Prospective Single-centre, Double-blind, Randomised Study to Evaluate the Effect of Spinal Cord Stimulation Frequency on wash-in/Wash-out Time and Clinical Outcomes in Subjects Using Fast-Acting Sub-perception Therapy (FAST) for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI) for Randomisation Arm A
研究概览
简要总结
The study design is prospective, post-market, exploratory, single-centre, rate randomised, double-blinded (subject, evaluator blinded; programmer un-blinded). The study is designed to evaluate the wash-in and wash-out time of FAST (Fast Acting Sub-perception Therapy) at 90 Hz and various frequencies above and below 90 Hz.
A prospective study design will eliminate the bias associated with case selection in a retrospective review and will ensure that identical procedures are followed for data capture and review.
Randomization of rates will be used to minimise the sequence effects and the impact of carryover effects, as well as addressing issues that may be related to order effect.
The electronic diary will be used to log the subjects' pain intensity and medication usage. Additionally, the numerical rating scale for measuring pain intensity is a validated measure and has been used in other randomized controlled trials to measure the outcomes of spinal cord stimulation (SCS).
The electronic real-time NRS (Numerical rating score) recording will be used to log the subjects' pain intensity and time during wash-in evaluation session.
This study aims to evaluate pain relief and wash-in/wash-out frequency sensitivity using FAST at different stimulation rates. The different randomization period included in the study design allows for comparing these treatments using one of the stimulation rates as an active control.
详细描述
Chronic Pain Background
Chronic intractable pain is a significant worldwide health issue, which consumes considerable healthcare resources and heavily impacts the quality of life for many patients. It is often defined as pain persisting for at least 6 months and not responding to conservative treatment(s). Chronic pain may be induced by current or past nerve injury and causes significant disability. People affected by such condition often experience reduced health-related quality of life, reduced ability to engage in activities of daily living, depression, sleep disturbances and weight gain due to the adoption of a sedentary lifestyle.
Typical entry into the pain management continuum includes over-the-counter medications, followed by physical therapy and complementary medicine. Interventional Pain management, Interdisciplinary pain management and surgery are attempted next and are often followed by long-term oral opioids intake. Active implantable options, including Spinal Cord Stimulation (SCS), lie within the continuum of chronic pain therapies and can be recommended as an alternative to long-term opioids intake (as recommended by National Institute of Clinical Excellence- NICE).
Spinal Cord Stimulation (SCS)
SCS refers to the application of small amounts of electrical energy, often via wires (a.k.a. "leads") to stimulate nerves in the spinal cord and reduce chronic pain symptoms. SCS is a less invasive treatment option for chronic pain that has generally been reserved for patients who have failed multiple, and sometimes all, conservative chronic pain therapies. With SCS, an implanted pulse generator (IPG) delivers electrical current to leads implanted in the epidural space at specific spinal level. Electrical currents stimulates nerves and can be shaped to optimise stimulation of fibres innervating the painful locations, thereby reducing pain sensation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is between 18 and 75 years of age when written informed consent is obtained.
- •Complaint of persistent or recurrent low back pain, with or without equal or lesser leg pain, for at least 90 days prior to Screen.
- •Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy.)
- •Diagnosed with chronic neuropathic pain of the low back and legs (of neuropathic origin only).
- •Eligible candidate for SCS from a psychological and psychiatric standpoint as determined prior to Baseline Visit, per site's routine screening process No back surgery within 6 months prior to Screening.
- •Average low back pain intensity, during the position/activity, which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale during Baseline period based on eDiary.
- •If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) 30 days prior to Screening to a total of less than 180 mg Oral Morphine equivalent.
- •Willing and able to comply with all protocol-required procedures and assessments/evaluations (e.g. willing to comply with opioid prescription lock from the Baseline visit through End of Rate Randomization and protocol required stimulation parameter locks, complete daily eDiary).
- •If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening.
- •Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
排除标准
- •Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
- •Have untreated major psychiatric comorbidity, serious drug related behaviour issues.
- •Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator).
- •Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
- •Currently on any anticoagulant medications that cannot be discontinued during perioperative period
- •Current condition associated with risk of immunocompromised that might increase risk of infection during study duration.
- •A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
- •Primary pain complaint of vascular origin (e.g. peripheral vascular disease). Spinal pain secondary to neoplasm, infection, autoimmune disorder with spinal involvement, or a spinal metabolic disorder.
- •Clinically significant lumbosacral stenosis which would interfere with lead placement
- •Prior history of lumbar-sacral spine fusion
- •Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment might confound reporting of study outcomes (e.g. pelvic pain, angina pain, chronic migraine.
- •Radiographic evidence of spinal instability requiring fusion
- •Terminal illness with anticipated survival 1 year.
结局指标
主要结局
Oswestry Disability Index (ODI) for Randomisation Arm A
时间窗: up to 6 weeks
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Patient Global Impression of Change (PGI-C) for Randomisation arm B
时间窗: up to 6 weeks
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm B
时间窗: Up to 6 weeks
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Numerical Rating scale for Randomisation Arm A
时间窗: up to 6 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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Oswestry Disability Index (ODI)
时间窗: At 6 months post randomisation
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Oswestry Disability Index (ODI) for Randomisation Arm B
时间窗: up to 6 weeks
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Patient Global Impression of Change (PGI-C)
时间窗: At 6 Months post randomisation
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm B
时间窗: up to 6 weeks
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Numerical Rating scale for Randomisation Arm B
时间窗: up to 6 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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Numerical Rating scale
时间窗: 6 months post randomisation
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Numerical Rating scale for Randomisation Arm D
时间窗: up to 6 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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Oswestry Disability Index (ODI) for Randomisation Arm C
时间窗: up to 6 weeks
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Pain and sleep index 3 for Randomisation Arm A
时间窗: up to 6 weeks
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Numerical Rating scale for Randomisation Arm C
时间窗: up to 6 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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Oswestry Disability Index (ODI) for Randomisation Arm D
时间窗: up to 6 weeks
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Patient Global Impression of Change (PGI-C) for Randomisation arm A
时间窗: up to 6 weeks
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Patient Global Impression of Change (PGI-C) for Randomisation arm C
时间窗: up to 6 weeks
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Patient Global Impression of Change (PGI-C) for Randomisation arm D
时间窗: up to 6 weeks
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
EQ-5D 5 Level (EQ-5D-5L)
时间窗: At 6 months post- randomisation
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm D
时间窗: up to 6 weeks
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Pain and sleep index 3
时间窗: At 6 months post randomisation
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm A
时间窗: up to 6 weeks
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm C
时间窗: up to 6 weeks
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm A
时间窗: up to 6 weeks
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm C
时间窗: up to 6 weeks
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Pain and sleep index 3 (PSQ-3)
时间窗: Baseline
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain and sleep index 3 for Randomisation Arm B
时间窗: up to 6 weeks
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain and sleep index 3 for Randomisation Arm C
时间窗: up to 6 weeks
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain Drawing
时间窗: Baseline
Pain drawing will be used to help patients highlight all the body areas affected by neuropathic pain on a printed dermatome map. It will be collected at the baseline.
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm D
时间窗: up to 6 weeks
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Patient Satisfaction with Treatment (PSWT)
时间窗: At 6 months post randomisation
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Pain and sleep index 3 for Randomisation Arm D
时间窗: up to 6 weeks
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Electronic pain diary (e-diary)
时间窗: Up to 7 months
The patient will be asked to collect information about their pain daily with an e-Diary. A paper version of the diary will be included as a backup if the e-Diary malfunctions or the patient experiences difficulties with the e-Diary recordings.
次要结局
未报告次要终点