTs on BTX intra-articular injection for the treatment of knee OA revealed modest methodological quality. However, based on the data retrieved, botulinum toxin has been proven to provide good short-term outcomes, especially in patients with pain sensitization, by modulating neurotransmitter release, peripheral nociceptive transduction, and acting on the control of chronic pain from central sensitization.

Is There a Relationship between Idiopathic Scoliosis and Body Mass? A Scoping Review.

The etiopathogenesis of idiopathic scoliosis remains unknown, although genetic or hereditary factors, neurological disorders, hormonal and metabolic dysfunctions, biomechanical factors, and environmental factors seem to be involved. Several studies have found that patients with scoliosis have common characteristics of taller stature, lower body mass index (BMI), and low systemic bone mass. We conducted a scoping review to analyze the association between idiopathic scoliosis and BMI. The search for articles was performed on PubMed and Cochrane, including the English language, full-text and free-full-text articles published from 31 December 2011 to 31 December 2021. Most of the results analyzed are in favor of a relationship between low BMI and scoliosis. Having a low BMI could be associated with the presence of scoliosis, although the reason for which is still doubtful. However, further large-scale epidemiological studies on different ethnicities and a comparison of BMI with the healthy population will be needed to better define the correlation between BMI and scoliosis.

Postural Assessment Systems in the Prevention of Haemophilic Arthropathy: A Narrative Review.

This narrative review aims to give an overview of some postural evaluation systems currently used in patients with haemophilia. Among them, first, we analyse the HJHS scale, recognized as a specific evaluation tool for haemophilic arthropathy. Second, we focus on other systems usually used in non-haemophilic patients that have also shown good applicability in this patient category, such as gait analysis, stabilometry, and baropodometric examination. This review underlines the use these tools could have in clinical practice to identify the early postural alterations in patients with haemophilia and set up personalised rehabilitation programs.

Can the Combination of Rehabilitation and Vitamin D Supplementation Improve Fibromyalgia Symptoms at All Ages?

Several studies have indicated a correlation between vitamin D deficiency and widespread chronic pain syndromes, such as fibromyalgia. During this study, the effect of supplementation with vitamin D in association with physical exercise in patients with fibromyalgia was evaluated, in terms of improvement of pain, functional capacity and quality of life, also evaluating the presence of any differences in age. A single-center, observational, comparative study was conducted in 80 fibromyalgia patients. They are randomized into 2 groups: Group A, consisting of patients ≤50 years; and group B, consisting of patients >50 years. Both received weekly supplementation with 50,000 IU cholecalciferol for 3 months in association with a rehabilitation protocol. Patients were assessed at enrollment (T0), 3 months (T1), and 6 months (T2) from the initial assessment with blood vitamin D dosage and administration of rating scales (NRS, FIQ, and SF-12). From the comparison between the two groups, we have seen that in young people, supplementation with high-dose vitamin D improves short-term musculoskeletal pain and long-term functional capacity. Conversely, musculoskeletal pain and long-term quality of life improve in the elderly. Supplementing with high doses of vitamin D in fibromyalgia patients improves the quality of life and pain in the elderly and also the functional capacity in the young.

Peri-Implant Distal Radius Fracture: Proposal of a New Classification.

A peri-implant fracture near the volar plate of the distal radius represents a rarity and can be associated with a mechanical failure of the devices. A literature review was conducted including all fractures that occurred around a volar wrist plate, which could be associated with an ulna fracture. All articles published until December 2021 were considered according to the guidelines presented in the PRISMA Statement. The search was conducted with the PubMed electronic database, Cochrane Database of Systematic Reviews, Medline, Embase, and Google Scholar. Only nine cases of these fractures were reported in the literature. The causes could be due to delayed union/non-union of the old fracture after low energy traumas, high energy trauma in patients with poor bone quality, or hardware mechanical failure. Furthermore, the literature review of peri-implant radius fracture shows different level of radius fracture and types of implant failure. In accordance with these different cases, a new classification of peri-implant fracture of the distal radius is proposed.

Rehabilitative interventions for ischaemic digital ulcers, pain, and hand functioning in systemic sclerosis: a prospective before-after study.

BACKGROUND: Systemic sclerosis (SSc) is a rare connective tissue disease characterised by immune dysfunction, vasculopathy, cellular inflammation, fibrosis of the skin associated with multiple internal organs involvement. Ischaemic digital ulcers (IDU) of the hands commonly occur in patients with SSc adversely affecting functional independence. PURPOSE: Aim of the study is to investigate the effectiveness of a rehabilitation protocol based on the combined use of ultrasound (US) therapy and therapeutic exercise in terms of ulcers healing, pain relief, and hand functioning in patients affected by SSc with IDUs. Moreover, we also investigated the safety of the proposed intervention. STUDY DESIGN: Prospective before-after study. METHODS: We included 20 patients with IDUs secondary to SSc. All patients were treated with US combined with manual therapy, including McMennel joint manipulation, pompage mobilization technique and connective tissue massage, for 10 sessions. We evaluated softness, dyschromia, pain, and hand mobility using the Pressure Sore Status Tool (PSST), the Numerical Rating Scale (NRS), and the Duruoz Hand Index (DHI) at T0 and at the end of the treatment (T1). RESULTS: Treatment with US combined with manual therapy significantly reduced ulcers depth, improved ulcers margins, and reduced periwound skin damage (median PSST score 16 at T1, p<0.0001). Moreover, significant benefits were reported in terms of pain relief (NRS 3 at T1; p<0.0005), and hand function (DHI score 19 at T1; p<0.0005). Finally, this approach seems to be safe, without side effects reported at the end of treatment, along with an optimal compliance. CONCLUSION: Therapeutic US combined with manual therapy should be used as additional intervention to manage IDUs in SSc patients.

Hybrid Hyaluronic Acid versus High Molecular Weight Hyaluronic Acid for the Treatment of Hip Osteoarthritis in Overweight/Obese Patients.

Background: Obesity is the main risk factor for hip osteoarthritis, negatively affecting the outcome of the disease. We evaluated the effectiveness of viscosupplementation with hybrid hyaluronic acid compared to that with high molecular weight hyaluronic acid in overweight/obese patients with hip osteoarthritis (OA). Methods: 80 patients were divided into two groups: a treatment group received two ultrasound-guided intra-articular hip injections of hybrid HA 15 days apart; a control group received a single ultrasound-guided infiltration with medium-high molecular weight hyaluronic acid (1500−2000 kDa). We assessed the pain, functional and cardiovascular capacity of the patients at baseline, after 3 months, and after 6 months of the infiltrative sessions. Results: The treatment group showed greater improvements in the scores on the NRS scale (5.4 ± 0.8 vs. 6.3 ± 0.8; p < 0.05) and in the Lequesne index (11.4 ± 2.6 vs. 13.6 ± 2.7; p < 0.05) and in the distance traveled at 6MWT (238.1 ± 53.9 m vs. 210.7 ± 46.2 m; p = 0.02) both at 3 months (T1) and at 6 months (T2). Conclusions: This study underlines the importance of exploiting the anti-inflammatory, analgesic, and chondrogenic properties of hybrid HA for the treatment of hip OA in overweight/obese patients.

Does the association of therapeutic exercise and supplementation with sucrosomial magnesium improve posture and balance and prevent the risk of new falls?

BACKGROUND: Fracture of the proximal femur is the most feared complication of osteoporosis. Given the numerous physiological functions that magnesium performs in our body, in the literature there is a correlation between osteoporosis and low serum levels of magnesium. AIM: Evaluate the incidence of hypomagnesemia in patients with lateral fragility fracture of the proximal femur, the possible correlation between serum magnesium levels and fractures, and the effectiveness of supplementing Sucrosomial® magnesium associated with therapeutic exercise on the outcome of these patients. METHODS: We divided the study into two parts. In the first part, we assessed the preoperative incidence of hypomagnesemia in patients using a blood test. In the second part, patients with hypomagnesemia were divided, in the post-operative period, into two groups, who received, respectively, only therapeutic exercise or oral supplementation with sucrosomial magnesium associated with therapeutic exercise. RESULTS: Half of the patients with fragility femoral fracture had hypomagnesemia, with a higher incidence of the subclinical form. From the comparison between the two groups, the T1 treatment group showed a significant improvement in blood levels of magnesium (2.11 ± 0.15 vs. 1.94 ± 0.11; p < 0.05), on the NRS scale (5.7 ± 0.81 vs. 6.6 ± 1.18; p < 0.05), the Tinetti scale (17.3 ± 1.15 vs. 15.2 ± 2.98; p < 0.05) and the SarQoL questionnaire (47.3 ± 5.21 vs. 44.9 ± 5.54; p < 0.05). CONCLUSIONS: More attention would be needed in the diagnosis and correction of subclinical hypomagnesemia and not just the simple and clinically evident one, including hypomagnesemia among the modifiable risk factors for osteoporosis.

Risk Factors, Lifestyle and Prevention among Adolescents with Idiopathic Juvenile Scoliosis: A Cross Sectional Study in Eleven First-Grade Secondary Schools of Palermo Province, Italy.

Adolescent idiopathic scoliosis (AIS) has an incidence of 2-3% in the general population and a multifactorial etiology. The present study aims to analyze modifiable risk factors and their interactions in the development of AIS in order to increase knowledge about the disease and to prevent the evolution of AIS in young students with tailored public health strategies. A cross-sectional study was conducted over two consecutive school years among students attending 11 first-grade secondary schools in the province of Palermo, Italy. A self-administered questionnaire that investigated socio-demographical, physical and anamnestic characteristics and habits, focusing on possible risk factors associated with idiopathic scoliosis, was administered. In addition, a clinical evaluation was performed with Adams' test and Bunnel's inclinometer. Suspected AIS cases were associated with the practice of high-risk sports (p < 0.05), weekly physical activity lasting ≥3 h (p < 0.05), lower back pain (p < 0.001), posture disorders (p < 0.01) and having had no contact with a physician (p < 0.01). Practice of high-risk sports (adj OR = 1.83; CI 95% 1.11-4.76) and suffering of posture disorders (adj OR = 1.67; CI 95% 1.12-3.60) showed a significant association with a confirmed diagnosis of AIS (Cobb angle ≥ 10° at X-ray). The risk factors associated with AIS are still unclear. Therefore, it is crucial to identify early modifiable and multiple risk factors to prevent the evolution of scoliosis in school-age children.

Effectiveness of rehabilitation on pain and function in people affected by hemophilia.

INTRODUCTION: Literature provides unclear evidence of the effectiveness of many physiotherapy interventions on pain intensity, quality of life, and functional ability in hemophilic patients, and suggests that rehabilitation programs should be focused on functional goals and the disability of patients. AIM: The aim of the present study is to present the outcome of a case series of patients with hemophilia in which a rehabilitation program has been carried out on the basis of a specific individual patient's functional impairment. METHODS: Fifty-one patients were enrolled: 32 patients (Rehab Group) received a rehabilitative treatment, 19 patients for different reasons (living far from the hospital, family problems) did not receive rehabilitation (Control Group). The rehabilitation program was planned with respect to the emergent problems: musculoskeletal pain, joint range of motion limitation, muscle flexibility, walking difficulties, the appearance of hematomas/hemartro, and postural problems. All the patients were assessed at baseline (T0), after 1 month (T1), and after 3 months (T2) through visual analogic scale for musculoskeletal pain, the Hemophilia Joint Health Score for joint range of motion, the Functional Independence Score in Hemophilia for disability, and postural assessment by visual inspection. RESULTS: A significant reduction of pain and improvement of Hemophilia Joint Health Score and Functional Independence Score in Hemophilia score was found in the Rehab Group along with the follow-up. Pain in the Control Group was lower with respect to the other group at baseline and significantly decreased after 1 month. CONCLUSION: A rehabilitation program focused on individual impairment of patients with hemophylia determined satisfying results in terms of pain control, functional, and disability improvement in 3 months follow-up.

Physical Agent Modalities in Early Osteoarthritis: A Scoping Review.

Early osteoarthritis (EOA) still represents a challenge for clinicians. Although there is no consensus on its definition and diagnosis, a prompt therapeutic intervention in the early stages can have a significant impact on function and quality of life. Exercise remains a core treatment for EOA; however, several physical modalities are commonly used in this population. The purpose of this paper is to investigate the role of physical agents in the treatment of EOA. A technical expert panel (TEP) of 8 medical specialists with expertise in physical agent modalities and musculoskeletal conditions performed the review following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) model. The TEP searched for evidence of the following physical modalities in the management of EOA: "Electric Stimulation Therapy", "Pulsed Electromagnetic field", "Low-Level Light Therapy", "Laser Therapy", "Magnetic Field Therapy", "Extracorporeal Shockwave Therapy", "Hyperthermia, Induced", "Cryotherapy", "Vibration therapy", "Whole Body Vibration", "Physical Therapy Modalities". We found preclinical and clinical data on transcutaneous electrical nerve stimulation (TENS), extracorporeal shockwave therapy (ESWT), low-intensity pulsed ultrasound (LIPUS), pulsed electromagnetic fields stimulation (PEMF), and whole-body vibration (WBV) for the treatment of knee EOA. We found two clinical studies about TENS and PEMF and six preclinical studies-three about ESWT, one about WBV, one about PEMF, and one about LIPUS. The preclinical studies demonstrated several biological effects on EOA of physical modalities, suggesting potential disease-modifying effects. However, this role should be better investigated in further clinical studies, considering the limited data on the use of these interventions for EOA patients.

Pharmacological Treatment for Acute Traumatic Musculoskeletal Pain in Athletes.

Pain management is a crucial issue for athletes who train and compete at the highest performance levels. There are still evidence gaps for the use of analgesics for sports injuries despite the growing interest in training and competition settings. However, high-quality research is needed to determine the most appropriate and optimal timing and formulations in non-steroidal anti-inflammatory drug and opioid management, particularly given the strictness of anti-doping regulations. Indeed, the role of pharmacological therapy in reducing acute traumatic pain in athletes should still be addressed to minimize the timing of return to sport. Therefore, the aim of this comprehensive review was to summarize the current evidence about pain management in the setting of acute injury in elite athletes, providing the most informed strategy for pain relief and performance recovery.

A Prospective Open-Label Observational Study of a Buffered Soluble 70 mg Alendronate Effervescent Tablet on Upper Gastrointestinal Safety and Medication Errors: The GastroPASS Study.

Upper gastrointestinal (GI) side effects are a main reason for discontinuing bisphosphonate treatment, an important therapeutic option for osteoporosis patients. Consequently, the development of novel formulations with improved tolerability is warranted. In this multicenter prospective, observational, postauthorization safety study conducted in Italy and Spain, postmenopausal women (PMW) with osteoporosis (naïve to bisphosphonates) were treated weekly with a buffered soluble alendronate 70 mg effervescent (ALN-EFF) tablet (Binosto®) and followed for 12 ± 3 months. Information was collected on adverse events (AEs), medication errors, persistence, and compliance using the Morisky-Green questionnaire. Patients (N = 1028) aged 67 ± 9 years (mean ± SD) received ALN-EFF weekly. The cumulative incidence of upper GI AEs (oesophageal toxicity, gastritis, gastric ulcers, and duodenitis) related to ALN-EFF (primary endpoint) was 9.6% (95% confidence interval [CI] 7.9-11.6%), the vast majority being of mild intensity. The most frequently occurring upper GI AEs related to ALN-EFF were dyspepsia (2.7%), gastroesophageal reflux disease (2.4%), and nausea (2.2%). None of the relevant upper GI AEs listed in the primary endpoint and no serious AEs were reported. At least one medication error occurred in 29.9% (95% CI 27.1-32.8%) of patients. However, the majority of medication errors were associated with administration instructions applicable to any oral bisphosphonate and only seven medication errors were associated with the ALN-EFF formulation. ALN-EFF was discontinued in 209 of 1028 (20.3%) patients. The most frequent reasons for discontinuation were AEs related to ALN-EFF (46.9%) and patients' decision (42.6%). Compliance with ALN-EFF was high, reflected by a mean Morisky-Green score of 92.8 ± 18.6. PMW with osteoporosis treated with ALN-EFF in a real-world setting experienced few upper GI AEs. In addition, they had a low discontinuation and high compliance compared with other formulations, suggesting that ALN-EFF may increase patient satisfaction and therefore long-term adherence and efficacy. © 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Effectiveness of Rehabilitative Intervention on Pain, Postural Balance, and Quality of Life in Women with Multiple Vertebral Fragility Fractures: A Prospective Cohort Study.

Patients with vertebral fragility fractures often experience chronic pain, postural and balance disorders, and poor quality of life (QoL). Although several studies have investigated the role of rehabilitation in severe osteoporosis, the effectiveness of this intervention in patients with multiple vertebral fractures is poorly known. The aim of our longitudinal cohort study is to evaluate the effectiveness of rehabilitation, including postural training, resistance exercises, and visual stabilization exercises, for a 7-week period, on the pain, postural balance, and QoL of subjects with at least two vertebral fragility fractures receiving denosumab and vitamin D. We investigated, before (T0) and after (T1, at 7 weeks) rehabilitation, the following outcome measures on 28 patients: pain (Numerical Rating Scale (NRS)), self-perceived QoL (36-Item Short Form Survey (SF-36) and Mini-Osteoporosis Quality of Life Questionnaire (Mini-OQOL)), dizziness (Dizziness Handicap Inventory (DHI-I)), mobility (Timed-Up and Go (TUG) test), and instrumental posturographic assessment (FreeMed posturography system). At the end of the treatment, improvements of pain and QoL were recorded. Pain relief was highly obtained in patients with more than two vertebral fractures. Moreover, a significant functional improvement (TUG test) was found in those with two vertebral fractures, without any statistically significant change reported for other outcomes. Our findings suggest that combined intervention, including anti-osteoporotic drugs and postural rehabilitation, should be proposed to osteoporotic patients with multiple vertebral fractures.