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Trial registered on ANZCTR
Registration number
ACTRN12615000724572
Ethics application status
Approved
Date submitted
4/06/2015
Date registered
15/07/2015
Date last updated
12/02/2024
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
The Effect of Physiotherapy Integrated Motivational Interviewing and Smartphone Technology to Increase Physical Activity in Patients with Low Back Pain: A Cluster Randomised Controlled Trial
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Scientific title
The effect of Physiotherapy Integrated Motivational Interviewing and Smartphone Technology to Increase Physical Activity in Patients with Low Back Pain: A Cluster Randomised Controlled Trial
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Secondary ID [1]
286859
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Low Back Pain
295254
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Condition category
Condition code
Musculoskeletal
295499
295499
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0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
295687
295687
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will receive 6, 30 minute weekly sessions of usual physiotherapy care, the physiotherapy content of which will be at the discretion of the treating therapist. This will be in addition to their initial physiotherapy session, during which they will be recruited for the trial. Throughout each session the physiotherapist will communicate with patients in a style consistent with Motivational Interviewing (MI). Physiotherapists will be trained on how to communicate in an MI consistent style via two 4 hour training sessions prior to the commencement of the study. Training will be provided by two of the study coordinators who are both trained in the use of MI. One of the study coordinators is a PhD candidate and current practicing physiotherapist and the other an academic and current practicing psychologist. As part of training physiotherapists will participate in an audio recorded role play with one of the study coordinators. Therapists will be provided with a copy of this recording to reflect and improve on their MI techniques. Physiotherapists will practice learned MI techniques until patient recruitment commences. Prior to patient recruitment physiotherapists will receive a 3 hour training session to review learned MI techniques. To establish a measure of MI proficiency, physiotherapists will participate in a 20-30 minute role play with one of the study coordinators following this review session. This will be audio recorded and reviewed by a third party assessor not otherwise associated with the study. The assessor will use the Motivational Interviewing Treatment Integrity scale to assess the interaction and provide a measure of therapist proficiency in MI. This will be repeated 6 weeks into patient recruitment to establish any change in MI proficiency. Between sessions, patients will access a newly developed MI app. The app will endeavor to replicate face to face MI and help participants to formulate their own reasons for increasing their activity levels though a question and answer format. The majority of questions will be open ended and focus on building the importance of increasing activity levels and the confidence the participant has in being able to achieve this. Finally an activity related goal will be developed in conjunction with the physiotherapist and the smartphone application. Participants will access the app two to three times per week. The amount of time required for each log in will vary between participants and depend on how skilled they are at using smartphones, however each session has been designed to last no longer than 15 minutes. Participants will then access the smartphone application for a further 6 weeks after physiotherapy has ceased. There will be a central web server accessible to physiotherapists from intervention clusters and the study coordinators. This will allow app usage to be monitored and the answers participants provide may be reviewed. A review of the answers may take place if the therapist wishes to use this information to plan upcoming sessions. The app will contain a feature, whereby if the participant gets stuck on a certain module, an email will be generated to one of the study coordinators, a current practicing psychologist who has extensive training in MI. The participant and the study coordinator will converse via email to problem solve why the participant is not progressing though the application. This will be done in an MI consistent manner. Once the study coordinator establishes that the participant is ready to recommence the app they will be instructed to do so.
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Intervention code [1]
292027
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Rehabilitation
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Intervention code [2]
292028
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Behaviour
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Intervention code [3]
292183
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Treatment: Other
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Comparator / control treatment
Participants in the control group will receive 6 sessions of usual physiotherapy care. The content of each physiotherapy session will be at the discretion of the treating therapist.
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Control group
Active
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Outcomes
Primary outcome [1]
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Average number of minutes of moderately vigorous activity per day measured by accelerometer recordings and activity diaries in the week of assessment.
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Assessment method [1]
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Timepoint [1]
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Baseline and 7 weeks. Participants will receive a reminder call from a research assistant half way through their assessment weeks. The purpose of this call will be to remind participants to wear their accelerometer and complete their activity diary and to ensure there are no issues with either of these procedures.
In addition to this, participants will be provided with the email address of their research assistant. In the event there are issues with the accelerometer, participants will be able to contact their research assistant for assistance.
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Secondary outcome [1]
315156
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Participant Function (Patient Specific Functional Scale average score and primary activity score)
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Assessment method [1]
315156
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Timepoint [1]
315156
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Baseline and 7 weeks
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Secondary outcome [2]
315157
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Back pain related disability (Oswestery Disability Index)
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Assessment method [2]
315157
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Timepoint [2]
315157
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Baseline and 7 weeks
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Secondary outcome [3]
315158
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Pain-related self efficacy (Pain Self Efficacy Questionnaire)
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Assessment method [3]
315158
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Timepoint [3]
315158
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Baseline and 7 weeks
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Secondary outcome [4]
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Motivational Interviewing therapist proficiency (Client Evaluation of Motivational Interviewing Questionnaire)
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Assessment method [4]
315159
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Timepoint [4]
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7 weeks, patients in the intervention group only.
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Secondary outcome [5]
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Motivational Interviewing therapist proficiency (Motivational Interviewing Treatment Integrity Scale), physiotherapists in the intervention group only.
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Assessment method [5]
315160
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Timepoint [5]
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Baseline and 6 weeks into patient recruitment
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Eligibility
Key inclusion criteria
3-12 week history of a new episode of low back pain (present for at least 24 hours and symptom free or at a baseline considered normal for the patient in the preceding 30 days), with or without radicular pain or radiculopathy.
English speaking.
Able to use simple smartphone applications.
Access to a Google Play or iTunes account or willing to create one.
Reside within 40km of their attending healthcare site.
Access to a compatible smartphone (iPhone 4 or greater or Android based phone), or tablet PC.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
High risk of severe or extremely severe depression or anxiety (Patients will be screened prior to entry using the 21 item Depression Anxiety and Stress Scale)
Pregnant
Wait listed for lumbar surgery
Signs and symptoms consistent with cauda equina syndrome
Presence of medical red flags
Current spinal fracture
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Physiotherapists: Physiotherapists at intervention sites will be recruited as follows; Physiotherapists will be selected to be participated by the musculoskeletal unit stream leader based on work loads and other unit specific factors. Interested physiotherapists will contact one of the study coordinators to confirm their participation, who will advise the stream leader of this decision.
Patients: Patients will be selected by their treating physiotherapist based on the selection criteria. Physiotherapists will explain the study to patients and make it clear to patients that participation is voluntary. Physiotherapists will administer the DASS 21 to ensure they meet the inclusion criteria regarding depression and anxiety. Patients will be provided with an information and consent form to review and will be followed up by a research assistant who will confirm participation and obtain written consent at the initial home visit when baseline outcome measures will be taken.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A cluster randomised controlled trial with health care site as the unit of randomisation. An independent researcher will place the name of each healthcare site will be placed into an opaque envelope using a random number generator. Sites will then alternately be allocated to intervention or control sites using a random number generator.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
Assessments will be carried out by a blinded research assistant who will conduct home visits to patients at baseline and 7 weeks. At the start of the assessment week the research assistant will drop off the accelerometer and patients will complete the standardised pen and paper outcome measures. Half way through the assessment week the research assistant will call the patient to remind them to wear their accelerometer. At the end of the assessment week the research assistant will pick up the accelerometer and download the data using propriety software.
Participants will also be provided with the email address of one of the study coordinators, so they can contact them if the accelerometer stops working.
To acknowledge the work and time physiotherapists will be donating to the project, physiotherapists will be provided with recruitment incentives for every 5 patients recruited (up to a maximum of 10 patients), and for the therapist who recruits the most patients overall across sites.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Primary and secondary outcomes will be entered into an ANCOVA using baseline scores as a co-variate to establish between groups at 7 weeks.
To establish consistency in the Motivational Interviewing skills of therapists, paired-sampled t-tests will be used comparing baseline scores with obtained at the conclusion of the study.
To achieve 80% power at a 0.05 significance level with a large effect size a total of 34 patients are required (Faul, Franz
Erdfelder & Edgar, 2007). As this is a cluster randomised trial the sample size needs to be increased due to outcome variation between clusters (van Breukelen & Candel, 2012). Assuming an intracluster correlation coefficient of 0.05, a total of 14 patients per cluster is required (Machin, Campbell, Tan & Tan, 2009). Therefore the target sample size will be set at 60 patients (15 for each cluster), to allow some loss to follow up.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
27/03/2017
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Actual
29/03/2017
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Date of last participant enrolment
Anticipated
1/09/2018
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Actual
10/09/2018
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Date of last data collection
Anticipated
22/10/2018
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Actual
23/02/2019
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Sample size
Target
60
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Accrual to date
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Final
47
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
3882
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [2]
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Monash Medical Centre - Moorabbin campus - East Bentleigh
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Recruitment hospital [3]
3884
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The Alfred - Prahran
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Recruitment hospital [4]
3885
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Angliss Hospital - Upper Ferntree Gully
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Recruitment postcode(s) [1]
9775
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3168 - Clayton
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Recruitment postcode(s) [2]
9776
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3165 - Bentleigh East
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Recruitment postcode(s) [3]
9777
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3004 - Melbourne
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Recruitment postcode(s) [4]
9778
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3156 - Upper Ferntree Gully
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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La Trobe University
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Address [1]
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La Trobe University
Kingsbury Drive
Bundoora
VIC
3086
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Alumni & Advancement Office, La Trobe University
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Address
La Trobe University
Kingsbury Drive
Bundoora
VIC
3086
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Country
Australia
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Secondary sponsor category [1]
290093
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Commercial sector/Industry
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Name [1]
290093
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Telstra Australia
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Address [1]
290093
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242 Exhibition Street
MELBOURNE
VIC, AUSTRALIA, 3000
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Country [1]
290093
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Australia
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Secondary sponsor category [2]
294506
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University
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Name [2]
294506
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La Trobe University School of Public Health
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Address [2]
294506
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Kingsbury Drive
Bundoora
3086
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Country [2]
294506
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
292966
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Eastern Health Human Ethics Committee
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Ethics committee address [1]
292966
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Office of Research and Ethics 5 Arnold Street Box Hill Vic 3128
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Ethics committee country [1]
292966
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Australia
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Date submitted for ethics approval [1]
292966
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Approval date [1]
292966
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16/02/2015
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Ethics approval number [1]
292966
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E12-2014
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Ethics committee name [2]
292967
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Monash Health
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Ethics committee address [2]
292967
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Research Support Services Monash Health Monash Medical Centre 246 Clayton Road Clayton Vic 3168
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Ethics committee country [2]
292967
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Australia
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Date submitted for ethics approval [2]
292967
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Approval date [2]
292967
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02/06/2015
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Ethics approval number [2]
292967
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15067X
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Ethics committee name [3]
292968
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Alfred Health
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Ethics committee address [3]
292968
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Office of Ethics & Research Governance 5 Commercial Road Melbourne Victoria 3004
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Ethics committee country [3]
292968
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Australia
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Date submitted for ethics approval [3]
292968
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Approval date [3]
292968
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26/05/2015
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Ethics approval number [3]
292968
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47/15
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Ethics committee name [4]
294263
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La Trobe University Human Ethics Committee
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Ethics committee address [4]
294263
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La Trobe University Ethics and Integrity/Research Office Kingsbury Drive Bundoora Victoria Australia 3086
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Ethics committee country [4]
294263
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Date submitted for ethics approval [4]
294263
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Approval date [4]
294263
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01/04/2015
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Ethics approval number [4]
294263
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E12-2014
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Summary
Brief summary
This trial will aim to determine if smartphone based Motivational Interviewing supplemented with Motivational Interviewing provided during usual physiotherapy care can increase activity in patients with sub-acute low back pain.
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Trial website
N/A
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Trial related presentations / publications
N/A
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Public notes
N/A
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Contacts
Principal investigator
Name
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Mr Jason Holden
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Address
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C/o
Dr Paul O'Halloran
School of Psychology and Public Health
La Trobe University
Kingsbury Drive
Bundoora
VIC 3086
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Country
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Australia
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Phone
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+61 3 9479 5607
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Paul O'Halloran
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Address
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School of Psychology and Public Health
La Trobe University
Kingsbury Drive
Bundoora
VIC 3086
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Country
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Australia
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Phone
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+61 3 9479 5607
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
57828
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Paul O'Halloran
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Address
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School of Psychology and Public Health
La Trobe University
Kingsbury Drive
Bundoora
VIC 3086
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Country
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Australia
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Phone
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+61 3 9479 5607
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Fax
57828
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data is de-identified for analysis to maintain patient confidentiality.
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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
No additional documents have been identified.
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