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Manual Therapy Dosage Factorial Study

22 września 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Wycofane

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Faza

  • Faza 2
  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

21 lat do 60 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przypisanie czynnikowe
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: A
Zero treatment/3 weeks
Aktywny komparator: B
Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks
Procedura: 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.
Aktywny komparator: C
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks
Procedura: 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.
Aktywny komparator: D
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks
Procedura: 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.
Aktywny komparator: F
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks
Procedura: 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.
Aktywny komparator: G
Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks
Procedura: 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.
Aktywny komparator: H
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks
Procedura: 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.
Aktywny komparator: J
Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks
Procedura: 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.
Aktywny komparator: K
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks
Procedura: 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.
Aktywny komparator: L
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks
Procedura: 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.
Brak interwencji: E
Zero treatment/6 weeks
Brak interwencji: I
Zero treatment/12 weeks

Co mierzy badanie?

Podstawowe miary wyniku

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

Miary wyników drugorzędnych

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

McMaster University

Współpracownicy

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

Śledczy

  • Główny śledczy: Joy C MacDermid, PhD, McMaster University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Daty rejestracji na studia

Pierwszy przesłany

19 listopada 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 listopada 2007

Pierwszy wysłany (Oszacować)

20 listopada 2007

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

23 września 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 września 2015

Ostatnia weryfikacja

1 września 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1 R21 AT004263

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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