Manual Therapy Dosage Factorial Study - Full Text View

Sponsors and Collaborators:	Hamilton Health Sciences National Institutes of Health (NIH) University of Guelph
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) and 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 (0 ,1, 2 or 3 times per week) and the duration of treatment (duration of treatment intervention will be 3, 6, or 12 weeks).

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 (NW), the Upper Quadrant Reach and Grasp Task, muscle biology analyses (cytokine analyses), central breathing control tests (capnography) and self-report symptoms and disability (Neck Disability Index; Disabilities of the Arm, Shoulder, Hand; pain threshold and tolerance algometry; and perceived self-efficacy).

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

U.S. FDA Resources

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

Further study details as provided by McMaster University:

Primary Outcome Measures:

Quantitative Sensory Testing [ Time Frame: During treatment period ] [ Designated as safety issue: No ]
Current Perception Threshold [ Time Frame: During treatment period ] [ Designated as safety issue: No ]
Neck Walk Index [ Time Frame: During treatment period ] [ Designated as safety issue: No ]
Upper Quadrant Reach and Grasp Task [ Time Frame: During treatment period ] [ Designated as safety issue: No ]
Muscle Biology (cytokine analyses) [ Time Frame: During treatment period ] [ Designated as safety issue: No ]
Central Breathing Control Test [ Time Frame: During treatment period ] [ Designated as safety issue: No ]
Neck Disability Index [ Time Frame: During treatment period ] [ Designated as safety issue: No ]
Disabilities of the Arm, Shoulder, Hand [ Time Frame: During treatmetn period ] [ Designated as safety issue: No ]
Pain Threshold and Tolerance Algometry [ Time Frame: During time period ] [ Designated as safety issue: No ]
Perceived Self-Efficacy [ Time Frame: During time period ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (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:	18 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
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

Hamilton Health Sciences

National Institutes of Health (NIH)

University of Guelph

Investigators

Principal Investigator:	Joy C MacDermid, PhD	McMaster University
Principal Investigator:	Michael Pierrynowski, PhD	McMaster University

More Information

Responsible Party:	McMaster University ( Joy MacDermid )
Study ID Numbers:	1 R21 AT004263
Study First Received:	November 19, 2007
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00560807
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

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Neck Injuries
Whiplash Injuries

ClinicalTrials.gov processed this record on January 15, 2009