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Trial registered on ANZCTR
Registration number
ACTRN12609000825257
Ethics application status
Approved
Date submitted
17/09/2009
Date registered
22/09/2009
Date last updated
29/11/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
A randomised clinical trial of a comprehensive exercise program for chronic whiplash
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Scientific title
A randomised clinical trial on the effect of a comprehensive exercise program on average weekly pain intensity in chronic whiplash
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Secondary ID [1]
281225
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Nil
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Universal Trial Number (UTN)
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Trial acronym
PROMISE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic whiplash (defined as whiplash symptoms for greater than 3 months duration and less than 12 months duration)
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Condition category
Condition code
Musculoskeletal
240020
240020
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The educational booklet in conjunction with 20 one-hour sessions of the comprehensive exercise program over 12 weeks. The program begins with specific cervical spine and scapular motor relearning exercises (8 sessions over 4 weeks) and transitions to a graded whole body activity program focussing on functional activities (12 sessions over 8 weeks). All exercise sessions are conducted one-on-one with a physiotherapist.
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Intervention code [1]
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Rehabilitation
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Comparator / control treatment
Educational booklet and one half-hour physiotherapy consultation. During the 12 week trial period, participants in this group will, if required, be able to contact the physiotherapist by phone on two occasions to clarify the information/exercise contained in the educational booklet.
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Control group
Active
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Outcomes
Primary outcome [1]
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Average pain intensity over last week (numerical rating 0-10 scale).
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Assessment method [1]
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Timepoint [1]
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Baseline, 14 weeks, 6 months and 12 months.
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Secondary outcome [1]
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Average pain intensity over last 24 hours (numerical 0 to 10 scale)
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Assessment method [1]
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Timepoint [1]
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Baseline, 14 weeks, 6 months and 12 months.
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Secondary outcome [2]
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Patient's global impression of recovery (-5 to +5 scale)
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Assessment method [2]
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Timepoint [2]
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Baseline, 14 weeks, 6 months and 12 months.
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Secondary outcome [3]
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Patient-generated measure of disability (Patient-Specific Functional Scale)
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Assessment method [3]
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Timepoint [3]
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Baseline, 14 weeks, 6 months and 12 months.
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Secondary outcome [4]
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Neck-specific measure of disability (Neck Disability Index)
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Assessment method [4]
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Timepoint [4]
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Baseline, 14 weeks, 6 months and 12 months.
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Secondary outcome [5]
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Generic measure of health status (SF-36)
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Assessment method [5]
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Timepoint [5]
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Baseline, 14 weeks, 6 months and 12 months.
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Secondary outcome [6]
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Whiplash-specific measure of disability (Whiplash Disability Questionnaire)
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Assessment method [6]
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Timepoint [6]
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Baseline, 14 weeks, 6 months and 12 months.
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Secondary outcome [7]
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Measures of physical impairment (Cervical range of movement)
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Assessment method [7]
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Timepoint [7]
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Baseline, 14 weeks, 6 months and 12 months.
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Eligibility
Key inclusion criteria
Key inclusion criteria:
1. Grade I or II whiplash of at least 3 months duration but less than 12 months duration.
2. Currently experiencing at least moderate pain OR moderate activity limitation due to pain (modified items 7 & 8 of SF36).
3. Not currently receiving care for whiplash.
4. Aged between 18 years and 65 years old.
5. Proficient in written and spoke English.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Key exclusion criteria:
1. Known or suspected serious spinal pathology (e.g. metastatic disease of the spine).
2. Confirmed fracture or dislocation at time of injury.
3. Nerve root compromise.
4. Spinal surgery in the past 12 months.
5. Any coexisting medical condition which would severely restrict participation in the exercise program e.g. traumatic brain injury.
6. Any of the contraindications to exercise listed in the American College of Sports Medicine (ACSM) guideline screened using the Physical Activity Readiness Questionnaire (PAR-Q).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur immediately following the baseline assessment by opening the next sealed opaque envelope. Participants will be considered to have entered the study at the time that the envelope is opened.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence, stratified for recruitment site (Sydney and Brisbane), will be produced prior to commencement of the trial by an independent researcher.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Due to the nature of the intervention we are unable to blind therapists or participants.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
25/09/2009
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Actual
21/09/2009
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Date of last participant enrolment
Anticipated
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Actual
27/02/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
172
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Motor Accidents Authority of New South Wales
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Address [2]
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Motor Accidents Authority of NSW
Level 25, 580 George St
Sydney NSW 2000
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Country [2]
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Australia
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Funding source category [3]
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Government body
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Name [3]
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Motor Accidents Insurance Commission Queensland
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Address [3]
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Motor Accidents Insurance Commission Queensland
Level 9, 33 Charlotte Street
GPO Box 1083
BRISBANE QLD 4001 Australia
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Country [3]
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Australia
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Primary sponsor type
University
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Name
The George Institute For International Health, The University of Sydney
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Address
The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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The University of Queensland
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Address [1]
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Centre for National Research on Disability and Rehabilitation Medicine (CONROD), The University of Queensland
Herston Rd
Herston QLD 4006
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Country [1]
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Professor Chris Maher
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Address [1]
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The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
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Country [1]
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Australia
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Other collaborator category [2]
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Individual
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Name [2]
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Associate Professor Michele Sterling
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Address [2]
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Centre for National Research on Disability and Rehabilitation Medicine (CONROD), The University of Queensland.
Herston Rd,
Herston QLD 4006
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Country [2]
864
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Australia
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Other collaborator category [3]
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Individual
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Name [3]
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Professor Jane Latimer
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Address [3]
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The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
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Country [3]
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Australia
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Other collaborator category [4]
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Individual
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Name [4]
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Professor Gwen Jull
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Address [4]
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National Health and Medical Research Council (NHMRC) Centres of Clinical Research Excellence (CCRE): Spinal Pain, Injury and Health,
Division of Physiotherapy,
The University of Queensland
Herston Rd,
Herston QLD 4006
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Country [4]
866
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Australia
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Other collaborator category [5]
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Individual
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Name [5]
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Professor Luke Connelly
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Address [5]
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Centre for National Research on Disability and Rehabilitation Medicine (CONROD), The University of Queensland.
Herston Rd,
Herston QLD 4006
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Country [5]
867
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Australia
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Other collaborator category [6]
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Individual
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Name [6]
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Dr Christine Lin
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Address [6]
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The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
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Country [6]
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Australia
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Other collaborator category [7]
879
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Individual
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Name [7]
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Dr Trudy Rebbeck
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Address [7]
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The University of Sydney
Faculty of Health Sciences
Discipline of Physiotherapy
75 East Street,
Lidcombe NSW 2141
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Country [7]
879
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Australia
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Other collaborator category [8]
880
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Individual
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Name [8]
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Zoe Michaleff
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Address [8]
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The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
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Country [8]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
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The University of Sydney Human Research Ethics Committee Level 6, Jane Foss Russell Building The University of Sydney NSW 2006
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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23/03/2009
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Ethics approval number [1]
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11509
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Ethics committee name [2]
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The University of Queensland Human Research Ethics Committee
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Ethics committee address [2]
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The University of Queensland Human Research Ethics Committee Cumbrae-Stewart Building The University of Queensland QLD 4072
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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Approval date [2]
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10/12/2008
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Ethics approval number [2]
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2008002059
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Summary
Brief summary
The aim of the proposed research is to determine the effectiveness of a comprehensive exercise program for chronic whiplash. Currently, for the majority of sufferers with chronic whiplash there are no proven therapies available to manage this personal and financially costly condition. Promising results have been identified in randomised controlled trials evaluating the effects of different exercise programs, graded activity and specific exercise. However, success rates from these studies were too low to represent a solution to the problem of chronic whiplash and further development was necessary. A comprehensive exercise program that combined both specific exercises and graded activity was developed. A small uncontrolled phase I/II trial provided evidence that this new exercise program had a much higher success rate with 56% of subjects having minimal or no disability at the end of the program. This success rate approximates that of radiofrequency neurotomy (58%) but avoids such invasive surgical techniques. Based upon the exciting results of the pilot study and the strong biological rationale for the superior results with the combined program we now propose to definitively establish the effectiveness of the new program in a large phase III randomised controlled trial.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Chris Maher
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Address
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The George Institute for International Health Level 7, 341 George St, Sydney NSW 2000
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Country
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Australia
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Phone
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+61 2 96570382
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Zoe Michaleff
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Address
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The George Institute for International Health
Level 7, 341 George St,
Sydney NSW 2000
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Country
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Australia
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Phone
13535
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+61 2 96570321
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Fax
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Email
13535
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[email protected]
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Contact person for scientific queries
Name
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Professor Chris Maher
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Address
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The George Institute for International Health
Level 7, 341 George St,
Sydney NSW 2000
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Country
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Australia
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Phone
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+61 2 96570382
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Fax
4463
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Comprehensive physiotherapy exercise programme or advice for chronic whiplash (PROMISE): A pragmatic randomised controlled trial.
2014
https://dx.doi.org/10.1016/S0140-6736%2814%2960457-8
N.B. These documents automatically identified may not have been verified by the study sponsor.
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