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Trial registered on ANZCTR


Registration number
ACTRN12619001579189p
Ethics application status
Submitted, not yet approved
Date submitted
16/10/2019
Date registered
18/11/2019
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Integration of Coping Strategies after Spine Surgery: a pilot trial
Scientific title
In addition to exercise, do psychologically informed interventions or support interventions improve pain levels, coping ability, disability, anxiety and depression levels in individuals with high anxiety and/or depression prior to spine surgery?
Secondary ID [1] 299556 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 314818 0
Spine Surgery 314819 0
Anxiety 314950 0
Condition category
Condition code
Surgery 313157 313157 0 0
Other surgery
Mental Health 313158 313158 0 0
Anxiety
Mental Health 313159 313159 0 0
Depression
Physical Medicine / Rehabilitation 313160 313160 0 0
Other physical medicine / rehabilitation
Musculoskeletal 313296 313296 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised controlled trial whereby patients will be allocated to one of three treatment arms. The two intervention arms include:
1. Patients undergoing either a laminectomy or spinal fusion procedure with high depression and/or anxiety undergoing a Cognitive Behavioural Therapy and exercise intervention
2. Patients undergoing either a laminectomy or spinal fusion procedure with high depression and/or anxiety undergoing a clinician support and exercise intervention
An information sheet and consent form will be provided to participants if they fit the eligibility criteria for the study.

Cognitive Behavioural Therapy Intervention
A Cognitive Behavioural Therapy guide will be used by clinicians to deliver the intervention to participants. The patients will also receive a copy of this material. This intervention will be delivered via teleconference, weekly for six weeks following surgery. The intervention will take approximately 30 minutes. Follow-up visits will occur 6 weeks, 6 months and 12 months after surgery. The CBT resource is available on request and was designed by the Vanderbilt University Medical Center and John Hopkins University. It's official title is the Spine Surgery Recovery Program - Changing Behaviour through Physical Therapy (CBPT). A summary of the content addressed in the guide is listed below. Activities such as setting activity goals and walking goals are re-visited weekly with the participant. However, each week there is a new theme introduced in each session.
Week 1: Setting activity goals and walking goals, recognizing what makes pain and stress better and worse, introduction to deep breathing as a coping mechanism
Week 2: Re-setting activity goals and walking goals, evaluating success with deep breathing, introducing distraction techniques
Week 3: Re-setting activity goals and walking goals, evaluating success of distraction techniques, learning how to balance negative thoughts with positive thoughts
Week 4: Re-setting activity goals and walking goals, evaluating success of balancing negative and positive thoughts, recognising differences in underactive and overactive activity types and introducing pacing strategies to avoid excessive activity in those who are overactive, introducing sleeping tips (if applicable)
Week 5: Re-setting activity goals and walking goals, evaluating success with pacing strategies, recognising the benefits of the program over the past 4 weeks, discussing how to manage any setbacks
Week 6: Re-setting activity goals and walking goals, develop a recovery plan centered around activity levels, walking frequency, relaxation time, distraction techniques, pacing and using positive thoughts in everyday activity.

Clinician Support
Clinician Support is a pre-determined set of questions will be used by the clinician who delivers this intervention to participants. The following questions are asked to patients in the clinician support intervention:
1. How do you feel you are coping after surgery/ this week?
2. What is your activity like since surgery/ this week?
3. How many times this week have you completed your exercises at home?
4. How many times this week have you completed your exercises with a physiotherapist or exercise physiologist?
5. Are you back at work (if applicable)? If not, when do you plan on going back to work?
6. What type of help are you getting from your family and /or friends?
7. What are you doing now/ this week to help with your recovery?
8. Do you have any concerns with your recovery that you would like to discuss with me?
- The clinician support intervention will be delivered via teleconference weekly, for six weeks following surgery. The intervention delivery will take approximately 10 minutes and follow-up visits will occur 6 weeks, 6 months and 12 months after surgery.

It has been requested that study participants are blinded to the other treatment groups. After the patient has consented to the study they will be randomised to a treatment intervention and the contents of the intervention will be explained to the participant. This will occur at the patients' pre-operative appointment at the surgical practice SpinePlus, next door to BackSpace.

The intervention will be delivered by an Exercise Physiologist with training in motivational interviewing. The Exercise Physiologist has two years' experience with rehabilitation for spine surgery patients. A separate Exercise Physiologist with over three years' in post-surgical back rehabilitation will deliver the exercise interventions to patients. The exercise sessions will occur at the BackSpace rehabilitation clinic located within the Brisbane Private Hospital. The exercise sessions are one-on-one sessions with the exercise physiologist and the frequency of exercise sessions will occur at the discretion of the participant for up to 12 months. Each session runs for 30 minutes to 1 hour. The exercise sessions are low intensity however patients assess the intensity through the Borg RPE scale. Exercises that may be prescribed as part of the sessions include:
1. Pelvic tilts
2. Supine knee rocks
3. Cross brace exercise
4. Pelvic tilt into bridge
5. Finding neutral spine
6. Clams
7. Squats with a chair
8. Standing hip abduction
9. Passive shoulder raise
10. Archer bow and arrow
11. Chin tucks
12. Scapular retraction
13. Chest stretch
Adherence to the facility sessions are managed through BackSpace clinics practice management software, where clinicians can track how often the patient has attended the clinic to undergo exercise sessions. Adherence to the home based sessions is monitored via the app, PhysiTrack. Participants acknowledge they have completed the exercises by selecting 'completed' on the app. This information can be accessed by the Exercise Physiologist. For participants who require a printed copy of the exercises, they will be emailed weekly to confirm their exercise adherence and asked to keep track of their exercising habits through their own means. I.e. participants may choose to keep a diary.
Intervention code [1] 315810 0
Rehabilitation
Intervention code [2] 315813 0
Behaviour
Intervention code [3] 315889 0
Treatment: Other
Comparator / control treatment
This study is a randomised controlled trial whereby patients will be allocated to one of three treatment arms. The control intervention is as follows:
Patients undergoing either a laminectomy or spinal fusion procedure with high depression and/or anxiety undergoing a control intervention. The control intervention refers to standard treatment which in this case is exercise only. Standard treatment at the BackSpace rehabilitation clinic refers to post-operative visits two and six weeks after surgery. At these visits the patient sees the physiotherapist, exercise physiologist and remedial massage therapist. Between the two and six week post-operative visits the patient is provided with exercises to complete at home and has the option to return to BackSpace to see the clinicians and modify their exercise program.

Control Group
- A data recording sheet will be provided to patients in the control group so they can comment on the number of exercise sessions they have undertaken in the past week.
- The data recording sheet will be emailed to the participant, weekly for six weeks following surgery.
- The data recording sheet will take approximately 5 minutes for the participant to complete.
- A follow-up questionnaire will be emailed 6 weeks, 6 months and 12 months after surgery.

Control group
Active

Outcomes
Primary outcome [1] 321683 0
Overall disability as assessed by the Oswesty Disability Index (ODI).
Timepoint [1] 321683 0
Baseline, 6 weeks after surgery (primary timepoint), 6 months after surgery and 12 months after surgery
Primary outcome [2] 321684 0
Pain as represented on the 100mm Visual Analogue Scale (VAS).
Timepoint [2] 321684 0
Baseline, 6 weeks after surgery (primary timepoint), 6 months after surgery and 12 months after surgery
Primary outcome [3] 321685 0
Depression and/or anxiety as measured on the Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 321685 0
Baseline, 6 weeks after surgery (primary timepoint), 6 months after surgery and 12 months after surgery
Secondary outcome [1] 375888 0
Sleep quality assessed using the Insomnia Severity Index (ISI)
Timepoint [1] 375888 0
Baseline, 6 weeks after surgery (secondary timepoint), 6 months after surgery and 12 months after surgery.
Secondary outcome [2] 375889 0
Lower limb strength assessed using the 30 Second Sit to Stand (30 STS) assessment
Timepoint [2] 375889 0
Baseline, 6 weeks after surgery (secondary timepoint), 6 months after surgery and 12 months after surgery
Secondary outcome [3] 375890 0
Walking speed assessed using the 6 metre gait speed walk test
Timepoint [3] 375890 0
Baseline, 6 weeks after surgery (secondary timepoint), 6 months after surgery and 12 months after surgery
Secondary outcome [4] 375891 0
Mobility assessed using the Timed Up and Go (TUG) test
Timepoint [4] 375891 0
Baseline, 6 weeks after surgery (secondary timepoint), 6 months after surgery and 12 months after surgery
Secondary outcome [5] 375892 0
Health status assessed using the EQ-5D questionnaire
Timepoint [5] 375892 0
Baseline, 6 weeks after surgery (secondary timepoint), 6 months after surgery and 12 months after surgery
Secondary outcome [6] 375893 0
Pain coping ability assessed on the two item Chronic Pain Coping Inventory (CPCI)
Timepoint [6] 375893 0
Baseline, 6 weeks after surgery (secondary timepoint), 6 months after surgery and 12 months after surgery

Eligibility
Key inclusion criteria
Eligible participants are those who score borderline normal (8-10 points) or abnormal (11-21 points) for anxiety or depression on the Hospital Anxiety and Depression Scale (HADS) before spine surgery. Additional inclusion criteria were as follows: 18 years old or older, neck and/or arm pain, back and/or leg pain, undergoing a discectomy, laminectomy, disc replacement or spinal fusion (anterior or posterior) procedure and a good understanding of written and spoken English.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded from the study if they fit any of the following exclusion criteria: <18 years old, medically unsafe to participate as deemed by the treating surgeon, undergoing current treatment with a psychologist, high risk of safety to the individual or to the researchers and if the patient had a spinal tumour.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, allocation concealment principles have been followed. The randomisation process occurs off-site, at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14963 0
Brisbane Private Hospital - Brisbane
Recruitment postcode(s) [1] 28248 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 304042 0
University
Name [1] 304042 0
Queensland University of Technology
Address [1] 304042 0
School of Exercise & Nutrition Sciences
Faculty of Health | Queensland University of Technology
Location: O Block A Wing, A420 | Address: Victoria Park Rd, Kelvin Grove, QLD 4059
Country [1] 304042 0
Australia
Funding source category [2] 304045 0
Other Collaborative groups
Name [2] 304045 0
SpinePlus
Address [2] 304045 0
Brisbane Private Hospital
Level 7, 259 Wickham Terrace, Spring Hill
QLD, 4000
Country [2] 304045 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
School of Exercise & Nutrition Sciences
Faculty of Health | Queensland University of Technology
Location: O Block A Wing, A420 | Address: Victoria Park Rd, Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 304325 0
Other Collaborative groups
Name [1] 304325 0
SpinePlus
Address [1] 304325 0
Brisbane Private Hospital
Level 7, 259 Wickham Terrace, Spring Hill
QLD, 4000
Country [1] 304325 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304533 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 304533 0
School of Exercise & Nutrition Sciences
Faculty of Health | Queensland University of Technology
Location: O Block A Wing, A420 | Address: Victoria Park Rd, Kelvin Grove, QLD 4059
Ethics committee country [1] 304533 0
Australia
Date submitted for ethics approval [1] 304533 0
15/10/2019
Approval date [1] 304533 0
Ethics approval number [1] 304533 0

Summary
Brief summary
The integration of CBT into the spine model of care aims to ameliorate the psychological elements that may dictate the patients’ return to normal function. No clinic offers CBT or clinician support in conjunction with passive therapies as a first-line treatment option, and as a mechanism to prevent acute pain from becoming pathological. This research will provide insight into whether post-operative interventions – other than physical therapy alone – can improve acute and long-term outcomes in spinal surgery patients. In addition to this, the study strives to determine whether an intervention must be psychologically informed in order to improve patient outcomes. In addition to a CS and CBT arm, a control arm has been included in the study design as previous interventions in this area of research have found minimal variation between the CBT and corresponding intervention (which was not a control intervention), raising the question, are clinician support and CBT effective in comparison to standard treatment?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97294 0
Dr Justin Holland
Address 97294 0
School of Exercise & Nutrition Sciences
Faculty of Health | Queensland University of Technology
Location: O Block A Wing, A420 | Address: Victoria Park Rd, Kelvin Grove, QLD 4059
Country 97294 0
Australia
Phone 97294 0
+61 7 3138 0669
Fax 97294 0
Email 97294 0
justin.holland@qut.edu.au
Contact person for public queries
Name 97295 0
Dr Justin Holland
Address 97295 0
School of Exercise & Nutrition Sciences
Faculty of Health | Queensland University of Technology
Location: O Block A Wing, A420 | Address: Victoria Park Rd, Kelvin Grove, QLD 4059
Country 97295 0
Australia
Phone 97295 0
+61 7 3138 0669
Fax 97295 0
Email 97295 0
justin.holland@qut.edu.au
Contact person for scientific queries
Name 97296 0
Dr Justin Holland
Address 97296 0
School of Exercise & Nutrition Sciences
Faculty of Health | Queensland University of Technology
Location: O Block A Wing, A420 | Address: Victoria Park Rd, Kelvin Grove, QLD 4059
Country 97296 0
Australia
Phone 97296 0
+61 7 3138 0669
Fax 97296 0
Email 97296 0
justin.holland@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, all of the individual participant data will be shared.
When will data be available (start and end dates)?
Data will be available immediately following publication and will be available for five years following publication.
Available to whom?
Data will be available after dissemination upon request and at the discretion of the sponsor. Data is available via the QUT data repository (upon request) which is accessible to anyone. However, the data will only be distributed to researchers.
Available for what types of analyses?
Data will be available for primary and secondary analyses on the basis that the secondary analysis is related to the topic of interest.
How or where can data be obtained?
Data can be obtained on the Queensland University of Technology's Data Repository: https://researchdatafinder.qut.edu.au/dataCollections#http://www.qut.edu.au/ontologies/vivoqut#researchDataSet&alpha=e&page=1
What supporting documents are/will be available?
No other documents available
Summary results
No Results