Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals
12. mars 2018 oppdatert av: Nuno Filipe Pinho Nogueira, Escola Superior de Tecnologia da Saúde do Porto
This study had the goal of analyse the neurophysiologic effects of both mechanical and manual cervical manipulation, in asymptomatic individuals.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
In this study, the investigators compared the effects of manual manipulation and instrument assisted manipulation of C3/C4 on muscle tone, elasticity and stiffness and on pressure pain threshold , and pressure pain perception.
The muscles evaluated were upper trapezius and biceps brachialis, bilaterally.
The study also had a placebo and a control group.
All individuals were asymptomatic.
Studietype
Intervensjonell
Registrering (Faktiske)
59
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy subjects.
- Minimum of 18 years old.
Exclusion Criteria:
- Pain in cervical region, shoulders or arms.
- History of trauma or disease in the cervical region or upper limb.
- Use of medication that could affect the outcomes (painkillers, NSAID, or anti depressives) during the last week.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Manual manipulation
In the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation.
Then, a low amplitude, high velocity thrust in rotation was delivered.
|
In the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation.
Then, a low amplitude, high velocity thrust in rotation was delivered.
|
|
Aktiv komparator: Mechanical manipulation
In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.
|
In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.
|
|
Placebo komparator: Placebo
The subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur.
Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position.
|
The subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur.
Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position.
|
|
Ingen inngripen: Control
The subjects stayed in supine position and no intervention occurred.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pressure pain thresholds
Tidsramme: Immediately after the intervention
|
To measure the pressure pain threshold, it was used an electronic pressure dynamometer FORCE ONE™ FDIX (Wagner Instruments - Greenwich, USA), with 1cm2 of surface.
The values were expressed in Kg/cm2.
The pressure was increased at a rate of 1 kg/cm2/s until the subject inform that the sense of pressure has become a sense of pain.
|
Immediately after the intervention
|
|
Pressure pain perception
Tidsramme: Immediately after the intervention
|
To evaluate the pressure pain perception, it was used a Visual Analogue Scale (VAS).
The pressure increased until 2,5 kg/cm2 and was hold for 5 seconds, and the subject used the VAS scale to record the pressure pain perception he felt.
|
Immediately after the intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle tone
Tidsramme: Immediately after the intervention
|
To measure muscle tone it was used the MyotonPro device.
It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally.
The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them.
The non-neural tone was recorded as frequency.
|
Immediately after the intervention
|
|
Muscle stiffness
Tidsramme: Immediately after the intervention
|
To measure muscle stiffness it was used the MyotonPro device.
It was used to evaluate this parameter both on the biceps and on the upper trapezius, bilaterally.
The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them.
The muscle stiffness was recorded as N/m.
|
Immediately after the intervention
|
|
Muscle elasticity
Tidsramme: Immediately after the intervention
|
To measure muscle elasticity it was used the MyotonPro device.
It was used to evaluate those parameters both on the biceps and on the upper trapezius, bilaterally.
The device was located perpendicular to the middle point of each muscle and it were recorded 6 impulses in each one of them.
The elasticity was indicated by logarithmic decrement.
|
Immediately after the intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Nuno Nogueira, MSc, Instituto Politécnico da Saúde do Norte
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2013
Primær fullføring (Faktiske)
1. juli 2014
Studiet fullført (Faktiske)
1. oktober 2016
Datoer for studieregistrering
Først innsendt
8. september 2017
Først innsendt som oppfylte QC-kriteriene
10. mars 2018
Først lagt ut (Faktiske)
13. mars 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mars 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 20122017
Plan for individuelle deltakerdata (IPD)
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