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严重慢性神经性疼痛：采用脊髓电刺激和多学科治疗的治疗方案，以减轻疼痛并改善身体功能。 (SCS-R)

2026年5月4日 更新者：Lars-Petter Granan、Oslo University Hospital

优化慢性神经病理性疼痛的治疗：一项评估由多学科康复和脊髓电刺激（SCS-R）组成的治疗方案的重复单病例实验设计

神经受损者可能发展为神经痛。 疼痛有时可能严重且难以预测，引起异常或令人警觉的感觉——例如，受损神经支配区域出现闪电样或电击感。

我们将研究一种针对腿部神经痛的治疗方法，这种疼痛可由椎间盘突出或骨折（无论是否经过手术）后的神经损伤引起。

先前研究表明，脊髓刺激可以缓解手术后或损伤后的腿部神经痛，但其有效性仍存在争议。 其他研究显示，多学科治疗有助于长期疼痛患者改善生活质量并更好地应对生活。 国家和国际指南均推荐对长期疼痛采用此类多学科综合治疗。

目前尚未有人发表过关于脊髓刺激与多学科治疗联合作为整体干预措施的研究。 因此，我们希望探究这种联合疗法是否能减轻腿部神经痛并改善身体功能。

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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:

  1. For leg pain intensity A1 vs B1 is the primary comparison and A1 vs B2 is secondary, with A1 vs FU and B2 vs FU reported descriptively.
  2. For physical function (PROMIS-29), A1 vs B2 is the primary comparison as onset of rehabilitation effect is expected to be delayed. A1 vs B1 is exploratory, with A1 vs FU and B2 vs FU reported descriptively.

Other repeated-measures outcomes (PROMIS-29 domains and additional NRS/physical activity measures) follow the same structure, with A1 vs B2 generally defined as secondary and A1 vs FU descriptive as shown in the statistical tables

研究类型

介入性

注册 (估计的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Christopher Ekholdt, PhD-student
  • 电话号码：+4723026161
  • 邮箱：chrekh@ous-hf.no

研究联系人备份

  • 姓名：Lars-Petter Granan, Ph.D
  • 电话号码：+4723026161
  • 邮箱：largra@ous-hf.no

学习地点

  • 挪威
      • Oslo、挪威
        • 招聘中
        • Department of pain management and research, Oslo university hospital
        • 接触：
        • 接触：
          • Christopher Ekholdt, Ph.D-student
          • 电话号码：+4723026161
          • 邮箱：chrekh@ous-hf.no

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

纳入标准：

  • 由于以下原因导致单腿或双腿外周神经病理性疼痛超过6个月：

    • (1) 脊柱术后疼痛综合征（1型或2型）。
    • (2) 局部神经损伤。
  • 腿部神经病理性疼痛区域必须是主要的疼痛组成部分。
  • 年龄范围18-60岁。
  • 曾尝试过标准保守治疗（或手术治疗）。
  • 植入时阿片类药物使用在允许限度内（每日阿片剂量<50 mg OMEQ）。
  • 愿意积极参与治疗套餐。
  • 居住在奥斯陆合理通勤距离内。
  • 具备理解挪威语口语和书面语的能力，这对于从项目中获益至关重要，因为项目依赖于相互理解、细致对话和情感表达，这些都依赖于语言能力。
  • 具备提供知情同意的认知能力。
  • 能够掌握SCS系统的技术操作（通过遥控器切换程序）。

排除标准：

  • 目前正在申请健康福利索赔流程（例如挪威劳工和福利管理局的残疾养老金）。
  • 存在可能影响治疗效果的心理或精神障碍。
  • 慢性全身性疼痛病症。
  • 受影响区域存在其他疼痛病症，如骨关节炎。
  • 妊娠期。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：治疗方案组合
由脊髓刺激加多学科康复组成的治疗组合
其他：治疗方案组合
干预措施是一个治疗组合，包括脊髓刺激加多学科康复。 多学科康复包括运动疗法、认知疗法和SCS设备的个性化编程。
其他名称：
  • 复原
  • 理疗
  • 接纳与承诺疗法
  • 认知疗法
  • 脊髓刺激
  • 运动疗法

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pain intensity in leg(s)
大体时间：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) .
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
Physical function (PROMIS-29)
大体时间：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) .
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

次要结果测量

结果测量
措施说明
大体时间
Pain intensity in the lower back
大体时间：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 lower back 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)
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)
大体时间：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 Pain Interference domain T-score. Higher scores indicate more interference of pain with daily activities. Improvement is defined as a decrease of ≥5 T-score points (MCID).

Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
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)
大体时间：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 pain intensity last 7 days in PROMIS-29, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points.

Assessed at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
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)
大体时间：Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

Functional walking capacity is assessed using the Six-Minute Walk Test (6MWT). Distance walked in 6 minutes on a flat course is recorded in meters; higher distances indicate better walking capacity.

Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
Physical function (sit-to-stand test)
大体时间：Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
Lower limb functional strength and endurance are assessed with a Sit-to-Stand Test, recorded as number of repetitions in a fixed time. More repetitions indicate better performance. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
Physical function (stair test)
大体时间：Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

Functional mobility is assessed using a Stair test (ST; time to climb 18 stairs 3 times; lower times indicate better function).

Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
Physical activity (MET-minutes per week)
大体时间：From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

Physical activity is assessed as metabolic equivalent (MET) minutes per week, calculated from reported frequency and duration of activities (International Physical Activity Questionnaire (IPAQ)). Higher values indicate greater weekly physical activity.

Assessed once per week during baseline (A1), SCS+rehabilitation (B1/B2), and follow-up (FU) within the single-case experimental design.
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)
大体时间：From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

EQ-5D-5L index score (range 0-1; higher scores indicate better health-related quality of life).

Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
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-5L VAS)
大体时间：From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

EQ-5D Visual Analogue Scale (EQ-5D VAS; 0-100; higher scores indicate better health-related quality of life).

Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
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)
大体时间：From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
PROMIS Depression scale (T-score; mean 50, SD 10 in U.S. population; higher scores indicate greater symptom severity). Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
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)
大体时间：From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.

PROMIS Ability to Participate in Social Roles and Activities short form, reported as a T-score (higher scores indicate better function). MCID: increase of ≥5 T-score points.

Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
Fatigue (PROMIS-29)
大体时间：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 Fatigue domain T-score. Higher scores indicate greater fatigue. Improvement is defined as a decrease of ≥5 T-score points (MCID).

Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
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)
大体时间：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 Sleep Disturbance domain T-score. Higher scores indicate more sleep problems. Improvement is defined as a decrease of ≥5 T-score points (MCID).

Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
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
大体时间：Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

Total opioid consumption quantified as milligrams of oral morphine equivalents (OMEQ) per day; non-opioid analgesics quantified in milligrams per day per medication.

Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
Return to work
大体时间：Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

Return to work status, quantified as hours worked per week (higher values indicate greater work participation).

Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
Fear of movement (Tampa Scale)
大体时间：Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

Fear of movement is assessed using the Tampa Scale for Kinesiophobia (TSK). Higher scores indicate greater fear of movement. Improvement is defined as a decrease of >6 points.

Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
Patient-specific functioning
大体时间：Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

Patient-Specific Functional Scale (PSFS), up to five activities selected in cooperation with personnel, rated 0-10 (higher scores indicate better function; average score reported).

Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
Patient satisfaction
大体时间：End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
Patient Global Impression of Change (PGIC), 7-point Likert scale (1 = "very much worse" to 7 = "very much improved").
End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Oslo University Hospital

调查人员

  • 首席研究员：Lars-Petter Granan, Ph.D、Department of pain management and research, Oslo university hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月4日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年2月4日

首先提交符合 QC 标准的

2026年2月4日

首次发布 (实际的)

2026年2月11日

研究记录更新

最后更新发布 (实际的)

2026年5月6日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 942321

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

研究中生成的所有收集变量的个体参与者数据，将在完整记录的数据字典（详细说明变量名称、代码、值、单位和衍生规则）的伴随下，在发表后根据合格研究人员的合理请求提供。访问权限将仅限于提交申请并获得相关伦理委员会和数据保护机构批准的合格研究人员。

直接和间接标识符——包括姓名、确切日期和其他再识别风险——将被系统性地移除或转换（例如，通过索引调整日期以保留时间间隔同时防止数据关联），确保数据集支持稳健的二次分析，同时维护参与者的隐私。

研究方案计划发布。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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