TY - JOUR
T1 - Effectiveness and cost-effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures
T2 - protocol for a multicentre, two-armed, parallel-group randomised controlled trial with 12 months of follow-up
AU - Weber, Annemarijn
AU - Huysmans, Stephanie M D
AU - van Kuijk, Sander M J
AU - Evers, Silvia M A A
AU - Jutten, Elisabeth M C
AU - Senden, Rachel
AU - Paulus, Aggie T G
AU - van den Bergh, Joop P W
AU - de Bie, Rob A
AU - Merk, Johannes M R
AU - Bours, Sandrine P G
AU - Hulsbosch, Mark
AU - Janssen, Esther R C
AU - Curfs, Inez
AU - van Hemert, Wouter L W
AU - Schotanus, Martijn G M
AU - de Baat, Paul
AU - Schepel, Niek C
AU - den Boer, Willem A
AU - Hendriks, Johannes G E
AU - Liu, Wai-Yan
AU - Kleuver, Marinus de
AU - Pouw, Martin H
AU - van Hooff, Miranda L
AU - Jacobs, Eva
AU - Willems, Paul C P H
N1 - © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/5/24
Y1 - 2022/5/24
N2 - 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.
AB - 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.
KW - Cost-Benefit Analysis
KW - Female
KW - Follow-Up Studies
KW - Fractures, Compression/therapy
KW - Humans
KW - Multicenter Studies as Topic
KW - Osteoporosis/complications
KW - Osteoporotic Fractures/therapy
KW - Pain
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Spinal Fractures/therapy
KW - EFFICACY
KW - bone diseases
KW - orthopaedic & trauma surgery
KW - PATHOGENESIS
KW - KYPHOSIS
KW - QUALITY-OF-LIFE
KW - QUESTIONNAIRE
KW - DEFORMITY
KW - MANAGEMENT
KW - spine
KW - STRENGTH
KW - PERCUTANEOUS VERTEBROPLASTY
KW - SPINAL ORTHOSIS
KW - back pain
U2 - 10.1136/bmjopen-2021-054315
DO - 10.1136/bmjopen-2021-054315
M3 - Article
C2 - 35613823
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e054315
ER -