Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Mean VAS Back Pain (7 Day Subject VAS Pain Diary)
研究概览
简要总结
Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.
详细描述
The prevalence of chronic low back pain in the population is estimated to range between at 12% and 28% (1-4). Within this group an estimated 12-15% of adults suffer from chronic neuropathic lower back pain (CNLBP), have relatively greater pain severity, and account for more of the costs of this condition (5,6). This subgroup of people with CNLBP are the focus of the proposed trial.
The National Institute for Health and Care Excellence (NICE) recommends SCS for refractory neuropathic pain (TA159) (7). It is routinely used for people with predominant, neuropathic, radicular pain typically resulting from, or persisting after, spinal surgery (so-called failed back surgery syndrome (FBSS) (8-10). SCS has been shown to be cost effective for this indication (11).
Conventional SCS consists of the insertion of a medical wire (lead) introduced into the epidural space through a needle puncture. The lead is then positioned to target the pain by passing current into the lead from an external power source to generate a pins and needles sensation (paraesthesias) over the painful area. Analgesia occurs when the paraesthesia overlaps and therefore masks the painful area. Once pain reduction is demonstrated, the battery is implanted under the skin of the abdomen, flank or buttock. SCS is most commonly used in the treatment of leg pain of FBSS. However, due to lack of existing evidence and the difficulty of obtaining paraesthesia over the low back, SCS has traditionally not been recommended for treating patients with back pain without previous back surgery (10, 12).
High frequency 10kHz-SCS is a recent major advance in SCS technology. The current is delivered at 10kHz frequency as opposed to the 40 to 60Hz generated by the conventional SCS (13). The key advantages of a higher frequency current are:
10kHz-SCS has been shown to be superior (14) to conventional SCS in targeting residual low back pain following back surgery. Moreover, it does not generate any stimulation related sensations or paraesthesia so is preferred by patients as they are saved from needing to experience these distracting and occasional shocking sensations of conventional SCS. Therefore, 10kHz-SCS allows to smoothly conduct sham controlled or double blind studies in the field of SCS without the need for device modifications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind. Implanter is blinded, research staff are blinded, subject is blinded. One unblinded research personnel at each recruiting site programming the patients at device activation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over the age of 18
- •Onset of low back pain > 12 months
- •Low back pain intensity > 60 out of 100mm on pain visual analogue scale (VAS)
- •Presence of clear component of neuropathic pain based on a PainDETECT Questionnaire score of >19 (we will monitor this inclusion criteria in the early stage of the trial and revise if necessary)
- •Degenerative disc disease confirmed by imaging or internal disc disruption as confirmed by discography
- •On stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and not change medication dosage without consulting Investigator
- •Legally able to provide informed consent
- •Able to comply with study-related requirements, procedures and visits
排除标准
- •Had previous spinal surgery
- •Chronic widespread pain
- •Subject has an active implanted device, whether turned on or off (e.g. pacemaker, intrathecal pump, deep brain stimulator etc.)
- •A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumour, or severe/critical central or foraminal spinal stenosis
- •Mechanical spine instability detected by a clinician (validation by flexion/extension films of lumbar spine within the past 6 months showing 4 mm or more translational movement or excessive angular movement manifested by >5 degrees segmental angular movement) e.g. any forms of spondylolisthesis
- •A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- •Bleeding diathesis such as coagulopathy or thrombocytopenia
- •Immunocompromised and at an increased risk for infection
- •Systemic infection or local infection that would contraindicate SCS placement
- •Metastatic malignant disease or active local malignant disease
- •Pregnant (if female and sexually active, subject must be using a reliable form of contraception, be surgically sterile or be at least 2 years post-menopausal)
- •Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication.
- •Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator
- •Concomitant participation in another clinical trial (surgery, device or drug)
结局指标
主要结局
Mean VAS Back Pain (7 Day Subject VAS Pain Diary)
时间窗: 6 months post randomisation
Changes in mean VAS back pain between intervention and control at 6 months post-randomisation
次要结局
- PSQI Questionnaire(1, 3, and 6 months post randomisation)
- PGIC Questionnaire(1, 3, and 6 months post randomisation)
- PHQ-9 Questionnaire(1, 3, and 6 months post randomisation)
- EQ-5D Questionnaire(1, 3, and 6 months post randomisation)
- Sensation Map(1, 3, and 6 months post randomisation)
- Oswestry disability index (v2.1a)(1, 3, and 6 months post randomisation)
- Healthcare utilisation, work status, work absence, and out of pocket expenses(6 months post randomisation)
- Safety/Adverse Events(6 months post randomisation)
- Medication Usage(1, 3, and 6 months post randomisation)