Capacitively Coupled Electric Fields in the Treatment of Acute Vertebral Fragility Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 主要终点
- VBME resolution in MRI
研究概览
简要总结
in recent years the search for therapeutic protocols that could enhance the VFFs healing, thus reducing bed rest-related complications and improving the quality of life of osteoporotic patients. In this context, biophysical stimulation with Capacitively Coupling Electric Fields (CCEF) together, antiresorptive therapy, vitamin D supplementation, and analgesic drugs could play a central role.
CCEF is a non-invasive type of biophysical stimulation used to enhance fracture repair and spinal fusion. Positive effects of CCEF have been reported in osteoporotic vertebral fractures to resolve chronic pain and in postoperative pain, disability, and quality of life after spinal fusion In a preliminary observational study, Piazzolla et al. showed a significantly faster VBME resolution and back pain improvement in patients suffering from VFFs.
详细描述
Between January 2015 and December 2020, patients referring to the spine centres participating in this multicentre randomized controlled trial with acute VFFs type OF1 or OF2 were included in the present study. Ethical clearance was obtained from our centre's clinical research ethics, as per the 1964 Declaration of Helsinki, and all patients gave informed consent before enrolment in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female;
- •years≥ 60 years old;
- •BMI ≤ 35 kg/cm2;
- •fracture site between T10 and L3;
- •pain at the VCF level;
- •low back pain onset within twenty days;
- •VBME>60% in MRI at baseline;
- •VBME in a maximum of two vertebral bodies.
排除标准
- •posterior wall /pedicle injury;
- •previous vertebroplasty/ kyphoplasty;
- •history of spine infection or tuberculosis;
- •history of malignant tumours that could spread to the spine;
- •concomitant rheumatoid arthritis or spondylarthritis;
- •scoliosis ≥ 40° according to Cobb;
- •thoracolumbar kyphosis>20° or thoracic kyphosis>70°;
- •any contraindication to MRI;
- •use of biomedical devices.
研究组 & 干预措施
CCEF group
In the CCEF Group, patients received, as an adjunct to the clinical study protocol, CCEF stimulation (Osteospine®, IGEA SpA, Carpi, Italy) 8 h/die for sixty days.
Clinical study protocol: (1) bed rest for the first twenty-five days and subsequent mobilization with a three-point hyperextension brace; (2) antiresorptive therapy (75 mg risedronate tablet weekly); (3) supplemental calcium carbonate with 1000 mg of elemental calcium daily if needed based on serum calcium concentration; (4) Vitamin D (≤500 IU daily) if the serum 25-hydroxyvitamin D concentration at the time of screening was below 16 ng/ml). Analgesic therapy with paracetamol 1000mg tablets was assumed for seven days and further depending on pain intensity; patients were required to report on a specific sheet paracetamol assumption.
干预措施: Capacitive Coupled Electric Fields (CCEF) (Device)
Control Group
(1) bed rest for the first twenty-five days and subsequent mobilization with a three-point hyperextension brace; (2) antiresorptive therapy (75 mg risedronate tablet weekly); (3) supplemental calcium carbonate with 1000 mg of elemental calcium daily if needed based on serum calcium concentration; (4) Vitamin D (≤500 IU daily) if the serum 25-hydroxyvitamin D concentration at the time of screening was below 16 ng/ml). Analgesic therapy with paracetamol 1000mg tablets was assumed for seven days and further depending on pain intensity; patients were required to report on a specific sheet paracetamol assumption.
干预措施: Calssic clinical protocol (Other)
结局指标
主要结局
VBME resolution in MRI
时间窗: Changes of VMBE at 60 days FU
MRI of the spine
次要结局
- quality of life and back pain improvement(Improvement of quality of life at 180 days FU compared to baseline)
- Pain improvement(Changes of pain at 180 days FU compared to baseline)
研究者
Davide Bizzoca
MD, PhDs. PhDs in Public health, Clinical Medicine and Oncology. DiMePre-J, University of Bari
University of Bari Aldo Moro