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Trial registered on ANZCTR


Registration number
ACTRN12614001036606
Ethics application status
Approved
Date submitted
14/08/2014
Date registered
25/09/2014
Date last updated
25/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Physiotherapist led stress inoculation intervention integrated with exercise for acute whiplash injury: A randomised controlled trial
Scientific title
In individuals with acute whiplash, is stress inoculation therapy and exercise more effective than exercise alone on pain and disability levels?
Secondary ID [1] 284735 0
Nil known
Universal Trial Number (UTN)
Trial acronym
StressModEx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute whiplash 292088 0
Condition category
Condition code
Musculoskeletal 292431 292431 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise and stress inoculation therapy (SIT). SIT: A physiotherapist will provide 6 sessions (1 per week) of SIT, teaching strategies to assist participants in managing acute stress responses. In the first session this will include an educational session about the effects of acute stress following an injury. At subsequent sessions additional strategies will be utilised including progressive muscle relaxation and breath control exercises, simple cognitive behavioural skills to encourage positive coping, and reduce avoidance behaviours, and problem solving skills. SIT consists of three phases: 1. Identify and understanding stress. Identifying specific stressors and how these impact on pain, behaviour, emotions, physical performance and thoughts. 2. Developing skills for managing stress such as relaxation, problem solving and helpful coping self-statements. Participants will practice these skills on a weekly basis with home practice (once/day). The duration of the home practice will be dependant on the participants. It is anticipated that some participants make take longer to complete the home practice than others. 3. Applying skills in various stressful situations to develop tolerance and confidence. All intervention sessions will be for a maximum of 50 minutes.

Participants will be provided with a specific app called Stressmod which will be available through the Apple app store and the Android play store to assist with their required daily practice of the taught skills. As part of Stress Inoculation Training (SIT), a complementary smart phone application has been created. StressMod is a mobile application that helps users learn and practice relaxation and stress management techniques. Compliance will be monitored by logging the use of the app. The home practice will take a maximum of 5-10 minutes/day.

Exercise:The 6-week exercise program will be carried out under the supervision of the physiotherapist (2 sessions in weeks 1-4 and 1 session in the weeks 5 and 6).The exercise program will comprise specific exercises to improve the movement and control of the neck and shoulder girdles as well as exercises to improve eye/head co-ordination. The exercises will be tailored by the physiotherapist for each individual participant. The exercises are of a low load nature and are designed to be pain free. At the same time, the physiotherapist will guide the participant’s return to normal activities. The program begins with a clinical examination of the cervical muscles and the axio-scapular-girdle muscles and includes tests that assess ability to recruit the muscles in a coordinated manner, tests of balance, cervical kinaesthesia and eye movement control and tests of muscle endurance at low levels of maximum voluntary contraction. The specific impairments that are identified are then addressed with an exercise program that is supervised and progressed by the physiotherapist. This specific treatment program focuses on activating and improving the co-ordination and endurance capacity of the neck flexor, extensor and scapular muscles in specific exercises and functional tasks, and a graded program directed to the postural control system, including balance exercises, head relocation exercises and exercises for eye movement control. Participants will also perform the exercises at home, once/day. Written and illustrated exercise instructions will be provided. A log book will be completed by participants to record compliance with the exercises. Duration of exercises at home will depend on the exercises prescribed by the physiotherapist and the ability of the participant to perform these exercises but will be no longer that 15 minutes/day.
Intervention code [1] 289518 0
Rehabilitation
Comparator / control treatment
Exercise only: The 6-week exercise program will be carried out under the supervision of the physiotherapist (2 sessions in weeks 1-4 and 1 session in the weeks 5 and 6).The exercise program will comprise specific exercises to improve the movement and control of the neck and shoulder girdles as well as exercises to improve eye/head co-ordination. The exercises will be tailored by the physiotherapist for each individual participant. The exercises are of a low load nature and are designed to be pain free. At the same time, the physiotherapist will guide the participant’s return to normal activities. The program begins with a clinical examination of the cervical muscles and the axio-scapular-girdle muscles and includes tests that assess ability to recruit the muscles in a coordinated manner, tests of balance, cervical kinaesthesia and eye movement control and tests of muscle endurance at low levels of maximum voluntary contraction. The specific impairments that are identified are then addressed with an exercise program that is supervised and progressed by the physiotherapist. This specific treatment program focuses on activating and improving the co-ordination and endurance capacity of the neck flexor, extensor and scapular muscles in specific exercises and functional tasks, and a graded program directed to the postural control system, including balance exercises, head relocation exercises and exercises for eye movement control. Participants will also perform the exercises at home, once/day. Duration of exercises at home will depend on the exercises prescribed by the physiotherapist and the ability of the participant to perform these exercises but will be no longer than 15 minutes/day. Written and illustrated exercise instructions will be provided. A log book will be completed by participants to record compliance with the exercises.
Control group
Active

Outcomes
Primary outcome [1] 292289 0
Neck disability index (NDI)
Timepoint [1] 292289 0
6 weeks, 6 months, 12 months
Secondary outcome [1] 308649 0
Acute Stress Disorder Scale (ASDS)
Timepoint [1] 308649 0
6 weeks, 6 months, 12 months
Secondary outcome [2] 308650 0
Post Traumatic Stress Diagnostic Scale (PDS)
Timepoint [2] 308650 0
6 weeks, 6 months, 12 months
Secondary outcome [3] 308651 0
Depression, Anxiety and Stress Scale (DASS)
Timepoint [3] 308651 0
6 weeks, 6 months, 12 months
Secondary outcome [4] 308652 0
Pain Catastrophising Scale (PCS)
Timepoint [4] 308652 0
6 weeks, 6 months, 12 months
Secondary outcome [5] 308653 0
Patient’s global impression of recovery (-5 to +5 scale)
Timepoint [5] 308653 0
6 weeks, 6 months, 12 months
Secondary outcome [6] 308654 0
Average pain intensity over the last 24 hours (0-10 scale)
Timepoint [6] 308654 0
6 weeks, 6 months, 12 months
Secondary outcome [7] 308655 0
Generic measure of health status (SF-36)
Timepoint [7] 308655 0
6 weeks, 6 months, 12 months
Secondary outcome [8] 309965 0
Coping Strategies Questionnaire
Timepoint [8] 309965 0
6 weeks, 6 months, 12 months
Secondary outcome [9] 309966 0
Pain Self Efficacy Questionnaire
Timepoint [9] 309966 0
6 weeks, 6 months, 12 months

Eligibility
Key inclusion criteria
* Grade II or III whiplash of less than 4 weeks duration
* Currently experiencing at least moderate pain related disability due to pain (NDI equals 28% as per the clinical prediction rule for progression to chronicity of symptoms);
* Currently experiencing some level of arousal symptoms (equals 3 of the arousal subscale of the PDS as per the clinical prediction rule)
* Not currently receiving care for whiplash.
* Proficient in English
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known or suspected serious spinal pathology (e.g. metastatic disease of the spine)
* Confirmed fracture or dislocation at time of injury (i.e. whiplash grade IV)
* Spinal surgery in the past 12 months
* Meeting the criteria for probable acute stress disorder (ASD) diagnosis on the Acute Stress Disorder Scale (ASDS)
* Screening positive for a current major depressive episode on the PHQ-9
* A history of psychosis, bipolar disorder, organic brain disorder or severe depression

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)
Allocation will occur immediately following the baseline assessment. At this time, an independent (un-blinded) researcher will select the next envelope in the box, record the participant’s randomisation number and then open the envelope. In this way concealment of allocation and blinding of baseline measures is ensured. Participants will be considered to have entered the study at the time that the envelope is opened. The independent researcher who randomised the participant will then arrange the initial appointment with the treatment provider site within one week of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated by the study biostatistician. Randomisation will be by random permuted blocks. Consecutively numbered, sealed, opaque envelopes will be used to conceal randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The effect of treatments will be analysed separately for each outcome utilising linear mixed models with time as a repeated factor. Correlation over time within participants, and correlation with clinical potential confounders (e.g. important prognostic factors) will be accounted for in the model. The effect of potential confounders on the results obtained in the analysis will be examined. Any potentially confounding variable will be retained if its inclusion changes the estimated treatment effects by a clinically relevant amount. Estimates of the effect of the intervention will be obtained by constructing linear contrasts comparing the mean change in outcome from baseline to each time point between the treatment and control groups, with adjustment for the other variables.
Sample size: We are interested in detecting a clinically important difference between the two interventions, given that baseline values for each group are statistically equivalent as a result of the randomisation. Based on a two-sided t-test a sample of 86 (43 per group) will provide 80% power to detect a significant difference at alpha 0.05 between the group means of 10 points on the 100 point NDI (assuming a SD of 16, based on our pilot data and data from recent trials ). Effects smaller than this are unlikely to be considered clinically worthwhile. Allowing for a 15% loss to follow up by 12 months, we would require 50 subjects per treatment group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2014
Actual
Date of last participant enrolment
Anticipated
24/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8229 0
4222 - Griffith University
Recruitment postcode(s) [2] 8230 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 289351 0
Government body
Name [1] 289351 0
National Health and Medical Research Council (NHMRC)
Country [1] 289351 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Centre for Musculoskeletal Research
Griffith Health Institute
Griffith University - Gold Coast Campus
Parklands Dr
Southport QLD 4222
Country
Australia
Secondary sponsor category [1] 288035 0
University
Name [1] 288035 0
University of Queensland
Address [1] 288035 0
Centre of National Reserach on Disability and Rehabilitation
School of Medicine
The University of Queensland
Edith Cavill Building
Herston QLD 4029
Country [1] 288035 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291119 0
Griffith University Human Ethics Committee
Ethics committee address [1] 291119 0
Griffith University - Gold Coast Campus
Parklands Dr
Southport QLD 4222
Ethics committee country [1] 291119 0
Australia
Date submitted for ethics approval [1] 291119 0
Approval date [1] 291119 0
24/04/2014
Ethics approval number [1] 291119 0
AHS/14/14/HREC
Ethics committee name [2] 291120 0
University of Queensland Medical Research Ethics
Ethics committee address [2] 291120 0
Research Management Office
UQ Research and Innovation
Cumbrae-Stewart Building
The University of Queensland
Brisbane QLD 4072
Ethics committee country [2] 291120 0
Australia
Date submitted for ethics approval [2] 291120 0
Approval date [2] 291120 0
04/02/2014
Ethics approval number [2] 291120 0

Summary
Brief summary
The primary aim of this study is to investigate the effectiveness, measured in terms of pain and disability, of the integrated addition of an intervention aimed at modulating early stress responses (SIT) to a standard physiotherapy exercise approach for individuals with acute whiplash injury. The second aim is to investigate the effectiveness of integrated SIT and physiotherapy exercise in decreasing post-traumatic stress symptoms, anxiety and depression.

It is hypothesised that:

* In individuals with acute whiplash, SIT integrated into a physiotherapy exercise program will be more effective than exercise alone where effect is measured in terms of pain related disability. That is, individuals in the SIT and exercise group will experience statistically significant, greater improvements in self-reported pain and disability than the exercise only group immediately following the 6 week block of treatment. These improvements will be sustained at the 6 month and 12 month follow-up.
* The effect of SIT integrated into physiotherapy exercise will also be greater than that of physiotherapy exercise alone where effect is measured in terms of post-traumatic stress symptoms, anxiety, depression, pain catastrophising and fear of movement. In other words, participants who receive SIT intervention will exhibit improved coping strategies, reflected by statistically significant reductions in psychological parameters listed above.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48950 0
Prof Michele Sterling
Address 48950 0
Centre for Musculoskeletal Research
Griffith Health Institute
Griffith University - Gold Coast Campus
Parklands Drive
Southport QLD 4222
Country 48950 0
Australia
Phone 48950 0
+617 3365 5560
Fax 48950 0
Email 48950 0
[email protected]
Contact person for public queries
Name 48951 0
Michele Sterling
Address 48951 0
Centre for Musculoskeletal Research
Griffith Health Institute
Griffith University - Gold Coast Campus
Parklands Drive
Southport QLD 4222
Country 48951 0
Australia
Phone 48951 0
+617 3365 5560
Fax 48951 0
Email 48951 0
[email protected]
Contact person for scientific queries
Name 48952 0
Michele Sterling
Address 48952 0
Centre for Musculoskeletal Research
Griffith Health Institute
Griffith University - Gold Coast Campus
Parklands Drive
Southport QLD 4222
Country 48952 0
Australia
Phone 48952 0
+617 3365 5560
Fax 48952 0
Email 48952 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23338Clinical study reportBr J Sports Med. 2019 Oct;53(19):1240-1247. doi: 10.1136/bjsports-2018-100139  

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4477Study results articleYes Br J Sports Med. 2019 Oct;53(19):1240-1247. doi: 1... [More Details] 366473-(Uploaded-20-02-2020-12-57-07)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStressModEx--Physiotherapist-led Stress Inoculation Training integrated with exercise for acute whiplash injury: study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1016/j.jphys.2015.04.003
EmbasePhysiotherapist-delivered Stress Inoculation Training for acute whiplash-associated disorders: A qualitative study of perceptions and experiences.2018https://dx.doi.org/10.1016/j.msksp.2018.09.005
N.B. These documents automatically identified may not have been verified by the study sponsor.