- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04394741
Effects of Dry Needling on Stiffness in Latent Trigger Points
Effects of Dry Needling on Stiffness in Latent Myofascial Trigger Points: a Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Toledo, Spanien, 45071
- Performance and Sport Rehabilitation Laboratory
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age between 18 and 30 years
- The presence of LTrP in the middle third of the upper trapezius muscle on the dominant side
- Being able to provide written informed consent
- Being able to follow instructions and realize clinical tests
Exclusion Criteria:
- Any pharmacological therapeutic
- Any medical treatment or physical therapies at cervical region during the 6-month before this study - Any diagnosed health problem
- Any history of head and upper extremity surgery or trauma
- Any red flags to DN, (ie: metabolic diseases, pregnancy, kinesiophobia, Infection, cancer)
- Absence of recurrent history of neck pain
- No neck pain symptomatology the previous 6 months
- Cervical disk herniation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Deep Dry Needling
Intervention-Dry Needling: Deep Dry Needling i det latente triggerpunkt i den øvre trapezius-muskel
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Dyb tør nålning ind i stedet for det latente triggerpunkt i den øvre trapezius-muskel. 1 session i øvre trapezius muskel bevæger nålen op og ned ti gange. |
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Sham-komparator: Sham Dry Needling
Control-Dry Needling: Sham Dry Needling ind i det latente triggerpunkt i den øvre trapezius-muskel
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Dyb tør nålning ind i stedet for det latente triggerpunkt i den øvre trapezius-muskel. 1 session i øvre trapezius muskel bevæger nålen op og ned ti gange. Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles 1 session in upper trapezius muscle moving the needle up and down ten times. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change on Stiffness (Shear wave elastography and Strain Elastography)
Tidsramme: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Shear-wave Elastography (SWE) as assessed using an Logiq S8 US system (GE Healthcare). The stiffness was determined with measuring velocity of shear waves in trapezius muscle on SWE exam. Strain elastography (SEL) as assessed using an Logiq S8 US system (GE Healthcare). The stiffness was determined by applying light repetitive compression with the hand-held transducer |
Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring i smertetryktærskel (PPT)
Tidsramme: Baseline, 30 minutter efter behandling, 24 timer efter behandling, 72 timer efter behandling
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Tryk-smerte-tærskel vurderet af et manuelt mekanisk algometer.
PPT er den minimale mængde tryk, der frembringer smerte og bruges til at vurdere abnormiteter i nociceptiv behandling eller hyperalgesi.
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Baseline, 30 minutter efter behandling, 24 timer efter behandling, 72 timer efter behandling
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Change in Thickness of muscle
Tidsramme: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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The muscle was scanned in the longitudinal and axial planes, taking care to avoid anisotropy.
B-Mode gray scale was employed to measure muscle thickness
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Change in Post-needling soreness
Tidsramme: Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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The procedure performed was the subject had to characterize the level of pain using a visual analog scale (VAS), ranging from 0mm (no pain) to 10mm (worst imaginable pain)
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Baseline, at 30 minutes after treatment, at 24 hours after treatment, at 72 hours after treatment
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Javier Abián-Vicén, PhD, Castilla-La Mancha University
Publikationer og nyttige links
Generelle publikationer
- Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.
- Ruiz-Saez M, Fernandez-de-las-Penas C, Blanco CR, Martinez-Segura R, Garcia-Leon R. Changes in pressure pain sensitivity in latent myofascial trigger points in the upper trapezius muscle after a cervical spine manipulation in pain-free subjects. J Manipulative Physiol Ther. 2007 Oct;30(8):578-83. doi: 10.1016/j.jmpt.2007.07.014.
- Grabowski PJ, Slane LC, Thelen DG, Obermire T, Lee KS. Evidence of Generalized Muscle Stiffness in the Presence of Latent Trigger Points Within Infraspinatus. Arch Phys Med Rehabil. 2018 Nov;99(11):2257-2262. doi: 10.1016/j.apmr.2018.03.024. Epub 2018 Apr 28.
- Luan S, Zhu ZM, Ruan JL, Lin CN, Ke SJ, Xin WJ, Liu CC, Wu SL, Ma C. Randomized Trial on Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Dry Needling in Myofascial Trigger Points. Am J Phys Med Rehabil. 2019 Aug;98(8):677-684. doi: 10.1097/PHM.0000000000001173.
- Sanchez-Infante J, Bravo-Sanchez A, Jimenez F, Abian-Vicen J. Effects of Dry Needling on Muscle Stiffness in Latent Myofascial Trigger Points: A Randomized Controlled Trial. J Pain. 2021 Jul;22(7):817-825. doi: 10.1016/j.jpain.2021.02.004. Epub 2021 Feb 23.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- DNStiffness
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Triggerpunkter
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National Taiwan University HospitalIkke rekrutterer endnu
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Research Unit Of General Practice, CopenhagenUniversity of Copenhagen; Region Capital Denmark; The Copenhagen General... og andre samarbejdspartnereAfsluttet
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University Health Network, TorontoIkke rekrutterer endnu
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National Taiwan University HospitalAfsluttetPoint-of-care ultralydTaiwan
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Asociacion Española Primera en SaludIntensive Care Unit Pasteur HospitalAfsluttetPoint of Care UltralydUruguay
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Aga Khan UniversityThe Hospital for Sick Children; Grand Challenges CanadaUkendtPoint of Care UltralydPakistan
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Research Unit Of General Practice, CopenhagenUniversity of Copenhagen; Region Capital Denmark; The Copenhagen General... og andre samarbejdspartnereAfsluttet
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Indiana UniversityRekruttering
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Aalborg UniversityAfsluttetPoint-of-care ultralyd (POCUS)Danmark
Kliniske forsøg med Intervention-Dry Needling
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University of Castilla-La ManchaAfsluttetTriggerpunktssmerter, MyofascialSpanien
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University of Castilla-La ManchaAfsluttetTriggerpunktssmerter, MyofascialSpanien
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University of Castilla-La ManchaUniversidad San Jorge; Hospital Nacional de Parapléjicos de ToledoAfsluttetAbnormiteter i muskeltonusSpanien
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Brigham Young UniversityAfsluttetMyofascial smertesyndrom | Myofascial triggerpunktssmerterForenede Stater
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Kutahya Health Sciences UniversityRekrutteringSkuldersmerterTyrkiet (Türkiye)
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University of Kansas Medical CenterRekruttering
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Universidad de ZaragozaAfsluttet
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Institute of Technology, CarlowAfsluttetTriggerpunkterIrland
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Universidad de ZaragozaUkendt
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Universitat Internacional de CatalunyaRekrutteringMyofascial triggerpunktssmerterSpanien