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Trial registered on ANZCTR


Registration number
ACTRN12619000749101
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
20/05/2019
Date last updated
20/05/2019
Date data sharing statement initially provided
20/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing a booster intervention to supplement complex interventions, focusing on interventions for chronic low back pain. A feasibility study.
Scientific title
Developing a booster intervention to supplement complex interventions, focusing on interventions for chronic low back pain. A feasibility study.
Secondary ID [1] 298109 0
Nil known
Universal Trial Number (UTN)
U1111-1232-5886
Trial acronym
Linked study record
RESOLVE: A randomised controlled trial investigating the effectiveness of two treatment programs at reducing pain intensity for people with chronic non-specific low back pain.
Trial Id: ACTRN12615000610538

Health condition
Health condition(s) or problem(s) studied:
Low back pain
 312642 0
Condition category
Condition code
Musculoskeletal 311134 311134 0 0
Other muscular and skeletal disorders
Neurological 311163 311163 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The booster trial is designed to investigate the feasibility of developing a booster intervention. The goal of a booster intervention is to maintain any improvement in symptoms achieved as part of the primary trial.
The booster intervention will supplement the treatment provided as part of the RESOLVE trial.
The booster session will be delivered between 36-42 weeks from baseline of the RESOLVE trial. The session will last 30-60 minutes. It will be conducted in the same setting as the RESOLVE trial. The booster session will revisit the same treatment interventions introduced during the RESOLVE trial. No new content will be raised during the booster session.
The booster session will be tailored to each participant and could focus on any element of the RESOLVE trial.

The RESOLVE trial interventions include;
Discussion of the low back pain experience
- delivered over twelve weeks
Laterality recognition training
- delivered over eleven weeks
- involves distinguishing between images of trunks rotated to left or right using Recognise (NOIgroup) software package
Tactile acuity training
- delivered over ten weeks
- involves localising and/or discriminating between different types of non-noxious tactile stimuli or multiple simultaneous non-noxious tactile stimuli applied by the therapist to the lower back.
Motor Imagery
- delivered over ten weeks
- involves mental visualisation of movements of the lower back and lower limbs, with or without videos
Feedback enhanced functional movement training
- delivered over seven weeks
- involves graded, individualised training of functional movement patterns with mirror visual feedback

Discussion of the low back pain experience
- delivered over twelve weeks
Transcranial direct current stimulation (tDCS)
- delivered over eleven weeks
- involves application of tDCS whilst comfortably seated for 10-20mins
Cranial electrical stimulation
- delivered over eight weeks
- involves application of CES whilst comfortably seated for 30mins
Low-intensity laser therapy
- delivered over ten weeks
- involves application of low-intensity laser to the lower back whilst lying comfortably
Pulsed electromagnetic energy
- delivered over seven weeks
- involves application of pulsed electromagnetic energy to the lower back whilst lying comfortably

Where possible the same researcher who delivered the RESOLVE intervention will deliver the booster session to that participant. The researchers involved in delivering the RESOLVE intervention have physiotherapy or exercise physiology qualifications.

Participants allocated to the control arm of the booster trial will not receive a booster session. As part of the RESOLVE trial we will collect data on all participants at 18 weeks and 52 weeks post randomisation.

The researchers will follow a protocol for the intervention to ensure fidelity. The researcher will log data specific to the booster session to maintain fidelity such as time spent on booster session, perceived benefit of booster session.
Intervention code [1] 314334 0
Treatment: Other
Intervention code [2] 314354 0
Rehabilitation
Comparator / control treatment
No intervention
Control group
Active

Outcomes
Primary outcome [1] 319903 0
Feasibility of booster intervention- number of contacts made to participant to arrange a booster session
Timepoint [1] 319903 0
The primary outcome for the RESOLVE trial will serve as the baseline outcome for the booster trial, which will be measured at 18 weeks post randomisation of the RESOLVE trial.

The outcome for the booster trial will be 34 weeks later at week 52 of the RESOLVE trial.
Primary outcome [2] 319904 0
Feasibility of booster intervention- withdrawal of consent for booster session
Timepoint [2] 319904 0
The primary outcome for the RESOLVE trial will serve as the baseline outcome for the booster trial, which will be measured at 18 weeks post randomisation of the RESOLVE trial.

The outcome for the booster trial will be 34 weeks later at week 52 of the RESOLVE trial.
Primary outcome [3] 319905 0
Feasibility of booster intervention- researcher time spent on booster session.
Measured as time in minutes with the participant.
Timepoint [3] 319905 0
The primary outcome for the RESOLVE trial will serve as the baseline outcome for the booster trial, which will be measured at 18 weeks post randomisation of the RESOLVE trial.

The outcome for the booster trial will be 34 weeks later at week 52 of the RESOLVE trial.
Secondary outcome [1] 369830 0
Feasibility of booster intervention- satisfaction with booster session
On a 0-10 scale, where 0 is not beneficial to 10 being very beneficial, how beneficial do you think this booster session was to you?
Timepoint [1] 369830 0
The primary outcome for the RESOLVE trial will serve as the baseline outcome for the booster trial, which will be measured at 18 weeks post randomisation of the RESOLVE trial.

The outcome for the booster trial will be 34 weeks later at week 52 of the RESOLVE trial.

Eligibility
Key inclusion criteria
(As per RESOLVE trial)
Participation in the RESOLVE trial
Primary complaint of pain in the area between the 12th rib and buttock crease with or without accompanying leg pain
Low back pain of at least 12 weeks duration
Mean pain intensity Numerical Rating Scale (NRS) greater than or equal to 3/10 in the past week
Sufficient fluency in English language to understand and respond to English language questionnaires and to engage with the intervention
Partner (friend or spouse) who is able to assist with home component of intervention
Internet access
Age 18-70, inclusive
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(As per RESOLVE trial)
Known or suspected serious spinal pathology (fracture; malignant, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder)
Suspected or confirmed pregnancy or less than six months post-partum
Nerve root compromise (any two of altered strength, reflex or sensation for the same nerve root)
Spinal surgery less than twelve months previously
Scheduled for major surgery during the treatment or follow-up period
Any of the contraindications to exercise listed in the American College of Sports Medicine guidelines
Uncontrolled mental health condition (eg, schizophrenia, bipolar disorder, major depressive disorder) that precludes successful participation
Any of the contra-indications to electrotherapeutic agents

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)
The research assistant who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated.
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using a computer generated number sequence, performed by a researcher not otherwise involved in either the Booster feasibility or RESOLVE trial.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2019
Actual
Date of last participant enrolment
Anticipated
2/03/2020
Actual
Date of last data collection
Anticipated
26/10/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302640 0
Government body
Name [1] 302640 0
National Health and Medical Research Council (NHMRC)
Country [1] 302640 0
Australia
Primary sponsor type
Individual
Name
Associate Professor James McAuley
Address
Neuroscience Research Australia
Barker St
Randwick
Sydney NSW 2031
Country
Australia
Secondary sponsor category [1] 302555 0
None
Name [1] 302555 0
Address [1] 302555 0
Country [1] 302555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303266 0
University of New South Wales Research Ethics Committee A
Ethics committee address [1] 303266 0
UNSW Kensington
Sydney, NSW 2031
Ethics committee country [1] 303266 0
Australia
Date submitted for ethics approval [1] 303266 0
02/08/2018
Approval date [1] 303266 0
09/08/2018
Ethics approval number [1] 303266 0
HC15357 (Modification request)

Summary
Brief summary
Chronic low back pain (LBP), that is LBP that has persisted for longer than 3 months, is a growing health burden. One factor that contributes to the burden of low back pain is that the improvements in symptoms that effective treatments provide are not sustained over time. Effective treatments for LBP are becoming increasing complex. There is need to develop and test interventions aimed at maintaining the initial improvements from complex interventions.

One way to maintain improvements from complex interventions is by implementing booster interventions. The aim of a booster session is to maintain improvements in symptoms by reinforcing the training components of the intervention.

The RESOLVE will provide platform to test the feasibility of a booster intervention. The RESOLVE trial assesses the effectiveness of two complex treatment programs that combine central nervous system-directed and traditional interventions to promote recovery in participants with chronic LBP (the protocol is described elsewhere). One method to sustain any benefits achieved as a result of such a complex treatment intervention, such as in the RESOLVE trial, is to include a booster session.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93070 0
A/Prof James McAuley
Address 93070 0
Neuroscience Research Australia
Barker St
Randwick
Sydney NSW 2031
Country 93070 0
Australia
Phone 93070 0
+61 2 9399 1266
Fax 93070 0
Email 93070 0
[email protected]
Contact person for public queries
Name 93071 0
James McAuley
Address 93071 0
Neuroscience Research Australia
Barker St
Randwick
Sydney NSW 2031
Country 93071 0
Australia
Phone 93071 0
+61 2 9399 1266
Fax 93071 0
Email 93071 0
[email protected]
Contact person for scientific queries
Name 93072 0
James McAuley
Address 93072 0
Neuroscience Research Australia
Barker St
Randwick
Sydney NSW 2031
Country 93072 0
Australia
Phone 93072 0
+61 2 9399 1266
Fax 93072 0
Email 93072 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Summary results will be made available to interested participants


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.