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NCT07788872
More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
Conditions: Spinal Stenosis Lumbar, Disc Herniation, Lumbar, Degenrative Disc Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 440
Sponsor: University Hospital, Akershus
Location: Akershus University Hospital Oslo Nordbyhagen
Summary
This multicenter randomized controlled trial will evaluate whether an additional preoperative consultation using the Dialogue Support (DS) tool improves patient information, expectations, and outcomes among adults scheduled for lumbar spine surgery for degenerative spinal disorders.
The DS tool predicts outcomes one year after surgery based on patient characteristics and presents these estimates numerically and visually. Participants will be randomized to either standard preoperative care or standard care plus an additional consultation in which DS results are presented and explained.
The study will assess whether the additional DS consultation influences postoperative outcomes, preoperative expectations, surgery cancellations, and cost-effectiveness. In addition, the project will externally validate the DS tool using data from the Norwegian Registry for Spine Surgery (NORspine) and assess the inter-rater reliability of DS assessments across spine surgeons.
Eligibility Criteria
Inclusion Criteria:
* Patients scheduled to undergo lumbar spinal surgery for disc herniation, spinal stenosis, or degenerative disc disease.
Exclusion Criteria:
* Patients who do not understand spoken or written Norwegian will be excluded, as language barriers may interfere with the intervention consultation, comprehension of the information provided, and completion of study questionnaires. Other exclusion criteria are patients with spondylolysis or lytic spondylolisthesis, as well as patients already participating in other clinical studies.
Source: ClinicalTrials.gov (NCT07788872). StuddyBuddy aggregates publicly available trial information.