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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07788872). StuddyBuddy aggregates publicly available trial information.