Clinical trial NCT00560807: Manual Therapy Dosage Factorial Study
Official title: Manual Therapy Dosage Factorial Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Whiplash Injuries
Keywords: 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
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: National Institutes of Health (NIH)
name: University of Western Ontario, Canada
First posted: 2007-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Quantitative Sensory Testing (QST)
timeFrame: Within 24 weeks
measure: Current Perception Threshold (CPT)
timeFrame: Within 24 weeks
measure: Neck Walk Index (NWI)
timeFrame: Within 24 weeks
measure: Cyclical Reach and Grasp Test (CRGT)
timeFrame: Within 24 weeks
measure: Muscle Biology (cytokine analyses)
timeFrame: Within 24 weeks
measure: Central Breathing Control Test
timeFrame: Within 24 weeks
measure: Neck Disability Index
timeFrame: Within 24 weeks
measure: Pain Intensity - Visual Analogue Scale (VAS)
timeFrame: Within 24 weeks
Secondary outcomes:
measure: Global Perceived Effect (GPE)
timeFrame: Within 24 weeks
measure: Disabilities of the Arm, Shoulder, and Hand (DASH)
timeFrame: Within 24 weeks
measure: Pain Threshold and Pain Tolerance Algometry
timeFrame: Within 24 weeks
measure: Head Flexion Endurance
timeFrame: Within 24 weeks
measure: Range of Motion
timeFrame: Within 24 weeks
measure: Quality of Life (SF-36v2)
timeFrame: within 24 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Joy C MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
References: