Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture: a Single-center, Double-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in physical activity before and after intervention
研究概览
简要总结
The aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis.
The focus of the study is on the physical activity and mobility of participants.
The main questions the trial aims to answer are:
- Does vertebroplasty lead to increased physical activity as measured by accelerometer?
- Does vertebroplasty lead to increased mobility as measured by GPS (global positioning system)?
- Do physical activity and mobility correlate with pain, disability and quality of life?
Researchers will compare vertebroplasty to sham (simulated surgery without active intervention) to understand if vertebroplasty improves physical activity and mobility.
Participants will
- Undergo vertebroplasty or sham procedure
- Wear an accelerometer and a GPS-reciever in a belt for 1 week before to 4 weeks after the surgery
- Answer questionnaires regarding pain, disability and quality of life at regular intervals.
The knowledge gained from this can help determine who would benefit from vertebroplasty.
详细描述
Despite attempts at prevention, osteoporotic vertebral fracture occurs with increasing frequency as lifespans increase.
Patients with this disease can experience severe pain and disability, and when conservative treatment is inadequate, vertebroplasty is an option.
In this surgical procedure, polymethyl metacrylate, or "bone cement" is injected into the fractured vertebral body. However, the procedure is currently controversial for the treatment of osteoporotic vertebral fractures because there is not yet consensus on the efficacy.
By investigating the effect of vertebroplasty on mobility and physical activity, this study aims to contribute to resolution of the controversy.
The study is a prospective, double-blind, randomized, sham-controlled clinical trial, where participants will be randomized to either vertebroplasty or a sham operation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).
- •Focal tenderness on the level of the vertebral fracture.
- •Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence.
- •Osteoporotic Fractures type 1-
- •Fracture involves no more than 4 vertebral body levels.
- •Vertebroplasty can be done in one session.
- •Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥
- •Able to understand and read Danish.
- •Written informed consent.
- •Relevant pain started ≤ 3 months prior to enrollment.
排除标准
- •Contra-indications for spine surgery.
- •Platelets < 30 mia/l.
- •Osteoporotic Fractures type 5 and Pincer-type.
- •Complete collapse of the vertebral body precluding insertion of needle.
- •Presence of neurologic deficit.
- •Contraindications for MRI scanning.
- •Psychological or psychiatric disorder that is expected to interfere with compliance.
- •Active malignancy.
- •Mini Mental State Examination (MMSE) test score below
- •History of chronic back pain requiring ongoing opiate use.
- •Systemic or local infection of the spine.
结局指标
主要结局
Change in physical activity before and after intervention
时间窗: One week preoperatively to the end of the fourth postoperative week.
Physical activity is measured by accelerometer and presented as mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). An unweighted average of valid days within the preoperative week is compared with the unweighted average of valid days within the four postoperative weeks by relative change in percent.
次要结局
- Daily and weekly physical activity(One week preoperatively to 4 weeks postoperatively)
- Change in daily and weekly physical activity(One week preoperatively to 4 weeks postoperatively)
- Physical activity levels(One week preoperatively to 4 weeks postoperatively)
- Change in physical activity levels(One week preoperatively to 4 weeks postoperatively)
- Total daily distance and change in total daily distance(One week preoperatively to 4 weeks postoperatively)
- Time spent stationary and change in time spent stationary(One week preoperatively to 4 weeks postoperatively)
- Time spent away from home and change in time spent away from home(One week preoperatively to 4 weeks postoperatively)
- Patient-reported pain intensity.(VAS will be recorded once preoperatively and again 1, 2, 3, 4 and 5 days + 2 and 4 weeks postoperatively.)
- Patient-reported disability(Preoperatively and at 4 weeks postoperatively)
- Patient-reported health-related quality of life.(Preoperatively and at 4 weeks postoperatively)