Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine : Effects on Low Back Pain, Sagittal Alignment and Lipomatosis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Oswestry disability Index (ODI)
研究概览
简要总结
The purpose of this study is to determine how an important weight loss after bariatric surgery affects obese patients ' spine, and the effects it has on low back pain, sagittal alignment and lipomatosis .
详细描述
Obesity and back pain are massive public health problems, and the relationship between the two has not been described and studied. However, the investigators have also observed that many ex-obese patients still suffer from back and leg pain after an important weight loss.
The aim of this study is to measure the effect of weight loss on back pain, and to find out what parameters can explain such modifications (increasing or decreasing back pain).
The investigators will study clinical parameters, as well as radiological (to measure the effect of weight loss on spine sagittal alignment) and MRI (to measure lipomatosis, which is a fat epidural accumulation, responsible for nerve compression and therefore back and leg pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •BMI > 40 or BMI > 35 with comorbidities due to obesity ( criteria for bariatric surgery)
- •Follow up in Pompidou's Hospital Nutrition service
- •Bariatric surgery intervention ( Sleeve gastrectomy or By pass)
- •Follow up possible for one year or more
- •Being covered by French social insurance
- •Consent to participate in the study
排除标准
- •History of spine surgery
- •Bariatric surgery postoperative complication
- •Non mastering of french language
- •MRI contraindication
- •Patient under legal protection ( e.g. guardianship)
研究组 & 干预措施
Obese patients
干预措施: Full Spine Radiography (Diagnostic Test)
Obese patients
干预措施: Lumbar spine MRI (Diagnostic Test)
结局指标
主要结局
Oswestry disability Index (ODI)
时间窗: 2 years postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
Oswestry disability Index (ODI)
时间窗: 1 year postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
次要结局
- Short Form 12 (SF12)(2 years postoperative)
- Sagittal alignment(2 years postoperative)
- Visual Analog Scale (VAS)(2 years postoperative)
- Disc degeneration(2 years postoperative)
- Lipomatosis(2 years postoperative)
- Hospital anxiety and depression (HAD) scale(2 years postoperative)
- Oswestry disability Index (ODI)(6 months postoperative)
- Neck disability Index (NDI)(2 years postoperative)
- Sagittal alignment(6 months postoperative)
- Sagittal alignment(1 year postoperative)
- Disc degeneration(6 months postoperative)
- Disc degeneration(1 year postoperative)
- Lipomatosis(6 months postoperative)
- Lipomatosis(1 year postoperative)
- Visual Analog Scale (VAS)(6 months postoperative)
- Visual Analog Scale (VAS)(1 year postoperative)
- Neck disability Index (NDI)(6 months postoperative)
- Neck disability Index (NDI)(1 year postoperative)
- Short Form 12 (SF12)(6 months postoperative)
- Short Form 12 (SF12)(1 year postoperative)
- Hospital anxiety and depression (HAD) scale(6 months postoperative)
- Hospital anxiety and depression (HAD) scale(1 year postoperative)