- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Hyunjoong Kim, PhD
- Telefonnummer: +82-62-958-7598
- E-post: hjkim@ghu.ac.kr
Studiesteder
-
-
-
Gwangju, Sør -Korea
- Jin's Ballet Academy, Pulse Dance Academy
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Active tDCS + Manual Therapy (ANT)
|
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). |
|
Sham-komparator: Sham tDCS + Manual Therapy (SCT)
|
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. |
|
Eksperimentell: Sham tDCS + Manual Therapy + Expectation-Enhancement Education (ECT)
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Intensity (Numeric Pain Rating Scale, NPRS)
Tidsramme: Baseline (before intervention), immediately after intervention, and 1 week after intervention
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hyunjoong Kim, PhD, Gwangju Health University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Muskel- og skjelettsykdommer
- Muskelsykdommer
- Psykiske lidelser
- Fobiske lidelser
- Angstlidelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Kinesiofobi
- Muskel- og skjelettsmerter
- Kronisk smerte
- Terapeutikk
- Komplementære terapier
- Fysioterapi -modaliteter
- Rehabilitering
- Muskel- og skjelettmanipulasjoner
Andre studie-ID-numre
- 1040198-260618-HR-137-04
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .