Objective Long-term Data Recording of Daily Activity in Patients with Failed Back Surgery Syndrome Treated with Spinal Cord Stimulation - a Prospective 12-month Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Position reporting: Intellis SnapShot Reporting
研究概览
简要总结
In spinal cord stimulation (SCS), most outcome data are based on patient questionnaires. The lack of tools for objective evaluation of the effects of SCS on chronic pain has posed a barrier for providing solid proof of the therapy. Currently, however, SCS-devices with an accelerator included are available on the market. The position orientation data provided by the neurostimulator therefore gives new possibilities for objective measurement of gross activity in daily life.
详细描述
Although the interaction between chronic pain and physical functioning is a well-accepted paradigm, objective data on how pain affects individuals' daily life is scanty. Most data are based on patient questionnaires. The purpose of this study is to objectively assess the activity of daily living in chronic pain patients treated with spinal cord stimulation (SCS).
Indication: Chronic pain in the low-back and/or leg(s) due to failed back surgery syndrome
Study Design: Prospective, open-label, multi-center, observational, study.
Sample Size: 50 patients receiving an Intellis neurostimulator for treatment with SCS.
Study Centers: Up to 10 sites in Europe
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractory chronic pain in low-back and/or legs that persists for at least 6 months following the most recent spinal surgery
- •18-70 years of age. Patients >70 years will not be included due to the reduction in general activity level that is usually seen in older patient cohorts.
- •Mean pain intensity should be 5 or higher measured on a Visual Analogue Scale (VAS).
- •Patient has been informed of the study procedures and has given written informed consent.
排除标准
- •Expected inability of patients to receive or properly operate the spinal cord stimulation system
- •History of coagulation disorders, lupus erythematosus, rheumatoid arthritis
- •Addiction to drugs, alcohol (5E/day) and/or medication
- •Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- •Active malignancy
- •Life expectancy < 1 year
- •Local infection or other skin disorder at site of incision
- •Pregnancy
结局指标
主要结局
Position reporting: Intellis SnapShot Reporting
时间窗: Change from baseline Intellis SnapShot Reporting at 12 months
The Intellis neurostimulator provides reports (extracted with the physician programmer) on the position of the patient over a certain time-period. The built-in software provides summary reports over periods of weeks.
次要结局
- Disability: Oswestry Disability Index (ODI)(Change from baseline ODI at 12 months)
- Sleep: Pain and Sleep Questionnaire eight item index (PSQ-8)(Change from baseline PSQI at 12 months)
- Health Related Quality of Life: EuroQoL Group - 5 Dimensional (EQ-5D)(Change from baseline EQ-5D at 12 months)
- Pain: Visual Analogue Scale (VAS)(Change from baseline VAS at 12 months)
研究者
Kliment Gatzinsky
MD, PhD
Vastra Gotaland Region