Trial Review

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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
Scientific title
A randomised clinical trial on the effect of a comprehensive exercise program on average weekly pain intensity in chronic whiplash
Secondary ID [1] 281225 0
Nil
Universal Trial Number (UTN)
Trial acronym
PROMISE
Linked study record

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) 243845 0
Condition category
Condition code
Musculoskeletal 240020 240020 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 241279 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 240916 0
Average pain intensity over last week (numerical rating 0-10 scale).
Timepoint [1] 240916 0
Baseline, 14 weeks, 6 months and 12 months.
Secondary outcome [1] 257628 0
Average pain intensity over last 24 hours (numerical 0 to 10 scale)
Timepoint [1] 257628 0
Baseline, 14 weeks, 6 months and 12 months.
Secondary outcome [2] 257631 0
Patient's global impression of recovery (-5 to +5 scale)
Timepoint [2] 257631 0
Baseline, 14 weeks, 6 months and 12 months.
Secondary outcome [3] 257632 0
Patient-generated measure of disability (Patient-Specific Functional Scale)
Timepoint [3] 257632 0
Baseline, 14 weeks, 6 months and 12 months.
Secondary outcome [4] 257633 0
Neck-specific measure of disability (Neck Disability Index)
Timepoint [4] 257633 0
Baseline, 14 weeks, 6 months and 12 months.
Secondary outcome [5] 257634 0
Generic measure of health status (SF-36)
Timepoint [5] 257634 0
Baseline, 14 weeks, 6 months and 12 months.
Secondary outcome [6] 257635 0
Whiplash-specific measure of disability (Whiplash Disability Questionnaire)
Timepoint [6] 257635 0
Baseline, 14 weeks, 6 months and 12 months.
Secondary outcome [7] 257636 0
Measures of physical impairment (Cervical range of movement)
Timepoint [7] 257636 0
Baseline, 14 weeks, 6 months and 12 months.

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

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 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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Due to the nature of the intervention we are unable to blind therapists or participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/09/2009
Actual
21/09/2009
Date of last participant enrolment
Anticipated
Actual
27/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243740 0
Government body
Name [1] 243740 0
NHMRC
Country [1] 243740 0
Australia
Funding source category [2] 243741 0
Government body
Name [2] 243741 0
Motor Accidents Authority of New South Wales
Country [2] 243741 0
Australia
Funding source category [3] 243742 0
Government body
Name [3] 243742 0
Motor Accidents Insurance Commission Queensland
Country [3] 243742 0
Australia
Primary sponsor type
University
Name
The George Institute For International Health, The University of Sydney
Address
The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 237101 0
University
Name [1] 237101 0
The University of Queensland
Address [1] 237101 0
Centre for National Research on Disability and Rehabilitation Medicine (CONROD), The University of Queensland
Herston Rd
Herston QLD 4006
Country [1] 237101 0
Australia
Other collaborator category [1] 863 0
Individual
Name [1] 863 0
Professor Chris Maher
Address [1] 863 0
The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
Country [1] 863 0
Australia
Other collaborator category [2] 864 0
Individual
Name [2] 864 0
Associate Professor Michele Sterling
Address [2] 864 0
Centre for National Research on Disability and Rehabilitation Medicine (CONROD), The University of Queensland.
Herston Rd,
Herston QLD 4006
Country [2] 864 0
Australia
Other collaborator category [3] 865 0
Individual
Name [3] 865 0
Professor Jane Latimer
Address [3] 865 0
The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
Country [3] 865 0
Australia
Other collaborator category [4] 866 0
Individual
Name [4] 866 0
Professor Gwen Jull
Address [4] 866 0
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
Country [4] 866 0
Australia
Other collaborator category [5] 867 0
Individual
Name [5] 867 0
Professor Luke Connelly
Address [5] 867 0
Centre for National Research on Disability and Rehabilitation Medicine (CONROD), The University of Queensland.
Herston Rd,
Herston QLD 4006
Country [5] 867 0
Australia
Other collaborator category [6] 868 0
Individual
Name [6] 868 0
Dr Christine Lin
Address [6] 868 0
The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
Country [6] 868 0
Australia
Other collaborator category [7] 879 0
Individual
Name [7] 879 0
Dr Trudy Rebbeck
Address [7] 879 0
The University of Sydney
Faculty of Health Sciences
Discipline of Physiotherapy
75 East Street,
Lidcombe NSW 2141
Country [7] 879 0
Australia
Other collaborator category [8] 880 0
Individual
Name [8] 880 0
Zoe Michaleff
Address [8] 880 0
The George Institute for International Health, The University of Sydney,
Level 7, 341 George St,
Sydney NSW 2000
Country [8] 880 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243866 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 243866 0
The University of Sydney Human Research Ethics Committee
Level 6, Jane Foss Russell Building
The University of Sydney NSW 2006
Ethics committee country [1] 243866 0
Australia
Date submitted for ethics approval [1] 243866 0
Approval date [1] 243866 0
23/03/2009
Ethics approval number [1] 243866 0
11509
Ethics committee name [2] 243867 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 243867 0
The University of Queensland Human Research Ethics Committee
Cumbrae-Stewart Building
The University of Queensland QLD 4072
Ethics committee country [2] 243867 0
Australia
Date submitted for ethics approval [2] 243867 0
Approval date [2] 243867 0
10/12/2008
Ethics approval number [2] 243867 0
2008002059

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30288 0
Prof Chris Maher
Address 30288 0
The George Institute for International Health Level 7, 341 George St, Sydney NSW 2000
Country 30288 0
Australia
Phone 30288 0
+61 2 96570382
Fax 30288 0
Email 30288 0
[email protected]
Contact person for public queries
Name 13535 0
Dr Zoe Michaleff
Address 13535 0
The George Institute for International Health
Level 7, 341 George St,
Sydney NSW 2000
Country 13535 0
Australia
Phone 13535 0
+61 2 96570321
Fax 13535 0
Email 13535 0
[email protected]
Contact person for scientific queries
Name 4463 0
Prof Professor Chris Maher
Address 4463 0
The George Institute for International Health
Level 7, 341 George St,
Sydney NSW 2000
Country 4463 0
Australia
Phone 4463 0
+61 2 96570382
Fax 4463 0
Email 4463 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
SourceTitleYear of PublicationDOI
EmbaseComprehensive physiotherapy exercise programme or advice for chronic whiplash (PROMISE): A pragmatic randomised controlled trial.2014https://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.