- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00560807
Manual Therapy Dosage Factorial Study
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.
Studieöversikt
Studietyp
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8S 1C7
- McMaster University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: A
Zero treatment/3 weeks
|
|
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.
|
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.
|
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.
|
Inget ingripande: E
Zero treatment/6 weeks
|
|
Inget ingripande: I
Zero treatment/12 weeks
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Quantitative Sensory Testing (QST)
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Current Perception Threshold (CPT)
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Neck Walk Index (NWI)
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Cyclical Reach and Grasp Test (CRGT)
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Muscle Biology (cytokine analyses)
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Central Breathing Control Test
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Neck Disability Index
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Pain Intensity - Visual Analogue Scale (VAS)
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Global Perceived Effect (GPE)
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Disabilities of the Arm, Shoulder, and Hand (DASH)
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Pain Threshold and Pain Tolerance Algometry
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Head Flexion Endurance
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Range of Motion
Tidsram: Within 24 weeks
|
Within 24 weeks
|
Quality of Life (SF-36v2)
Tidsram: within 24 weeks
|
within 24 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Joy C MacDermid, PhD, McMaster University
Studieavstämningsdatum
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1 R21 AT004263
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Whiplash skador
-
Seoul National University Bundang HospitalSeoul National University HospitalOkändWhiplash skada | Herniated Nucleus PulposusKorea, Republiken av
-
Linkoeping UniversityAvslutadWhiplash associerad sjukdomSverige
-
University Hospital, Clermont-FerrandJacques Lacarin Hospital Center; CH Issoire; CH Montluçon; CH Aurillac; CH Moulins och andra samarbetspartnersAvslutad
-
Linkoeping UniversityAvslutad
-
Soroka University Medical CenterOkänd
-
The Back Research Center, DenmarkDanish Pain Research CenterAvslutad
-
University Hospitals, LeicesterAvslutadWhiplash associerad sjukdomStorbritannien
-
Karolinska InstitutetOkändWhiplash syndromSverige
-
University of British ColumbiaOkänd
Kliniska prövningar på Mobilization
-
Muş Alparlan UniversityAvslutadLumbal diskbråckKalkon
-
Brenau UniversityAvslutadSmärta | Smärta, NeuropatiskFörenta staterna
-
Riphah International UniversityAvslutad
-
Foundation University IslamabadAktiv, inte rekryterande
-
Riphah International UniversityRekryteringCervikal radikulopatiPakistan
-
Hacettepe UniversityAvslutad
-
Istanbul University - Cerrahpasa (IUC)Istanbul Aydın UniversityAvslutadSmärta, axel | Myofacial smärta | Adhesion; AxelKalkon
-
Foundation University IslamabadRekrytering
-
Riphah International UniversityRekryteringFramåt huvudhållning | NacksyndromPakistan
-
Cleveland Chiropractic CollegeAvslutadPatellofemoralt smärtsyndromFörenta staterna