末梢反復末梢磁気刺激が肘または手首の慢性疼痛を有する個人に与える影響 (rPMS)
周辺反復末梢磁気刺激が肘または手首の慢性疼痛を持つ個人に与える影響、パイロット無作為化比較試験
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mari Garcia, M.Sc.
- 電話番号：(204) 478-6352
- メール：MARITERE.GARCIACAMPUZANO@umanitoba.ca
研究連絡先のバックアップ
- 名前：Zahra Moussavi, Ph.D.
- 電話番号：204-474-7023
- メール：Zahra.Moussavi@umanitoba.ca
研究場所
-
-
Manitoba
-
Winnipeg、Manitoba、カナダ、R3L 2P4
- 募集
- Riverview Health Center
-
コンタクト：
- Cassandra Aldaba, M.Sc.
- 電話番号：204-478-6163
- メール：umaldabc@myumanitoba.ca
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity. |
|
偽コンパレータ：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. |
Sham coil gives very weak pulses off target that does not penetrate to the skin. |
|
実験的：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. |
It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity. |
|
偽コンパレータ：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. |
Sham coil gives very weak pulses off target that does not penetrate to the skin. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in pain pressure threshold (PPT)
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in visual subjective pain scale
時間枠：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.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Zahra Moussavi、University of Manitoba
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Rithim Harmony - 5266
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
This is a small pilot study. Once there is enough data with good quality, the investigators will consider data sharing.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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