Strategic Use of Big Data in Spine Surgery - a Multicenter Clinical Trial Testing Digital Prediction of Outcome in Clinical Praxis

Study Overview
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Brief Summary
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The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice. The main questions it aims to answer are: Does its use alter patient-reported outcome measured by general assessment regarding leg pain and Satisfaction in lumbar spinal stenosis? Does its use alter patient-reported outcome as measured by general assessment regarding arm pain and Satisfaction in cervical rhizopathy? How does the Quality of Life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery? Eligible participants will be presented with their predicted postoperative outcome generated by the Dialogue Support tool, as an adjunct to the ordinary assessment by a spine surgeon. Researchers will compare participants with a matched control group from the Swedish Spine Register (Swespine) to see if the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction.

Official Title
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Strategic Use of Big Data in Spine Surgery - a Multicenter Clinical Trial Testing a Digital Prediction of Outcome Tool in Clinical Praxis

Conditions
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Constriction, Pathologic, Spine Degeneration, Surgery, Radiculopathy

Intervention / Treatment
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* Other: Dialogue support tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Refered to a participating clinic regarding surgery for lumbar spinal stenosis or cervical radiculopathy 18 years of age or older Magnetic Resonance Imaging (MRT) examination within the last 12 months confirming the diagnosis, concurrent with symptoms described by the referring physician Giving informed consent Exclusion Criteria: Another condition found to be the reason for the symptoms. Not giving informed consent Need for further investigation that prevents inclusion within one month of the doctor visit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: On all participants the dialogue support tool will be used and will thereafter be put into either of two treatment-arms (surgical, or non-surgical treatment)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br>Participants will after the dialogue support tool has been undergo surgery. | Other: Dialogue support tool<br>* The dialogue support tool will be used as a support for the participant and surgeon to decide on which treatment arm is optimal for the participant.<br>|
| Placebo Comparator: Non-surgery<br>Participants will after the dialogue support tool has been used not undergo surgery. | Other: Dialogue support tool<br>* The dialogue support tool will be used as a support for the participant and surgeon to decide on which treatment arm is optimal for the participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment (GA) | A retrospective single-item question (How is your back/leg or neck/arm pain today as compared to before the surgery?), with six response options (not back/leg pain before surgery/completely gone/much improved/slightly improved/unchanged/worse). | One year post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | assesses the impact of lumbar pain on a patient´ physical function. It consists of ten questions concerning intensity of pain, ability to care for oneself, lifting, ability to walk, ability to sit, ability to walk, sexual function, social life, sleep quality and ability to travel. Min. value 0 points (no disability) and max. value 50 points (completely disabled). | One year post surgery | 
| Neck Disability index (NDI) | Used to assess the self-rated disability in patients with neck pain and consisting of ten questions scaled from 0-5 concerning pain-intensity, ability to care for oneself, lifting, reading, headache, concentration, working, driving, sleep and recreational activity | One year post surgery | 
| Euroqol-5-Dimensions quality of life questionnaire (EQ-5D) | Assess quality of life. It describes health in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). | One year post surgery | 
| Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS) | The NRS is a common way of grading pain experience and is presented to the patient as a line with numbers from 0-10 and the patient is asked to grade their pain experience where zero is no pain and ten is maximal pain | One year post surgery | 
| Mortality | The number of participants that have died within one year of surgery | One year post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prognostic model, External validation, Spine, Cervical radiculopathy, Lumbar spinal stenosis, Surgery, Neck