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Trial registered on ANZCTR


Registration number
ACTRN12617000317392
Ethics application status
Approved
Date submitted
9/02/2017
Date registered
28/02/2017
Date last updated
28/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
GLITtER (Green Light Imaging Interpretation to Enhance Recovery): a psychoeducational intervention for adults with low back pain attending secondary care.
Scientific title
A quasi-randomised, controlled, feasibility trial of GLITtER (Green Light Imaging Interpretation to Enhance Recovery) – a psycho-educational intervention for adults with low back pain attending secondary care.
Secondary ID [1] 291148 0
None
Universal Trial Number (UTN)
U1111-1192-7436
Trial acronym
GLITtER
Linked study record
N/a

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 301998 0
Condition category
Condition code
Musculoskeletal 301639 301639 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive ‘GLITtER’, integrated into the routine Spinal Assessment Clinic (SAC) consultation at the Royal Adelaide Hospital.
What is GLITtER (Green Light Imaging Interpretation to Enhance Recovery)?
* GLITtER is a brief intervention that will be integrated into current practice in the SAC. It will be conducted face-to-face by clinicians with more than 5 years of experience working in this setting.
* It will extend the clinic consultation time by a maximum of 10 minutes
* GLITtER offers the treating clinicians a framework for interpreting imaging findings. Key components (to be verbally delivered while reviewing the patient's own imaging results) are:
1. Reframing of ‘normal’ imaging findings. E.g. “We now understand that many scan findings like degeneration and disc bulges are actually completely normal – you can think of them a bit like wrinkly skin or grey hair: as physical changes that ‘just happen’ over time”.
2. Most/many of the findings on your scan are also found on scans of people who have never had back pain. They would have been present well BEFORE your back pain started and they will still be there once your back pain has settled.
3. There is often very little link between scan findings and a person’s activity levels.
4. Summary: Scans (on their own) actually don’t explain much about
a. Your current pain – especially why you have good days and bad
b. The activity you are capable of
c. Or how likely you are to recover: because the changes on your scans will still be there when your pain goes away.

* On the basis of the above information patients will be ‘given’ (verbally) a metaphorical ‘green light’. The clinician will explain to the patient that after reviewing their imaging and assessing them in the clinic they consider that movement and activity is safe: the patient is given the green light to increase their activity level (and it is important for their recovery). This green light message is re-iterated on the first page of the take-home information.
* GLITtER offers a simple strategy for promotion of activity. Patients will be introduced to the activity “TICK” list – an acronym for: make a Time, it’s Important, be Consistent, Know your back is up to it. This TICK list is included on each page of the 4-week take-home information.
* GLITtER offers take home information: designed as a 4-week series of key messages displayed in poster style. Participants will be instructed to display Week 1 when they arrive home, and change the poster weekly. The main themes of this information are as follows:
1. Scan findings should not cause worry; it is safe to be active. Many ‘abnormal’ findings on scans are actually completely normal (“like wrinkles on the inside”) and are not associated with pain or likely recovery. The spine is a strong and stable structure and needs to move.
2. Pain is complex and lots of things contribute to the experience of pain. Chronic pain often has little to do with damage – it is produced by a nervous system that is ‘over-protective’.
3. Activity and exercise are important for recovery and have many benefits. These include benefits to physical health and well-being, psychological benefits and restoration of the ‘over-protective’ system.
* Involves SMS follow ups (X4) with links to online education resources. Brief SMS messages will be sent on Mondays for the subsequent 4 weeks (following the consultation). The SMS message will prompt the participant to display/turn over/read the information sheet they were provided at their consultation, and to plan some activity/exercise for the week ahead.
* Includes brief written communication with the patient’s General Practitioner. This information will inform the GP that their patient was part of a pilot study assessing an educational intervention designed to reassure patients and promote activity. It will outline the main messages provided to the patient:
1. Surgical intervention is not indicated and further scans are not required
2. Scan findings should not cause worry; it is safe to be active
3. Pain is complex (chronic pain often has little to do with damage)
4. Activity and exercise are important for recovery and have many benefits
Contact details for the principal researcher will also be provided.

Adherence to reading of the poster information will be assessed at one-month follow-up.
Intervention code [1] 297129 0
Rehabilitation
Intervention code [2] 297309 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will receive ‘standard care’ in the SAC. This involves routine assessment, interpretation of imaging findings and advice regarding conservative management. Standard care will be delivered by clinicians who are naive to the content of ‘GLITtER’ and operate according to what is considered to be best-practice SAC care. The components of GLITtER that are underlined above will be unique to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 301265 0
The primary outcome of this study is to determine feasibility of the “GLITtER’ intervention for LBP patients attending the Spinal Assessment Clinic (SAC). This is a composite outcome that will include meeting of the following specific feasibility criteria:
1. One subject per clinician per week can be recruited (4 Clinicians at each weekly clinic).
2. At least 70% of all eligible patients can be recruited.
3. Complete follow-up data are obtained in at least 95% of all recruited subjects.
4. GLITtER consultations do not extend clinic appointments by longer than 10 minutes (on average).
5. Acceptability of the “GLITtER’ intervention for LBP patients attending the Spinal Assessment Clinic (SAC) is indicated by: >80% of responses to questions 1-7 of the Participant Experience Questionnaire are rated as “agree” or “strongly agree”.
6. SAC Clinicians delivering GLITtER report that they are “confident” or “very confident” when asked: “How confident are you that you could integrate GLITtER into standard practice on an ongoing basis?”, and “How confident are you that integrating GLITtER would enhance SAC care?” (4 point scale).
Timepoint [1] 301265 0
Collection of all primary outcome data will be completed via a questionnaire administered 3 months post consultation. This will include a participant experience questionnaire.
Secondary outcome [1] 332128 0
Pain, assessed by 11-point numeric rating scale
Timepoint [1] 332128 0
Questionnaire administered at 3 months post consultation
Secondary outcome [2] 332129 0
Disability, assessed by an 11 point numeric rating scale
Timepoint [2] 332129 0
Questionnaire administered at 3 months post consultation
Secondary outcome [3] 332131 0
Kinaesiophobia, assessed by the Tampa Scale for Kinaesiophobia
Timepoint [3] 332131 0
Questionnaire administered at 3 months post consultation
Secondary outcome [4] 332132 0
Healthcare utilisation, assessed by 3 self-report questions
Timepoint [4] 332132 0
Questionnaire administered at 3 months post consultation

Eligibility
Key inclusion criteria
- Adults with lumbar spine disorders (low back pain with or without leg symptoms)
- 18 – 75 year old men and women
- Paper-based triage undertaken and patients identified as “non-urgent”, requiring scheduling on an outpatient clinic booking queue
- Patients have access to a recent CT or MRI scan of their lumbar spine (performed during the previous 6 months)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to speak and understand (verbal and written) English
- History of lumbar spine surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation is determined by clinic scheduling and clinician availability.
I.e. 4 clinicians routinely provided consultations in the spinal assessment clinic. Patients are booked into one of four time-slots spread throughout the morning clinic. The 'next available' clinician calls the 'next patient' (ie. the patient with the earliest scheduled appointment time who has been waiting the longest) into their consulting room. Two of the treating clinicians will deliver the GLITtER intervention to patients who fulfil all eligibility criteria (the intervention group). The other 2 clinicians will identify patients who meet all eligibility criteria and will deliver a routine consultation (the control group). All patients will provide informed consent prior to attending their consultation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a prospective, quasi-randomised, controlled, feasibility trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline clinical and demographic characteristics of the participants will be reported using descriptive statistics. Patient eligibility, recruitment and retention rates will be calculated, and reasons for refused consent will be recorded. Questionnaire completion rates will also be calculated. Exploratory analysis of changes in pain, disability and kinaesiophobia from baseline to follow-up will be assessed using an ANOVA, however treatment effects will be interpreted with caution. The standard deviation of the primary outcome measure (pain NRS at 3 months) will be used to inform future sample size calculations for a larger RCT.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2017
Actual
Date of last participant enrolment
Anticipated
1/06/2017
Actual
Date of last data collection
Anticipated
1/09/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7457 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 15283 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 295584 0
Charities/Societies/Foundations
Name [1] 295584 0
Royal Adelaide Hospital Research Foundation
Country [1] 295584 0
Australia
Primary sponsor type
Individual
Name
Emma Karran
Address
University of South Australia
Cnr Frome Rd and North Terrace,
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 294415 0
Hospital
Name [1] 294415 0
Royal Adelaide Hospital
Address [1] 294415 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country [1] 294415 0
Australia
Secondary sponsor category [2] 294417 0
University
Name [2] 294417 0
University of South Australia
Address [2] 294417 0
Cnr Frome Rd and North Tce,
Adelaide
SA 5000
Country [2] 294417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296906 0
Royal Adelaide Hospital
Ethics committee address [1] 296906 0
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 296906 0
Australia
Date submitted for ethics approval [1] 296906 0
Approval date [1] 296906 0
04/01/2017
Ethics approval number [1] 296906 0
R20150308 HREC/15/RAH/73
Ethics committee name [2] 296908 0
University of South Australia
Ethics committee address [2] 296908 0
Cnr Frome Rd and North Tce
Adelaide
SA 5000
Ethics committee country [2] 296908 0
Australia
Date submitted for ethics approval [2] 296908 0
Approval date [2] 296908 0
12/01/2017
Ethics approval number [2] 296908 0
0000034887

Summary
Brief summary
Current practice guidelines universally recommend ‘reassurance’ as an important component of low back pain (LBP) management. However, despite the recognition that clinicians are able to effectively reassure LBP patients (and with lasting effect), how best to reassure – and its impact on pragmatic outcomes – is poorly understood.

Approximately 2000 adults with spinal pain are referred by medical practitioners (annually) for surgical opinion in the spinal outpatient clinics at the Royal Adelaide Hospital (RAH). Surgery, however, is likely to benefit less than 10% of these patients. It has been suggested that the communication of imaging reports may increase fear of re-injury and reduce the likelihood of a good outcome. Indeed, the highly prevalent ‘abnormalities’ detailed in radiology reports are rarely reassuring. Recent evidence suggests that many ‘degenerative’ changes found on spinal imaging are not abnormal and highly likely to be found in asymptomatic individuals. It is also understood that spinal imaging findings are not well associated with pain or prognosis. Our intervention involves a new and standardised method of communicating radiological findings in a manner designed to reassure patients, and promote engagement in an active recovery.

This study is a feasibility trial which will be conducted in the spinal outpatient setting at the RAH. It is the crucial first step towards definitive testing of GLITtER (Green Light Imaging Intervention to Enhance Recovery).

Aim
The aim of this study is to inform feasibility of definitive testing of the GLITtER intervention in a quasi-randomised controlled trial. This trial would ultimately address the question of whether the proposed intervention – integrated into routine practice in a spinal outpatient clinic setting - is a cost-effective strategy for reducing chronic LBP and disability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72394 0
Ms Emma Karran
Address 72394 0
School of Health Sciences
University of South Australia
City East Campus
Cnr Frome Rd and North Tce,
Adelaide
SA 5000
Country 72394 0
Australia
Phone 72394 0
+61 451 631 511
Fax 72394 0
Email 72394 0
[email protected]
Contact person for public queries
Name 72395 0
Emma Karran
Address 72395 0
School of Health Sciences
University of South Australia
City East Campus
Cnr Frome Rd and North Tce
Adelaide
SA 5000
Country 72395 0
Australia
Phone 72395 0
+61 451 631 511
Fax 72395 0
Email 72395 0
[email protected]
Contact person for scientific queries
Name 72396 0
Emma Karran
Address 72396 0
School of Health Sciences
University of South Australia
City East Campus
Cnr Frome Rd and North Tce
Adelaide
SA 5000
Country 72396 0
Australia
Phone 72396 0
+61 451 631 511
Fax 72396 0
Email 72396 0
[email protected]

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