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Cardiovascular Response to Two Manual Techniques for Neck Pain

5. januar 2016 opdateret af: Azusa Pacific University

Randomized Trial of Cardiovascular Response to Two Manual Techniques Non-thrust Joint Manipulation of the Cervical Spine in Patients With Non-traumatic Mechanical Neck Pain.

The aim of the investigators study is to investigate whether posteriorly directed (AP) pressures and laterally directed (LAT) glides, cause blood pressure and heart rate elevation or lowering in patients with neck pain. The answer will advance the investigators understanding of why manual therapy works.

Studieoversigt

Detaljeret beskrivelse

To be included in the study, these subjects with unilateral non-traumatic, non-chronic neck pain (operationally defined as neck pain with mobility deficits lasting less than 3 months) shall have numeric pain rating scale (NPRS) of between 0 and 5 out of 10 as the most painful neck movement even with passive scapular elevation, neck disability index (NDI) of between 16 and 50 out of 100%, resting systolic and diastolic blood pressure between 90/60 and 138/88, and resting heart rate between 60 and 90. Subjects are excluded if they are current smoker, over 50 years of age, has a history of fainting spells or loss of consciousness, is on blood thinners, is taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease, has a history of spinal surgeries, and has neck pain classified or associated with headache, radiating pain, and movement coordination impairments. A convenience sample of subjects will be randomly allocated to 1 of 2 groups. Both Group 1: AP and Group 2: LAT will receive posterior pressures and lateral glides respectively to one hypomobile segment. Baseline NPRS, and NDI will be collected at the initial visit. Systolic blood pressure (SBP) and heart rate (HR) will be measured with a OMRON automatic monitor recording time points: (1) 5 minutes, and (2) 7 minutes after lying supine; (3) during the 1st set, (4) 5th set of one of the glides, (5) 2 minutes after time point #4, and (6) 4 minutes after time point #4. After time point #6, a global rating of change (GROC) will immediately be collected based on the most painful neck movement. A finger pulse oximeter will be placed on the subjects' index finger to constantly monitor their pulse rate for slowing heart rate or asystole. The primary author will perform one of the techniques on all subjects. After one visit, a follow-up NPRS, and NDI will be collected again.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

34

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • Azusa, California, Forenede Stater, 91784
        • Rekruttering
        • Physical Therapy Department
        • Kontakt:
          • Michael Wong, DPT
        • Ledende efterforsker:
          • Michael Wong, DPT

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 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Unilateral, non-traumatic, non-chronic mechanical neck pain
  • Numeric pain rating scale between 0-5/10 as the most painful neck movement (with passive scapular elevation)
  • Neck Disability Index between 16-50/100 percent
  • Resting blood pressure between 90/60 and 138/88 mmHg
  • Resting heart rate between 60 and 90 beats per minute

Exclusion Criteria:

  • Current smoker
  • Under 18 years and over 50 years of age
  • History of fainting spells or loss of consciousness
  • Currently on blood thinners
  • Taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease
  • History of spinal surgery
  • Has neck pain classified or associated headache, arm pain, trauma/whiplash

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AP
Anterior to posterior pressures 5x10 seconds per set with 10 seconds rest between each set
Anterior to posterior pressures
Eksperimentel: Lateral glides
Lateral glides 5x10 seconds per set with 10 seconds rest between each set
Lateral glide

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in heart rate
Tidsramme: 7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4

Sekundære resultatmål

Resultatmål
Tidsramme
Change in blood pressure
Tidsramme: 7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
7 minutes before, 5 minutes before, During first set, During fifth set, 2 minutes after time point 4, 4 minutes after time point 4
Change in Numeric Pain Rating Scale
Tidsramme: Baseline and within 7 days after the intervention
Baseline and within 7 days after the intervention
Change in Neck Disability Index
Tidsramme: Baseline and 7 days after the intervention
Baseline and 7 days after the intervention
Global rating of change
Tidsramme: Immediately after intervention
Immediately after intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Michael Wong, DPT, Azusa Pacific University
  • Ledende efterforsker: Emmanuel Yung, DPT, Sacred Heart University

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.

Generelle publikationer

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. juli 2014

Primær færdiggørelse (Forventet)

1. juli 2016

Studieafslutning (Forventet)

1. juli 2016

Datoer for studieregistrering

Først indsendt

15. juli 2014

Først indsendt, der opfyldte QC-kriterier

23. juli 2014

Først opslået (Skøn)

24. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AP vs LAT

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 Nakke smerter

Kliniske forsøg med Anterior to posterior pressures

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