Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000507482
Ethics application status
Approved
Date submitted
20/04/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A hybrid implementation and effectiveness trial to assess the effectiveness of cognitive functional therapy compared to usual physiotherapy for people with chronic disabling low back pain (IMPACT-CFT trial).
Scientific title
A hybrid implementation and effectiveness trial to assess the effectiveness of cognitive functional therapy compared to usual physiotherapy for people with chronic disabling low back pain (IMPACT-CFT trial).
Secondary ID [1] 314246 0
2023 MRFF Clinician Researchers - Applied Research in Health. Grant application ID: 2031880
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record
There are no linked studies.

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 337165 0
Condition category
Condition code
Musculoskeletal 333581 333581 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 333582 333582 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Functional Therapy (CFT).
CFT is a physiotherapist-led individualised cognitive and behavioural intervention for people with disabling musculoskeletal pain. CFT is person-centred, where the individuals pain experience is validated, their pain story including their concerns, worries and fears are heard, cognitive reassurance is provided, and their goals and preferences are honoured. This helps to build a strong therapeutic relationship. Motivational approaches are used to help to guide people to engage in positive behaviour change.

The clinician uses a multi-dimensional clinical reasoning framework to synthesise information from screening questionnaires and an extensive biopsychosocial interview and physical examination to identify modifiable barriers to their recovery. This allows treatment to be targeted towards the biopsychosocial drivers of the person's pain, distress and disability. These factors may include addressing a person’s pain cognitions (e.g. misconceptions about pain and the body), emotions (e.g. pain-related fear, distress and depressed mood), social factors (e.g. isolation), behaviours (e.g. movement, activity or work avoidance, over-protective muscle guarding) and lifestyle factors (e.g. inactivity, poor sleep and dietary habits).

CFT is a model of care that has three broad components 1) Making sense of pain: personalised biopsychosocial pain education, helping the person understand the multiple factors that drive their pain, distress and disability. Pain exacerbation plans are provided to help people effectively manage flare-ups; 2) Graded exposure with control: a process of graded exposure to painful, feared or avoided movements and activities linked to the person's valued goals. During this process the clinician guides the person to develop pain control strategies (e.g. body relaxation, control and awareness) to gain confidence and generalised learnings to re-engage in valued activities of daily living, work and or social engagement; 3) Healthy lifestyle behaviours: engaging in regular physical activity based on their preference, improving sleep hygiene where sleep is disrupted, or employing stress management strategies such as meditation and relaxation techniques).

CFT treatment sessions will be delivered one-on-one and can be delivered either in-person or online. The CFT treatment dosage (number of sessions) will be at the patient's and therapist's discretion and will be individualised based on each patient's unique treatment requirements. While there is no minimum or maximum treatment dosage, the trial will partially re-imburse up to 8 sessions and clinician training will suggest this as a rough guide for patients based on previous trials. Clinicians in the CFT arm will be encouraged to provide a booster session to reinforce the management plan and reinforce pain exacerbation plans if the patient has a flare up (e.g. 3-6 months after the initial treatment sessions), but when this occurs it will be at the patient and therapists discretion. The time taken to see patients will be approximately 60 minutes for an initial consultation and 30-45 minutes for a follow-up. Treatment frequency will start at approximately one session per 1-2 weeks, and then become less frequent.

Physiotherapist CFT Training
Clinicians allocated to the CFT-arm will receive a combination of online asynchronous self-directed modules and 4 weekends of synchronous training. Self-paced online training will occur in Month 1 and 2. Knowledge: covering content related to the multidimensional nature of chronic low back pain; clinical reasoning, key principles of person-centred care, and best-practice conduct of a person-centred interview and physical examination, and key elements of CFT applied to two patients with chronic disabling low back pain by a CFT expert. Self-reflections and a knowledge quiz are embedded into the online training to facilitate deeper learning. Online training will be followed by 4 face-to-face weekend workshops that will occur across the following 4 months, involving 1 peer-to-peer skills training workshop. This involves training skills in person-centred communication, screening, biopsychosocial interview, behavioural examination, clinical reasoning and CFT management. Videos of real patients will be used to facilitate this. The subsequent 3 weekends involve mentoring while each clinician works with patients with chronic low back pain. Each mentoring session is videoed and used for self-reflection. During this process, the trainers will provide guidance and personalised feedback on the clinician's performance based on a competency checklist. Rural and regional clinicians will be offered all the training online (self-directed) and via live teleconferencing (4 weekend workshops).

The CFT training will be delivered by a team of physiotherapists (approximately 6) who have successfully completed a CFT trainer mentoring program and demonstrated competency in training clinicians. Two members of the research team (O’Sullivan, Caneiro) will lead and mentor the training team. All CFT clinicians in this trial will have completed all online training modules, attended weekend workshops and demonstrated competency based on the CFT competency checklist (as assessed by the CFT trainers) prior to delivering CFT in the trial.
Intervention code [1] 330857 0
Rehabilitation
Comparator / control treatment
Clinicians allocated to the usual physiotherapy-arm, will continue with their current practice for treating patients with chronic low back pain. This could typically include, but is not limited to, exercise, manual therapy, electrophysical and thermal modalities, dry needling, advice, education, etc.

Treatment dosage will be at the discretion of both the patient and therapist. Treatment session usually occur over a duration between 30-60 minutes but is at the discretion of the clinician. This care may be delivered in-person or through an online/telehealth platform.
Control group
Active

Outcomes
Primary outcome [1] 341160 0
Self-reported low back pain (LBP) related disability.
Timepoint [1] 341160 0
Baseline, 2 weeks, 6 weeks, 3 months (primary timepoint), 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [1] 446531 0
Pain intensity
Timepoint [1] 446531 0
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [2] 446532 0
Health related Quality of Life (health utility)
Timepoint [2] 446532 0
Baseline, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [3] 446533 0
Pain catastrophisation
Timepoint [3] 446533 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [4] 446534 0
Pain Self-Efficacy
Timepoint [4] 446534 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [5] 446535 0
Patient satisfaction with care
Timepoint [5] 446535 0
3 months post completion of baseline questionnaire 1
Secondary outcome [6] 446536 0
Patient reported treatment credibility
Timepoint [6] 446536 0
2 weeks post completion of baseline questionnaire 1
Secondary outcome [7] 446537 0
Fear of movement
Timepoint [7] 446537 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [8] 446538 0
Depression
Timepoint [8] 446538 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [9] 446539 0
Anxiety
Timepoint [9] 446539 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [10] 446540 0
Adverse events
Timepoint [10] 446540 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [11] 446541 0
Therapeutic Alliance
Timepoint [11] 446541 0
2 weeks post completion of baseline questionnaire 1.
Secondary outcome [12] 446542 0
Global perceived improvement
Timepoint [12] 446542 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [13] 446543 0
Treatment Adherence
Timepoint [13] 446543 0
3 months post completion of baseline questionnaire 1.
Secondary outcome [14] 446544 0
Clinician beliefs and attitudes about managing LBP
Timepoint [14] 446544 0
Baseline, 6 months and 12 months
Secondary outcome [15] 446545 0
Practitioner Confidence in treating LBP
Timepoint [15] 446545 0
Baseline, 6 months and 12 months
Secondary outcome [16] 446546 0
Fidelity testing
Timepoint [16] 446546 0
Clinicians will have treatments recorded (initial and a follow-up consultation) of approximately every 5th patient
Secondary outcome [17] 446547 0
Direct health care use costs (including cost to patient)
Timepoint [17] 446547 0
Baseline, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [18] 446548 0
Direct health care use costs (publicly subsidized)
Timepoint [18] 446548 0
Data extraction request for data from a 15-month period for each participant (3 months prior to baseline assessment, to 12 months following baseline assessment) to be made following trial completion
Secondary outcome [19] 446550 0
Productivity costs such as work absenteeism/presenteeism
Timepoint [19] 446550 0
Baseline, 3 months, 6 months, 9 months and 12 months post completion of baseline questionnaire 1.
Secondary outcome [20] 446551 0
Number of clinicians who meet CFT competency and time taken
Timepoint [20] 446551 0
Start of training to when competency is met
Secondary outcome [21] 447747 0
Total number of physiotherapy treatment sessions attended for presenting LBP episode (CFT and usual physiotherapy group)
Timepoint [21] 447747 0
12 months.

Eligibility
Key inclusion criteria
For Patients
To be eligible, potential participants need to meet all the following criteria:
- 18 years old or older
- Current episode of LBP lasting 3 months or longer;
- At least moderate levels of pain interference with work (item 8 of the SF-36).
- New patient to the clinic or has not attended the clinic for low back pain since randomisation of the clinic.
- Completed preliminary baseline screening questionnaires (BLQ1) prior to initial consultation and able to complete remaining baseline questionnaires (BLQ2) within 72 hours of the initial visit.

For Physiotherapists
Physiotherapy clinics may be in the community (private care) or hospital outpatient clinics (public care). To be included, the clinics need to meet all the following criteria:
- One or two physiotherapists working in the clinic and willing to undertake 6-months of CFT training, who intend to remain working in the same clinic for a period of 2 years;
- Each physiotherapist currently sees at least 2 new patients with chronic LBP per month (using average over the previous year from clinic records) and are at least 1 year post- graduation;
- Physiotherapists have less than 2 days of formal training in CFT since graduating from their clinical degree;
- Clinic either currently uses longer consultation times (1hr initial consultations, 30-45min repeat consultations), or is willing to adopt longer consultation times for the participants in the trial;
- Clinic willing to adopt delivery of a short battery of clinical questions prior to first consultation for patients presenting with LBP;
- Clinic willing to be randomised to intervention or control group and participating clinicians agree not to undertake CFT training during the trial training and intervention periods if randomised to the control group. Control group physiotherapists will be offered free access to the online knowledge and introductory skills training modules for CFT at the end of the trial period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for patient participants are spinal pain caused by serious pathology (e.g., fracture, infection, cancer, cauda equina); progressive neurological loss, currently or planning to become pregnant in the next 12 months; if the LBP is linked to a compensable claim; or, inadequate English to complete questionnaires or engage in the intervention and no access to a formal or informal interpreter.

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)
Randomisation of physiotherapy clinics will be performed centrally by a statistician who is not involved with the recruitment of clinics or the trial processes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial is a cluster randomised trial with 30 physiotherapy clinical sites randomised 1:1 to the intervention (Cognitive Functional Therapy (CFT)), or control group (usual physiotherapy practice).

We will use stratified covariate constrained allocation to balance key characteristics of clinics likely to impact the success of the intervention, or the training delivery, using the following constraints:
1) Equal number of practices between arms across Sydney, Perth, and rural/remote;
2) No constraints imposed on within-stratum differences;
3) Overall difference in number of public physiotherapy practices between arms cannot exceed 1;
4) Overall difference in number of practices with postgraduate trained physiotherapists can not exceed 1;
5) Overall difference in number of practices with two clinicians cannot exceed 1;
6) The overall mean socio-economic indexes of areas (SEIFA) score cannot differ by more than 20% between arms.
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
A sample size of 15 clinics in the intervention arm and 15 in the control arm, each with an average of 15 patients (i.e., 450 patients in total) achieves 81% power to detect a difference between the group means of 2 points on the RMDQ using a two-sided t-test with a significance level of 5%. We assumed a standard deviation of 5 and an intracluster correlation coefficient of 0.05 as well as a coefficient of cluster size variation of 80%. To account for up to a 20% patient loss to follow-up, the total target number of patients is 564.

All analyses will be by intention-to-treat. Our primary outcome (RMDQ) measured at 0, 2-week, 6-weeks, 3-, 6-, 9-, and 12-months will be analysed using linear mixed-effects regression, estimated using restricted maximum likelihood (REML). The model will include fixed effects for time, group by time interaction (omitting the group main effect to ensure baseline differences are constrained to 0 as recommended), factors used in the covariate constrained allocation procedure, and prespecified covariates associated with LBP-related disability (i.e., symptom duration and pain intensity) to improve power and precision. The correlation in repeated measures on the same participant will be modelled using a suitable covariance structure, identified using information criteria (AIC/BIC) and likelihood ratio tests. To account for clustering within practices, site and physiotherapist within site will be modelled as random effects. The intervention effect at the primary endpoint will be obtained as the adjusted (least square mean) difference between arms at 12-months together with 95% confidence intervals. The use of REML estimation under an assumption of missing at random allows the use of all available data without the need for multiple imputation. To examine the risk of bias due to missing data, we will compare characteristics of those remaining and those lost to follow-up to identify factors associated with attrition and adjust for any such factors as covariates. We will conduct exploratory subgroup analyses for rural and regional populations compared to metropolitan, public setting vs private setting, baseline RMDQ score and StarT Back risk category. More detailed analyses plans for these moderation analysis will be published before data collection is completed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
564
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318766 0
Government body
Name [1] 318766 0
Medical Research Future Fund (MRFF). Australian Government - Department of Health and Aged Care
Country [1] 318766 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 321207 0
University
Name [1] 321207 0
Curtin University
Address [1] 321207 0
Country [1] 321207 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317376 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 317376 0
Ethics committee country [1] 317376 0
Australia
Date submitted for ethics approval [1] 317376 0
17/06/2024
Approval date [1] 317376 0
11/09/2024
Ethics approval number [1] 317376 0
520241737759117

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

Contacts
Principal investigator
Name 140858 0
Prof Mark Hancock
Address 140858 0
Level 5, 75 Talavera Rd, Macquarie University, Macquarie Park, NSW, 2109.
Country 140858 0
Australia
Phone 140858 0
+61 430 103 905
Fax 140858 0
Email 140858 0
[email protected]
Contact person for public queries
Name 140859 0
Mark Hancock
Address 140859 0
Level 5, 75 Talavera Rd, Macquarie University, Macquarie Park, NSW, 2109.
Country 140859 0
Australia
Phone 140859 0
+61 430 103 905
Fax 140859 0
Email 140859 0
[email protected]
Contact person for scientific queries
Name 140860 0
Mark Hancock
Address 140860 0
Level 5, 75 Talavera Rd, Macquarie University, Macquarie Park, NSW, 2109.
Country 140860 0
Australia
Phone 140860 0
+61 430 103 905
Fax 140860 0
Email 140860 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.