Identifying Biomarkers and Changes in Cerebrospinal Fluid Collected Pre and Post Spinal Cord Stimulation: A Single Centre, Prospective, Exploratory Study in Subjects Suffering From Chronic Refractory Pain Conditions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Pain Map
研究概览
简要总结
This is a single center exploratory study in subjects suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (CSF).
The study aims to identify any form of correlation between biological content of CSF and pain/treatment success. The study population include individuals suffering from chronic pain which has not been effectively treated with pharmacological treatment, medical intervention or alternative non-invasive treatments who have been scheduled for spinal cord stimulation.
详细描述
This is a single centre exploratory study in individuals suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (CSF).
The investigators aim to identify any form of correlation between biological content of CSF and pain/ spinal cord stimulator (SCS) therapy success. '
CSF will be sampled before and after SCS therapy, the samples will be analysed to explore and identify biomarkers that are potentially relevant to the chronic pain conditions
. All eligible participants who are enrolled in the study will undergo screening assessment. Specifically, assessments will include pain scores assessed by Visual Analogue Scale (VAS), quality of life as assessed by the EQ-5D, disability as assessed by the Oswestry Disability Index (ODI), quality of sleep as assessed by Pittsburgh Sleep Quality Index (PSQI), Pain sensation as assessed by Pain Map and neuropathic pain as assessed by Douleu Neuropathique 4 (DN4).
During trial implant participants will have CSF sample taken using lumbar puncture technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be capable of understanding and signing a written consent form
- •Subjects suffering from chronic neuropathic pain which has not been effectively managed with pharmacotherapy, medical interventions or alternative non-invasive treatments
- •Pain VAS score ≥ 5 on more than 3 days a week at least over three months.
- •Subjects deemed a suitable candidate receive spinal cord stimulator device as determined by a pain management specialist
- •No known contraindication to spinal cord stimulation
- •Does not have an active systemic or local infection
排除标准
- •Structural abnormalities of the spine at L2-L3 that may impact study procedure
- •Severe scoliosis
结局指标
主要结局
Pain Map
时间窗: 6 Months
A pain checklist with a list of anatomical locations from which the participants selects relevant sites to the site of his/her pain. It is used to assess location of pain. Participants will be asked to complete this questionnaires at baseline and follow up visits.
Patient Global Impression of Change (PGIC)
时间窗: 6 Months
Questionnaire used to assess patient satisfaction Participants will be asked to complete this questionnaires at follow up visits. .
Douleur Neuropathique 4 (DN4)
时间窗: 6 Months
A clinician-administered questionnaire consisting of 10 items. Seven items related to pain quality (i.e. sensory and pain descriptors) are based on an interview with the patient and 3 items based on the clinical examination. The questionnaire used to assess neuropathic pain Participants will be asked to complete this questionnaires at baseline and follow up visits.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 6 Months
A self report questionnaire that will used to assess improvements in sleep quality. The questionnaire consists of 19 items which measures several different aspects of sleep. Each item is weighted on a 0 - 3 interval scale, the overall score is calculated by totalling the seven component scores. Lower scores denote a healthier sleep quality Participants will be asked to complete this questionnaires at baseline and follow up visits.
Pain VAS
时间窗: 6 Months
Visual Analogue Scale (VAS) used to assess improvements in pain. It is a continuous scale comprised of a horizontal line which is 10 centimeters (100mm) in length, anchored by 2 verbal descriptors, one which is no pain and the other worst imaginable pain. Lower scores denote a better outcome. Participants will be asked to complete this questionnaires at baseline and follow up visits.
Oswestry Disability Index (ODI)
时间窗: 6 Months
A self completed questionnaire used to assess changes in disability and health. The participants checks the statements which most closely resembles their situation. The scores for all the questions are summed with lower scores denote no disability. Participants will be asked to complete this questionnaires at baseline and follow up visits.
EQ-5D-5L
时间窗: 6 Months
A self report questionnaire used to assess improvements in quality of life. Participants will be asked to complete this questionnaires at baseline and follow up visits.
次要结局
未报告次要终点