Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000089730
Ethics application status
Approved
Date submitted
6/12/2012
Date registered
23/01/2013
Date last updated
23/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physiotherapist delivered Stress Modulation Training: A randomised Controlled Trial in Acute Whiplash Injury.
Scientific title
In people with acute whiplash injury is a combined exercise and stress modulation training more effective than an exercise only intervention in reducing neck pain and disability.
Secondary ID [1] 281623 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whiplash Associated Disorder 287904 0
Posttraumatic Stress disorder 287905 0
Condition category
Condition code
Musculoskeletal 288283 288283 0 0
Other muscular and skeletal disorders
Mental Health 288284 288284 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapy Exercise and Stress Inocculation Training (SIT):

Exercise: The 6-week exercise intervention includes 2 sessions/week in weeks 1-4 and 1 session/week in weeks 5-6. Each session will be a maximum of 50minutes (determined by the physiotherapist) and comprise of specific exercises to improve movement and control of the neck and shoulder girdles as well as exercises to improve eye/head co-ordination. The exercises will be tailored and supervised by the physiotherapist for each individual participant. Exercises are of a low load nature and designed to be pain free. Paricipants will perform exercises at home once/day and a log book will be completed by participants to record compliance with the exercises.Physiotherapists will also guide participants to return to normal daily activities.

Stress Inoculation Training: Trained physiotherapists will provide information and strategies to assist participants in managing acute stress reactions following a motor vehicle accident. The Stress Inoculation Training will be delivered once per week and integrated with the exercise program sessions and incorporated into the 50minutes maximum session length to control for any attention placebo effect compared to the control group. The first session will include education about the effects of acute stress following an injury. At subsequent sessions additional strategies for managing stress will be introduced including abdominal breathing, progressive muscle relation, simple cognitive behavioural skills to encourage positive coping, reduce avoidance behaviours and develop problem solving skills. Participants will be required to perform daily practice of stress management skills and complete a log book to record compliance. Chief Investigator Kenardy will audit the SIT intervention to check for adherence.
Intervention code [1] 286156 0
Rehabilitation
Comparator / control treatment
Exercise only:

Exercise: The 6-week exercise intervention includes 2 sessions/week in weeks 1-4 and 1 session/week in weeks 5-6. Each session will be a maximum of 50minutes and comprise of specific exercises to improve 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. Exercises are of a low load nature and designed to be pain free. Paricipants will perform exercises at home once/day and a log book will be completed by participants to record compliance with the exercises.Physiotherapists will also guide participants to return to normal daily activities.
Control group
Active

Outcomes
Primary outcome [1] 288460 0
Neck Disability Index (NDI): A neck specific measre of pain and disability
Timepoint [1] 288460 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [1] 300202 0
Acute Stress Disorder Scale (ASDS)
Timepoint [1] 300202 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [2] 300203 0
Posttraumatic Stress Diagnostic Scale (PDS)
Timepoint [2] 300203 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [3] 300204 0
Depression, Anxiety and Stress Scale (DASS)
Timepoint [3] 300204 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [4] 300205 0
Resting Heart Rate will be measured manually by the assessor - taking a pulse measure at the wrist over 60 seconds timed with a stop watch
Timepoint [4] 300205 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [5] 300206 0
Patients Global Impression of Recovery. This will be measured using a -5 to +5 scale. (Pengel et al 2004)
Timepoint [5] 300206 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [6] 300207 0
Average Pain Intensity over the past week (0-10 VAS)
Timepoint [6] 300207 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [7] 300208 0
Short-Form 36 Health Survery (SF 36)
Timepoint [7] 300208 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [8] 300209 0
Cervical range of Movement (ROM)
Timepoint [8] 300209 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [9] 300210 0
Pressure Pain Thresholds (cervical spine, median nerve and tibialis anterior). These will be measured using a standard pressuer algometer (Somedic, Sweden)
Timepoint [9] 300210 0
Baseline, 6weeks, 3months and 6months after randomisation.
Secondary outcome [10] 300211 0
Thermal Pain Thresholds (cervical). These will be measured using a Thermotest system (Somedic, Sweden).
Timepoint [10] 300211 0
Baseline, 6weeks, 3months and 6months after randomisation.

Eligibility
Key inclusion criteria
- Whiplash Associated Disorder grade II of less than 6weeks duration.
- Currenting experiencing at least moderate pain (VAS > 5/10)or moderate disability due to pain (NDI > 30%).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not currently recieving any care for whiplash.
- Known or suspected serious spinal pathology (e.g. metastatic, inflamatory or inefective disease in the spine)
- Confirmed fractur or dislocation at the time of injury (i.e. WAD IV).
- nerve root compromise with atleast two of the following signs: weakness/reflex changes/sensory loss, associated with the same spinal nerve (i.e. WAD III).
- Spinal surgery in the past 12months
- Meeting criteria for a probably diagnosis of Acute Stress Disorder on te ASDS.
- Current diagnosis for major depressive episode requiring treatment or medicaiton.
- A history of psychosis, biopolar disorder, organic brain disprder 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)
Recruitment will be from the general community via adertisements. Individuals will be screened via telephne and those meeting the inclusion and exclusion criteria will be randomly allocated to the treatment and control groups using a randomisation schedule prepared by the study biostatistician. Randomisation will be concealed fro the assessors, other study staff and participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the study biostatiscian.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286436 0
Self funded/Unfunded
Name [1] 286436 0
Country [1] 286436 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Centre of National Research on Disability and Rehabilitation Medicine (CONROD)
University of Queensland
Level 1, Edith Cavell Building,
Royal Brisbane and Women's Hospital,
Herston, Brisbane, QLD 4006
Country
Australia
Secondary sponsor category [1] 285222 0
None
Name [1] 285222 0
Address [1] 285222 0
Country [1] 285222 0
Other collaborator category [1] 277208 0
Individual
Name [1] 277208 0
Professor Justin Kenardy
Address [1] 277208 0
Centre of National Research on Disability and Rehabilitation Medicine (CONROD)
University of Queensland
Level 1, Edith Cavell Building,
Royal Brisbane and Women's Hospital,
Herston, Brisbane, QLD 4006
Country [1] 277208 0
Australia
Other collaborator category [2] 277211 0
Individual
Name [2] 277211 0
Dr Rachael Dunne-Proctor
Address [2] 277211 0
Centre of National Research on Disability and Rehabilitation Medicine (CONROD)
University of Queensland
Level 1, Edith Cavell Building,
Royal Brisbane and Women's Hospital,
Herston, Brisbane, QLD 4006
Country [2] 277211 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288509 0
Medical Research Ethics Committee, University of Queensland
Ethics committee address [1] 288509 0
Ethics committee country [1] 288509 0
Australia
Date submitted for ethics approval [1] 288509 0
Approval date [1] 288509 0
Ethics approval number [1] 288509 0
2011000206

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

Contacts
Principal investigator
Name 35012 0
Prof Michele Sterling
Address 35012 0
Centre of National Research on Disability and Rehabilitation Medicine (CONROD)
University of Queensland
Level 1, Edith Cavell Building,
Royal Brisbane and Women's Hospital,
Herston, Brisbane, QLD 4006
Country 35012 0
Australia
Phone 35012 0
+61733655344
Fax 35012 0
Email 35012 0
[email protected]
Contact person for public queries
Name 18259 0
Michele Sterling
Address 18259 0
Centre of National Research on Disability and Rehabilitation Medicine (CONROD)
University of Queensland
Level 1, Edith Cavell Building,
Royal Brisbane and Women's Hospital,
Herston, Brisbane, QLD 4006
Country 18259 0
Australia
Phone 18259 0
+61733655344
Fax 18259 0
Email 18259 0
[email protected]
Contact person for scientific queries
Name 9187 0
Michele Sterling
Address 9187 0
Centre of National Research on Disability and Rehabilitation Medicine (CONROD)
University of Queensland
Level 1, Edith Cavell Building,
Royal Brisbane and Women's Hospital,
Herston, Brisbane, QLD 4006
Country 9187 0
Australia
Phone 9187 0
+61733655344
Fax 9187 0
Email 9187 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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