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外周重复外周磁刺激对肘或腕慢性疼痛患者的影响 (rPMS)

2026年9月24日 更新者：Dr. Zahra Kazem-Moussavi、University of Manitoba

外围重复经皮磁刺激对肘或腕慢性疼痛患者的影响：一项初步随机对照试验

This pilot, randomized, sham-controlled, single-blind study will evaluate the effectiveness of repetitive peripheral magnetic stimulation (rPMS) in reducing pain in adults with tennis/golfer's elbow or carpal tunnel syndrome. Approximately 40 participants will be randomly assigned to active or sham stimulation delivered over two consecutive days. Outcomes, including pressure pain threshold, subjective pain ratings, and local tissue oxygenation (fNIRS), will be assessed at baseline, immediately post-intervention, and during follow-up up to 6 months to evaluate both clinical effects and underlying physiological mechanisms.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Objectives - The primary objective is to investigate the effect of active repetitive peripheral magnetic stimulation (rPMS) in reducing pain in individuals with either tennis/golfer elbow syndrome (either medial or lateral epicondylitis) or carpal tunnel syndrome in a pilot randomized placebo-controlled clinical trial. The secondary objective is to investigate the duration of the rPMS effects up to 6 months.

Study Population - The study population will consist of two groups of individuals: one group including 10 with tennis/golfer elbow syndrome and second group including 10 with carpal tunnel syndrome. Participants will be recruited from volunteers by advertising and/or doctors' referral.

Research Design and Study Procedure - This study design is a parallel-cohort exploratory single-blind, randomized, sham-controlled study investigating the effect of rPMS in pain reduction in individuals with either elbow or wrist chronic pain. Eligible participants in each group will be stratified by condition (elbow vs carpal tunnel) and randomized within each stratum to active or sham rPMS. The sham group participants will have the option to receive the active treatment after a month of receiving the sham treatment.

The rPMS protocol is two consecutive days of therapy. In each day, the participants will receive 400 pulses at 10 HZ in 1.5 sec trains with 10-second intertrain intervals. All participants will be assessed for their pain levels at baseline, immediately post-intervention, one week after the intervention and then every month up to 6 months follow-up sessions.

The assessments include subjective Visual Analogue Scale (VAS) score for pain on a scale of 0 to 10, the minimum pressure pain threshold (PPT) and near-infrared spectroscopy (NIRS) over the target area.

研究类型

介入性

注册 (估计的)

40

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

研究联系人备份

学习地点

  • 加拿大
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3L 2P4
        • 招聘中
        • Riverview Health Center
        • 接触：

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Clinical diagnosis or self-reported history consistent with either medial or lateral epicondylitis or carpal tunnel syndromes.
  • Presence of chronic pain in the target area (mentioned above) at the time of enrollment.
  • Ability to understand the study procedures and provide informed consent.

Exclusion Criteria:

  • Contraindications to peripheral magnetic stimulation, including implanted electronic medical devices or metallic implants in locations deemed unsafe for stimulation.
  • Open wounds, active skin conditions, or other local conditions at the stimulation site.
  • Current neurological, musculoskeletal, or systemic medical conditions that, in the opinion of the investigators, would interfere with safe participation or interpretation of study outcomes.
  • Current upper-limb injury or condition other than tennis/golfer elbow or carpal tunnel syndromes that could confound pain or perfusion measurements.
  • Pregnancy.
  • Inability to tolerate the stimulation or measurement procedures.
  • Inability to adequately understand study instructions or provide informed consent.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Two days active rPMS - Tennis/golfer syndrome

Participants of this arm, suffer from chronic pain at elbow either medial or lateral epicondylitis (tennis/golder syndromes) and receive real rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz.
设备：Two days Active rPMS

It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity.
假比较器：Two days sham rPM - Tennis/golfer syndrome

Participants of this arm, suffer from chronic pain at elbow either medial or lateral epicondylitis (tennis/golder syndromes) and receive SHAM rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz.
设备：Two days Sham rPMS

Sham coil gives very weak pulses off target that does not penetrate to the skin.
实验性的：Two days Active rPMS - Carpal Tunnel Syndrome

Participants of this arm, suffer from chronic pain at wrist (carpal tunnel syndrome) and receive REAL rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz.
设备：Two days Active rPMS

It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity.
假比较器：Two days Sham rPMS - Carpal Tunnel syndrome

Participants of this arm, suffer from chronic pain at wrist (carpal tunnel syndrome) and receive SHAM rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz.
设备：Two days Sham rPMS

Sham coil gives very weak pulses off target that does not penetrate to the skin.

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
Change in pain pressure threshold (PPT)
大体时间：from baseline to post-treatment assessments on day 3 and week2 up to 6 months follow-up.

PPT is measured by a pressure altimeter and identifies the minimum pressure that the subject feels pain.
from baseline to post-treatment assessments on day 3 and week2 up to 6 months follow-up.

次要结果测量

结果测量
措施说明
大体时间
Change in visual subjective pain scale
大体时间：from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.

the visual subjective pain scale is a score using 0 to 10 on the pain level.
from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.

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

University of Manitoba

调查人员

  • 首席研究员：Zahra Moussavi、University of Manitoba

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 (实际的)

2026年7月1日

初级完成 (估计的)

2027年8月30日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年4月8日

首先提交符合 QC 标准的

2026年4月15日

首次发布 (实际的)

2026年4月22日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Rithim Harmony - 5266

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

This is a small pilot study. Once there is enough data with good quality, the investigators will consider data sharing.

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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