Manual Therapy Dosage Factorial Study
22 september 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Ingetrokken
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Fase
- Fase 2
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ontario
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Hamilton, Ontario, Canada, L8S 1C7
- McMaster University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
21 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: A
Zero treatment/3 weeks
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Actieve vergelijker: B
Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks
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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.
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Actieve vergelijker: C
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks
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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.
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Actieve vergelijker: D
Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks
|
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.
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Actieve vergelijker: F
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks
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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.
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Actieve vergelijker: G
Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks
|
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.
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Actieve vergelijker: H
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks
|
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.
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Actieve vergelijker: J
Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks
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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.
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Actieve vergelijker: K
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks
|
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.
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Actieve vergelijker: L
Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks
|
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.
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Geen tussenkomst: E
Zero treatment/6 weeks
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Geen tussenkomst: I
Zero treatment/12 weeks
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Quantitative Sensory Testing (QST)
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Current Perception Threshold (CPT)
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Neck Walk Index (NWI)
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Cyclical Reach and Grasp Test (CRGT)
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Muscle Biology (cytokine analyses)
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Central Breathing Control Test
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Neck Disability Index
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Pain Intensity - Visual Analogue Scale (VAS)
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Global Perceived Effect (GPE)
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Disabilities of the Arm, Shoulder, and Hand (DASH)
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Pain Threshold and Pain Tolerance Algometry
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Head Flexion Endurance
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Range of Motion
Tijdsspanne: Within 24 weeks
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Within 24 weeks
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Quality of Life (SF-36v2)
Tijdsspanne: within 24 weeks
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within 24 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Joy C MacDermid, PhD, McMaster University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Studieregistratiedata
Eerst ingediend
19 november 2007
Eerst ingediend dat voldeed aan de QC-criteria
19 november 2007
Eerst geplaatst (Schatting)
20 november 2007
Updates van studierecords
Laatste update geplaatst (Schatting)
23 september 2015
Laatste update ingediend die voldeed aan QC-criteria
22 september 2015
Laatst geverifieerd
1 september 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1 R21 AT004263
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