Remote Fu's Subcutaneous Needling for Patients With Chronic Neck Pain
Effect on Symptomatic Release and Sleep Quality of Remote Fu's Subcutaneous Needling on Patients With Chronic Neck Pain
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Neck pain combining limited range of motion is very common. Lasting for only a few days, it will taper off without any treatment. If the neck pain symptoms persist for more than two months without any improvement, it will be categorized as chronic neck pain causing not only pain but also functional impact, even in daily life, working, and sleep quality.
Fu's subcutaneous needling is utilized in treating disease related with myofascial trigger point, including soft tissue pain, joint pain, even some internal problems. Indeed it reduce pain immediately with no obvious side effects. There were some clinical articles of subjective symptoms description published lacking scientific accessment of efficacy.
Research team leading by Professor Chang-Zern Hong has already prove that excitability can be reduced by distal acupuncture. Needling TE5 and LI11 can reduce pain intensity and average amplitude of MTrPs end plate in upper trapezium m., and increase pain pressure threshold.
Comparing to traditional acupuncture, whether safer and pain-less Fu's subcutaneous needle also has the distal treatment effect or not still needs more scientific experiment to prove. This is a randomized controlled trial to compare the efficacy of Transcutaneous electrical nerve stimulation and Fu's subcutaneous needle on chronic neck pain by using more objective assessment tools such as Neck Disability Index, Visual Analog Scales, Pressure Pain Threshold and Myotone of MTrPs of Upper Trapezius Muscles, Range of Motion of Stretch of Upper Trapezius Muscle, and Pittsburgh sleep quality index.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Taichung, Taiwan, 999079
- Rekruttering
- China Medical University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Having chronic neck pain for more than 2 months and subjective subjective pain intensity (VAS) greater than 5 points.
- Patients with myofascial pain diagnosed with unilateral upper trapezius muscle.
- This pain is not effective for previous medication or physical therapy.
Exclusion Criteria:
- Contraindications for general treatment, such as serious medical problems, recent trauma, or pregnancy.
- There has been a history of drug abuse (including excess alcohol) that affects pain assessors.
- Have received neck, upper back, or upper and lower limb surgery.
- People with central or peripheral nerve disease.
- Cognitive dysfunction cannot be matched with the experimenter.
- People with cardiac pacemakers, epilepsy, etc. cannot place electrode patches on the skin.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Fu's subcutaneous needling
In this arm, the subjects will receive the intervention of FSN on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.
|
Fu's Subcutaneous Needle (FSN), er en innovation til behandling af myofascial smerte og triggerpunkter. Nålen er en ikke-injektionsnål, og det faktum, at begge nåle manipuleres og virker på blødt bindevæv. FSN afholder sig fra muskel- og dybe fascia-lag og er begrænset til kun det subkutane lag, hvor kollagenfibre er mest udbredt. Da det subkutane lag er dårligt innerveret, er smerten mindre end andre nålebehandlinger. FSN bruges også i øjeblikket med succes til at behandle ikke-muskuloskeletale tilstande. |
|
Aktiv komparator: Transcutaneous electrical nerve stimulation
In this arm, the subjects will receive the intervention of TENS on Day1, Day2 and Day4, in total 3 treatments and will be arrange to take efficacy two assessment on Day8 and Day15, separately.
|
Transkutan elektrisk nervestimulation (TENS eller TNS) er brugen af elektrisk strøm produceret af en enhed til at stimulere nerverne til terapeutiske formål. TENS dækker per definition hele rækken af transkutant påførte strømme, der anvendes til nerveexcitation, selvom udtrykket ofte bruges med en mere restriktiv hensigt, nemlig at beskrive den slags impulser, der produceres af bærbare stimulatorer, der bruges til at behandle smerte. Enheden er normalt forbundet til huden ved hjælp af to eller flere elektroder. En typisk batteridrevet TENS-enhed er i stand til at modulere pulsbredde, frekvens og intensitet. Generelt påføres TENS ved høj frekvens (>50 Hz) med en intensitet under motorisk kontraktion (sensorisk intensitet) eller lav frekvens ( |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visuelle analoge skalaer
Tidsramme: 1 dag
|
Den visuelle analoge skala eller den visuelle analoge skala (VAS) er en psykometrisk svarskala, som kan bruges i spørgeskemaer.
Det er et måleinstrument for subjektive egenskaber eller holdninger, som ikke direkte kan måles.
Når respondenterne svarer på et VAS-emne, angiver de deres enighed om et udsagn ved at angive en position langs en kontinuerlig linje mellem to slutpunkter.
|
1 dag
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neck Disability Index
Tidsramme: 1 week
|
The NDI is a modification of the Oswestry Low Back Pain Disability Index .
It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
The NDI has sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain
|
1 week
|
|
Pressure Pain Threshold
Tidsramme: 1day
|
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.
This measure has proven to be commonly useful in evaluating tenderness symptom.
|
1day
|
|
Myotone of MTrPs
Tidsramme: 1day
|
Muscle tone is the muscle's resistance to passive stretch during resting state.
Myotone will help the investigators to get muscle parameters such as tone, elasticity and stiffness.
|
1day
|
|
Pittsburgh sleep quality index
Tidsramme: 1 week
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations.
The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders.
Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures
|
1 week
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Li-Wei Chou, PhD, China Medical University Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CMUH107-REC2-031
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
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kroniske nakkesmerter
-
Insel Gruppe AG, University Hospital BernGaslini Children's HospitalTilmelding efter invitationAnæstesi | Trakeostomi komplikation | Emergency Front of Neck Airway hos børnSchweiz
-
The University of Texas Health Science Center,...EurofinsAfsluttetOdontogen Deep Space Neck InfectionForenede Stater
-
Istanbul University - CerrahpasaRekrutteringPatellofemoral Pain, PfpTyrkiet (Türkiye)
-
Pamukkale UniversityIkke rekrutterer endnuPatellofemoral Pain, PfpTyrkiet (Türkiye)
-
Beijing Sport UniversityAfsluttetPatellofemoral Pain, PfpKina
-
Beijing Sport UniversityIkke rekrutterer endnuPatellofemoral Pain, Pfp
-
Beijing Sport UniversityIkke rekrutterer endnu
-
University Children's Hospital, ZurichAfsluttetEmergency Front of Neck Airway hos børnSchweiz
-
Sahmyook UniversityAfsluttetMyofascial Pain Syndrome (MPS)Sydkorea
-
Camilo Jose Cela UniversityAfsluttetMyofascial Pain Syndrome (MPS)Spanien
Kliniske forsøg med Fus subkutane nål
-
China Medical University HospitalAfsluttet
-
China Medical University HospitalAfsluttet
-
China Medical University HospitalAfsluttet
-
Jiang XumeiGuangdong Provincial Hospital of Traditional Chinese MedicineUkendt
-
Brigham Young UniversityAfsluttetMyofascial smertesyndrom | Myofascial triggerpunktssmerterForenede Stater
-
University of Nevada, Las VegasAfsluttetRygsmerteForenede Stater
-
University GhentAfsluttetArbejdsrelateret tilstand | Nakkesmerter, posteriorBelgien
-
Bradley UniversityAfsluttetForsinket begyndende muskelømhedForenede Stater
-
University GhentAfsluttetCentrale smertemodulerende virkninger af dry-needling hos patienter med ikke-specifikke nakkesmerterNakkesmerter, posterior | Trapezius muskelbelastningBelgien
-
Universitat Internacional de CatalunyaRekrutteringMyofascial triggerpunktssmerterSpanien