Treatment of Neuropathic Pain With Spinal Cord Stimulation and Physiotherapy for More Effective Pain Relief, Increased Physical Activity and Improved Health Related Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pain intensity according to numeric rating scale (NRS)
研究概览
简要总结
The study evaluates the combined effect of optimized pharmacological treatment, spinal cord stimulation and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. All patients will receive optimized pharmacological treatment before start of spinal cord stimulation treatment. Half of the participants will be randomized to physiotherapy before start of spinal cord stimulation treatment while the other half will start physiotherapy after spinal cord stimulation treatment.
详细描述
Previous studies have indicated that almost half of the patients with moderate-severe pain receive inadequate pain relief. Neuropathic pain is a common pain condition, affecting 1.5-8% of the population. Conventional pharmacological treatment reduces pain but is often insufficient. Spinal cord stimulation (SCS) is associated with improved pain relief and health-related quality of life compared to conventional medical management. Despite SCS treatment, only half of the patients report >50% pain relief. Other studies have indicated that active, specific physiotherapy led by professionals reduces pain in chronic pain conditions. The aim of the study is to access the combined effect of optimized pharmacological treatment, SCS and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. Furthermore, the study evaluates when it is most effective to start the physiotherapy.
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
- Single (Outcomes Assessor)
盲法说明
Care Provider and Participants ar not masked. Data analysis of accelerometer data is masked (outcome assessor).
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neuropathic pain > 6 months
- •Pain intensity ≥ 5 according to NRS (for neuropathic pain component to be treated with SCS)
- •Known cause of the pain
- •Neuroanatomical correlation to the pain
- •≥50% of the painful area is to be treated with SCS
- •The patient has a physical and psychological health status that allows the patient to participate in physiotherapy and undergo SCS implantation.
排除标准
- •Not able to undergo SCS implantation
- •Inadequate knowledge of the Swedish language
- •Alcohol or substance abuse
- •Severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition
- •Incapacitating pain conditions of other causes than neuropathic pain
- •Pregnancy
- •Insufficient compliance
- •Malignant disease with short expected survival
研究组 & 干预措施
Spinal Cord Stimulation (SCS)
Spinal Cord Stimulation (SCS)
- Pharmacological analgetic treatment and treatment with SCS for 3 months
- Add-on physiotherapy for 6 months to SCS and pharmacological analgetic treatment
- Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months
干预措施: Spinal Cord Stimulation (SCS) (Device)
Spinal Cord Stimulation (SCS)
Spinal Cord Stimulation (SCS)
- Pharmacological analgetic treatment and treatment with SCS for 3 months
- Add-on physiotherapy for 6 months to SCS and pharmacological analgetic treatment
- Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months
干预措施: Physiotherapy (Other)
Physiotherapy
Physiotherapy
- Pharmacological analgetic treatment for 3 months
- Physiotherapy for 3 months and pharmacological analgetic treatment
- Add-on SCS in combination with physiotherapy and pharmacological analgetic treatment for 3 months
- Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months
干预措施: Spinal Cord Stimulation (SCS) (Device)
Physiotherapy
Physiotherapy
- Pharmacological analgetic treatment for 3 months
- Physiotherapy for 3 months and pharmacological analgetic treatment
- Add-on SCS in combination with physiotherapy and pharmacological analgetic treatment for 3 months
- Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months
干预措施: Physiotherapy (Other)
结局指标
主要结局
Pain intensity according to numeric rating scale (NRS)
时间窗: 3 months after implantation
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
次要结局
- Pain intensity according to NRS(21 months after implantation)
- Days of sick-leave(21 months)
- Patient treatment satisfaction according to NRS(21 months after implantation)
- Health Related Quality of Life (HRQL) according to SF36(21 months after implantation)
- Return to work(21 months)
- Number of hospital and primary care visits(21 months)
- Physical activity(21 months)
- Health Related Quality of Life (HRQL) assessed with EQ-5D(21 months after implantation)
- Medicine consumption(21 months)