ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

StressModEx

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute whiplash

Condition category

Condition code

Musculoskeletal

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]

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]

Neck disability index (NDI)

Timepoint [1]

6 weeks, 6 months, 12 months

Secondary outcome [1]

Acute Stress Disorder Scale (ASDS)

Timepoint [1]

6 weeks, 6 months, 12 months

Secondary outcome [2]

Post Traumatic Stress Diagnostic Scale (PDS)

Timepoint [2]

6 weeks, 6 months, 12 months

Secondary outcome [3]

Depression, Anxiety and Stress Scale (DASS)

Timepoint [3]

6 weeks, 6 months, 12 months

Secondary outcome [4]

Pain Catastrophising Scale (PCS)

Timepoint [4]

6 weeks, 6 months, 12 months

Secondary outcome [5]

Patient’s global impression of recovery (-5 to +5 scale)

Timepoint [5]

6 weeks, 6 months, 12 months

Secondary outcome [6]

Average pain intensity over the last 24 hours (0-10 scale)

Timepoint [6]

6 weeks, 6 months, 12 months

Secondary outcome [7]

Generic measure of health status (SF-36)

Timepoint [7]

6 weeks, 6 months, 12 months

Secondary outcome [8]

Coping Strategies Questionnaire

Timepoint [8]

6 weeks, 6 months, 12 months

Secondary outcome [9]

Pain Self Efficacy Questionnaire

Timepoint [9]

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?

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]

4222 - Griffith University

Recruitment postcode(s) [2]

4072 - University Of Queensland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

Level 1
16 Marcus Clarke Street
Canberra
ACT 2601

Country [1]

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]

University

Name [1]

University of Queensland

Address [1]

Centre of National Reserach on Disability and Rehabilitation
School of Medicine
The University of Queensland
Edith Cavill Building
Herston QLD 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Ethics Committee

Ethics committee address [1]

Griffith University - Gold Coast Campus
Parklands Dr
Southport QLD 4222

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/04/2014

Ethics approval number [1]

AHS/14/14/HREC

Ethics committee name [2]

University of Queensland Medical Research Ethics

Ethics committee address [2]

Research Management Office
UQ Research and Innovation
Cumbrae-Stewart Building
The University of Queensland
Brisbane QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

04/02/2014

Ethics approval number [2]

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

Prof Michele Sterling

Address

Centre for Musculoskeletal Research
Griffith Health Institute
Griffith University - Gold Coast Campus
Parklands Drive
Southport QLD 4222

Country

Australia

Phone

+617 3365 5560

Fax

m.sterling@griffith.edu.au

Contact person for public queries

Name

Michele Sterling

Address

Centre for Musculoskeletal Research
Griffith Health Institute
Griffith University - Gold Coast Campus
Parklands Drive
Southport QLD 4222

Country

Australia

Phone

+617 3365 5560

Fax

m.sterling@griffith.edu.au

Contact person for scientific queries

Name

Michele Sterling

Address

Centre for Musculoskeletal Research
Griffith Health Institute
Griffith University - Gold Coast Campus
Parklands Drive
Southport QLD 4222

Country

Australia

Phone

+617 3365 5560

Fax

m.sterling@griffith.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23338	Clinical study report	Br 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.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4477	Study results article	Yes		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

Source	Title	Year of Publication	DOI
Embase	StressModEx--Physiotherapist-led Stress Inoculation Training integrated with exercise for acute whiplash injury: study protocol for a randomised controlled trial.	2015	https://dx.doi.org/10.1016/j.jphys.2015.04.003
Embase	Physiotherapist-delivered Stress Inoculation Training for acute whiplash-associated disorders: A qualitative study of perceptions and experiences.	2018	https://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.

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Documents added automatically