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Manual Therapy Dosage Factorial Study

22. september 2015 opdateret af: McMaster University

This study will determine biological responses to different dosages of neck mobilization intervention in patients, providing opportunities to identify the optimal dosage, predictors of response, outcome measures as well as the longitudinal changes in biology.

Subjects with acute whiplash associated disorders (WAD) II and III with a symptom duration of less than 30 days (acute) or 30 to 90 days (subacute) will be randomly assigned to receive different doses of mobilization. The dosage treatment groups will differ in the number of sessions (1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks). A zero treatment/week option is included to insure that the impact of any mobilization is included and because previous studies suggest a single mobilization may have a treatment effect.

All patient participants will receive a core standard treatment of education, advice to stay active, and neck/postural stretching and strengthening exercise. All patient participants will receive supervised exercise and advice for the full 12 weeks. All patients will be provided with an instructional CD and exercise brochure to reinforce the whole program.

Follow-up assessments will consist of quantitative sensory testing (vibration threshold; current perception threshold), the Neck Walk Index (NWI), the Upper Cyclical Reach and Grasp Task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography), range of motion, head flexion endurance, and self-report symptoms and disability (Visual Analogue Scale; Neck Disability Index; Disabilities of the Arm, Shoulder, Hand; pain threshold and tolerance algometry; and perceived self-efficacy; SF-36).

Hypothesis: During recovery, patient are expected to transition from an acute painful state to one where they can resume normal activity and add intensive strengthening exercises.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1C7
        • McMaster University

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

21 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days or subacute (30 to 90 days)
  • pain in the neck but may radiate to the shoulder region or upper extremities or have an associated headache
  • pain intensity must be at or above 30 mm on a 100 mm visual analogue scale
  • must be a new episode of pain with ,no other occurrences of neck pain requiring treatment in the previous 4 months.

Exclusion Criteria:

  • arthritis, neurological diseases, fractures, dislocation, rheumatoid arthritis, long tract signs and malignancy
  • conditions that make the provision of neck exercise unsafe

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: Faktoriel opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: A
Zero treatment/3 weeks
Aktiv komparator: B
Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks
Procedure: Mobilization
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Aktiv komparator: C
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks
Procedure: Mobilization
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Aktiv komparator: D
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks
Procedure: Mobilization
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Aktiv komparator: F
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks
Procedure: Mobilization
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Aktiv komparator: G
Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks
Procedure: Mobilization
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Aktiv komparator: H
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks
Procedure: Mobilization
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Aktiv komparator: J
Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks
Procedure: Mobilization
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Aktiv komparator: K
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks
Procedure: Mobilization
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Aktiv komparator: L
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks
Procedure: Mobilization
Mobilizations are passive movements performed in such a manner that the patient can volitionally prevent the movement. Types of mobilization include: a) passive oscillatory movements (2-3 Hz) of small or large amplitude, applied anywhere in a range of movement, typically for anything between 30 seconds and several minutes depending on the response and desired effects, and b) sustained stretching (glides) with or without tiny amplitude oscillations at the limit of the range.
Ingen indgriben: E
Zero treatment/6 weeks
Ingen indgriben: I
Zero treatment/12 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Quantitative Sensory Testing (QST)
Tidsramme: Within 24 weeks
Within 24 weeks
Current Perception Threshold (CPT)
Tidsramme: Within 24 weeks
Within 24 weeks
Neck Walk Index (NWI)
Tidsramme: Within 24 weeks
Within 24 weeks
Cyclical Reach and Grasp Test (CRGT)
Tidsramme: Within 24 weeks
Within 24 weeks
Muscle Biology (cytokine analyses)
Tidsramme: Within 24 weeks
Within 24 weeks
Central Breathing Control Test
Tidsramme: Within 24 weeks
Within 24 weeks
Neck Disability Index
Tidsramme: Within 24 weeks
Within 24 weeks
Pain Intensity - Visual Analogue Scale (VAS)
Tidsramme: Within 24 weeks
Within 24 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Global Perceived Effect (GPE)
Tidsramme: Within 24 weeks
Within 24 weeks
Disabilities of the Arm, Shoulder, and Hand (DASH)
Tidsramme: Within 24 weeks
Within 24 weeks
Pain Threshold and Pain Tolerance Algometry
Tidsramme: Within 24 weeks
Within 24 weeks
Head Flexion Endurance
Tidsramme: Within 24 weeks
Within 24 weeks
Range of Motion
Tidsramme: Within 24 weeks
Within 24 weeks
Quality of Life (SF-36v2)
Tidsramme: within 24 weeks
within 24 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

McMaster University

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)
National Institutes of Health (NIH)
University of Western Ontario, Canada

Efterforskere

  • Ledende efterforsker: Joy C MacDermid, PhD, McMaster University

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.

Datoer for studieregistrering

Først indsendt

19. november 2007

Først indsendt, der opfyldte QC-kriterier

19. november 2007

Først opslået (Skøn)

20. november 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. september 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1 R21 AT004263

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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