The purpose of this pilot project is to determine the feasibility of a study design to investigate how many sessions of manual therapy and exercise produce the best results for people with whiplash injuries. Also, this study will help us determine the best way to measure the effect of treatment. Finally, the investigators will study how closely the physiotherapists follow the treatment instruction provided in the study protocol and training. In order to achieve these objectives, 12 people will receive manual therapy and exercise at one of twelve different doses. the investigators will have each of these people fill out questionnaires, measure sensation changes, and measure changes in the way people move their necks while walking. This study will help us determine if the study protocol can be carried out as planned. This includes: the training of all people involved in carrying out the assessments and treatments, the willingness and ability of participants to take part in all of the treatment and measures involved. This will provide us with important information to help us plan a larger study with 226 people with whiplash injuries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book
Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.
Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
McMaster Univervisty
Hamilton, Ontario, Canada
Lifemark Health, Hamilton
Hamilton, Ontario, Canada
Western University
London, Ontario, Canada
Feasibility
As a pilot study, the main outcome of interest is feasibility. This includes: ability to train assessors and health care providers, time it takes to complete all assessments, ability to recruit 12 patients within 1 year, and completeness of data collected.
Time frame: 1 year
Pain
Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.
Time frame: 12 weeks (end of treatment) and 6- and 12- month follow-ups
Function
Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.
Time frame: 12 weeks (end of treatment) and 6- and 12- month follow-up
Fidelity
As a pilot study, the secondary outcome of interest is treatment fidelity. We will measure this through ability of health care providers to provide treatment at the dosage described in the protocol.
Time frame: 1 year
Psychological measures
Catastrophic thinking measured by Pain Catastrophizing Scale (PCS) Anxiety and Depression measured by Hospital Anxiety and Depression Scale (HADS) Psychological distress measured by Trauma Anxiety and Distress Scale (TADS)
Time frame: 12 weeks (end of treatment)
Psychophysical measures
Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP)
Time frame: 12 weeks (end of treatment)
Motor coordination
Neck Walk Index (NWI)
Time frame: 12 weeks (end of treatment)
Health Status
Measured by SF-36
Time frame: 12 weeks (end of study) and 6- and 12- month follow-ups
Global perceived effect
Global perceived effect will be measured on a 7 point scale (-3 to +3)
Time frame: 12 weeks (end of treatment) and 6- and 12-month follow-ups
Upper extremity function
As measured by the shortened version of the Disability of the Arm, Shoulder, Hand (qDASH).
Time frame: 12 weeks (end of treatment) and 6- and 12-month follow-ups
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