Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001323314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
22/09/2026
Date registered
Help: Date registered
3/11/2026
Date last updated
Help: Date last updated
3/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
3/11/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
RESOLVE-D: a randomised controlled trial of graded sensorimotor retraining for people with chronic low back pain.
Scientific title
RESOLVE-D: a type 1 hybrid effectiveness-implementation randomised controlled trial investigating the effectiveness, cost-effectiveness and implementation of graded sensorimotor retraining for people with chronic low back pain.
Additional trial identifiers [1] 318503 0
Nil
Universal Trial Number (UTN)
Trial acronym
RESOLVE-D
Related trial records

Health condition
Health condition(s) studied:
Chronic low back pain 343680 0
Condition category
Condition code
Musculoskeletal 339801 339801 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Graded sensorimotor retraining is an intervention delivered in face-to-face primary care private practice clinics in Australia, by trained physiotherapists or exercise physiologists. The intervention involves 6–10 individual sessions (45 minutes each) over 12 weeks, with a home program (30 minutes, five times per week).
The program comprises of 4 intervention components that are introduced progressively, with components overlapping and varying in emphasis across sessions and between participants. Not all components are delivered in every session; earlier components are revisited and integrated as later components are introduced.
Intervention components:
1. Pain science education: Individualised patient education about pain neurobiology and the biopsychosocial nature of pain. This involves discussion of the participant’s low back pain experience and education delivered using graphical media, video, metaphor and narrative. Pain science education begins at the first session and continues throughout the intervention, with the content and emphasis tailored to the participant.
2. Graded sensory and motor precision training: Training intended to refine sensory processing and enhance movement precision. This includes tactile acuity tasks, such as localisation, discrimination and graphaesthesia; motor imagery, including observing and mentally rehearsing movements; and precision motor skill training involving focused practice of simple, precise, low-load spinal movement and control tasks.
3. Graded precision focused functional movement training: Individualised practice of functional movements relevant to the participant’s goals. Movements are introduced at a level that the participant can perform safely and confidently, then progressed from simple movements (e.g. squat) to more complex (e.g. squat to pick up object) and meaningful activities with a feedback rich environment.
4. Graded precision focused loading of functional movements: Progressive loading of functional movements to improve the participant’s capacity and confidence with activities relevant to their goals. Loading is gradually increased according to the participant’s performance, confidence, symptoms and functional goals.
The home program involves practice and consolidation of the intervention components introduced during the individual sessions, as prescribed by the treating clinician. The specific activities will vary between participants and may include pain science education activities, sensory and motor precision training, functional movement training and graded loading exercises.

The timing and progression of the intervention components, and the number of sessions delivered, will be individualised according to the participant’s progress, competence with each component, functional goals and symptom response, as assessed by the treating clinician. The flexible session number is intended to allow the intervention to be adapted to participants’ needs within the 12-week treatment period. Adherence to the graded sensorimotor retraining sessions will be monitored via session attendance and adherence to the home program will be monitored using an online individual weekly homework diary.

Clinician training:
Trial clinicians (AHPRA registered physiotherapists & ESSA accredited exercise physiologists) will undergo specific training in graded sensorimotor retraining. Clinicians will undergo (i) ~ 4 hours of online training modules, followed by (ii) a 1 day in person practical training component, delivered by senior clinicians experienced in this intervention. They will also receive an intervention manual to guide delivery of graded sensorimotor retraining.
A researcher not involved in intervention delivery will undertake audits to ensure that the interventions are being conducted as described in the study protocol. Graded sensorimotor retraining will be delivered across multiple physiotherapy/exercise physiology clinics in Australia.
Intervention code [1] 335401 0
Treatment: Other
Description of the comparator or control
As a three-armed trial there are 2 comparators:
1. Supervised exercise: Participants will receive up to 8 individual sessions (45-minutes each), over 12 weeks, including a home program (30 minutes, five times per week). Scheduling of the sessions will be dependent on the individual’s progress and availability. All treatment sessions are provided in person, one-on-one with the trial clinician. The intervention comprises of assessment and discussion of the participant’s low back pain experience, advice and education about low back pain and future self-management, and the provision of individualised supervised exercise. Supervised exercise will follow current best practice incorporating evidence, patient preferences and therapist expertise, including exercises suitable for independent practice at home. Adherence to the exercise sessions will be monitored through session attendance and adherence to the home exercise program (e.g. gentle stretching such as lower back rotation or flexion and extension movements; and strengthening exercise such as hip bridge) will be monitored using an online individual weekly homework diary.

2. Guideline care: Participants will receive one individual session (45 minutes), within the first week of randomisation. The session will be provided in person one-on-one with a trial clinician. The intervention comprises of assessment and discussion of the participant’s low back pain experience, and advice and education about low back pain and future self-management. The clinician will work with the individual to set goals and create a self-management plan, providing guidance on the management for low back pain based on World Health Organisation’s (WHO) guideline for non-surgical management of chronic low back pain, the Australian Low Back Pain Clinical Care Standard, the National Institute of Care and Excellence guidelines for low back pain and sciatica in over 16s and the European clinical practice guidelines for the management of non-specific low back pain in primary care.

Clinician training:
Trial clinicians (AHPRA registered physiotherapists & ESSA accredited exercise physiologists) will undergo specific training in evidence-based management of low back pain. Clinicians will undergo (i)~ 4 hours of online training modules based on low back pain guidelines, with a focus on evidence-based advice and education, low back pain self-management and exercise prescription and progression for low back pain rehabilitation.
Control group
Active

Outcomes
Primary outcome [1] 347228 0
Disability
Timepoint [1] 347228 0
18-weeks post randomisation
Primary outcome [2] 347229 0
Pain intensity
Timepoint [2] 347229 0
18-weeks post randomisation
Secondary outcome [1] 469603 0
Disability
Timepoint [1] 469603 0
26-, 52- weeks post randomisation
Secondary outcome [2] 469604 0
Pain Intensity
Timepoint [2] 469604 0
26-, 52- weeks post randomisation
Secondary outcome [3] 469605 0
Global Impression of Change
Timepoint [3] 469605 0
18- 26-, 52- weeks post randomisation
Secondary outcome [4] 469606 0
Health related Quality of life
Timepoint [4] 469606 0
18- 26-, 52- weeks post randomisation
Secondary outcome [5] 469607 0
Health related Quality of life
Timepoint [5] 469607 0
18- 26-, 52- weeks post randomisation
Secondary outcome [6] 469608 0
Pain interference
Timepoint [6] 469608 0
18- 26-, 52- weeks post randomisation
Secondary outcome [7] 469609 0
Pain Recovery
Timepoint [7] 469609 0
18- and 26- weeks post randomisation
Secondary outcome [8] 469610 0
Disability Recovery
Timepoint [8] 469610 0
18- and 26- weeks post randomisation
Secondary outcome [9] 469611 0
Response to intervention (greater than or equal to 30% reduction in pain intensity)
Timepoint [9] 469611 0
18-weeks post randomisation
Secondary outcome [10] 469612 0
Response to intervention (greater than or equal to 50% reduction in pain intensity)
Timepoint [10] 469612 0
18-weeks post randomisation
Secondary outcome [11] 469613 0
Response to intervention (greater than or equal to 30% reduction in disability)
Timepoint [11] 469613 0
18-weeks post randomisation
Secondary outcome [12] 469614 0
Response to intervention (greater than or equal to 50% reduction in disability)
Timepoint [12] 469614 0
18-weeks post randomisation
Secondary outcome [13] 469615 0
Beliefs about back pain consequences
Timepoint [13] 469615 0
18-, 26-, 52- weeks post randomisation
Secondary outcome [14] 469616 0
Adverse events
Timepoint [14] 469616 0
18-, 26-, 52- weeks post randomisation
Secondary outcome [15] 469617 0
Serious adverse events
Timepoint [15] 469617 0
18-, 26-, 52- weeks post randomisation
Secondary outcome [16] 469618 0
Economic evaluation outcome: Healthcare use over the previous month
Timepoint [16] 469618 0
18-, 26-, 52- weeks post randomisation
Secondary outcome [17] 469619 0
Economic evaluation outcome: Publicly subsidised healthcare use
Timepoint [17] 469619 0
Data request will be made for a 13-month period for each participant (1 month prior to baseline assessment, to 12 months post randomisation) after trial completion.
Secondary outcome [18] 469620 0
Economic evaluation outcome: General Productivity
Timepoint [18] 469620 0
18-, 26-, 52- weeks post randomisation
Secondary outcome [19] 469621 0
Economic evaluation outcome: Work productivity
Timepoint [19] 469621 0
18-, 26-, 52- weeks post randomisation
Secondary outcome [20] 469622 0
Implementation evaluation outcome: Acceptability of the intervention
Timepoint [20] 469622 0
18 weeks- post randomisation
Secondary outcome [21] 469623 0
Implementation evaluation outcome: Appropriateness of the intervention
Timepoint [21] 469623 0
18 weeks- post randomisation
Secondary outcome [22] 469624 0
Implementation evaluation outcome: Fidelity (intervention delivery)
Timepoint [22] 469624 0
Assessed at the conclusion of the 12-week treatment period
Secondary outcome [23] 469625 0
Implementation evaluation outcome: Fidelity (adherence)
Timepoint [23] 469625 0
Assessed weekly from baseline until the end of the 12-week treatment period.
Secondary outcome [24] 469626 0
Implementation context
Timepoint [24] 469626 0
18- weeks post randomisation

Eligibility
Key inclusion criteria
• A primary complaint of pain in the area between the 12th rib and buttock crease with or without accompanying non-radicular leg pain
• Episode of low back pain of at least 12 weeks duration
• Low back pain intensity rated greater than or equal to 4/10 (moderate to severe pain) in the past 7 days on the numerical rating scale (NRS)
• Low back pain rated as at least moderately interfering with normal work as assessed by Question 8 of the MOS 36-Item Short Form Survey (Ware & Sherbourne, 1992).
• Sufficient fluency in the English language to understand and respond to English language questionnaires and engage with the intervention
• Access to the internet and suitable device (e.g. smartphone, tablet, computer).
• Aged 18 years of age or over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Known or suspected serious spinal (e.g. fracture; malignancy, inflammatory or infective diseases of the spine; cauda equina syndrome, widespread neurological disorder) or non-spinal pathology (e.g. pyelonephritis)
• Suspected or confirmed pregnancy or less than six months post- partum
• Suspected radicular pain with or without radiculopathy
• Spinal surgery < 12 months previously
• Scheduled for major surgery during the treatment or follow-up period
• Unwillingness to travel to study clinics and facilities
• Uncontrolled medical conditions that preclude safe participation in physical activity

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation

The randomisation schedule will be generated by an independent statistician not involved in the trial. The allocation sequence will use a permuted block list of randomly varying sizes (3 to 12), with an 1:1:1 allocation ratio. The schedule will be uploaded to the trial REDCap project by the independent statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation considers repeated measures of the dual primary outcomes; disability (0 to 24 scale, Roland Morris Disability Questionnaire) and pain intensity (0-10 numerical rating scale); assumed to be continuous variables with normal distributions. To account for 15% loss to follow up the trial will require a sample size of 171 participants in each arm (total 513 participants) to provide, for each of the dual-primary endpoints, at least a 90% probability of rejecting the null hypothesis of no effect if the two-tailed alpha is set at 0.025 and the true effect of the intervention and comparisons (graded sensorimotor retraining vs supervised exercise, graded sensorimotor retraining vs guideline care) is at least 0.33 Standard deviations (SD) (i.e., Minimal clinically important difference (MCID) of 2/24 points with Standard Deviation of 6; MCID of 1/10 points with SD of 3 for both disability and pain). It was assumed that the correlation between baseline scores and outcome at 18 weeks was 0.6.

A blinded statistician will complete all analyses of the trial data. All analyses will be conducted according to the intention-to-treat principle, with participants analysed according to their randomised group regardless of the treatment received or treatment adherence. A linear mixed model will be used to estimate the between-group mean difference at 18 weeks for each comparison of interest (i.e., graded sensorimotor retraining vs guideline care, graded sensorimotor retraining vs supervised exercise) and each dual primary outcome. The model will include fixed effects of group (a binary variable), time (a categorical variable with three levels - 18 weeks, 26 weeks, and 52 weeks), the baseline value of the outcome, and the group by time interactions. The model will include random intercepts for participants. The point estimate (mean between group difference) and 95% confidence interval for the effect at each follow-up will be calculated from the model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/11/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
513
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 323081 0
Government body
Name [1] 323081 0
Australian Government Department of Health, Disability and Ageing, Medical Research Future Fund (MRFF)
Country [1] 323081 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Country
Australia
Secondary sponsor category [1] 326029 0
None
Name [1] 326029 0
Address [1] 326029 0
Country [1] 326029 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321483 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 321483 0
Ethics committee country [1] 321483 0
Australia
Date submitted for ethics approval [1] 321483 0
21/11/2025
Approval date [1] 321483 0
21/01/2026
Ethics approval number [1] 321483 0
10407

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

Contacts
Principal investigator
Name 153858 0
Dr Aidan Cashin
Address 153858 0
Neuroscience Research Australia PO Box 1165 Randwick Sydney NSW 2031
Country 153858 0
Australia
Phone 153858 0
+61 2 9399 1870
Fax 153858 0
Email 153858 0
[email protected]
Contact person for public queries
Name 153859 0
Aidan Cashin
Address 153859 0
Neuroscience Research Australia PO Box 1165 Randwick Sydney NSW 2031
Country 153859 0
Australia
Phone 153859 0
+61 293991870
Fax 153859 0
Email 153859 0
[email protected]
Contact person for scientific queries
Name 153860 0
Aidan Cashin
Address 153860 0
Neuroscience Research Australia PO Box 1165 Randwick Sydney NSW 2031
Country 153860 0
Australia
Phone 153860 0
+61 293991870
Fax 153860 0
Email 153860 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.