- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07917702
Effects of Transcranial Direct Current Stimulation and Manual Therapy on Musculoskeletal Pain in Adolescent Dancers
Effects of Non-invasive Brain Stimulation and Manual Therapy on Musculoskeletal Pain in Adolescent Dancers: A Three-Arm Randomized Controlled Trial
Adolescent dancers are at high risk of musculoskeletal pain due to repetitive, high-intensity training. Persistent pain may lead to kinesiophobia (fear of movement), which can further impair physical function according to the fear-avoidance model. Transcranial direct current stimulation (tDCS) has been used as a top-down intervention for musculoskeletal pain; however, it remains unclear whether its analgesic effect results from true neural stimulation or from contextual factors such as treatment expectation.
This three-arm, single-blind randomized controlled trial will enroll 24 adolescent dancers aged 13 to 18 years with musculoskeletal pain lasting at least 3 months. Participants will be randomly allocated, stratified by pain site, to (1) active tDCS plus manual therapy, (2) sham tDCS plus manual therapy, or (3) sham tDCS plus manual therapy plus structured expectation-enhancement education. Each participant will receive a single intervention session. Outcomes will be assessed before, immediately after, and 1 week after the intervention. The study aims to distinguish the neurophysiological effect of tDCS from the effect of treatment expectation on pain, kinesiophobia, and related outcomes.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hyunjoong Kim, PhD
- 전화번호: +82-62-958-7598
- 이메일: hjkim@ghu.ac.kr
연구 장소
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Gwangju, 대한민국
- Jin's Ballet Academy, Pulse Dance Academy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adolescent dancers or dance majors aged 13 to 18 years
- Musculoskeletal pain in a specific body region (e.g., lower back, ankle) for at least 3 months
- Understanding of the study purpose and voluntary assent from the participant, with written informed consent from a legal guardian
Exclusion Criteria:
- Metal implants in the head or implanted electronic devices (e.g., cardiac pacemaker)
- Current pregnancy
- Current use of psychiatric medication
- Acute inflammatory disease
- Bleeding disorder or current use of anticoagulants
- Recent trauma, surgery, or skin disease at the painful (measurement) site
- History of epilepsy
- Any other physical condition that makes participation in the study or intervention inappropriate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Active tDCS + Manual Therapy (ANT)
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Anodal tDCS delivered at 2 mA for 20 minutes using saline-soaked sponge electrodes, with the anode over the primary motor cortex (C3/C4) and the cathode over the contralateral frontal area according to the international 10-20 system. Current is ramped up and down gradually. Manual therapy including instrument-assisted soft tissue mobilization (Graston technique) applied to the painful region for 15 minutes, with the tool held at 30 to 60 degrees, within a tolerable pain range (VAS 3 to 4). |
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가짜 비교기: Sham tDCS + Manual Therapy (SCT)
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Manual therapy including instrument-assisted soft tissue mobilization (Graston technique) applied to the painful region for 15 minutes, with the tool held at 30 to 60 degrees, within a tolerable pain range (VAS 3 to 4). Identical electrode placement and procedure as active tDCS for 20 minutes, with current delivered only for the first 30 seconds and then turned off. |
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실험적: Sham tDCS + Manual Therapy + Expectation-Enhancement Education (ECT)
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Manual therapy including instrument-assisted soft tissue mobilization (Graston technique) applied to the painful region for 15 minutes, with the tool held at 30 to 60 degrees, within a tolerable pain range (VAS 3 to 4). Identical electrode placement and procedure as active tDCS for 20 minutes, with current delivered only for the first 30 seconds and then turned off. A 5- to 10-minute structured education session delivered by the investigator using a standardized script that explains the principles and expected effects of the treatment. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Pain Intensity (Numeric Pain Rating Scale, NPRS)
기간: Baseline (before intervention), immediately after intervention, and 1 week after intervention
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Pain intensity rated on a 0 to 10 scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate greater pain. |
Baseline (before intervention), immediately after intervention, and 1 week after intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hyunjoong Kim, PhD, Gwangju Health University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1040198-260618-HR-137-04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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