Manual Therapy Dosage Factorial Study - Full Text View

Sponsor:	McMaster University
Collaborators:	Canadian Institutes of Health Research (CIHR) National Institutes of Health (NIH) University of Western Ontario, Canada
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00560807

Purpose

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.

Condition	Intervention	Phase
Whiplash Injuries	Procedure: Mobilization	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Dose Comparison, Factorial Assignment, Efficacy Study
Official Title:	Manual Therapy Dosage Factorial Study

Further study details as provided by McMaster University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	September 2010
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention Zero treatment/3 weeks
B: Active Comparator Frequency of Mobilization:1/week Duration of Mobilization Treatment: 3 weeks	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.
C: Active Comparator Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 6 weeks	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.
D: Active Comparator Frequency of Mobilization: 1/week Duration of Mobilization Treatment: 12 weeks	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.
F: Active Comparator Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 3 weeks	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.
G: Active Comparator Frequency of Mobilization: 2/week Duration of Mobilization Treatment:6 weeks	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.
H: Active Comparator Frequency of Mobilization: 2/week Duration of Mobilization Treatment: 12 weeks	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.
J: Active Comparator Frequency of Mobilization: 3/week Duration of Mobilization Treatment: 3 weeks	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.
K: Active Comparator Frequency of Mobilization: 3/week Duration of Mobilization Treatment:6 weeks	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.
L: Active Comparator Frequency of Mobilization: 3/week Duration of Mobilization Treatment:12 weeks	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.
E: No Intervention Zero treatment/6 weeks
I: No Intervention Zero treatment/12 weeks

Eligibility

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560807

Locations

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 1C7

Sponsors and Collaborators

McMaster University

Canadian Institutes of Health Research (CIHR)

National Institutes of Health (NIH)

University of Western Ontario, Canada

Investigators

Principal Investigator:

Joy C MacDermid, PhD

McMaster University

More Information

No publications provided

Responsible Party:	McMaster University ( Joy MacDermid )
Study ID Numbers:	1 R21 AT004263
Study First Received:	November 19, 2007
Last Updated:	September 22, 2009
ClinicalTrials.gov Identifier:	NCT00560807 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

WAD II
WAD III
mobilization

dosage
acute whiplash associated disorders (WAD) II and III (113) with a symptom duration of less than 30 days
neck pain

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Neck Injuries
Whiplash Injuries

ClinicalTrials.gov processed this record on November 27, 2009