Optimizing Treatment for Chronic Neuropathic Pain: A Replicated Single Case Experimental Design Evaluating a Treatment Bundle Consisting of Multidisciplinary Rehabilitation and Spinal Cord Stimulation (SCS-R)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain intensity in leg(s)
研究概览
简要总结
People with nerve damage can develop nerve pain. The pain can sometimes be severe and unpredictable, causing odd or alarming sensations - for example, lightning-like or electric shock feelings in the area served by the damaged nerve.
The investigators will examine a treatment for nerve pain in the legs caused by nerve damage, which can occur after a herniated disc or a bone fracture, with or without surgery.
Previous research suggests that spinal cord stimulation can relieve nerve pain in the legs after surgery or injury, but its effectiveness is still debated. Other studies show that multidisciplinary treatment helps people with long-term pain to improve their quality of life and to better cope in life. National and international guidelines recommend this kind of multidisciplinary care for long-term pain.
There has yet been published research on spinal cord stimulation combined with multidisciplinary treatment as a bundle intervention. The investigators therefore want to find out whether this combined approach can reduce nerve pain in the legs and improve physical functioning.
详细描述
Single-case experimental design (SCED) with repeated measurements structured into phases is the method of this study.
Phase A1 is the pre-implantation baseline, Phase A2 is waiting time from implantation to start of the intervention (SCS+rehabilitation). Length of A2 is randomized (2-4 weeks).
Phase B is the active SCS+rehabilitation intervention and lasts for 12 weeks (for analysis split into an early B1 (week 1-5) and a later B2 period (week 8-12), and FU is the 5 week follow-up approximately 6 months after implantation.
Outcomes are measured repeatedly within these phases, allowing within-patient phase contrasts.
In general, baseline (A1) is compared with the intervention periods (B1 and B2) and with follow-up (FU). The main pre-specified contrasts for the primary outcomes are:
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peripheral neuropathic pain in one or both legs for >6 months due to:
- •(1) Post Spinal Pain Syndrome (type 1 or 2).
- •(2) Localized nerve damage.
- •The area of the neuropathic pain in the leg(s) must be the dominant pain component.
- •Age ranges from 18-60 years.
- •Previous standard conservative (or surgical) treatment attempted.
- •Opioid use within permissible limits at implantation time (daily opioid dose <50 mg OMEQ).
- •Willingness to actively participate in the treatment bundle.
- •Living within reasonable travelling distance from Oslo.
- •Proficiency in understanding oral and written Norwegian, essential to benefit from the program that relies on mutual comprehension, nuanced conversation, and emotional expression, which are language-dependent.
- •Cognitive capacity to provide informed consent.
- •Ability to master the technical aspects of the SCS system (switching programs on the remote control).
排除标准
- •Currently undergoing the claims process for health benefits (e.g., disability pensions from NAV (Norwegian Labour and Welfare Administration).
- •Presenting a psychological or psychiatric disorder that may impact treatment efficacy.
- •Chronic generalized pain conditions.
- •Other pain conditions in the affected area, such as osteoarthritis.
- •Pregnancy.
研究组 & 干预措施
Treatment bundle
Treatment bundle consisting of spinal cord stimulation plus multidisciplinary rehabilitation
干预措施: Treatment bundle (Other)
结局指标
主要结局
Pain intensity in leg(s)
时间窗: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for leg pain the last 24 hours, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) .
Physical function (PROMIS-29)
时间窗: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
Assessed using the PROMIS-29 Physical Function domain T-score (mean 50, SD 10 in the reference population). Higher scores indicate better physical function. MCID: increase of ≥5 T-score points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) .
Pain intensity in leg(s)
时间窗: 3 times per week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.
Assessed using an 11-point Numeric Rating Scale (NRS 0-10), where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain.
Physical function
时间窗: 3 times per week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.
PROMIS-29 Physical Function domain, reported as a T-score (higher scores indicate better function).
次要结局
- Pain intensity in the lower back(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Pain interference (PROMIS-29)(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Pain intensity (PROMIS-29)(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Physical function (6-min-walk test)(Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.)
- Physical function (sit-to-stand test)(Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.)
- Physical function (stair test)(Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.)
- Physical activity (MET-minutes per week)(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Health-related quality of life (EQ-5D index)(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Patient satisfaction(End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.)
- Health-related quality of life (EQ-5D-5L VAS)(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Depression symptoms (PROMIS-29)(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Social participation (PROMIS-29)(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Fatigue (PROMIS-29)(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Sleep disturbance (PROMIS-29)(From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.)
- Opioid and Analgesic Use(Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.)
- Return to work(Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.)
- Fear of movement (Tampa Scale)(Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.)
- Patient-specific functioning(Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.)
- Pain intensity in the lower back(3 times per week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.)
- Physical function(Once pre-implantation, at end of intervention (approximately 12 weeks post-implantation), and once during follow-up period at 6 months post-implantation.)
- Health-related quality of life (index)(Once a week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.)
- Health-related quality of life (VAS)(Once a week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.)
- Depression symptoms(Once a week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.)
- Social participation(Once a week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.)
- Fatigue(Once a week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.)
- Pain interference(Once a week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.)
- Sleep disturbance(Once a week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.)
- Opioid and Analgesic Use(Once pre-implantation, at end of intervention (approximately 12 weeks post-implantation), and once during follow-up period at 6 months post-implantation.)
- Return to work(Once pre-implantation, at end of intervention (approximately 12 weeks post-implantation), and once during follow-up period at 6 months post-implantation.)
- Fear of movement(Once pre-implantation, at end of intervention (approximately 12 weeks post-implantation), and once during follow-up period at 6 months post-implantation.)
- Patient-specific functioning(Once a week during (A) baseline period (randomized length: 5, 6, or 7 weeks), (B) intervention period (12 weeks), and (C) follow-up period (5 weeks) at 6 months post-implantation.)
- Patient satisfaction(Measured at end of intervention (approximately 12 weeks post-implantation) and 26-week follow-up (6 months post-implantation).)
研究者
Lars-Petter Granan
Head of Department, Department for pain management and research. Ph.D.
Oslo University Hospital