Physiotherapy Screening for Referral of a Patient with Patent Foramen Ovale Presenting with Neck Pain as Primary Complaint: A Case Report.

Neck pain is a common musculoskeletal disorder encountered by physiotherapists. However, it may be the early manifestation of more alarming conditions, such as cardiovascular diseases mimicking musculoskeletal pain. Patent foramen ovale (PFO) is a congenital heart defect consisting of a small opening between the right and the left atrium. A 56-year-old male presented with neck pain and head heaviness as primary complaints. The cardiovascular profile and the behavioral symptoms led the physiotherapist to find an exaggerated blood pressure response during exercise; in addition to subtle neurological signs, this prompted the physiotherapist to make an urgent referral. At the emergency department a PFO was diagnosed. To the best of the authors' knowledge, this is the first case to describe a rare clinical presentation of a PFO presenting neck pain as primary complaint. This case report emphasizes the importance for physiotherapists to be able to triage patients for conditions outside their scope suggestive of further medical investigation.

Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies.

BACKGROUND: Etrasimod, a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively activates S1P receptor subtypes 1, 4, and 5, with no detectable activity on S1P2,3, is in development for the treatment of immune-mediated diseases, including ulcerative colitis. In these two phase 3 trials, we aimed to evaluate the safety and efficacy of etrasimod in adult patients with moderately to severely active ulcerative colitis. METHODS: In two independent randomised, multicentre, double-blind, placebo-controlled, phase 3 trials, ELEVATE UC 52 and ELEVATE UC 12, adults with active moderate-to-severe ulcerative colitis and an inadequate or loss of response or intolerance to at least one approved ulcerative colitis therapy were randomly assigned (2:1) to once-daily oral etrasimod 2 mg or placebo. Patients in ELEVATE UC 52 were enrolled from 315 centres in 40 countries. Patients in ELEVATE UC 12 were enrolled from 407 centres in 37 countries. Randomisation was stratified by previous exposure to biologicals or Janus kinase inhibitor therapy (yes vs no), baseline corticosteroid use (yes vs no), and baseline disease activity (modified Mayo score [MMS]; 4-6 vs 7-9). ELEVATE UC 52 comprised a 12-week induction period followed by a 40-week maintenance period with a treat-through design. ELEVATE UC 12 independently assessed induction at week 12. The primary efficacy endpoints were the proportion of patients with clinical remission at weeks 12 and 52 in ELEVATE UC 52 and week 12 in ELEVATE UC 12. Safety was evaluated in both trials. ELEVATE UC 52 and ELEVATE UC 12 were registered with ClinicalTrials.gov, NCT03945188 and NCT03996369, respectively. FINDINGS: Patients in ELEVATE UC 52 were enrolled between June 13, 2019, and Jan 28, 2021. Patients in ELEVATE UC 12 were enrolled between Sept 15, 2020, and Aug 12, 2021. ELEVATE UC 52 and ELEVATE UC 12 screened 821 patients and 606 patients, respectively, with 433 and 354 subsequently undergoing random assignment. The full analysis set of ELEVATE UC 52 comprised 289 patients assigned to etrasimod and 144 to placebo. In ELEVATE UC 12, 238 patients were assigned to etrasimod and 116 to placebo. In ELEVATE UC 52, a significantly greater proportion of patients in the etrasimod group achieved clinical remission compared with patients in the placebo group at completion of the 12-week induction period (74 [27%] of 274 patients vs ten [7%] of 135 patients; p<0·0001) and at week 52 (88 [32%] of 274 patients vs nine [7%] of 135 patients; p<0·0001). In ELEVATE UC 12, 55 (25%) of 222 patients in the etrasimod group had clinical remission compared with 17 (15%) of 112 patients in the placebo group at the end of the 12-week induction period (p=0·026). Adverse events were reported in 206 (71%) of 289 patients in the etrasimod group and 81 (56%) of 144 patients in the placebo group in ELEVATE UC 52 and 112 (47%) of 238 patients in the etrasimod group and 54 (47%) of 116 patients in the placebo group in ELEVATE UC 12. No deaths or malignancies were reported. INTERPRETATION: Etrasimod was effective and well tolerated as an induction and maintenance therapy in patients with moderately to severely active ulcerative colitis. Etrasimod is a treatment option with a unique combination of attributes that might address the persistent unmet needs of patients with ulcerative colitis. FUNDING: Arena Pharmaceuticals.

Assessing Cranial Nerves in Physical Therapy Practice: Findings from a Cross-Sectional Survey and Implication for Clinical Practice.

BACKGROUND AND OBJECTIVE: Serious pathologies of the neck can potentially result in cranial nerve palsy. Knowledge about cranial nerve examination (CNE) seems sparse, and its use is still unknown. We aim to investigate the knowledge, skills, and utilization of CNE of Italian physiotherapists. MATERIALS AND METHODS: An online cross-sectional survey. RESULTS: 396 completed the survey, reaching the required sample size. Although Italian physiotherapists consider CNE relevant (mean ± SD = 7.6/10 ± 2.0), over half of all responders (n = 229 (57.8%)) were not trained in the fundamentals and around a third did not use it in their daily practice (n = 138 (34.8%)). Additionally, participants were unconfident and insecure in conducting (n = 152 (38.4%) and n = 147 (37.1%)), interpreting (n = 140 (35.4%) and n = 164 (41.4%)), and managing the CNE (n = 141 (35.6%) and n = 154 (38.9%)). Possessing a musculoskeletal specialization was associated with an increased value attributed to clinical practice guidelines and reduced the lack of confidence in conducting, interpreting, and managing the CNE (respectively, n = 35 (25.5%), p = 0.0001; n = 32 (23.4%) p = 0.0002; n = 32 (23.4%) p = 0.0002). Working in a direct access setting significantly increased the considered relevance of guidelines and the concerns about arterial (p = 0.004) and other serious pathologies (p = 0.021). Pain and visual disturbances were considered the main indicators to CNE, demonstrating limited knowledge of signs and symptoms' indicating CNE. Participants considered specific training in CNE as relevant (mean ± SD = 7.6/10 = 2.1). CONCLUSIONS: a substantial proportion of Italian physiotherapists are not schooled in the fundamentals of cranial nerve examination. Given the number of physiotherapists who work in first contact roles, this is a professional concern.