- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Tanulmány típusa
Fázis
- 2. fázis
- 3. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Ontario
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Hamilton, Ontario, Kanada, L8S 1C7
- McMaster University
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Tényező hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Nincs beavatkozás: A
Zero treatment/3 weeks
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Aktív összehasonlító: 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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Aktív összehasonlító: 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.
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Aktív összehasonlító: 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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Aktív összehasonlító: 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.
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Aktív összehasonlító: 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.
|
Aktív összehasonlító: 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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Aktív összehasonlító: 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.
|
Aktív összehasonlító: 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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Aktív összehasonlító: 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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Nincs beavatkozás: E
Zero treatment/6 weeks
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Nincs beavatkozás: I
Zero treatment/12 weeks
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
---|---|
Quantitative Sensory Testing (QST)
Időkeret: Within 24 weeks
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Within 24 weeks
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Current Perception Threshold (CPT)
Időkeret: Within 24 weeks
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Within 24 weeks
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Neck Walk Index (NWI)
Időkeret: Within 24 weeks
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Within 24 weeks
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Cyclical Reach and Grasp Test (CRGT)
Időkeret: Within 24 weeks
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Within 24 weeks
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Muscle Biology (cytokine analyses)
Időkeret: Within 24 weeks
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Within 24 weeks
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Central Breathing Control Test
Időkeret: Within 24 weeks
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Within 24 weeks
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Neck Disability Index
Időkeret: Within 24 weeks
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Within 24 weeks
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Pain Intensity - Visual Analogue Scale (VAS)
Időkeret: Within 24 weeks
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Within 24 weeks
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Másodlagos eredményintézkedések
Eredménymérő |
Időkeret |
---|---|
Global Perceived Effect (GPE)
Időkeret: Within 24 weeks
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Within 24 weeks
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Disabilities of the Arm, Shoulder, and Hand (DASH)
Időkeret: Within 24 weeks
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Within 24 weeks
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Pain Threshold and Pain Tolerance Algometry
Időkeret: Within 24 weeks
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Within 24 weeks
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Head Flexion Endurance
Időkeret: Within 24 weeks
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Within 24 weeks
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Range of Motion
Időkeret: Within 24 weeks
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Within 24 weeks
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Quality of Life (SF-36v2)
Időkeret: within 24 weeks
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within 24 weeks
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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Joy C MacDermid, PhD, McMaster University
Tanulmányi rekorddátumok
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 1 R21 AT004263
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Klinikai vizsgálatok a Ostorcsapásos sérülések
-
Linkoeping UniversityBefejezveWhiplash Associated DisorderSvédország
-
University Hospital, Clermont-FerrandJacques Lacarin Hospital Center; CH Issoire; CH Montluçon; CH Aurillac; CH Moulins; CH Thiers és más munkatársakBefejezve
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Karolinska InstitutetIsmeretlenWhiplash szindrómaSvédország
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Jaseng Medical FoundationBefejezveKözlekedési baleset | Whiplash szindrómaKoreai Köztársaság
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University of ValenciaBefejezveNyaki fájdalom | Whiplash szindrómaSpanyolország
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University Hospitals, LeicesterBefejezveWhiplash Associated DisorderEgyesült Királyság
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Kyunghee University Medical CenterUniversity of TsukubaBefejezveWhiplash Associated Disorder (WAD)Koreai Köztársaság