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

NCT07788872 · tracked via the Priya Life Science Norway tracker

Sponsor

University Hospital, Akershus

Phase

Not applicable

Started

2026-09-01

Last updated

2026-08-27

Condition(s) studied

Spinal Stenosis LumbarDisc Herniation, LumbarDegenrative Disc Disease

Investigational drug(s) / intervention(s)

Dialogue Support Consultation

Dialogue Support Consultation: This consultation will be scheduled approximately 2-6 weeks prior to surgery. The consultation 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 consultation, the DS results are presented and explained to the patient.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Oswestry Disability Index (ODI) — 12 months follow-up
Disability measured using the Oswestry Disability Index (ODI), ranging from 0 to 100, with higher scores indicating greater disability. Mean ODI scores will be compared between the intervention and control groups.

Trial sites (2)

Facility	City	Region	Status
Akershus University Hospital	Oslo	Nordbyhagen
Innlandet Hospital Trust.	Gjøvik	Norway

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07788872 on ClinicalTrials.gov ↗ ← All trials in Norway