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Trial registered on ANZCTR


Registration number
ACTRN12615000610538
Ethics application status
Approved
Date submitted
25/05/2015
Date registered
11/06/2015
Date last updated
11/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The RESOLVE Trial: Retraining the brain to reduce pain intensity of chronic low back pain
Scientific title
A randomised controlled trial investigating the effectiveness of two treatment programs at reducing pain intensity for people with chronic non-specific low back pain
Secondary ID [1] 286789 0
nil
Universal Trial Number (UTN)
Trial acronym
RESOLVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 295165 0
Condition category
Condition code
Musculoskeletal 295407 295407 0 0
Other muscular and skeletal disorders
Neurological 295460 295460 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twelve week treatment program delivered during one 60min session once per week. All treatment sessions are one-on-one. There is a home training component - 30mins 5x/week. The intervention comprises discussion of the low back pain experience, laterality recognition and tactile acuity training, motor imagery and feedback enhanced functional movement training. The treatments are not mutually exclusive and are likely to overlap.
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
Interventions will be monitored using an individual treatment diary
Intervention code [1] 291946 0
Rehabilitation
Comparator / control treatment
Twelve week treatment program delivered during one 60min session once per week. All treatment sessions are one-on-one. There is a home training component - 30mins 5x/week. The intervention comprises discussion of the low back pain experience, transcranial direct current stimulation, cranial electrical stimulation, low-intensity laser therapy and pulsed electromagnetic energy. .
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
Interventions will be monitored using an individual treatment diary
Control group
Active

Outcomes
Primary outcome [1] 295144 0
Pain intensity (Numerical Rating Scale)
Timepoint [1] 295144 0
18 weeks post randomisation
Secondary outcome [1] 314850 0
Disability (Roland Morris Disability Questionnaire)
Timepoint [1] 314850 0
18 weeks post randomisation
Secondary outcome [2] 314851 0
Global perceived effect
Timepoint [2] 314851 0
18 weeks post randomisation

Eligibility
Key inclusion criteria
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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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)
Recruitment will be via community distribution of posters. The phone and fax numbers and email address for the RESOLVE trial will be listed on the posters and participants will be invited to contact the RESOLVE research team. Once being contacted by a potential participant, RESOLVE study researchers will screen them for eligibility to enter the trial.
Participants will also be recruited via primary care practitioners in the greater Sydney area. These practitioners will be contacted using the database of practitioners from the PREVENT trial and using contact information freely available on the Internet. Practitioners will be invited to participate in the RESOLVE study and provided with training on recruitment should they consent to participate. Posters will be placed in the waiting rooms of the practitioners clinic, should they consent to this. Participants will be given contact details of the researchers by their practitioner if they consider their client to be eligible. Potential participants can contact the researchers immediately while they are in their practitioner's room or at a later point of time. RESOLVE study researchers will screen the potential participant for eligibility to enter the trial on the phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher not involved in patient recruitment or data collection will create a randomisation schedule using randomisation software. The randomisation schedule will be used to create 275 consecutively numbered, sealed, opaque envelopes containing allocations
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291325 0
Government body
Name [1] 291325 0
National Health and Medical Research Council (NHMRC)
Address [1] 291325 0
GHD Building Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 291325 0
Australia
Primary sponsor type
Individual
Name
Dr James McAuley
Address
Neuroscience Research Australia
Barker St
Randwick
Sydney NSW 2031
Country
Australia
Secondary sponsor category [1] 290017 0
None
Name [1] 290017 0
Address [1] 290017 0
Country [1] 290017 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292892 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 292892 0
Human Research Ethics Committee (HREC)
The University of New South Wales
Sydney, NSW, 2052
Australia
Ethics committee country [1] 292892 0
Australia
Date submitted for ethics approval [1] 292892 0
28/05/2015
Approval date [1] 292892 0
21/08/2015
Ethics approval number [1] 292892 0
HC15357

Summary
Brief summary
The primary concern of people with chronic low back pain (CLBP) is pain relief, for which current treatments are not very effective. Our current understanding of pain and CLBP indicates that we should target the central nervous system in new treatment approaches. This project will test two new treatment approaches that target the central nervous system as part of the treatment of chronic low back pain. We predict that one of the new treatment approaches will result in a clinically meaningful reduction in pain intensity at six weeks post intervention
Trial website
http://neura.edu.au/resolve
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57534 0
Dr James McAuley
Address 57534 0
Neuroscience Research Australia
PO Box 1165 Randwick
Sydney NSW 2031
Country 57534 0
Australia
Phone 57534 0
+61 2 9399 1266
Fax 57534 0
Email 57534 0
J.McAuley@neura.edu.au
Contact person for public queries
Name 57535 0
Dr James McAuley
Address 57535 0
Neuroscience Research Australia
PO Box 1165 Randwick
Sydney NSW 2031
Country 57535 0
Australia
Phone 57535 0
+61 2 9399 1266
Fax 57535 0
Email 57535 0
J.McAuley@neura.edu.au
Contact person for scientific queries
Name 57536 0
Dr James McAuley
Address 57536 0
Neuroscience Research Australia
PO Box 1165 Randwick
Sydney NSW 2031
Country 57536 0
Australia
Phone 57536 0
+61 2 9399 1266
Fax 57536 0
Email 57536 0
J.McAuley@neura.edu.au

No information has been provided regarding IPD availability
Summary results
No Results