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RECRUITING Not applicable ClinicalTrials.gov

More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.

Sponsor: University Hospital, Akershus • ClinicalTrials.gov ID: NCT07788872

Registry updated: 2026-10-05
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Description

This multicenter randomized controlled trial will evaluate whether an additional preoperative study visit 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 one additional study visit in which DS results are presented and explained, or a control study visit during which DS will not be employed The study will assess whether the additional DS study visit 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.

Interventions

  • Dialogue Support Study Visit (Behavioral)
    This study visit will be scheduled approximately 2-6 weeks prior to surgery. It will occur in the outpatient clinic and is expected to last approximately 30 to 40 minutes. It will be conducted in person to facilitate communication. During the study visit, the DS results are presented and explained to the patient.

Eligibility criteria

Inclusion Criteria: Patients scheduled to undergo lumbar spinal surgery for: * Disc herniation * Spinal stenosis * 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. * Patients with spondylolysis or lytic spondylolisthesis * Patients already participating in other clinical studies.

Conditions

Spinal Stenosis Lumbar Disc Herniation, Lumbar Degenrative Disc Disease

Locations

  • Akershus University Hospital — Oslo, Nordbyhagen, Norway
  • Innlandet Hospital Trust. — Gjøvik, Norway
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record