Whiplash Injuries
Conditions
Keywords
whiplash, neck pain, manual therapy, exercise, dosage
Brief summary
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.
Interventions
BEHAVIORALExercise and education once/week for 6 weeks
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
BEHAVIORALExercise and education twice/week for 6 weeks
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.
BEHAVIORALExercise and education 3 times/week for 6 weeks
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.
OTHERManual therapy once/week for 3 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
OTHERManual therapy twice/week for 3 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
OTHERManual therapy 3 times/week for 3 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
OTHERManual therapy once/week for 6 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
OTHERManual therapy twice/week for 6 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
OTHERManual therapy 3 times/week for 6 weeks
Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
Sponsors
Physiotherapy Foundation of Canada
Jordan Miller, Graduate Student
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults ≥ 21 years * main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache. * pain intensity must be ≥ 12/40 on the 4-item pain scale (P4).
Exclusion criteria
* non-mechanical sources of neck pain or over-riding comorbidity listed below: * rheumatoid arthritis * neurological diseases * fractures * dislocation * rheumatoid arthritis * upper motor neuron dysfunction or malignancy * pregnant women * closed head injury * on steroid-based medications within the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 1 year | 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. |
| Pain | 12 weeks (end of treatment) and 6- and 12- month follow-ups | Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial. |
| Function | 12 weeks (end of treatment) and 6- and 12- month follow-up | Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor coordination | 12 weeks (end of treatment) | Neck Walk Index (NWI) |
| Health Status | 12 weeks (end of study) and 6- and 12- month follow-ups | Measured by SF-36 |
| Fidelity | 1 year | 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. |
| Upper extremity function | 12 weeks (end of treatment) and 6- and 12-month follow-ups | As measured by the shortened version of the Disability of the Arm, Shoulder, Hand (qDASH). |
| Global perceived effect | 12 weeks (end of treatment) and 6- and 12-month follow-ups | Global perceived effect will be measured on a 7 point scale (-3 to +3) |
| Psychological measures | 12 weeks (end of treatment) | 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) |
| Psychophysical measures | 12 weeks (end of treatment) | Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP) |
Countries
Canada
Outcome results
None listed