- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01984021
Evaluation of the Immediate Effect of Acupuncture on the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain.
29. maj 2015 opdateret af: Cid André Fidelis de Paula Gomes, University of Nove de Julho
Evaluation of the Immediate Effect of Acupuncture on Pain, Cervical Range of Motion and Electromyographic Activity of the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain: Randomized, Single-blinded, Sham-controlled Study.
The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized, single-blind, crossover study.
Each patient will receive two forms of treatment in random order: a single session of traditional acupuncture and sham acupuncture.
To eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions.
Surface electromyography will be used to determine motor control in the upper trapezius muscle before and after treatment.
The outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0 [no pain] to 10 [maximum pain]), documentation of the pain area on a body chart and cervical range of motion.
Linear regression analysis will be applied for each individual to investigate associations between the sEMG variables and force (excluding the sixth step).
The slopes of the regression lines will be used to measure the sensitivity of the sEMG variables regarding changes in force.
The Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS and MDF values in the third and sixth step of the step contraction.
Paired samples (Student's t-test or Wilcoxon test) will be used to test differences between third and sixth contraction step.
A mixed linear model will be used to analyze and compare the sEMG data during sustained contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2) evaluations.
These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the activity of the upper trapezius muscle, as hypothesized.
The pain (NRS, PPT and area) and cervical ROM data collected during the four evaluations will also be compared using a mixed linear model.
The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows) will be employed for the statistical analysis, with the level of significance set to 5% (p < 0.05).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sao Paulo, Brasilien, 01415000
- University of Nove de Julho
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 18 to 40 years
- male and female volunteers
Exclusion Criteria:
- history of neurological disorders
- neck surgery
- chronic neck pain resulting from a traumatic incident
- chronic musculoskeletal condition
- medical diagnosis of fibromyalgia; systemic disease
- connective tissue disorder
- non-tolerance of needles; current pregnancy
- having undergone physical therapy use of analgesic, muscle relaxant.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: traditional acupuncture (tACP)
In the upper trapezius muscle with the greatest area pain and lowest PPT score will be chosen for acupuncture.
Sterile acupuncture needles measuring 0.25 x 13 mm (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd.®) will be inserted in TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and LI-11 (located at the outermost point of the skinfold of elbow flexion in the direction of the lateral epicondyle of the elbow).
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Placebo komparator: sham acupuncture (sACP)
The needles will be inserted 1 cm to the side of TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and 1 cm to the side of LI-11 (in the direction of the styloid process of the radius).The acupuncture needles are positioned at different acupoints.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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electromyographic activity
Tidsramme: 1 Year
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The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.
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1 Year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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cervical range of motion
Tidsramme: 1 Year
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A cervical range of motion instrument will be used to determine cervical spine movements.
This instrument is composed of two gravity goniometers and a compass goniometer and has demonstrated to be a reliable tool with adequate validity.
The device will be placed on the top of the head and the patient will be instructed to move the head as far as possible without pain in a standard fashion: right rotation, left rotation, flexion, extension, right lateral flexion and left lateral flexion.
Three trials will be conducted in randomized order for each direction of movement and mean values will be recorded for analysis.
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1 Year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2013
Primær færdiggørelse (Faktiske)
1. maj 2015
Studieafslutning (Faktiske)
1. maj 2015
Datoer for studieregistrering
Først indsendt
7. november 2013
Først indsendt, der opfyldte QC-kriterier
13. november 2013
Først opslået (Skøn)
14. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2015
Sidst verificeret
1. maj 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 483712
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 .
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