A Prospective Single Centre Pilot Study to Investigate the Response to 1000Hz Frequency in Patients With Spinal Cord Stimulation With Intractable Neuropathic Pain Who Have Not Undergone Spinal Surgery (Virgin Back)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change from baseline numerical Rating Score (NRS) at 3 months
研究概览
简要总结
Spinal Cord stimulation (SCS) is a common intervention used in patients who suffer from chronic nerve pain following back surgery. This is known as failed back surgery syndrome (FBSS). Equally, the National Institute of Clinical Excellence (NICE) who work with the NHS, recommend suitable medicines and treatments for patients in their guidelines; suggest that SCS can be used in patients who have never had back surgery. The is no outcome data to define that SCS works in patients with neuropathic back pain, therefore this study will provide clinical data to see if this works.
SCS delivers mild electrical impulses to the nerves along the spinal cord. This blocks the pain pathway from reaching the brain. This helps manage the pain experienced the lower back.
A common side effect of the conventional system is that patients may experience 'pins and needles', tingling, and numbness, known as parathesia at site of stimulation. This can be particularly uncomfortable for patients. However, parathesia can be eliminated by changing certain settings on the stimulator. This could include increasing the frequency of the stimulator known as high frequency (HF). This works by delivering energy to site of stimulation below the parathesia threshold, so minimal or no parathesia is experienced.
Only one study has been completed previously using HF frequency on patients with FBSS. The major findings from these studies have found that when compared to conventional SCS (uses a frequency of 40-80 Hz) that HF has provided better pain relief with minimal or no parathesia. Higher frequencies parameters are not completely novel because they have been used in patients who have FBSS. However, settings of 1000Hz which will be used in this study have not been done in patients who suffer from neuropathic pain and have not had any previous spinal surgery.
Therefore, the main reason of this study is to investigate the response patients suffering from neuropathic pain and have not had previous spinal surgery, have to 1000Hz (HF) frequency spinal cord stimulation. We will also investigate the effect this setting has on the quality of life of the patients.
详细描述
Spinal cord stimulation (SCS) is a successful treatment in patients with intractable neuropathic pain. This therapy is most commonly used in patients who have chronic neuropathic pain following failed surgery, known as failed back surgery syndrome (FBSS) . There is evidence from previous studies to demonstrate that SCS can provide a 50- 70% reduction in pain medication and pain scores. A randomised controlled study compared SCS with conventional medical management (CMM). When compared with the CMM group; the SCS patients had a 50% pain reduction in their back pain and leg pain. The results suggested that patients who received SCS had better pain relief and health related quality of life over a period of 6 to 12 months compared to the CMM group. Additionally, these patients reported satisfaction in SCS treatment, continuous pain relief, and clinical improvements in functional capacity and health-related quality of life.
On the other hand, SCS has been progressively being used in patients with intractable neuropathic pain who have not undergone spinal back surgery ("Virgin-back''). The UK NICE guidelines have recommended SCS as a treatment option for patients with intractable neuropathic spinal pain, including patients who have not undergone previous spinal surgery (NICE, 2008).
One of the main drawbacks of conventional SCS is the onset of parathesia, despite being an effective therapy for neuropathic pain. This can cause abnormal sensations or considerable discomfort to the patient during activity or sudden position changes. Typically, conventional SCS operate at frequencies ranging from 40-80 Hz, long pulse widths of 300-500 µsec, and amplitudes to stimulate patient's pain sensory percept distribution. These frequencies are often used because sensory perception is often lost at 300 Hz. Current studies have found that delivering stimulating frequencies below the upper limit of what may cause parathesia; may reduce discomfort and abnormal sensations, increasing the tolerability of SCS treatment. Parathesia is considered necessary in order to cover the painful area and provide maximum pain relief. However recent research suggests that parathesia may not be necessary for pain relief, and in fact that pain awareness can provide full benefits of SCS.
Data from (PROCO RCT) indicates that similar pain relief and improvement in quality of life measures are experienced independent of the type of frequency (from 1kHz up to 10kHz) used in paraesthesia free SCS therapy when the proper target and dose are identified. Further, the study showed that 1kHz stimulation provides similar pain relief using significantly less energy than higher frequencies.
High frequency (HF) stimulation is a new promising, new stimulation paradigm involving higher frequency, lower pulse widths, and lower amplitudes when compared to conventional SCS. The effectiveness of HF-SCS is controlled by the amount of Neural dose (frequency, amplitude and pulse width) passing the electrodes and reaching the neural tissue, resulting in minimal discomfort and damage to the tissues before the definite shape of the impulse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patients will be required to adhere to the study and attend all follow up visits. Informed consent and questionnaires will be administered at visit 0. They will be followed up 4, 12, 24 weeks and 12 months, 24 months after their SCS permanent implant. Questionnaires will be administered at each visit.
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
- •Chronic Back Pain (≥ 6 mo) with NRS ≥ 6/10
- •Back pain predominant over leg pain (if leg pain present)
- •Failure to respond to conventional treatment including intense rehababilitation and facet/MBB/SI interventions
- •No prior spinal surgery for the back and leg pain on the same site of implantation.
- •Presence of lumbar degenerative disc disease
- •Absence of spinal pathology which would require surgical intervention
- •Stable dose of opioids and anti-neuropathic drugs for ≥ 6 months
- •Patients with intractable lumbar neuropathic pain who are due to receive Percutaneous Spinal Cord Stimulation as part of their standard treatment per NICE HTA guidance 159 at Barts Health NHS Hospitals.
- •Patients who have given their written informed consent.
- •Female patients of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test.
- •Patients must be able to communicate in English in order to complete validated questionnaires written in English.
排除标准
- •Patients not able to comply or understand the study-related requirements
- •Active alcohol, recreational or prescription drug abuse in the last 3 months.
- •Unwilling to reduce excessive pain medications
- •A medical/psychiatric condition that could interfere with study procedures, accurate pain reporting, and/or confound study outcomes
- •Patients with diabetes or any current diagnosis of progressive neurological disease (i.e., CIDP, Multiple sclerosis)
- •Immuno-compromised/high risk for surgical infection
- •Pregnant and/or breast feeding
- •Terminal illness with anticipated survival < 12 months
- •Patients who have been part of a previous spinal cord stimulation trial
- •Currently implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- •Untreated clinically significant sleep disorder as judged by the CI.
- •Unresolved issues of secondary gain (i.e., litigation)
- •Participation in another clinical study in the last 30 days that would confound data.
结局指标
主要结局
change from baseline numerical Rating Score (NRS) at 3 months
时间窗: 3 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Change from baseline numerical Rating Score (NRS) at 24 months
时间窗: 24 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Change from baseline Oswestry Disability Index (ODI) scores at 24 months
时间窗: 24 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Change from baseline Patient's Global Impression of change (PGIC) scores to 6 months
时间窗: 6 months
A standard seven point scale would be used to assess the SCS outcome.
change from baseline EQ-5D-5L scores at 24 months
时间窗: 24 months.
The EQ-5D is a standardised instrument used to measure health outcome.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 3 months
时间窗: 3 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline numerical Rating Score (NRS) at 6 months
时间窗: 6 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Change from baseline Oswestry Disability Index (ODI) scores at 3 months
时间窗: 3 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Change from baseline Patient's Global Impression of change (PGIC) scores to 4 weeks
时间窗: 4 weeks
A standard seven point scale would be used to assess the SCS outcome.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 6 months
时间窗: 6 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline Oswestry Disability Index (ODI) scores at 6 months
时间窗: 6 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Change from baseline Oswestry Disability Index (ODI) scores at 12 months
时间窗: 12 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
change from baseline EQ-5D-5L scores at 3 months
时间窗: 3 months.
The EQ-5D is a standardised instrument used to measure health outcome.
change from baseline EQ-5D-5L scores at 6 months
时间窗: 6 months.
The EQ-5D is a standardised instrument used to measure health outcome.
Change from baseline numerical Rating Score (NRS) at 4 weeks
时间窗: 4 weeks
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Change from baseline numerical Rating Score (NRS) at 12 months
时间窗: 12 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Change from baseline Oswestry Disability Index (ODI) scores at 4 weeks
时间窗: 4 weeks
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Change from baseline Patient's Global Impression of change (PGIC) scores to 3 months
时间窗: 3 months
A standard seven point scale would be used to assess the SCS outcome.
Change from baseline Patient's Global Impression of change (PGIC) scores to 24 months
时间窗: 24 months
A standard seven point scale would be used to assess the SCS outcome.
change from baseline EQ-5D-5L scores at 4 weeks
时间窗: 4 weeks
The EQ-5D is a standardised instrument used to measure health outcome.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 4 weeks
时间窗: 4 weeks
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 24 months
时间窗: 24 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline Resource Questionnaire at 24 months
时间窗: 24 months.
The resource questionnaire measures the impact of health on employment.
Change from baseline Patient's Global Impression of change (PGIC) scores to 12 months
时间窗: 12 months
A standard seven point scale would be used to assess the SCS outcome.
change from baseline EQ-5D-5L scores at 12 months
时间窗: 12 months.
The EQ-5D is a standardised instrument used to measure health outcome.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 12 months
时间窗: 12 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline Resource Questionnaire at 12 months
时间窗: 12 months.
The resource questionnaire measures the impact of health on employment.
次要结局
未报告次要终点