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

NCT07788872 | Not Yet Recruiting DMC

• 2 other identifiers: 934578P360 nr:2512715
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spinal Stenosis Lumbar; Disc Herniation, Lumbar; Degenrative Disc Disease

Keywords

Dialogue Support; Shared decision-making; Predictive tool; Spine surgery; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI)

  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.

  12 months follow-up

Secondary Outcomes (6)

• Successful Outcome According to Global Perceived Effect (GPE)

  3 months and 12 months follow-up

• ≥30% Improvement in Oswestry Disability Index (ODI)

  3 months and 12 months follow-up

• Oswestry Disability Index (ODI)

  3 months follow-up

• Patient Expectations for Postoperative Disability

  After randomization and before surgery

• Cancellation of Planned Spine Surgery

  From randomization until the scheduled surgery

Study Arms (2)

Standart Care

NO INTERVENTION

No additional consultation prior to the planned surgery

Dialogue Support Consultation

ACTIVE COMPARATOR

one additional consultation using the Dialogue Support tool prior to the planned surgery

Behavioral: Dialogue Support Consultation

Interventions

Dialogue Support Consultation BEHAVIORAL

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.

Dialogue Support Consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo lumbar spinal surgery for disc herniation, spinal stenosis, or degenerative disc disease.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Sykehuset Innlandet HF: collaborator

Study Sites (2)

Akershus University Hospital

Oslo, Nordbyhagen, 1478, Norway

Location

Innlandet Hospital Trust.

Gjøvik, 2819, Norway

Location

Related Publications (10)

• Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. Lancet. 2025 Apr 14:S0140-6736(25)00672-5. doi: 10.1016/S0140-6736(25)00672-5. Online ahead of print.

  PMID: 40245901 BACKGROUND

• Taylor RS, Taylor RJ. The economic impact of failed back surgery syndrome. Br J Pain. 2012 Nov;6(4):174-81. doi: 10.1177/2049463712470887.

  PMID: 26516490 RESULT

• Ferreira GE, Zadro J, Liu C, Harris IA, Maher CG. Second opinions for spinal surgery: a scoping review. BMC Health Serv Res. 2022 Mar 18;22(1):358. doi: 10.1186/s12913-022-07771-3.

  PMID: 35300677 RESULT

• Fritzell P, Mesterton J, Hagg O. Prediction of outcome after spinal surgery-using The Dialogue Support based on the Swedish national quality register. Eur Spine J. 2022 Apr;31(4):889-900. doi: 10.1007/s00586-021-07065-y. Epub 2021 Nov 27.

  PMID: 34837113 RESULT

• Wellington IJ, Karsmarski OP, Murphy KV, Shuman ME, Ng MK, Antonacci CL. The use of machine learning for predicting candidates for outpatient spine surgery: a review. J Spine Surg. 2023 Sep 22;9(3):323-330. doi: 10.21037/jss-22-121. Epub 2023 Jul 6.

  PMID: 37841781 RESULT

• Giordano C, Brennan M, Mohamed B, Rashidi P, Modave F, Tighe P. Accessing Artificial Intelligence for Clinical Decision-Making. Front Digit Health. 2021 Jun 25;3:645232. doi: 10.3389/fdgth.2021.645232. eCollection 2021.

  PMID: 34713115 RESULT

• Pedersen CF, Andersen MO, Carreon LY, Eiskjaer S. Validating the predictive precision of the dialogue support tool on Danish patient cohorts. N Am Spine Soc J. 2022 Dec 2;13:100188. doi: 10.1016/j.xnsj.2022.100188. eCollection 2023 Mar.

  PMID: 36579158 RESULT

• Grundnes IB, Alhaug OK, Reis JABPRD, Jakobsen RB. Expectations in patients undergoing spine surgery are high and unmet. Spine J. 2024 Dec;24(12):2224-2231. doi: 10.1016/j.spinee.2024.09.004. Epub 2024 Sep 19.

  PMID: 39303830 RESULT

• Alhaug OK, Dolatowski FC, Solberg TK, Lonne G. Predictors for failure after surgery for lumbar spinal stenosis: a prospective observational study. Spine J. 2023 Feb;23(2):261-270. doi: 10.1016/j.spinee.2022.10.010. Epub 2022 Nov 5.

  PMID: 36343913 RESULT

• Solberg TK, Ingebrigtsen T, Thyrhaug AM, Olsen LR. Annual Report 2024 National Quality Register for Spinal Surgery (NORSpine). Septentrio Reports. 2025(2).

  RESULT

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Per-Henrik Randsborg, MD, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Reis, MD

CONTACT

+47 67 96 00 00; jorore@ahus.no

Ole Kristian Alhaug, MD, PhD

CONTACT

+47 67 96 00 00; ole.kristian.alhaug@ahus.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)