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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
900
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.
Aleris Ortopedi Ängelholm
Ängelholm, Skåne County, Sweden
RECRUITINGAleris Ortopedi Malmö
Malmo, Skåne County, Sweden
ACTIVE_NOT_RECRUITINGSahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
RECRUITINGSpine Center Göteborg
Gothenburg, Västra Götaland County, Sweden
RECRUITINGRyggkirurgiskt Centrum
Stockholm, Sweden
RECRUITINGSpine Center Stockholm
Stockholm, Sweden
RECRUITINGSundsvalls sjukhus
Sundsvall, Sweden
RECRUITINGNorrland University Hospital
Umeå, Sweden
RECRUITINGUppsala University Hospital
Uppsala, Sweden
RECRUITINGAleris Elisabethsjukhuset
Uppsala, Sweden
ACTIVE_NOT_RECRUITINGGlobal 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 surgery
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 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
Time frame: 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).
Time frame: 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
Time frame: One year post surgery
Mortality
The number of participants that have died within one year of surgery
Time frame: One year post surgery
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