脊椎管狭窄症の高齢者における手術がバランスと活動に与える影響

タイトル: A multi-center investigation on the effect of decompressive surgery on Balance and physical ActiviTy Levels in patients with lumbar Spinal stenosis (B-ATLAS): Protocol for a prospective cohort study.

概要: BackgroundPatients with lumbar spinal stenosis may complain of poor balance, decreased physical function and problems maintaining physical activity levels due to radiculopathy. Decompressive surgery is often indicated if conservative management fails to achieve a satisfactory clinical outcome. While surgical management has proven effective at treating radiculopathy, and patients report increased physical function post-operatively, objective measures of postural control and physical activity remains sparse. This study aims to investigate the effects of decompressive surgery on balance and activity levels of elderly patients with lumbar spinal stenosis using objective measurements. Methods and analysisThis is a 24-month, multi-centre, prospective cohort study. Patients [≥] 65 years of age with MRI-verified symptomatic lumbar spinal stenosis will be recruited from two separate inclusion centres, and all participants will undergo decompressive surgery for lumbar spinal stenosis. Pre-operative data is collected up to 3 months before surgery, with follow-up data collected at 3, 6, 12 and 24-months post-operatively. Balance measurements are performed using the Wii Balance Board, mini-Balance Evaluation Systems Test and Tandem test, and data concerning physical activity levels are collected using ActiGraph wGT3X-BT accelerometers. Patient reported outcomes regarding quality of life and physical function are collected from the EuroQol-5D, 36-Item Short Form Health Survey and Zurich Claudication Questionnaire. Primary outcomes are the change in sway area of centre of pressure and total activity counts per day from baseline to follow-up at 24-months. A sample size of 80 participants has been calculated. Ethics and disseminationThe study has been approved by the Regional Ethics Committee of Region Zealand (ID EMN-2022-08110) and the Danish Data Protection Agency (ID REG-100-2022). All results from the study will be published in international peer-reviewed journals and presented at national and international conferences. Study findings will be disseminated through national patient associations. Trial registration numberNCT06075862 & NCT06057428 STRENGTHS AND LIMITATIONSO_LIThis study will provide new knowledge concerning the effects of lumbar spinal decompression surgery on postural control and physical activity levels. C_LIO_LIA follow-up period of two years ensures that changes in the primary outcomes are sufficiently documented. C_LIO_LIThis will be the first study to correlate changes in postural control with changes in physical activity levels amongst patients with lumbar spinal stenosis. C_LIO_LIA pre-post prospective cohort design provides the necessary comparative control group. C_LI