A Prospective Open Label Feasibility Study to Investigate the Dynamic Brain Imaging in Patients With Intractable Neuropathic Pain Routinely Treated With Targeted Spinal Cord Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- The changes of PET-CT and metabolic activity/ mapping at 2 weeks.
研究概览
简要总结
Targeted SCS is a standard and safe interventional pain procedure that is offered to patients with intractable neuropathic pain for their symptomatic relief. The known and reported complications include technical failure to perform the procedure, failure to gain symptomatic relief, trauma to nerve, and infection. These risks are very low in incidence and part of any interventional pain procedure in the spine.
PET-CT scan involves insertion of a cannula and administration of a dye (FDG) as a contrast in a patient who has been fasted for at least 6 hours. The procedure is lengthy and can take up to 2 to 3 hours. This includes a 30-60 minute resting time following the injection of contrast. The actual scan itself takes up to 30 minutes. There is a small chance of pain and redness at the injection site. Allergic reaction to the radio-contrast is rare and is usually mild. Patients with known allergy to FDG will not be recruited in the study. Some patients can feel claustrophobic at the time of the scan which can make them feel anxious. The PET-CT scan involves radiation with associated risks as detailed in the previous section. All these risks will be explained to the patients at the time of the informed consent.
详细描述
Targeted Spinal Cord Stimulation (SCS) using dorsal root ganglion (DRG) stimulation is an effective therapy for a number of different chronic painful conditions of neuropathic origin. British Pain Society has issued a detailed list of indications for SCS which includes intractable neuropathic of various ethiologies. These patients may present with both peripheral and central sensitisation, clinically manifested as hyperalgesia and allodynia.
The National Institute for Health and Care Excellence (NICE- TA 159) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on SCS for chronic pain of neuropathic or ischemic origin. However much debate still exists about the exact mechanism and the pathways remain to be elucidated.
The neural pathway at the level of Dorsal root ganglion (DRG) is well described in anatomical dissections. DRG is no longer considered a passive anatomical structure but is an important junction in the pain pathway through which both afferent and efferent pain impulses are transmitted and there by the pathway is modulated.
Targeting DRG using both local anaesthetic and steroid as well as radiofrequency are well recognised techniques for managing patients with neuropathic back and leg pain both with and without previous surgery. It is a common practice for patients with radicular type back pain to undergo a trial of intervention such as DRG injection prior to undergoing surgery.
A growing body of evidence is emerging to support the use of targeted SCS at the level of DRG. Targeted SCS is a chronic pain management technique targeting the DRG - a cluster of sensory neurons that serve as a conduit of pain signals from the peripheral nervous system to the central nervous system. By stimulating this structure, pain signals can be blocked before they are transmitted to the spinal cord and processed in the brain. Unlike traditional SCS therapy, which targets nerves along the spinal cord's dorsal column, DRG stimulation offers selective targeting of pain areas, with fewer side effects, such as paresthesias. This will allow us to target more specific dermatomes and there by treating a much larger number of neuropathic pains including more localised lesions. The strongest evidence for the successful use of targeted SCS emerges from the 'ACCURATE' study which is a large a large multicentre study conducted in the United States of America. The ACCURATE study showed that DRG stimulation using the Axium system was better than traditional SCS (81.2 vs 55.7 percent) in providing pain relief. Participants also reported no differences in the intensity of paresthesias due to postural changes, a common side effect of traditional SCS therapy, while using the targeted SCS during the three-month trial. They also reported feeling less stimulated outside their area of pain, demonstrating the precision of DRG stimulation. The results of the U.S. study is also supported by a number of international, peer-reviewed scientific abstracts from Australia and Europe highlighting positive clinical outcomes of targeted SCS for the treatment of chronic, intractable pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between the age of 18-80 years who has intractable neuropathic pain.
- •Minimum baseline pain rating of 50mm on a 100mm NRS in the back and/or leg
- •Chronic pain of at least 6 months
- •Subject satisfies standard criteria in the study centre for SCS implantation and the NICE 159 criteria for management of intractable neuropathic pain.
- •Patients who have given their written informed consent.
- •Patient is able and willing to comply with study procedures and follow up schedule.
排除标准
- •Female patients of childbearing age who is or plans on becoming pregnant during the course of the study
- •Patients who have undergone radiofrequency or injection therapy at or on a target neural structure (DRG) during the past 90 days
- •Patient deemed unsuitable to have targeted SCS as assessed by the MDT.
- •Patients known to have a condition that in the investigator's judgement precludes participation in the study.
- •Patients who have received an investigational drug or have used an investigational device in the 30 days proceeding to study entry
- •Patients who are needle phobic or claustrophobic.
- •Known allergic reaction to radio-contrast.
- •Patients who are at high risk of a radiation hazard (previous radiation induced injury or cancer or previously received high radiation doses).
结局指标
主要结局
The changes of PET-CT and metabolic activity/ mapping at 2 weeks.
时间窗: 2 weeks
Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 2 weeks post treatment.
The changes PET-CT and metabolic activity/ mapping at 3 months.
时间窗: 3 months
Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 3 months post treatment.
The changes PET-CT and metabolic activity/ mapping at 6 months.
时间窗: 6 months
Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 6 months post treatment.
The PET-CT and metabolic activity/ mapping at baseline.
时间窗: baseline
Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at baseline
The changes PET-CT and metabolic activity/ mapping at 4 weeks.
时间窗: 4 weeks
Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 4 weeks post treatment.
次要结局
- Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 6 months(6 months)
- Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at baseline(Baseline)
- Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 12 months(12 months)
- Pain and satisfaction to treatment assessed using painDETECT at baseline.(Baseline)
- Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at 6 months(6 months)
- Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at baseline(Baseline)
- Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at 4 weeks(4 weeks)
- Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at 3 months(3 months)
- Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at 6 months(6 months)
- Pain and satisfaction to treatment assessed using painDETECT questionnaires at 4 weeks.(4 weeks)
- Pain and satisfaction to treatment assessed using painDETECT questionnaires at 12 months.(12 months)
- Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at baseline.(Baseline)
- Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at 6 months(6 months)
- Pain and satisfaction to treatment assessed using Brief Pain Inventory (BPI), questionnaires at 12 months(12 months)
- Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 4 weeks(4 weeks)
- Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 3 months(3 months)
- Pain and satisfaction to treatment assessed using painDETECT questionnaires at 3 months.(3 months)
- Pain and satisfaction to treatment assessed using painDETECT questionnaires at 6 months.(6 months)
- Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at baseline(Baseline)
- Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at 4 weeks.(4 weeks)
- Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at 12 months(12 months)
- Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at 3 months(3 months)
- Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at 12 months(12 months)
- Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at 3 months.(3 months)
- Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at 6 months.(6 months)
- Pain and satisfaction to treatment assessed using Pain Self- efficacy Questionnaire (PSEQ) at 12 months.(12 months)
- Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at 3 months(3 months)
- Pain and satisfaction to treatment assessed using Hospital Anxiety and Depression Scale (HADS) questionnaires at 4 weeks(4 weeks)
- Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at baseline.(Baseline)
- Pain and satisfaction to treatment assessed using quality of life EQ5D questionnaires at 4 weeks(4 weeks)