Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001525279
Ethics application status
Approved
Date submitted
8/09/2018
Date registered
11/09/2018
Date last updated
10/09/2019
Date data sharing statement initially provided
10/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying which patients will benefit from the UPLIFT program
Scientific title
Identifying responders and non-responders to the UPLIFT program for people with persistent low back pain: a prospective cohort study.
Secondary ID [1] 296029 0
Nil
Universal Trial Number (UTN)
U111-1220-0961
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent low back pain 308947 0
Condition category
Condition code
Musculoskeletal 307845 307845 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Name: The UPLIFT program.
The UPLIFT program is an evidence-informed, biopsychosocial program for people with persistent lower back pain (LBP). UPLIFT is a 5-week, face to face group program, that combines cognitive therapy (e.g. pain neuroscience education) with exercise therapy (e.g. restoration of normal movement patterns, dynamic functional movements, global body exercise).
Adults over 18 years who have been referred to the Gold Coast University Hospital (GCUH) Neurosurgical Screening Clinic with persistent (>6 months) LBP will be observed. Following consent to participate in the study, a research assistant will ask participants to complete 10 questionnaires. Participants will then commence the existing 5-week UPLIFT program consisting of five 90-minute sessions, held once per week at the GCUH physiotherapy outpatients department. The sessions are a combination of education and a graded exercise program conducted by two physiotherapists. Immediately upon completion of the program, and at six months, the research assistant (who will be blinded to program performance) will ask participants to complete the same questionnaires that were collected at baseline.
Intervention code [1] 301924 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306819 0
Patient's perception of success measured using the global rating of change (GROC) score. Success is defined by a GROC score of greater or equal to +3.
Timepoint [1] 306819 0
Immediately upon completion of the UPLIFT program and at six months following completion.
Secondary outcome [1] 349798 0
Nil
Timepoint [1] 349798 0
Nil

Eligibility
Key inclusion criteria
Inclusion criteria will be adults over 18 years who have been referred to the GCUH Neurosurgical Screening Clinic with persistent (>6 months) LBP, and who are able to read and write adequate English to comprehend education delivered within the program and complete written questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes contraindications for exercise, recent spinal surgery (< 6 months), active inflammatory disorders, such as rheumatoid arthritis, and neurological conditions.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Considering (a) the anticipated success rate based on pilot data (55%), (b) the rule-of-thumb of 10 participants in the limiting sample size per predictor variable, and (c) the fact that we want to investigate 10 baseline variables in each prediction model (one to identify responders, one to identify non-responders to the UPLIFT program), 223 participants are required (limiting sample size: 223 participants x 45% non-success = 100 participants; Rule-of-thumb (10 participants per potential predictor variable at baseline): 100 participants = 10 predictor variables). Taking into account a drop-out rate of 10% at 6-months follow up (primary time-point), a sample size of 248 participants is required.
The association between the baseline predictor variables and the primary outcomes will be evaluated using multivariable logistic regression analyses with Backward Wald selection. All assumptions (linearity between independent continuous variables, log odds and multicollinearity) will be checked before model building. The reliability of the multivariable model will be determined with the Hosmer-Lemeshow goodness-of-fit statistic and the explained variance with the Nagelkerke R2. Discriminative ability of the two models will be assessed using the area under the receiver operating characteristic curve. An area under the curve of 0.5 indicates poor discrimination above chance, 0.7 fair discrimination, 0.8 acceptable discrimination, whereas an AUC of 1.0 indicates perfect discrimination. To correct for over fitting, the internal validity of the two models will be assessed through bootstrapping techniques with 500 repetitions.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
29/05/2018
Date of last participant enrolment
Anticipated
8/02/2019
Actual
26/06/2019
Date of last data collection
Anticipated
26/12/2019
Actual
Sample size
Target
248
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11480 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 23499 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 300198 0
Hospital
Name [1] 300198 0
Gold Coast Hospital and Health Service
Country [1] 300198 0
Australia
Primary sponsor type
Individual
Name
Kerrie Evans
Address
Griffith University, Parklands Drive, Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 299785 0
Individual
Name [1] 299785 0
Michel Coppieters
Address [1] 299785 0
Griffith University, Parklands Drive, Southport, QLD 4215
Country [1] 299785 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301025 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 301025 0
1 Hospital Boulevard, Southport, QLD, 4215
Ethics committee country [1] 301025 0
Australia
Date submitted for ethics approval [1] 301025 0
08/02/2018
Approval date [1] 301025 0
05/04/2018
Ethics approval number [1] 301025 0
HREC/18/QGC/41
Ethics committee name [2] 301160 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 301160 0
Griffith University, Nathan Campus, QLD 4111
Ethics committee country [2] 301160 0
Australia
Date submitted for ethics approval [2] 301160 0
10/05/2018
Approval date [2] 301160 0
15/05/2018
Ethics approval number [2] 301160 0
GU Ref No: 2018/408

Summary
Brief summary
The primary aim of this study is to derive prediction models from baseline variables from the biological and psychosocial domains to identify responders and non-responders to the UPLIFT program. The secondary aim is to gain insight into what characteristics from the biological and psychosocial domains change following completion of the UPLIFT program and at 6 months follow-up.
Considering the patient population referred to the program and the characteristics of the UPLIFT program, we hypothesise that the prediction model for success will include baseline variables such as high fear avoidance behaviours, low pain self-efficacy and matched treatment expectations. We hypothesise that the prediction model for non-success will include baseline variables such as high pain catastrophising, high perceived injustice and high scores on the disability and anxiety stress scale. We hypothesise that the derived prediction models will be significantly better at predicting responders and non-responders than the current 55%:45% ratio for treatment success versus non-success from pilot data.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3087 3087 0 0
/AnzctrAttachments/375643-HREC18QGC41 HREC Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 85630 0
Miss Hayley Thomson
Address 85630 0
Gold Coast University Hospital, 1 Hospital Boulevard, Southport, Qld, 4215
Country 85630 0
Australia
Phone 85630 0
+61756873027
Fax 85630 0
Email 85630 0
[email protected]
Contact person for public queries
Name 85631 0
Kerrie Evans
Address 85631 0
Griffith University, Parklands Drive, Southport, QLD 4215
Country 85631 0
Australia
Phone 85631 0
+61755527680
Fax 85631 0
Email 85631 0
[email protected]
Contact person for scientific queries
Name 85632 0
Michel Coppieters
Address 85632 0
Griffith University, Parklands Drive, Southport, QLD 4215
Country 85632 0
Australia
Phone 85632 0
+61755527680
Fax 85632 0
Email 85632 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the study being conducted in a tertiary hospital site, the hospital and health service ethics committee and site specific assessment will not approve the use of data for secondary analysis, even if it is de-identified.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4571Study protocolThomson, H., Evans, K., Dearness, J., Kelley, J., Conway, K., Morris, C., Coppieters, M. W. (2019). Identifying psychosocial characteristics that predict outcome to the UPLIFT programme for people with persistent back pain: protocol for a prospective cohort study. BMJ Open, 9(8), e028747. https://bmjopen.bmj.com/content/9/8/e028747 
4572Statistical analysis plan https://bmjopen.bmj.com/content/9/8/e028747 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIdentifying psychosocial characteristics that predict outcome to the UPLIFT programme for people with persistent back pain: Protocol for a prospective cohort study.2019https://dx.doi.org/10.1136/bmjopen-2018-028747
N.B. These documents automatically identified may not have been verified by the study sponsor.