Manual Therapy Dosage Factorial Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by McMaster University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Western Ontario, Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00560807
First received: November 19, 2007
Last updated: May 3, 2011
Last verified: May 2011

November 19, 2007
May 3, 2011
January 2012
January 2014   (final data collection date for primary outcome measure)
  • Quantitative Sensory Testing (QST) [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Current Perception Threshold (CPT) [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Neck Walk Index (NWI) [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Cyclical Reach and Grasp Test (CRGT) [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Muscle Biology (cytokine analyses) [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Central Breathing Control Test [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Neck Disability Index [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Pain Intensity - Visual Analogue Scale (VAS) [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Quantitative Sensory Testing [ Time Frame: During treatment period ]
  • Current Perception Threshold [ Time Frame: During treatment period ]
  • Neck Walk Index [ Time Frame: During treatment period ]
  • Upper Quadrant Reach and Grasp Task [ Time Frame: During treatment period ]
  • Muscle Biology (cytokine analyses) [ Time Frame: During treatment period ]
  • Central Breathing Control Test [ Time Frame: During treatment period ]
  • Neck Disability Index [ Time Frame: During treatment period ]
  • Perceived Self-Efficacy [ Time Frame: During time period ]
  • Disabilities of the Arm, Shoulder, Hand [ Time Frame: During treatmetn period ]
  • Pain Threshold and Tolerance Algometry [ Time Frame: During time period ]
Complete list of historical versions of study NCT00560807 on ClinicalTrials.gov Archive Site
  • Global Perceived Effect (GPE) [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Disabilities of the Arm, Shoulder, and Hand (DASH) [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Pain Threshold and Pain Tolerance Algometry [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Head Flexion Endurance [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Range of Motion [ Time Frame: Within 24 weeks ] [ Designated as safety issue: No ]
  • Quality of Life (SF-36v2) [ Time Frame: within 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Manual Therapy Dosage Factorial Study
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Whiplash Injuries
Procedure: 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.
  • No Intervention: A
    Zero treatment/3 weeks
  • Active Comparator: B
    Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks
    Intervention: Procedure: Mobilization
  • Active Comparator: C
    Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks
    Intervention: Procedure: Mobilization
  • Active Comparator: D
    Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks
    Intervention: Procedure: Mobilization
  • Active Comparator: F
    Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks
    Intervention: Procedure: Mobilization
  • Active Comparator: G
    Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks
    Intervention: Procedure: Mobilization
  • Active Comparator: H
    Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks
    Intervention: Procedure: Mobilization
  • Active Comparator: J
    Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks
    Intervention: Procedure: Mobilization
  • Active Comparator: K
    Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks
    Intervention: Procedure: Mobilization
  • Active Comparator: L
    Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks
    Intervention: Procedure: Mobilization
  • No Intervention: E
    Zero treatment/6 weeks
  • No Intervention: I
    Zero treatment/12 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
September 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 60 Years
No
Canada
 
NCT00560807
1 R21 AT004263
Not Provided
Joy MacDermid, McMaster University
McMaster University
  • Canadian Institutes of Health Research (CIHR)
  • National Institutes of Health (NIH)
  • University of Western Ontario, Canada
Principal Investigator: Joy C MacDermid, PhD McMaster University
McMaster University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP