Manual Therapy Dosage Factorial Study
22. september 2015 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Fase
- Fase 2
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
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Hamilton, Ontario, Canada, L8S 1C7
- McMaster University
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-
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
21 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Faktoriell oppgave
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: A
Zero treatment/3 weeks
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|
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Aktiv komparator: B
Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 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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Aktiv komparator: C
Frequency of Mobilization: 1/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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: F
Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 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.
|
|
Aktiv komparator: 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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Aktiv komparator: 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.
|
|
Aktiv komparator: J
Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Ingen inngripen: E
Zero treatment/6 weeks
|
|
|
Ingen inngripen: I
Zero treatment/12 weeks
|
Hva måler studien?
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
|
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Central Breathing Control Test
Tidsramme: Within 24 weeks
|
Within 24 weeks
|
|
Neck Disability Index
Tidsramme: Within 24 weeks
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Within 24 weeks
|
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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
|
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Quality of Life (SF-36v2)
Tidsramme: within 24 weeks
|
within 24 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Joy C MacDermid, PhD, McMaster University
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.
Datoer for studieregistrering
Først innsendt
19. november 2007
Først innsendt som oppfylte QC-kriteriene
19. november 2007
Først lagt ut (Anslag)
20. november 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. september 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. september 2015
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1 R21 AT004263
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