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

Not Applicable

Recruiting

• Conditions: Surgery; Spine Degeneration; Radiculopathy; Constriction, Pathologic
• Interventions: Other: Dialogue support tool

• Registration Number: NCT05817747
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2023-03-19
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Dialogue support tool	Participants will after the dialogue support tool has been undergo surgery.
Non-surgery	Dialogue support tool	Participants will after the dialogue support tool has been used not undergo surgery.

Primary Outcome Measures

Name	Time	Method
Global Assessment (GA)	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).

Secondary Outcome Measures

Name	Time	Method
Mortality	One year post surgery	The number of participants that have died within one year of surgery
Oswestry Disability Index (ODI)	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).
Euroqol-5-Dimensions quality of life questionnaire (EQ-5D)	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).
Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS)	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
Neck Disability index (NDI)	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

Trial Locations

Locations (10)

Aleris Ortopedi Malmö; 🇸🇪 Malmö, Skåne, Sweden

Aleris Ortopedi Ängelholm; 🇸🇪 Ängelholm, Skåne, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götaland, Sweden

Spine Center Göteborg; 🇸🇪 Göteborg, Västra Götaland, Sweden

Ryggkirurgiskt Centrum; 🇸🇪 Stockholm, Sweden

Spine Center Stockholm; 🇸🇪 Stockholm, Sweden

Sundsvalls sjukhus; 🇸🇪 Sundsvall, Sweden

Norrland University Hospital; 🇸🇪 Umeå, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Aleris Elisabethsjukhuset; 🇸🇪 Uppsala, Sweden