말초 반복적 말초 자기 자극이 팔꿈치 또는 손목 만성 통증 환자에게 미치는 영향 (rPMS)
말초 반복적 말초 자기 자극이 팔꿈치 또는 손목 만성 통증 환자에게 미치는 영향, 예비 무작위 대조 시험
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Mari Garcia, M.Sc.
- 전화번호: (204) 478-6352
- 이메일: MARITERE.GARCIACAMPUZANO@umanitoba.ca
연구 연락처 백업
- 이름: Zahra Moussavi, Ph.D.
- 전화번호: 204-474-7023
- 이메일: Zahra.Moussavi@umanitoba.ca
연구 장소
-
-
Manitoba
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Winnipeg, Manitoba, 캐나다, R3L 2P4
- 모병
- Riverview Health Center
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연락하다:
- Cassandra Aldaba, M.Sc.
- 전화번호: 204-478-6163
- 이메일: umaldabc@myumanitoba.ca
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
가짜 비교기: 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. |
|
실험적: 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. |
|
가짜 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in pain pressure threshold (PPT)
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in visual subjective pain scale
기간: 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.
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Zahra Moussavi, University of Manitoba
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- Rithim Harmony - 5266
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
This is a small pilot study. Once there is enough data with good quality, the investigators will consider data sharing.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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