Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001217897
Ethics application status
Approved
Date submitted
18/07/2021
Date registered
10/09/2021
Date last updated
3/10/2023
Date data sharing statement initially provided
10/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of assessing acceptability, cost-effectiveness and comparative clinical efficacy of the UPLIFT program vs. usual physiotherapy care for people with persistent low back pain: a pilot randomised non-inferiority design controlled trial
Scientific title
Feasibility of assessing acceptability, cost-effectiveness and comparative clinical efficacy of the UPLIFT program vs. usual physiotherapy care for people with persistent low back pain: a pilot randomised non-inferiority design controlled trial
Secondary ID [1] 303956 0
Gold Coast Health Collaborative Research Grants Scheme
Application ID # RGS2020052
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
persistent low back pain 321562 0
pain management 323068 0
Condition category
Condition code
Musculoskeletal 319308 319308 0 0
Other muscular and skeletal disorders
Anaesthesiology 320646 320646 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention group will participate in the UPLIFT program. UPLIFT is a 5-week program consisting of weekly 90-minute group sessions that combine education (60 Minutes) followed by exercise (30 Minutes). Sessions take place in the allied health outpatient clinic at thenGold Coast University Hospital, utilizing a meeting room for the education and an adjacent exercise gym room for the exercise. The education is delivered in a group setting. Group sizes are between 8 to 10 participants including 2 physiotherapists and an "expert" patient. Each education session targets a different theme: 1) pain neuroscience; 2) activity pacing; 3) flare-up management; 4) acceptance; and 5) adopting healthy lifestyle behaviors (including sleep hygiene and movement). UPLIFT incorporates motivational interviewing techniques allowing participants to undertake appropriate cognitive and experiential processing of the program’s content. The 'expert" patient is a volunteer peer mentor who has successfully completed UPLIFT. They assist in facilitating the program by sharing their own experience with participants during the group sessions. The mentors are given three hours of face-to-face training by the program’s lead physiotherapists on the program’s content, communication skills (ie motivational interviewing techniques and coaching principles) and self-care strategies. Lessons are open and conversational, rather than didactic. UPLIFT’s interactive delivery style aims to improve participants’ knowledge, which underpins behavior change. Patients in the UPLIFT program are considered active partners in their rehabilitation, aiming to reconceptualize their understanding of pain, develop active coping strategies to self-manage LBP, and re-engage in value-based activities. Participants' attendance is recorded in a participation log maintained by the research assistant. The exercise component of the program is patient directed , in line with the capacity, interest and resources of the patient. Each patient will choose from a number of available cardiovascular ( walking, cycling, rowing ergometer) and strength exercises. In addition, Tai Chi, yoga and stretching is included. The program is delivered by 2 physiotherapists with a minimum of 5 years clinical experience in musculoskeletal practice.
Intervention code [1] 320269 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will attend individual physiotherapy sessions, which allow a pragmatic approach for selection of treatment modalities and treatment frequency (maximum of six treatment sessions), over a maximum period of ten weeks. The physiotherapy treatment is all delivered by staff physiotherapist from the hospital. They will treat using their own clinical judgement and it is expected treatment will include exercise, education in line with accepted guidelines. Individual physiotherapy was chosen as the control group as this is the most widely adopted approach for low back pain management. Treatment will be delivered by an experienced physiotherapist with a minimum of 5 years clinical experience in musculoskeletal medicine.
Control group
Active

Outcomes
Primary outcome [1] 327184 0
Primary outcomes: Feasibility
outcome 1: Feasibility of conducting a full-scale clinical trial of UPLIFT will be assessed against the following a-priori defined criteria on recruitment, retention and intervention delivery, with recruitment feasibility success defined as 75%or more eligible patients approached for recruitment agreeing to participate, Retention success is defined as 75% or more of recruited patients remaining in study long enough for adequate outcome data to be collected; and Intervention delivery success is defined as 90% or more of patients receiving the intervention as intended.
Timepoint [1] 327184 0
Feasibility data: Number and proportion of patients recruited (from those eligible) will be documented by recruiters on a recruitment log at the time of recruitment . A participant log will be kept by researchers, detailing patient attendance at UPLIFT sessions and completion of outcome data collection after each session. Loss-to-follow-up and participant withdrawals will also be noted on this log. Physiotherapists who deliver the UPLIFT program will keep an intervention delivery log, recording participant attendance at each session, topics covered and any adaptations (e.g. if any content was missed or adapted).
Primary outcome [2] 328461 0
Outcome 2 : Acceptability data:( Surveys) Acceptability will be assessed both quantitatively and qualitatively, focusing on two elements: patient satisfaction with the UPLIFT program itself, and acceptability of outcome data collection measures. This will be done via a previously validated patient satisfaction survey and semi-structured interviews with patients.
The previously validated Short Assessment of Patient Satisfaction survey, based on a theoretic model covering the seven known dimensions of patient satisfaction with health care treatment, will be used to quantitatively assess patients’ acceptance of the UPLIFT program. An additional question will be added to this survey to measure how acceptable patients found the outcome data collection methods in this study (using a Likert-type scale).
Timepoint [2] 328461 0
The survey will be administered via paper at Gold Coast University Hospital, upon program completion (5-week follow-up).
Primary outcome [3] 328743 0
Outcome 3 : Acceptability Data ( Interviews) A qualitative evaluation of patients’ acceptance of the UPLIFT program will be conducted using semi-structured interviews with a subset of participants, purposively sampled for maximum variation in age, gender and symptom duration. A semi-structured interview guide, which will be piloted and refined prior to study commencement, will be developed based on a theoretical framework for acceptability of healthcare interventions .. Interview data will be collected by a trained research assistant, using a conversational style of interviewing that allows patients to tell a story.
Timepoint [3] 328743 0
Interviews will be conducted within 1 month of completion of the UPLIFT program.
Secondary outcome [1] 394100 0
Secondary outcome 1: The effect of the UPLIFT program on patients’ pain disability (as compared to usual physiotherapy care) will be evaluated using the
Oswestry (LBP) Disability Index (ODI) which measures the level of function (degree of disability) in activities of daily living in a person with LBP.
Timepoint [1] 394100 0
At baseline (immediately prior to program commencement), a research assistant will ask participants to complete a questionnaire, which will take between 5 and 10 minutes. This will be administered via a paper survey, at Gold Coast University Hospital. Immediately upon completion of the UPLIFT program for the intervention group and at 5-weeks following completion of baseline measures for the control group and again at 6-month follow-up, participants will complete the same questionnaire, as well as the GROC scale. Assessment at baseline and 5-week follow-up will occur at Gold Coast University Hospital. At 6-month follow-up, participants will be sent the questionnaires, either electronically or printed copy, as per patient preference. These will be completed at home without staff assistance. All measures will be collected by a blinded researcher.
Secondary outcome [2] 399124 0
Secondary outcome 5: The effect of the UPLIFT program on patients’ pain intensity (as compared to usual care) will be assessed using a 100 point visual analog scale. which has good test-retest reliability for pain intensity and interference, high internal consistency and good construct validity.
Timepoint [2] 399124 0
At baseline (immediately prior to program commencement), a research assistant will ask participants to complete a questionnaire, which will take between 5 and 10 minutes. This will be administered via a paper survey, at Gold Coast University Hospital. Immediately upon completion of the UPLIFT program for the intervention group and at 5-weeks following completion of baseline measures for the control group and again at 6-month follow-up, participants will complete the same questionnaire, as well as the GROC scale. Assessment at baseline and 5-week follow-up will occur at Gold Coast University Hospital. At 6-month follow-up, participants will be sent the questionnaires, either electronically or printed copy, as per patient preference. These will be completed at home without staff assistance. All measures will be collected by a blinded researcher.
Secondary outcome [3] 399125 0
Secondary outcome 6: The effect of the UPLIFT program on patients’ self assessment of global change (compared to usual physiotherapy care) will be evaluated using the Global rating of change (GROC) score. Success of the UPLIFT program or usual care is defined as a GROC score of =+3 evaluated at immediate and 6 months follow-up, indicates success. The boundaries of the GROC scale are: -5 (very much worse) and +5 (completely recovered). The GROC is recommended for use in persistent pain clinical research as a core outcome measure of global improvement with treatment
Timepoint [3] 399125 0
At baseline (immediately prior to program commencement), a research assistant will ask participants to complete a questionnaire, which will take between 5 and 10 minutes. This will be administered via a paper survey, at Gold Coast University Hospital. Immediately upon completion of the UPLIFT program for the intervention group and at 5-weeks following completion of baseline measures for the control group and again at 6-month follow-up, participants will complete the same questionnaire, as well as the GROC scale. Assessment at baseline and 5-week follow-up will occur at Gold Coast University Hospital. At 6-month follow-up, participants will be sent the questionnaires, either electronically or printed copy, as per patient preference. These will be completed at home without staff assistance. All measures will be collected by a blinded researcher.
Secondary outcome [4] 399126 0
Secondary outcome 7 : The cost-effectiveness of UPLIFT compared to usual physiotherapy will be evaluated in an embedded economic study. Incremental cost-effectiveness ratio from a health system perspective, defined as the net cost of UPLIFT (including program costs and cost consequences, i.e. outpatient appointments, emergency department attendances, medical imaging, surgery, injections, prescription medication), divided by the incremental change in quality adjusted life years (QALYs). QALYs will be estimated using an area under the curve approach based on participant responses to the EuroQol 5-domain health related quality of life utility instrument., administered at baseline and follow-up.
Timepoint [4] 399126 0
QALYs will be estimated using an area under the curve approach based on participant responses to the EuroQol 5-domain health related quality of life utility instrument., administered at baseline and 6 month follow-up post completion of intervention..
Secondary outcome [5] 399128 0
Secondary Outcome 9 : For the economic evaluation, a cost-utility analysis from the perspective of the health system will be the primary analysis. A micro-costing study will be undertaken to estimate the program costs per participant for both UPLIFT and the comparator. All cost consequences with respect to health service utilisation will be captured using administratively linked data. Specifically, for each patient linked admitted patient, outpatient, emergency department presentation and hospital costing data from Queensland state statistical services will be requested following consent from participants. Additionally, Medicare Benefits and Pharmaceutical Benefits claims data will be requested from the Commonwealth department of health. The net cost per person will be estimated and the mean cost per person in the UPLIFT cohort will be compared against the mean cost per person in the control group. Incremental utility of UPLIFT compared to usual care will be measured using quality adjusted life years (QALYs). QALYS are a summary health outcome measure that combines life years (mortality) and the qualify of the those years lived (morbidity). In order to estimate QALYs a multi-attribute utility instrument, the EQ5D5L, will be administered at baseline and follow up. Productivity losses estimated based on responses to the work productivity and activity impairment questionnaire
Timepoint [5] 399128 0
The multi-attribute utility instrument, the EQ5D5L, will be administered at baseline and follow up. All statistical data from Qld health, PBS and MBS will be collected at or following 6 month follow up post completion of intervention

Eligibility
Key inclusion criteria
Inclusion criteria: 1) Adults aged 18–70 years; 2) persistent LBP ( that is pain in the region between the iliac crests and the ribs that has been present for greater than 3 months); and 3) sufficient English language skills to complete questionnaires and comprehend/participate in interactive education sessions within the UPLIFT program.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: 1) Contraindications for exercise; 2) recent spinal surgery; 3) active inflammatory conditions (such as rheumatoid arthritis); and 4) neurological conditions.

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)
Study participants will be patients with persistent LBP, recruited from the Neurosurgery Screening Service at GCUH. Consenting patients referred to physiotherapy will be randomly allocated (in a concealed manner) to either individual physiotherapy or the group-based UPLIFT program. The allocation of participants will be recorded on dark, non-transparent card, and inserted into opaque envelopes that will be numbered consecutively. As participants consent to participate, the experimenter will open a sealed opaque envelope, pre-prepared by a third party, containing the participant’s allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A concealed allocation approach will be employed, where participants are randomly allocated to the intervention or control group. Blocked randomisation will be used to form the allocation list for the two groups, with randomly assigned block sizes of two, four and six, with an equal allocation ratio. The random allocation sequence will be generated using Microsoft Excel by a researcher not involved in data collection.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
Feasibility data (recruitment, retention, intervention delivery) will be expressed using frequencies and percentages and will be assessed against pre-determined feasibility criteria. Quantitative acceptability data (satisfaction survey) will be presented using frequencies and percentages. An inductive approach to thematic analysis, following Braun & Clarke’s six-step guide, will be used for qualitative interview data. This will involve: 1) data familiarisation (two researchers will read/reread transcripts to become immersed in the data); 2) generating initial codes (two researchers will use one interview transcript to formulate a coding strategy, and a second transcript to test/refine this strategy, which will be used for all remaining transcripts); 3) searching for themes (codes will be grouped into themes/subthemes according to similarity); 4) reviewing potential themes (two researchers will review all grouped codes for relevance and coherence to potential themes/subthemes and iteratively refine); 5) defining and naming themes (two researchers will iteratively revise theme names and descriptions with other team members’ input); and 6) writing up of findings. We will use NVivo for qualitative data management, coding and analysis.

For the secondary outcomes, mean and variability data will be reported. The secondary outcome measures will be analysed according to intention-to-treat principles, using two-way analyses of variance (ANOVA) or any other suitable analyses which may be appropriate at the time, with one between-group factor (UPLIFT vs individual physiotherapy), and one repeated-measure factor (baseline, completion of intervention period, six months follow-up).
For the economic evaluation, a cost-utility analysis from the perspective of the health system will be the primary analysis. A micro-costing study will be undertaken to estimate the program costs per participant for both UPLIFT and the comparator. All cost consequences with respect to health service utilisation will be captured using administratively linked data. Specifically, for each patient linked admitted patient, outpatient, emergency department presentation and hospital costing data from Queensland state statistical services will be requested following consent from participants. Additionally, Medicare Benefits and Pharmaceutical Benefits claims data will be requested from the Commonwealth department of health. The net cost per person will be estimated and the mean cost per person in the UPLIFT cohort will be compared against the mean cost per person in the control group. Incremental utility of UPLIFT compared to usual care will be measured using quality adjusted life years (QALYs). QALYS are a summary health outcome measure that combines life years (mortality) and the qualify of the those years lived (morbidity). In order to estimate QALYs a multi-attribute utility instrument, the EQ5D5L, will be administered at baseline and follow up. Responses to the EQ5D5L will be scored using the Australian health utility algorithm with an area under the curve method applied to estimate QALYs per person. The mean QALYs for those in the UPLIFT program will be compared to the mean QALYs of those in the comparator arm. The incremental cost per QALY will be the primary outcome measure for the economic evaluation. This will be estimated as the difference between the mean cost per UPLIFT patient and usual care patient divided by the difference between the mean QALY per UPLIFT patient and usual care patient. The UPLIFT program will be considered cost-effective where the cost per QALY gained is less than $50,000 per QALY. Uncertainty in the economic results will be characterised using one-way and probabilistic sensitivity analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/09/2021
Actual
13/04/2022
Date of last participant enrolment
Anticipated
30/12/2023
Actual
Date of last data collection
Anticipated
30/07/2024
Actual
Sample size
Target
69
Accrual to date
31
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19100 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 33659 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 308337 0
Hospital
Name [1] 308337 0
Gold Coast University Hospital (Gold Coast Health Collaborative Research Grant Scheme. )
Country [1] 308337 0
Australia
Primary sponsor type
Hospital
Name
Office for Research Governance and Development, Gold Coast University Hospital
Address
Office for Research Governance & Development
Gold Coast Health
Gold Coast University Hospital
Lvl. 2 Pathology & Education Building
1 Hospital Boulevard
Southport QLD. 4215
Country
Australia
Secondary sponsor category [1] 310284 0
None
Name [1] 310284 0
Address [1] 310284 0
Country [1] 310284 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308312 0
Gold coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 308312 0
Ethics committee country [1] 308312 0
Australia
Date submitted for ethics approval [1] 308312 0
02/07/2021
Approval date [1] 308312 0
02/11/2021
Ethics approval number [1] 308312 0
HREC/2021/QGC/75050

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

Contacts
Principal investigator
Name 110266 0
Mr Jonathan Dearness
Address 110266 0
Allied Health Department
Gold Coast University Hospital
1 Hospital Boulevard
Parkwood
Queensland
4214
Country 110266 0
Australia
Phone 110266 0
+61 07 56874650
Fax 110266 0
Email 110266 0
[email protected]
Contact person for public queries
Name 110267 0
Jonathan Dearness
Address 110267 0
Allied Health Department
Gold Coast University Hospital
1 Hospital Boulevard
Parkwood
Queensland
4214
Country 110267 0
Australia
Phone 110267 0
+61 07 56874650
Fax 110267 0
Email 110267 0
[email protected]
Contact person for scientific queries
Name 110268 0
Jonathan Dearness
Address 110268 0
Allied Health Department
Gold Coast University Hospital
1 Hospital Boulevard
Parkwood
Queensland
4214
Country 110268 0
Australia
Phone 110268 0
+61 07 56874650
Fax 110268 0
Email 110268 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
To researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11403Study protocol    381802-(Uploaded-25-07-2023-15-16-01)-Study-related document.docx
11405Informed consent form    381802-(Uploaded-25-07-2023-15-08-06)-Study-related document.docx



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.