Subcutaneous Stimulation as Add on Therapy to Spinal Cord Stimulation (SCS) to Treat Low Back Pain in Failed Back Surgery Syndrome (FBSS) (SubQ Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- responder rate
研究概览
简要总结
Aim of the study Failed back surgery syndrome (FBSS) is a clinical entity consisting of chronic leg and /or back pain due to radicular nerve damage. The effectiveness of Spinal Cord Stimulation (SCS) in the pain management of patients with FBSS is proven. Patients mostly have dominant leg pain, however a significant percentage of FBSS patients has a more pronounced back pain and are commonly excluded from SCS as it is often inadequate in relieving both the back and leg pain components. Recently some reports showed the benefit of subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been confirmed by a feasibility study performed by our group. The aim of the randomized controlled study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives an inadequate back pain relief.
Hypothesis We hypothesize that SubQ in addition to SCS in FBSS patients with leg and low back pain is more effective in treating low back pain (i.e. >50% pain reduction) than SCS alone.
详细描述
Aim of the study FBSS is a clinical entity consisting of chronic leg and /or back pain due to radicular nerve damage. The effectiveness of SCS in the pain management of patients with FBSS is proven. Patients mostly have dominant leg pain, however a significant percentage of FBSS patients has a more pronounced back pain and are commonly excluded from SCS as it is often inadequate in relieving both the back and leg pain components. Recently some reports showed the benefit of subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been confirmed by a feasibility study performed by our group. The aim of the randomized controlled study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives an inadequate back pain relief.
Hypothesis We hypothesize that SubQ in addition to SCS in FBSS patients with leg and low back pain is more effective in treating low back pain (i.e. >50% pain reduction) than SCS alone.
Study design and duration of the study The study is a randomized controlled trial. Patients with FBSS with additional chronic back pain and an intensity of 5 or more for leg and back pain separately on the visual analogue scale are eligible for the study. About ninety patients will receive a SCS system targeting to relief leg and back pain. The study group consists of patients having a pain reduction of ≥50% in the leg after SCS trial stimulation. If, after trial stimulation, there is less than 50% back pain relief compared with initial values, patients will receive one or two Quad leads subcutaneously at the time of implantation of the pulse generator.
This group, a total of 56 patients,will be randomized in a 1:1 ratio in which group 1 (n=28) receives SCS plus non-activated SubQ(SubQ OFF) and group 2 (n=28) receives SCS plus activated SubQ (SubQ ON) (phase 1), for a period of 3 months.
After the controlled phase of the study, all 56 patients will receive maximal effective SCS and SubQ for the rest of the study duration (phase 2).
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
- None
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
- •Age between 18 and 75 years.
- •Chronic pain secondary to FBSS. Pain radiating in lumbar segments L4 and/or L5 and/or S1 for at least 6 months following at least one anatomically successful surgery.
- •Pain intensity in leg(s) and low back of 5 or higher for leg and back measured separately on a weighted visual analogue scale (VAS).
- •Previous treatment has been unsuccessful (insufficient pain relief and/or unacceptable side-effects).
- •Willing to provide informed consent.
排除标准
- •Exclusion criteria
- •Presence of any other clinically significant or disabling chronic pain condition
- •Expected inability of the patient to properly operate the neurostimulation system
- •History of coagulation disorders, lupus erythematosus, diabetes mellitus, rheumatoid arthritis or morbus Bechterew
- •Current use of medication affecting coagulation which cannot be temporarily stopped
- •Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
- •The patient has ever had SCS
- •Addiction: drugs, alcohol (>5 U / day) and/or medication
- •Insufficient cooperation from the patient (little motivation, understanding or communication)
- •Immune deficiency (HIV-positive, corticosteroids with a dose equivalent to
- •prednisolone 10 mg, immunosuppressives, etc.)
- •Life expectancy < 1 year
- •Pacemaker
- •Local infection or other skin disorders at site of incision
- •Existing or planned pregnancy
结局指标
主要结局
responder rate
时间窗: 3 months
The proportion of patients with SCS plus activated SubQ and SCS without activated SubQ having 50% or more pain relief(responder rate) in back after 3 months of stimulation, assessed with the VAS
次要结局
未报告次要终点