Effects of Peripheral Repetitive Peripheral Magnetic Stimulation on Individuals With Elbow or Wrist Chronic Pain

Официальное название

Effects of Peripheral Repetitive Peripheral Magnetic Stimulation on Individuals With Elbow or Wrist Chronic Pain, A Pilot Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Two days Active rPMS
  It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity.
• Устройство Two days Sham rPMS
  Sham coil gives very weak pulses off target that does not penetrate to the skin.

Первичные конечные точки

• Change in pain pressure threshold (PPT) [Срок оценки: from baseline to post-treatment assessments on day 3 and week2 up to 6 months follow-up.]

Вторичные конечные точки (1)

• Change in visual subjective pain scale [Срок оценки: from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07544914 · Rithim Harmony - 5266

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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