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Manual Therapy Dosage Factorial Study

Manual Therapy Dosage Factorial Study

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00560807
Enrollment
0
Registered
2007-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

PROCEDUREMobilization

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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
National Institutes of Health (NIH)
CollaboratorNIH
University of Western Ontario, Canada
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain Intensity - Visual Analogue Scale (VAS)Within 24 weeks
Current Perception Threshold (CPT)Within 24 weeks
Neck Walk Index (NWI)Within 24 weeks
Cyclical Reach and Grasp Test (CRGT)Within 24 weeks
Muscle Biology (cytokine analyses)Within 24 weeks
Central Breathing Control TestWithin 24 weeks
Neck Disability IndexWithin 24 weeks
Quantitative Sensory Testing (QST)Within 24 weeks

Secondary

MeasureTime frame
Disabilities of the Arm, Shoulder, and Hand (DASH)Within 24 weeks
Pain Threshold and Pain Tolerance AlgometryWithin 24 weeks
Head Flexion EnduranceWithin 24 weeks
Range of MotionWithin 24 weeks
Quality of Life (SF-36v2)within 24 weeks
Global Perceived Effect (GPE)Within 24 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026