Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Dialogue support tool
Other interventionThe 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.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: SurgeryExperimental treatment 1 intervention
Group B: Non-surgeryPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
One year post surgerySecondary outcomes
1
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).
Time frame
One year post surgery2
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
Time frame
One year post surgery3
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).
Time frame
One year post surgery4
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
Time frame
One year post surgerySponsors and contacts
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Source ClinicalTrials.gov