Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000852459
Ethics application status
Approved
Date submitted
24/04/2025
Date registered
7/08/2025
Date last updated
7/08/2025
Date data sharing statement initially provided
7/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of education and exercises for neck pain: A randomised controlled telehealth trial with cost-effectiveness analysis.
Scientific title
The ReconNECKt Trial: Effect of pain science education and graded sensorimotor retraining on disability in people with persistent idiopathic neck pain – a randomised controlled telehealth trial.
Secondary ID [1] 313117 0
Medical Research Future Fund (MRFF) Clinical Trials Activity grant (ID2023048)
Universal Trial Number (UTN)
U1111-1320-3228
Trial acronym
The ReconNECKt Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent idiopathic neck pain 335379 0
Condition category
Condition code
Musculoskeletal 331954 331954 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 333846 333846 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two groups will have consistent general advice and exercise components, but contrasting education and sensorimotor retraining components. Both groups will receive guideline-recommended care for persistent neck pain, including education/advice and exercise prescription.

In both groups, all treatment sessions will be delivered by an experienced and registered allied health clinician one-on-one via telehealth. All treatment sessions will be completed within the first 12 weeks after randomisation.

Intervention A:
‘The ReconNECKt Intervention’: In addition to guideline-recommended care, participants will receive individualised education; goal setting; a graded sensorimotor retraining program; graded movement, loading, and endurance training; and an ongoing self-management plan. Participants will receive prescribed exercises and homework activities to complete at home.

‘The ReconNECKt Intervention’ has been tested in an RCT for persistent low back pain (The RESOLVE Trial; DOI: 10.1001/jama.2022.9930). We have translated the RESOLVE intervention for persistent neck pain.

The intervention involves three phases underpinned by the ‘fit for purpose’ model (DOI: 10.1093/ptj/pzac151):
1. Operational understanding: Via pain science education (PSE), which aims to reduce the perceived danger associated with the neck through reconceptualising the neck as fit for purpose and safe to move, using proven conceptual change strategies such as: challenging existing knowledge; refining learning strategies for new concepts; using metaphor; providing experiential examples.
2. Cortical body matrix refinement: Via graded sensory precision training and via graded precision movement training [left/right judgments (implicit motor imagery), viewing videos of other people moving (motor empathy), and imagining themselves performing movements (explicit motor imagery), and actual performance of precision movements (focusing on cervical spine, thoracic spine, and scapular region)].
3. Graded movement, loading, and endurance training (re-engagement): Rehabilitative exercises in line with functional goals using the same progressive protocol as graded precision movement training.

For the PSE component of the intervention (Phase 1), all educational concepts will be covered in all participants, but clinicians will individualise the educational content to the individual. Participants will be mailed a custom-made handbook called ‘Explain Pain for Neck Pain’, which will guide them through the PSE component of the intervention. This handbook will be an adaptation the ‘Resolve Back Pain Handbook’ published by Noigroup (https://www.noigroup.com/product/resolve-back-pain-handbook/). The research team will adapt the content of this handbook for neck pain. The clinician will discuss relevant sections of the handbook with participants during the treatment sessions, providing additional explanations (individualised to each participant’s condition and goals), answering questions, and encouraging reflections. Participants will also receive homework activities to complete between sessions, including educational activities (e.g., readings, videos, quizzes) and a structured exercise program involving cortical body matrix refinement activities (Phase 2) and graded movement, loading, and endurance training (Phase 3).

The trial clinician will individualise the exercise/activity program to the participant. The trial clinician will individualise the exercise/activity program to the participant. Selection of graded movements (for Phases 2 and 3) will be individualised based on the participants impairments and functional goals. Graded movements will focus on precise scapular, thoracic, and cervical movements, which will then be progressed to integrate other body movements in line with their functional goals (e.g., precise cervical movements with arms overhead). Following precise movements, load (e.g., anti-gravity movements) and endurance (e.g., isometric or repeated anti-gravity movements) movements will be undertaken in line with their functional goals. Progression criteria will be based on participant competency (i.e., accuracy of left/right judgements, participant self-rated ease of observed/imagined movements, clinician judgement of precision/smoothness of movement performance) and symptom provocation (i.e., no/minimal increased symptoms or behavioural responses such as anxiety/distress during or after training).

Participants will have access to an online portal to schedule/attend telehealth sessions as well as complete activities at home between telehealth sessions. Each participant will attend 8 treatment sessions within the maximum of 12 weeks. The first four treatment sessions will be scheduled at approximately weekly intervals, after which clinicians may schedule more time between the final four sessions (e.g., two weeks instead of one), based on participant progress and clinical judgement. The duration of the first two sessions will be between 60-90 minutes, and the remaining six sessions will be up to 60 minutes. Participants will also receive weekly activities to complete at home via the online portal, including their exercise prescription/goals and educational activities (i.e., readings, videos, quizzes). Participants will record their progress with homework activities and exercises via the online portal, which their treating clinician will have access to. Clinicians will also document participant progress with the exercise program during each treatment session.

The trial intervention will be provided by allied health clinicians who have undertaken high-level pain science education training.

Intervention adherence: Assessed via review of attendance records for telehealth treatment sessions (recorded by treating clinicians), via review of each participant’s online portal activity, and via adherence rating scales completed by participants.

Intervention fidelity: All treatment sessions will be video recorded, and a random sample of treatment sessions (minimum of one for each clinician) will be audited for intervention fidelity for each group. Each clinician will only provide one of the trial interventions. Clinicians’ case notes for each session, recorded via standardised templates, will also be used to evaluate intervention fidelity.
Intervention code [1] 330818 0
Treatment: Other
Intervention code [2] 330819 0
Rehabilitation
Intervention code [3] 330820 0
Behaviour
Comparator / control treatment
The control group will receive a standard care intervention that reflects guideline-based current clinical practice for persistent idiopathic neck pain. Participants will be provided with general advice/education about neck pain; goal setting; an individualised progressive exercise program; and a self-management plan. Participants will receive prescribed exercises to complete at home. The guideline-based care will be consistent with what participants will receive in Intervention A. These intervention components align with international clinical guidelines (e.g., American Physical Therapy Association DOI: 10.2519/jospt.2017.0302; Danish Health Authority DOI: 10.1007/s00586-017-5121-8; Royal Dutch Society for Physical Therapy DOI: 10.1093/ptj/pzx118), which consistently recommend exercises, education/advice, and support for self-management.

The educational component of the intervention will involve education about the causes of neck pain, associated symptoms, evidence-based treatments, and self-management strategies, based on the MyPainHub.com resource. The exercise program will involve progressive range of motion, postural, motor control/coordination, strengthening/endurance, and functional/general exercises. The trial clinician will individualise the exercise program to the participant.

The treating clinician will decide how many treatment sessions are appropriate for each participant based on their clinical judgement, with a minimum of 2 sessions and a maximum of 4 sessions (e.g., clinicians may discharge the participant after Session 2). All treatment sessions will occur within the maximum of 12 weeks, with scheduling based on participant progress and clinical judgement by the treating clinician, to reflect standard clinical practice. The duration each treatment session will be between 30-60 minutes.

Clinicians will document participant progress with the exercise program, and participants will also record their progress with exercises via the online portal (as per Intervention A), which their treating clinician will have access to.

The trial intervention will be provided by allied health clinicians who have NOT undertaken high-level pain science education training or graded motor imagery training.

The same protocols for assessing intervention adherence and fidelity as Intervention A group will be followed.
Control group
Active

Outcomes
Primary outcome [1] 341111 0
Neck-related disability
Timepoint [1] 341111 0
Baseline, 12 weeks post-randomisation
Secondary outcome [1] 446282 0
Neck-related disability
Timepoint [1] 446282 0
Baseline, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [2] 446283 0
Pain intensity and pain interference
Timepoint [2] 446283 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [3] 446285 0
Health-related quality of life
Timepoint [3] 446285 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [4] 446287 0
Global change
Timepoint [4] 446287 0
12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [5] 446290 0
Recurrence
Timepoint [5] 446290 0
52 weeks post-randomisation
Secondary outcome [6] 446291 0
Headache intensity
Timepoint [6] 446291 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [7] 446292 0
Dizziness intensity
Timepoint [7] 446292 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [8] 446293 0
Mediating factor: Neck pain beliefs
Timepoint [8] 446293 0
Baseline, 12 weeks post-randomisation
Secondary outcome [9] 446294 0
Mediating factor: Pain science conceptualisations
Timepoint [9] 446294 0
Baseline, 12 weeks post-randomisation
Secondary outcome [10] 446295 0
Mediating factor: Neck fragility
Timepoint [10] 446295 0
Baseline, 12 weeks post-randomisation
Secondary outcome [11] 446296 0
Mediating factor: Neck perception/awareness
Timepoint [11] 446296 0
Baseline, 12 weeks post-randomisation
Secondary outcome [12] 446297 0
Mediating factor: Self-efficacy
Timepoint [12] 446297 0
Baseline, 12 weeks post-randomisation
Secondary outcome [13] 446298 0
Mediating factor: Fear of movement
Timepoint [13] 446298 0
Baseline, 12 weeks post-randomisation
Secondary outcome [14] 446300 0
Mediating factor: Pain catastrophising
Timepoint [14] 446300 0
Baseline, 12 weeks post-randomisation
Secondary outcome [15] 446301 0
Mediating factor: Reassurance
Timepoint [15] 446301 0
12 weeks post-randomisation
Secondary outcome [16] 446302 0
Procedural outcome: Adverse events
Timepoint [16] 446302 0
Participants: Immediately after first treatment session, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation. Clinicians: Immediately after each treatment session with each participant.
Secondary outcome [17] 446303 0
Procedural outcome: Co-interventions
Timepoint [17] 446303 0
Clinicians: Immediately after each treatment session with each participant
Secondary outcome [18] 446304 0
Treatment expectancy
Timepoint [18] 446304 0
Immediately after first treatment session
Secondary outcome [19] 446305 0
Procedural outcome: Treatment expectancy/credibility
Timepoint [19] 446305 0
Immediately after first treatment session
Secondary outcome [20] 446306 0
Procedural outcome: Therapeutic alliance
Timepoint [20] 446306 0
Immediately after first treatment session, 12 weeks post-randomisation
Secondary outcome [21] 446309 0
Procedural outcome: Intervention adherence
Timepoint [21] 446309 0
12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [22] 446310 0
Procedural outcome: Intervention acceptability
Timepoint [22] 446310 0
12 weeks post-randomisation
Secondary outcome [23] 446312 0
Procedural outcome: Clinician pain science conceptualisations
Timepoint [23] 446312 0
Clinicians: Pre-trial (before the pilot period), end of trial
Secondary outcome [24] 446313 0
Procedural outcome: Clinician neck pain beliefs
Timepoint [24] 446313 0
Clinicians: Pre-trial (before the pilot period), end of trial
Secondary outcome [25] 446315 0
Procedural outcome: Clinician perceived intervention credibility
Timepoint [25] 446315 0
Clinicians: Pre-trial (before the pilot period), after completing the treatment period with their pilot participant(s), mid-way through the trial (i.e., halfway through recruitment), end of trial.
Secondary outcome [26] 446316 0
Procedural outcome: Connectedness (clinician self-rated connection with the participant)
Timepoint [26] 446316 0
Clinicians: Immediately after the first treatment session (for each participant they treat)
Secondary outcome [27] 446317 0
Health economics outcome: Healthcare utilisation
Timepoint [27] 446317 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [28] 446318 0
Health economics outcome: Total healthcare costs
Timepoint [28] 446318 0
Data extracted for the time period of each individual participant’s enrolment in the trial (Baseline to 52 weeks post-randomisation).
Secondary outcome [29] 446328 0
Health economics outcome: Employment status
Timepoint [29] 446328 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [30] 446729 0
Mediating factor: Invalidation
Timepoint [30] 446729 0
12 weeks post-randomisation
Secondary outcome [31] 448089 0
Pain-free episodes
Timepoint [31] 448089 0
12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [32] 448090 0
Disability-free episodes
Timepoint [32] 448090 0
12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [33] 450614 0
Depressive symptoms
Timepoint [33] 450614 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [34] 450615 0
Anxiety
Timepoint [34] 450615 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [35] 450616 0
Stress
Timepoint [35] 450616 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [36] 450617 0
Stiffness intensity
Timepoint [36] 450617 0
Baseline, 12 weeks post-randomisation, 26 weeks post-randomisation, 52 weeks post-randomisation
Secondary outcome [37] 450618 0
Procedural outcome: Participant blinding effectiveness
Timepoint [37] 450618 0
52 weeks post-randomisation.

Eligibility
Key inclusion criteria
• Adults (age 18 years or older) living in Australia for the duration of their study participation
• Primary complaint of persistent idiopathic neck pain
• Neck pain and disability on most days (greater than 50%) for longer than the last 3 months
• Pain interference (at least ‘moderate’ on SF-36 item 22)
• Average neck pain in the past week rated 4 or greater on a 0-10 Numeric Rating Scale (NRS)
• Sufficient fluency in English to understand and respond to surveys and to engage with the intervention
• Normal or corrected to normal vision and hearing
• Access to an electronic device (e.g., tablet, smartphone, laptop, desktop computer) with internet and a front-facing camera for engagement in video telehealth sessions and online outcome assessment surveys
• A trusted person (e.g., partner, housemate) who is willing and able to assist with regular at-home treatment activities
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diagnosed Whiplash Associated Disorder
• Diagnosed migraine or severe headache/migraine (60 or greater on Headache Impact Test-6)
• Severe dizziness (rated 5 or greater on 0-10 NRS)
• Pain in other body areas that is worse than neck pain
• Diagnosed fibromyalgia or chronic widespread pain (defined as pain in at least 2 sections of 2 contralateral limbs + axial skeleton)
• A current (or previous) serious and/or uncontrolled chronic health condition that would prevent safe participation in the trial interventions [e.g., neurological conditions such as stroke, multiple sclerosis, Parkinson’s disease; previous intervention that would limit participation in the trial (e.g., spinal surgery); diabetes; kidney disease; cardiovascular disease; lung disease] – as assessed by the research team (including the ACSM criteria for safe participation in physical activity) and the participant’s GP as required
• A known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, widespread neurological disorder) or radiculopathy/nerve root compromise (two of strength, reflex or sensation affected for the same nerve root)
• Scheduled for major surgery during the treatment or follow-up period
• Diagnosed with a severe psychological or mental health disorder (e.g., major depression, post-traumatic stress disorder) or severe depression defined as at risk of self-harm
• Cognitive impairment (e.g., diagnosed Alzheimer’s disease or dementia)
• People who are currently receiving regular treatment for neck pain that would interfere with the trial intervention (e.g., physiotherapy) and not willing to stop this treatment

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)
Allocation will be concealed using central automated allocation, with security in place to ensure data
cannot be accessed/influenced. It will be stored within an electronic system (REDCap) that will be password-protected (as well as via a separate password-protected and securely stored Excel spreadsheet of the raw randomisation schedule in case the REDCap system fails). The person who determines if a participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the participant will be allocated.

Eligible patients who have provided informed consent will be allocated to the treatment groups by the trial coordinator who will then coordinate treatment appointment scheduling with the appropriate clinician. Only the unblinded trial coordinators will have access to raw copies of the randomisation scheduled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated (1:1), using permutated blocks of varying size (4 and 6). An independent statistician will create the randomisation schedule (using computer generated random numbers).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: A total of 208 subjects, obtained as 104 per group, will be recruited and assessed at 4 timepoints. The study achieves 80% power to detect the minimum clinically important difference of 5/50 (as recommended by systematic review and meta-analysis, DOI: 10.2519/jospt.2009.2930) between the (fixed) group NDI means at the primary endpoint. We conservatively assumed a standard deviation of 10 points and a correlation between measurements within a subject of 0.60. A test based on a mixed-model analysis is anticipated at a significance level of 0.05. The sample size calculation accounts for 15% loss to follow-up based on similar trials of neck pain conducted in Australia. We have conservatively ignored the increase in statistical power conferred by baseline covariates.

Primary and secondary analyses:
The data will be analysed by intention-to-treat and by a statistician blinded to group allocation. We will use linear mixed models with random intercepts for individuals (account for correlation for repeated measures) and will analyse the effect of treatment separately for the NDI outcome. The model may include terms for important prognostic factors for neck disability and pain (as applicable). If necessary, multiple imputation will be used for missing data. We will construct linear contrasts to compare the adjusted mean change in outcome from baseline to each time point between the ReconNECKt group and minimal intervention group (and 95% confidence interval) to obtain estimates of the effect. We will analyse primary and secondary outcomes without adjustment for multiple measures, but we will present unadjusted p-values and confidence intervals for all pre- specified analyses so readers can make adjustments (e.g., Bonferroni) at the level of Type I error control that they wish, at risk of making Type II errors.

Exploratory mediation analyses:
Using contemporary methodology, we will use causal mediation analysis to understand the mechanisms by which the interventions affect neck disability and pain. We will deconstruct the treatment effect into indirect effects via changes in pre-specified mediator outcomes. Changes in self-reported questionnaire outcomes will be tested in a multiple mediator model.

A detailed statistical analysis plan will be published online prior to analysis and unblinding.

Health economic evaluation:
Economic evaluation will be a trial-based cost-utility analysis, led by Prof Goodall.
Primary analysis will take the perspective of the health sector in which outcomes of the intervention [Quality Adjusted Life Years (QALYs) - estimated by the EQ-5D-5L], will be assessed against health sector costs, to obtain incremental cost per QALY gained. The use of medical services and pharmaceuticals will be recorded through the Medical Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) databases. Patients’ consent to access their individual records will be sought electronically at baseline. Health economics outcomes (collected from participants via online REDCap surveys) will be used to assess health services use and medications not covered by the MBS and PBS. The unit cost of services and medications will be based on standard published rates.

Secondary analysis will take a societal perspective in which the opportunity costs of lost labour and use of non-health care services will be factored in to generate an incremental social cost per QALY gained. Carer time will be costed at the average wage rate based on patients’ self-reported employment category at baseline. Unpaid work will be costed at the average wage rate. The models will be based on the 12 weeks and 52-week follow-up and extrapolated to determine the long-term cost-effectiveness. Sensitivity analysis will test for uncertainty in key parameters such as unit costs and effect estimates.

A detailed health economic analysis plan will be published online prior to analysis and unblinding.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2028
Actual
Date of last data collection
Anticipated
1/10/2029
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317562 0
Government body
Name [1] 317562 0
Medical Research Future Fund (MRFF) Clinical Trials Activity grant (ID2023048), Department of Health and Aged Care
Country [1] 317562 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 319866 0
None
Name [1] 319866 0
Address [1] 319866 0
Country [1] 319866 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316273 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 316273 0
Ethics committee country [1] 316273 0
Australia
Date submitted for ethics approval [1] 316273 0
24/09/2024
Approval date [1] 316273 0
09/12/2024
Ethics approval number [1] 316273 0
206544

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

Contacts
Principal investigator
Name 137354 0
A/Prof Tasha Stanton
Address 137354 0
South Australian Health and Medical Institute (SAHMRI), North Terrace, Adelaide SA, 5000
Country 137354 0
Australia
Phone 137354 0
+61 0449151463
Fax 137354 0
Email 137354 0
[email protected]
Contact person for public queries
Name 137355 0
Dr Felicity Braithwaite
Address 137355 0
South Australian Health and Medical Institute (SAHMRI), North Terrace, Adelaide SA, 5000
Country 137355 0
Australia
Phone 137355 0
+61 0405803820
Fax 137355 0
Email 137355 0
[email protected]
Contact person for scientific queries
Name 137356 0
Dr Felicity Braithwaite
Address 137356 0
South Australian Health and Medical Institute (SAHMRI), North Terrace, Adelaide SA, 5000
Country 137356 0
Australia
Phone 137356 0
+61 0405803820
Fax 137356 0
Email 137356 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:
• Researchers
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?
• 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.