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NCT Number: NCT05817747

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

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Key information

Conditions

Constriction, Pathologic Bone Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Spinal Diseases Spinal Stenosis Spine Degeneration Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aleris Ortopedi Malmö, Malmö, Skåne County, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dialogue support tool

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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

  3. 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).

  4. 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

  5. Mortality

    Time frame: One year post surgery

    The number of participants that have died within one year of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Catharina Parai, MD, PhD

CONTACT

[email protected]

0046313421000

Eric Brisby Enger, MD

CONTACT

[email protected]

0046735716723

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Apr 18, 2023
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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