An observational study in Low Back Pain, Neck Pain and Disc Herniation, sponsored by Oslo Metropolitan University. Enrolling by invitation at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Oslo Metropolitan University · Observational
The primary objective is to use machine learning methods on large survey and health register data to identify participants with different treatment trajectories and health outcomes after surgical and/or conservative treatment for spinal disorders.
Secondary objectives are to 1) conduct external validation of the prediction models, and 2) explore how the prediction models can be implemented into AI-based clinical co-decision tools and interventions.
Three work packages are conducted. In the first, the investigators will use data from three general population surveys in Norway (HUNT, Tromsø, and Ullensaker) linked to administrative health registry data (Norwegian Patient Registry (for secondary care) and Norwegian Registry for Primary Health Care) and clinical registers on spinal disorders (the Norwegian registry for spine surgery, NorSpine, and the Norwegian registry for neck and back pain) to explore treatment trajectories and health outcomes following an episode of back and/or neck pain. The investigators will use different combinations of these data sets to assess the impact of a wide range of risk/ prognostic factors and to develop prognostic models for different health and welfare outcomes.
Four major outcomes will be adressed; a) unfavourable outcomes, b) use of prescribed medication, c) use of sickness absence and other disability benefits, and d) patient-reported outcomes.
In the second work package, the investigators will conduct external validation studies of the prediction models by using Danish and Swedish data. There is a large overlap and similarities in health and welfare registers across the Nordic countries.
In the third work package the investigators will first conduct a feasibility study in a secondary care hospital setting in which surgeons examine and assess referred patients with disc herniation and spinal stenosis for surgical treatment (or not). Qualitative interviews will be used to gain a better understanding of today's clinical decision-making process.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 165,000 is above the median of 100 across 481 observational studies indexed under Low Back Pain.
Browse Low Back Pain studies →Oslo Metropolitan University is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients referred to secondary care for assessment of surgery or not due to disc herniation (lumbar or cervical).
Inclusion Criteria: patients referred to secondary care for assessment of surgery or not due to disc herniation (lumbar or cervical).
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Exclusion Criteria: ambulant cases who needs immediate treatment
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Surgical vs conservative treatment. Surgery procedures are based on the NOMESCO Classification of Surgical Procedures (NCSP). Conservative treatment includes all non-surgical treatment methods such as pharmaceutical treatment, physical medicine and physiotherapy modalities (information, patient education, exercise, manual therapy etc), cognitive-behavioural therapy, multidisciplinary treatment, acupuncture, and others (e.g. chiropractic treatment, homeopathy, naprapathy, osteopathy). The results will be described for important spinal subgroups (specific diagnoses, nerve-root affections, and non-specific conditions).
Patient-reported outcomes
Patient-reported outcome measures included in clinical registers
Time frame: depends upon the registry data, but in general between 2008 and 2022
Unfavourable outcomes
Healthcare utilization, reoperation, infection, or other complications after surgery.
Time frame: depends upon the registry data, but in general between 2008 and 2022
Prescribed medication
High use of prescribed medication (dispensed drugs)
Time frame: depends upon the registry data, but in general between 2008 and 2022
Sickness absence
Sickness absence and disability pension
Time frame: depends upon the registry data, but in general between 2008 and 2022
Plan to share: No
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Oslo Metropolitan University