Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis

May 12, 2025 updated by: Catharina Parai, MD, PhD, Sahlgrenska University Hospital

Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis

The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice.

The main questions it aims to answer are:

  • Does its use alter patient-reported outcome measured by general assessment regarding leg pain and Satisfaction in lumbar spinal stenosis?
  • Does its use alter patient-reported outcome as measured by general assessment regarding arm pain and Satisfaction in cervical rhizopathy?
  • How does the Quality of Life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery?

Eligible participants will be presented with their predicted postoperative outcome generated by the Dialogue Support tool, as an adjunct to the ordinary assessment by a spine surgeon.

Researchers will compare participants with a matched control group from the Swedish Spine Register ("Swespine") to see if the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, 114 33
      • Stockholm, Sweden, 194 89
      • Sundsvall, Sweden
        • Recruiting
        • Sundsvalls sjukhus
        • Contact:
          • Björn Knutsson, MD, PhD
      • Umeå, Sweden, 90737
        • Recruiting
        • Norrland University Hospital
        • Contact:
      • Uppsala, Sweden, 751 85
      • Uppsala, Sweden, 752 26
        • Active, not recruiting
        • Aleris Elisabethsjukhuset
    • Skåne
      • Malmö, Skåne, Sweden, 21532
        • Active, not recruiting
        • Aleris Ortopedi Malmö
      • Ängelholm, Skåne, Sweden, 26252
    • Västra Götaland
      • Gothenburg, Västra Götaland, Sweden, 41346
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
      • Göteborg, Västra Götaland, Sweden, 421 30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Refered to a participating clinic regarding surgery for lumbar spinal stenosis or cervical radiculopathy
  • 18 years of age or older
  • Magnetic Resonance Imaging (MRT) examination within the last 12 months confirming the diagnosis, concurrent with symptoms described by the referring physician
  • Giving informed consent

Exclusion Criteria:

  • Another condition found to be the reason for the symptoms.
  • Not giving informed consent
  • Need for further investigation that prevents inclusion within one month of the doctor visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery
Participants will after the dialogue support tool has been undergo surgery.
Other: Dialogue support tool
The dialogue support tool will be used as a support for the participant and surgeon to decide on which treatment arm is optimal for the participant.
Placebo Comparator: Non-surgery
Participants will after the dialogue support tool has been used not undergo surgery.
Other: Dialogue support tool
The dialogue support tool will be used as a support for the participant and surgeon to decide on which treatment arm is optimal for the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Assessment (GA)
Time Frame: One year post surgery
A retrospective single-item question ("How is your back/leg or neck/arm pain today as compared to before the surgery?"), with six response options (not back/leg pain before surgery/completely gone/much improved/slightly improved/unchanged/worse).
One year post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: One year post surgery
assesses the impact of lumbar pain on a patient´ physical function. It consists of ten questions concerning intensity of pain, ability to care for oneself, lifting, ability to walk, ability to sit, ability to walk, sexual function, social life, sleep quality and ability to travel. Min. value 0 points (no disability) and max. value 50 points (completely disabled).
One year post surgery
Neck Disability index (NDI)
Time Frame: One year post surgery
Used to assess the self-rated disability in patients with neck pain and consisting of ten questions scaled from 0-5 concerning pain-intensity, ability to care for oneself, lifting, reading, headache, concentration, working, driving, sleep and recreational activity
One year post surgery
Euroqol-5-Dimensions quality of life questionnaire (EQ-5D)
Time Frame: One year post surgery
Assess quality of life. It describes health in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression).
One year post surgery
Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS)
Time Frame: One year post surgery
The NRS is a common way of grading pain experience and is presented to the patient as a line with numbers from 0-10 and the patient is asked to grade their pain experience where zero is no pain and ten is maximal pain
One year post surgery
Mortality
Time Frame: One year post surgery
The number of participants that have died within one year of surgery
One year post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital

Investigators

  • Principal Investigator: Catharina Parai, MD, PhD, Sahlgrenska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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