IncobotulinumtoxinA for the treatment of spasticity in children with cerebral palsy - a retrospective case series focusing on dosing and tolerability.

BACKGROUND: IncobotulinumtoxinA (Xeomin®) is a botulinum neurotoxin type A with established efficacy in the treatment of upper-limb spasticity in adults. This retrospective case series in a university hospital setting aimed to elucidate the safety and tolerability of incobotulinumtoxinA for treatment of spasticity in children with cerebral palsy. METHODS: Participants received incobotulinumtoxinA injections up to a maximum total dose of 600 U, 24 U/kg body weight. Medical records were reviewed for key demographic information, incobotulinumtoxinA exposure, and adverse effects (AEs). RESULTS: Sixty-nine children were included (mean age [SD], 8.3 [3.9] years; 44/69 [63.8%] male). One-hundred-and-ninety-one injections were administered, with mean (SD) of 2.8 (1.5) treatment cycles/participant and dosing interval of 6.0 (1.7) months. The number of muscles injected increased from 2.4 (1.2) at cycle 1 to 4.2 (1.9) at cycle 6. The mean (SD) total incobotulinumtoxinA dose increased from 191.7 (126.2) U, (8.5 [5.4] U/kg body weight) at cycle 1 to 368.0 (170.1) U, (9.9 [5.5] U/kg body weight) at cycle 6. Seventy four adverse effects (37.5% of injections) were reported, the most frequent was injection pain (93.2% of AEs). Only three AEs were considered directly treatment-related by injectors: muscle weakness, generalized weakness, and fever. CONCLUSIONS: Our clinical experience indicates that incobotulinumtoxinA is a well-tolerated treatment option for focal spasticity in children with cerebral palsy. TRIAL REGISTRATION: As the study was observational and retrospective, no EudraCT registration number was requested. The internal code assigned to the study in the administrative resolution was: 1143-N-15.

Efficacy of myofascial therapy and kinesitherapy in improving function in shoulder pathology with prolonged immobilization: A randomized, single-blind, controlled trial.

BACKGROUND: The best physiotherapeutic approach in shoulder pathology that generates prolonged immobilization is still uncertain. Kinesitherapy remains the most widely used option. Myofascial therapy is a therapeutic approach in which the aim is to release fascial tension and regain mobility although its efficacy in shoulder pathology has not been sufficiently studied. This Prospective, single-blind randomized controlled trial in a university hospital setting aimed to compare the efficacy of myofascial therapy and kinesitherapy in improving function in shoulder pathology with prolonged immobilization. METHODS: Patients were randomly assigned to a control group or to the intervention group.Both groups completed a therapeutic exercise program. MAIN OUTCOME MEASURES: The QuickDash questionnaire was the primary outcome, Pain Visual Analog Scale and the Range Of Motion of the shoulder were the secondary outcomes. The outcomes were evaluated at baseline (T0), at 4 (T2), 8 (T2), and 12 weeks (T3) RESULTS: 44 participants were included. In the analysis of evolution over time, a significant improvement in functionality and range of motion measurements was observed in both groups (p < 0.05), although at 12 weeks only Myofasical Group achieved a clinically and statistically significant reduction in pain. Comparative analysis at 12 weeks revealed no statistically significant differences between the two therapies in the variables explored. CONCLUSIONS: Both, myofascial therapy and kinesitherapy can improve function, mobility, and pain in patients with painful shoulder associated with prolonged immobilization, with no significant differences between therapies, although in the medium term only myofascial therapy achieves a clinically and statistically significant improvement in pain. TRIAL REGISTRATION: Trial registration: ClinicalTrials.gov NCT04944446.