Effects of Peripheral Repetitive Peripheral Magnetic Stimulation on Individuals With Elbow or Wrist Chronic Pain, A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Change in pain pressure threshold (PPT)
研究概览
简要总结
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.
详细描述
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 randomly assigned to either 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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Two days Active rPMS (Device)
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.
干预措施: Two days Sham rPMS (Device)
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.
干预措施: Two days Active rPMS (Device)
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.
干预措施: Two days Sham rPMS (Device)
结局指标
主要结局
Change in pain pressure threshold (PPT)
时间窗: 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.
次要结局
- Change in visual subjective pain scale(from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.)
研究者
Dr. Zahra Kazem-Moussavi
Professor
University of Manitoba