Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000109606
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
9/08/2005
Date last updated
5/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effective management of acute whiplash injuries requires a pragmatic approach: An RCT with stratified treatments
Scientific title
A randomised clinical trial to evaluate the effectiveness of a pragmatic multi-professional management approach against usual care for acute whiplash associated disorders to improve neck pain and disability and reduce the rate of transition to chronic neck pain disorders
Secondary ID [1] 287810 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Acute WAD Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whiplash associated disorders 194 0
Condition category
Condition code
Alternative and Complementary Medicine 217 217 0 0
Pain management
Injuries and Accidents 218 218 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a RCT with unblinded treatment and blinded outcome assessment in patients with acute whiplash disorders, classified as WAD II, to test the effectiveness of a pragmatic multi-professional management approach (medical, physiotherapy and psychological management) to reduce the incidence of chronicity. Within the randomization process, subjects will be stratified on three factors predictive of a poor prognosis (high NDI score; signs of moderate post-traumatic distress reaction; abnormal sensory responses {at least two of cold hyperalgesia, pressure hyperalgesia, impaired sympathetic vasoconstriction}) to ensure equal distribution of these factors between the pragmatic intervention and usual care groups. The pragmatic management approach will be tested against a control intervention of usual care. The medical, physiotherapy and psychological management within the pragmatic approach will be prescribed in accordance with the subjects level of pain and presenting physical and psychological features. The intervention period and the number of medical, physiotherapy and/or psychological consultations will be variable and as required for the individual subject depending on the severity of their condition, but will be for a maximum of 10 weeks. Full recovery can be expected for at least 40% of whiplash patients within 12-24 weeks post-injury with usual care. Outcomes will be tested after the 10 week intervention period (week 11) regardless of the length of treatment time, and at 6 months and 12 months post-injury. The direct costs of this approach and of usual care will be measured and the costs associated with lost earnings and time in treatment will be calculated until 12 months post-injury. The treatment costs will be those incurred during the intervention period as well as any further treatment costs incurred in the 12 months post-injury. In addition to these measures of costs, utility weights (or health state preferences) will be measured using the standard gamble (SG), time-trade-off (TTO) and visual analogue scale (VAS) approaches.
Intervention code [1] 121 0
Rehabilitation
Intervention code [2] 293202 0
Rehabilitation
Comparator / control treatment
Control intervention of usual care.
Control group
Active

Outcomes
Primary outcome [1] 263 0
1.The Neck Disability Index (NDI) is a validated questionnaire which measures patients' self rated neck pain and disability. It will be used to calculate the proportion of subjects reporting recovery, defined as NDI score <8.
Timepoint [1] 263 0
At 6 months.
Primary outcome [2] 264 0
2. Utility weights/health preference data derived from the SG, TTO and VAS approaches. These methods have commonly been employed to create Quality-Adjusted Life-Years (QALYs) for the purposes of cost-utility analysis (CUA).
Timepoint [2] 264 0
NA
Secondary outcome [1] 586 0
1. Patient specific scale
The Patient Specific Functional Scale
Timepoint [1] 586 0
Outcomes will be measured at week 11, 6 and 12 months post injury.
Secondary outcome [2] 587 0
2. Psychosocial measures:
Tampa scale of kinesophobia: a measure of fear of movement/re-injury
GHQ 28: a standard measure of emotional distress in a medical setting
Impact of events scale (IES): a measure of post-traumatic distress
Timepoint [2] 587 0
Outcomes will be measured at week 11, 6 and 12 months post injury.
Secondary outcome [3] 588 0
3. Physical impairment measures:
Range of cervical motion measured with a 3D external measurement device (Fastrac)
Cranio-cervical flexion test: an EMG analysis of cervical flexor function
EMG measure of neck flexor, extensor muscle activity in a low load functional task
Assessment of balance using a force platform and wavelet analysis
Measures of cervical proprioception (joint position error) measured with a Fastrac.
Timepoint [3] 588 0
Outcomes will be measured at week 11, 6 and 12 months post injury.
Secondary outcome [4] 589 0
4. Psychophysical pain tests: Pressure pain thresholds using a pressure algometer over the cervical region and over a remote site, tibialis anterior
Temperature pain thresholds using a thermode (hot and cold) over the cervical region.
Sympathetic vasoconstrictor response: a measure of sympathetic nervous system function
Brachial plexus provocation test: a test of neural tissue mechanosensitivity
Timepoint [4] 589 0
Outcomes will be measured at week 11, 6 and 12 months post injury.
Secondary outcome [5] 590 0
5. Medication intake. The type and dose of all medications taken by subjects will be documented at baseline and throughout the 10 week period of the trial as well as for the 2 week period prior to follow-up points. Medication diaries will be used.
Timepoint [5] 590 0
NA

Eligibility
Key inclusion criteria
Volunteers suffering from acute neck pain and disability resulting from a motor vehicle crash and classifiable as WAD II, presenting within 4 weeks of injury. Evidence of cervical nociceptive and musculoskeletal impairment: restriction in active cervical motion, impairment in the cranio-cervical flexion muscle test, tenderness over the cervical joints.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with WAD I, III or IV. Previous whiplash injury. Prior neck pain condition for which treatment has been sought from a health professional. Current medical disorder that would preclude. Lack of fluency in spoken and written English for independent questionnaire completion. Lack of willingness to receive either pragmatic treatment or usual care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation process will be conducted by an independent body, the Clinical Trials Centre in the School of Population Health, UQ, on receipt of a phone call from the trial RA.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation process is using an ACCESS database structure with both customised programming and tested inbuilt function written in MS Visual Basic. We are using the minimisation technique with three stratification factors. Subjects will be stratified according to psychophysical measures indicative of a poor prognosis (values derived from confidence intervals of control subjects, except for the NDI and IES scores which are standard values of at least moderate dysfunction). Based on our regression analysis, we will regard initial NDI as the primary factor (F1), signs of severe post-traumatic distress reaction (IES) as the second factor (F2), and abnormal sensory responses as the third factor (F3). The third factor will be at least 2 of; elevated cold pain thresholds over the cervical region, lowered pressure pain thresholds over the tibialis anterior muscle (TA), impaired sympathetic vasoconstriction. The values for abnormal responses represent those outside the values for normative data. Subjects will be stratified prior to randomisation using the following values:
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/08/2005
Actual
4/08/2005
Date of last participant enrolment
Anticipated
1/06/2008
Actual
15/04/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 277 0
Government body
Name [1] 277 0
NHMRC Grant
Country [1] 277 0
Australia
Primary sponsor type
Individual
Name
Professor Gwendolen Jull
Address
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 212 0
University
Name [1] 212 0
The University of Queensland
Address [1] 212 0
University of Queensland St Lucia QLD 4072
Country [1] 212 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1126 0
The University of Queensland Medical Ethics Committee
Ethics committee address [1] 1126 0
Ethics committee country [1] 1126 0
Australia
Date submitted for ethics approval [1] 1126 0
29/11/2004
Approval date [1] 1126 0
31/01/2005
Ethics approval number [1] 1126 0
NA

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35166 0
Prof Gwendolen Jull
Address 35166 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Qld 4072
Country 35166 0
Australia
Phone 35166 0
61 7 336 57139
Fax 35166 0
Email 35166 0
[email protected]
Contact person for public queries
Name 9310 0
Professor Gwendolen Jull
Address 9310 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country 9310 0
Australia
Phone 9310 0
61 7 336 57139
Fax 9310 0
+61 7 33652775
Email 9310 0
[email protected]
Contact person for scientific queries
Name 238 0
Gwendolen Jull
Address 238 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country 238 0
Australia
Phone 238 0
61 7 336 57139
Fax 238 0
+61 7 33652775
Email 238 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.