Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000973213
Ethics application status
Approved
Date submitted
2/06/2018
Date registered
8/06/2018
Date last updated
8/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of physiotherapy in chronic whiplash individuals with and without posttraumatic stress: a pilot series of Single Case Experimental Designs (SCEDs)
Scientific title
Effectiveness of conservative multimodal physiotherapy in chronic whiplash-associated disorders in individuals with and without posttraumatic stress symptoms: a pilot series of Single Case Experimental Designs (SCEDs)
Secondary ID [1] 294868 0
None
Universal Trial Number (UTN)
U1111-1214-0050
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic whiplash 307818 0
Condition category
Condition code
Injuries and Accidents 306865 306865 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Advice booklet
All patients will be provided with an advice booklet Whiplash Injury Recovery: A Self Help Guide (2nd edition), co-authored by Prof Sterling and published by the Motor Accident Insurance Commission (MAIC), Qld. It provides information about whiplash, assurance about prognosis and advice to stay active and resume working; as well as information on correct posture, with pictorial descriptions of specific neck and upper limbs exercises and information on resuming functional daily activities. This second edition of the booklet was written based on consumer and health care professional feedback via focus groups. The booklet is based on the recommendations of the current Australian Guidelines for Whiplash Management (TRACsa, 2008).

Conservative Multimodal Physiotherapy
The 4-week exercise program will be carried out by the honors students under the supervision of the experienced physiotherapist (2 sessions per week). The exercise program will comprise specific exercises to improve the movement and control of the neck and shoulder girdle. Exercises will be tailored by the physiotherapist for each individual participant. The exercises will be of a low load nature and 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 and axio-scapular-girdle muscles and includes tests that assess an individual’s ability to recruit the muscles in a coordinated manner, and tests of muscle endurance at low levels of maximum voluntary contraction. The specific impairments identified are then addressed with an exercise program that is supervised and progressed by the physiotherapist. This specific treatment program as described in Jull et al (2008) focuses on activating and improving the coordination and endurance capacity of neck flexor, extensor and scapular muscles in specific exercises and functional tasks, and a graded program directed to the postural control system including exercises for balance, head relocation and eye movement control. Participants will also perform the exercises at home, once per day. Written and illustrated exercise instructions will be provided. A log book will be completed by participants to record compliance with the exercises. The exercise program follows the current Australian guidelines for the management of chronic whiplash (TRACsa, 2008).
Physiotherapists providing the intervention and control
Physiotherapy honours students who successfully complete a face-to-face, trial specific training workshop run by Prof Michele Sterling (MS) will provide the therapeutic interventions for this study. They will be supervised by a physiotherapist experienced in the management of whiplash injured individuals. The physiotherapy exercise sessions will be audited twice per honours student/physiotherapist (face to face by MS) to check for adherence to the exercise protocol.
Intervention code [1] 301178 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305855 0
Neck pain intensity on a Numerical Rating Scale (NRS)
Timepoint [1] 305855 0
4 and 8 weeks after intervention commencement
Primary outcome [2] 305856 0
Participants will be asked, "How confident are you in your ability to perform your daily tasks in the presence of your neck pain or disability?” with 1 indicating not at all confident, 2 a little confident, 3 moderately confident, 4 very confident and 5 extremely confident (adapted from Nicholas 2007).
Timepoint [2] 305856 0
4 and 8 weeks after intervention commencement
Secondary outcome [1] 346805 0
Neck Disability Index (NDI)
Timepoint [1] 346805 0
2, 4 and 8 weeks after intervention commencement
Secondary outcome [2] 346806 0
Patient Global Impression of Change: -5 to +5 scale (Hurst & Bolton, 2004)
Timepoint [2] 346806 0
2, 4 and 8 weeks after intervention commencement
Secondary outcome [3] 346809 0
The Pain Catastrophizing Scale (PCS)
Timepoint [3] 346809 0
2, 4 and 8 weeks after intervention commencement
Secondary outcome [4] 346810 0
Depression & Anxiety Stress Scales (DASS-21)
Timepoint [4] 346810 0
2, 4 and 8 weeks after intervention commencement
Secondary outcome [5] 346811 0
Generic measure of health status (EQ-5D-5L)
Timepoint [5] 346811 0
2, 4 and 8 weeks after intervention commencement
Secondary outcome [6] 346812 0
3 participant-specific questions from the Pain Self-Efficacy Questionnaire (Nicholas 2007), individualised per participant.
Timepoint [6] 346812 0
2, 4 and 8 weeks after intervention commencement

Eligibility
Key inclusion criteria
Individuals with Whiplash Associated Disorder.
> 12 weeks since injury.
Aged 35 -65 years.
Neck pain on numerical pain rating scale >= 5/10.
Neck Disability Index at start of trial > 28%.
Three individuals with moderate post-traumatic stress symptoms (revised Impact of Events Scale score > 24) and 3 individuals with minimal or no PTSS (r-IES < 20).
Minimum age
35 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).
Spinal surgery in the past 12 months.
History of any mental health conditions such as bipolar disorder, psychosis, schizophrenia
Score of 10 or more on the Patient Health Questionnaire (PHQ-9).
Not fluent in English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random number generator on Microsoft Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This will be a single case with randomized multiple baseline experimental design with simultaneous enrolment of 3 patients with PTSS, and 3 patients without PTSS. There will be a variable length baseline (A1) and then a randomly allocated staggered start to provide internal validity – one patient starting at 5 days, one at 8 and one at 11 days. This study will utilise an A1-B-A2 design: a baseline phase (A1 no intervention), intervention phase (B) and a no intervention phase (A2 follow up). Primary outcome measures will be collected daily during this time period. The baseline phase (A1) will be followed by a 4-week intervention period (B). Participants will have 8 one hour sessions over a 4-week period. The intervention will be delivered by an honours student physiotherapist, supervised by an experienced physiotherapist. During the intervention period, the daily collection of the primary outcome measures will coincide with the delivery of each intervention session twice per week. The intervention phase will be followed by a 4 week follow-up phase (A2) where participants will have no contact with the intervention personnel. This follow-up phase is implemented in order to determine the possible duration of improvement post intervention. Primary and secondary outcome measures will be collected at the completion of this 4 week follow-up period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome measures will be plotted against time and visually examined for: (1) level; (2) trend; (3) variability; (4) immediacy of the effect; (5) overlap; and (6) consistency of data patterns in similar phases.
The magnitude of change (i.e. effect size) between two phases (e.g. baseline versus intervention) will be measured using the improvement rate difference (IRD). IRD is an overlap measure that calculates the difference in ‘‘improvement rates’’ between two phases. For example, to measure a decrease from baseline (A) to intervention phase (B), an ‘‘improved’’ intervention average pain VAS score at the end of active treatment is lower than most or all of the baseline data points (by 1.5 VAS points). Parker et al. provided guidelines for interpretation of IRD scores, which were established based on their evaluation of 166 single case data sets comparing IRD results with visual analyses. They suggest that IRD of 0.50 or lower implies small or no effects, scores between about 0.50 and 0.70 indicate moderate effects, and scores of about 0.70 or 0.75 or higher indicate large or very large intervention effects. Parker et al. (2009) provide a detailed description of and the method of calculating IRD. A significant difference between the averaged IRD for each category (with or without PTSS) will be defined as lack of overlap in the confidence intervals for the two categories.
Next, the data from each active treatment phase of the SCEDs will be aggregated using a Bayesian hierarchical model where random effects account for repeated measures (within patients) over time. Upon developing and estimating an appropriate model including treatment effects and overall participant response against baseline, will be considered as follows for each of the two groups (with and without PTSS): 1) the posterior mean differences in group and individual expected outcomes at the end of the SCED and at 3 months follow up will be evaluated with associated 95% credible intervals, and 2) the posterior probability that the treatment effect is different from zero (in the direction of active treatment over baseline) will be calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2018
Actual
Date of last participant enrolment
Anticipated
27/07/2018
Actual
Date of last data collection
Anticipated
17/09/2018
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299455 0
University
Name [1] 299455 0
The University of Queensland
Country [1] 299455 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 298792 0
Other Collaborative groups
Name [1] 298792 0
RECOVER Injury Research Centre
Address [1] 298792 0
The University of Queensland
Level 7, UQ Oral Health Centre
288 Herston Road, Herston
QLD 4006, Australia
Country [1] 298792 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300361 0
The University of Queensland’s Human Research Ethics Committee
Ethics committee address [1] 300361 0
Ethics committee country [1] 300361 0
Australia
Date submitted for ethics approval [1] 300361 0
27/03/2018
Approval date [1] 300361 0
04/05/2018
Ethics approval number [1] 300361 0
2018000675

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2716 2716 0 0
/AnzctrAttachments/375086-KM03045_1_Form B Baseline v3 April 2018.docx (Supplementary information)
Attachments [2] 2717 2717 0 0
/AnzctrAttachments/375086-v2_KM03045_1_letter-head-consent-form-April 2018.doc (Participant information/consent)
Attachments [3] 2718 2718 0 0
/AnzctrAttachments/375086-v2_KM03045_1_N-of-1-conservative-multimodal-whiplash_PTSS-protocol-April 2018.docx (Protocol)
Attachments [4] 2719 2719 0 0
/AnzctrAttachments/375086-v2_KM03045_1_letter-head-PIS-April 2018.doc (Participant information/consent)
Attachments [5] 2720 2720 0 0
/AnzctrAttachments/375086-KM03045_1_Full-Diary-Patient-A.docx (Other)
Attachments [6] 2721 2721 0 0
/AnzctrAttachments/375086-KM03045_1_Full-Diary-Patient-B.docx (Other)
Attachments [7] 2722 2722 0 0
/AnzctrAttachments/375086-KM03045_1_Full-Diary-Patient-C.docx (Other)
Attachments [8] 2723 2723 0 0
/AnzctrAttachments/375086-KM03045_1_Form S Screening Part A.docx (Other)
Attachments [9] 2724 2724 0 0
/AnzctrAttachments/375086-KM03045_1_Form Z Personal Details.docx (Participant information/consent)
Attachments [10] 2725 2725 0 0
/AnzctrAttachments/375086-KM03045_1_chronic whiplash_pamphlet.pdf (Other)
Attachments [11] 2726 2726 0 0
/AnzctrAttachments/375086-KM03045_1_FORM A Initial Screening v1 Jan 2018jn.docx (Other)
Attachments [12] 2727 2727 0 0
/AnzctrAttachments/375086-KM03045_1_Form S Screening Part B.docx (Other)
Attachments [13] 2728 2728 0 0
/AnzctrAttachments/375086-KM03045_1_FOLLOW UP (M3) v1_2 Jan 2018.docx (Other)
Attachments [14] 2729 2729 0 0
/AnzctrAttachments/375086-__2018000675 - Approval Form HRECB.pdf (Ethics approval)

Contacts
Principal investigator
Name 83402 0
A/Prof Jane Nikles
Address 83402 0
The University of Queensland
Level 7, UQ Oral Health Centre
288 Herston Road, Herston
QLD 4006, Australia
Country 83402 0
Australia
Phone 83402 0
+61 7 3346 4821
Fax 83402 0
Email 83402 0
[email protected]
Contact person for public queries
Name 83403 0
Jane Nikles
Address 83403 0
The University of Queensland
Level 7, UQ Oral Health Centre
288 Herston Road, Herston
QLD 4006, Australia
Country 83403 0
Australia
Phone 83403 0
+61 7 3346 4821
Fax 83403 0
Email 83403 0
[email protected]
Contact person for scientific queries
Name 83404 0
Jane Nikles
Address 83404 0
The University of Queensland
Level 7, UQ Oral Health Centre
288 Herston Road, Herston
QLD 4006, Australia
Country 83404 0
Australia
Phone 83404 0
+61 7 3346 4821
Fax 83404 0
Email 83404 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

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