Chronic low back pain (CLBP) remains a leading cause of disability worldwide and imposes a substantial personal and socioeconomic burden. Despite exercise being the first-line recommended intervention in clinical guidelines, its efficacy on pain relief remains modest and the hypoalgesia induced by exercise seems to be limited in individuals with musculoskeletal pain. Previous transcranial direct current stimulation (tDCS) studies have mainly targeted the motor cortex, yielding heterogeneous results, underscoring the need to evaluate alternative brain areas. Recently, tDCS studies targeting the dorsolateral prefrontal cortex (DLPFC) may enhance endogenous pain modulation and thereby potentiate the response to exercise. This study aims to compare the effects of adjunctive anodal DLPFC tDCS combined with a standardised exercise programme versus sham tDCS combined with the same exercise programme on pain and function in adults with CLBP.
This is a single-centre, triple-blinded, parallel-group randomised controlled trial. 48 participants with CLBP will be randomly assigned to receive either anodal tDCS over the left PFC combined with exercises, or sham tDCS combined with the same exercise programme, over nine sessions during a 3-week period. The primary outcome is the change in the multidimensional impact of CLBP, assessed using the Core Outcome Measures Index, from baseline to postintervention (week 4). Secondary outcomes include pain intensity, disability, psychological factors (fear-avoidance beliefs, catastrophising, anxiety, depression), measured at baseline, postintervention and at 12- and 24-week follow-up. Functional brain connectivity via electroencephalography and neuromuscular function of the erector spinae (flexion–relaxation phenomenon) will be measured at baseline and postintervention.
This study was approved by the Commission Cantonale d’Ethique de la Recherche sur l’être humain (CCER) in December 2022 (reference number: 2022-D0077). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed publications and presentations at national and international conferences.
Neoplastic foot ulcers are particularly challenging for dermatologists and specialists in hard-to-heal wounds because their location and comorbidities can delay accurate diagnosis. We performed a multicentre, retrospective study analysing clinical and histological data, focusing on neoplastic foot ulcers collected over the past 5 years. We evaluated patients' demographic characteristics, clinical features, histological diagnosis, tumour onset and ulcer site. Statistical analyses were conducted using SPSS software, v.30. In total, 106 patients affected by foot skin ulcers were enrolled in the present protocol (52 women, 54 men). The mean age was 70.15 years. In most cases, the neoplastic ulcer was due to primary tumour ulceration. The dorsum of the foot was the most common site of neoplastic ulcers (66%). From a clinical perspective, most lesions were classified as ulcerated nodules (n = 58), ulcerated plaques (n = 8) or hypergranulating ulcers (n = 25), all with thickened, atypical edges. Histological diagnoses included melanoma (n = 45), non-melanoma skin cancers (n = 34), benign tumours (n = 18) and rarer malignancies (n = 9). A statistically significant correlation was found between histotype and clinical lesion type, and between age and histotype. The study provided preliminary data on the clinical and histological characteristics of neoplastic foot ulcers, warranting further exploration in a prospective, multicentre study.
Functional seizures (FS) are events that resemble epileptic seizures, but are not attributed to brain pathology and are instead thought to be due to psychological factors. A small, multisite, open-label, single-arm, pilot trial of a breathing intervention known as breathing control training (BCT) found it to be safe and effective in reducing seizure frequency in FS. We propose a protocol for a study to confirm these results.
A 24-week, multicentre, individually-randomised, assessor-blinded, two-arm, parallel-group efficacy and acceptability trial of BCT versus control (Befriending) in 220 participants ≥16 years of age with FS. Eligible participants will be randomly allocated to receive two sessions of either BCT or Befriending over a 4-week period. Sessions will be delivered by a respiratory physiotherapist at a clinical care site or via telehealth. They will complete assessments prior to commencing treatment and at 4, 12 and 24 weeks after their initial session of BCT/Befriending. The trial will be conducted alongside treatment as usual. An economic evaluation including cost-utility and cost-effectiveness analyses will be carried out from health sector and societal perspectives.
The study has been approved by The Austin Health Human Research Ethics Committee (HREC/84335/Austin-2022) and the New Zealand Central Health and Disability Ethics Committee (2022 FULL 12324). Findings will be reported to trial participants and consumers; presented at local, national and international conferences; and disseminated by a peer-reviewed scientific journal.