ABSTRACT
INTRODUCTION: Patients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a need for evidence-based conservative treatment to aid in the management of OVCFs. The objective of this randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of dynamic bracing in addition to standard care for improving quality of life (QoL) in patients suffering from an OVCF. METHODS AND ANALYSIS: Ninety-eight postmenopausal women from two academic and four community hospitals with a recent symptomatic thoracolumbar OVCF will be randomised into either the standard care or dynamic bracing group. In the dynamic bracing group, the Spinova Osteo orthosis will be used in addition to standard care. Standard care comprises pain control with analgesics, physical therapy and osteoporosis medication. The primary outcome parameter is QoL 1 year after inclusion, as measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. A trial-based economic evaluation consisting of both cost-effectiveness analysis and cost-utility analysis will be performed based on empirical data obtained in the RCT. A process evaluation will assess the feasibility of dynamic bracing. All outcomes will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee, University Hospital Maastricht and Maastricht University (METC azM/UM) (NL74552.068.20/METC 20-055). Patients will be included only after verification of eligibility and obtaining written informed consent. Results will be disseminated via the Dutch National Osteoporosis Patient Society and via publications and conferences. TRIAL REGISTRATION NUMBER: NL8746.
Subject(s)
Fractures, Compression , Osteoporosis , Osteoporotic Fractures , Spinal Fractures , Cost-Benefit Analysis , Female , Follow-Up Studies , Fractures, Compression/therapy , Humans , Multicenter Studies as Topic , Osteoporosis/complications , Osteoporosis/therapy , Osteoporotic Fractures/therapy , Pain , Quality of Life , Randomized Controlled Trials as Topic , Spinal Fractures/therapyABSTRACT
Torticollis in children is a frequently encountered problem. Whereas non-traumatic torticollis usually allows a non-urgent work-up, traumatic torticollis-even in the absence of neurologic abnormalities-needs prompt analysis for structural damage of the spinal column and myelum. Even a trauma as mild as a head-over-heels may result in atlanto-axial subluxation as demonstrated by this patient as described in this case report. In all children with post-traumatic torticollis, further analysis is needed. Atlanto-axial subluxation without neurological or radiological abnormalities can be treated conservatively with a soft collar and analgesics.
