The Effect of Protein Supplement on Paraspinal Muscles in Patients Undergoing Lumbar Posterior Spine Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The thickness of the paraspinal muscles in CT scan
研究概览
简要总结
Protein intake in spinal fusion surgery can prevent paraspinal muscle atrophy by maintaining muscle mass, regeneration, and growth. Also, by reducing the amount of pseudarthrosis, pain and disability can have a positive effect on recovery.
The high prevalence of this type of surgery, the instability and degeneration of adjacent surfaces of fused sections, lumbar muscle atrophy, increased muscle tissue fat, and negative impact on patient recovery, also with regard to the fact that research has so far aimed to determine The effect of protein supplementation on para-spinal muscles has not been studied in patients undergoing posterior lumbar spine fusion surgery, therefore clinical trials are necessary. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.
详细描述
A randomized, double blind, controlled trial will be conducted in patients undergoing elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 80 eligible posterior spine fusion surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and control patients will be received maltodextrin along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of paraspinal muscles after 3 months surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18-65 years
- •Body mass index 18.5-30
- •Candidate for the elective posterior spine fusion
- •Without history of severe liver disorder
- •Without history of Kidney disorder
- •Without history of diabetes
- •Without history of trauma and fracture of the vertebral
- •Without history of osteoporosis
- •Without history of Gastrointestinal malabsorption
- •Without history of Parathyroid gland disorders
- •Without taking medications that affect the metabolism of bone, such as calcitonin, bisphosphonate, corticosteroid
- •No smoking
- •Without history of neuromuscular diseases such as dystrophies and neurological disorders
排除标准
- •Allergy or intolerance to protein or maltodextrine supplement
- •Unwillingness to continue cooperation
研究组 & 干预措施
protein supplement
Intervention patients will be received protein diet (1.2 g/kg/day) and protein supplement (36 g/day) for 1 month after surgery.
干预措施: Three sachet of protein supplement to be mixed in with water used daily (Drug)
maltodextrin
Control patients will be received protein diet (1.2 g/kg/day) and maltodextrin for 1 month after surgery.
干预措施: Three sachet of protein supplement to be mixed in with water used daily (Drug)
结局指标
主要结局
The thickness of the paraspinal muscles in CT scan
时间窗: 3 months after surgery
The thickness of the paraspinal muscles (multifidus, erector spinae, Quadratus, and Lumborum) in CT scan
次要结局
- Degree and severity of paraspinal muscle mass atrophy in CT scan(baseline, and 3 months after surgery)
研究者
Zahra Vahdat Shariatpanahi
Principal Investigator
Shahid Beheshti University