Low Back PainAID-SpineNCT05745129
Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders
An observational study of Low Back Pain and Neck Pain, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Neck Pain, Disc Herniation
- How many people
- 165,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Dec 2021to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders (AID-Spine, Part I)
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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Neck Pain, Disc Herniation, Disc Degeneration, Spinal Stenosis, Radiculopathy
- Keywords
- prognosis, trajectories, risk factors, prognostic factors, prognostic model, prediction model, health outcomes, work outcomes
- Medical subject headings
- Low Back Pain, Neck Pain, Intervertebral Disc Displacement, Intervertebral Disc Degeneration, Spinal Stenosis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment cohort | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported outcomes
Patient-reported outcome measures included in clinical registers
Measured: depends upon the registry data, but in general between 2008 and 2022
Unfavourable outcomes
Healthcare utilization, reoperation, infection, or other complications after surgery.
Measured: depends upon the registry data, but in general between 2008 and 2022
Prescribed medication
High use of prescribed medication (dispensed drugs)
Measured: depends upon the registry data, but in general between 2008 and 2022
Sickness absence
Sickness absence and disability pension
Measured: depends upon the registry data, but in general between 2008 and 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Dec 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 165,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margreth Grotle, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745129
- Sponsor's protocol ID
- 371282
- Acronym
- AID-Spine
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zouch JH, Berg B, Pripp AH, Storheim K, Ashton-James CE, Ferreira ML, Grotle M, Ferreira PH. Reducing strain on primary healthcare systems through innovative models of care: the impact of direct access physiotherapy for musculoskeletal conditions-an interrupted time series analysis. Fam Med Community Health. 2024 Sep 24;12(3):e002998. doi: 10.1136/fmch-2024-002998.
PubMed 39317459
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders (AID-Spine, Part I)
- ClinicalTrials.gov ID
- NCT05745129
- Acronym / sponsor ID
- AID-Spine / 371282
- Conditions
- Low Back Pain, Neck Pain, Disc Herniation, Disc Degeneration, Spinal Stenosis, Radiculopathy
- Keywords
- prognosis, trajectories, risk factors, prognostic factors, prognostic model, prediction model, health outcomes, work outcomes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 165,000 participants (estimated)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment cohort | – | –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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients referred to secondary care for assessment of surgery or not due to disc herniation (lumbar or cervical).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-reported outcomes
Time frame: depends upon the registry data, but in general between 2008 and 2022
Patient-reported outcome measures included in clinical registers
Unfavourable outcomes
Time frame: depends upon the registry data, but in general between 2008 and 2022
Healthcare utilization, reoperation, infection, or other complications after surgery.
Prescribed medication
Time frame: depends upon the registry data, but in general between 2008 and 2022
High use of prescribed medication (dispensed drugs)
Sickness absence
Time frame: depends upon the registry data, but in general between 2008 and 2022
Sickness absence and disability pension
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 39317459Zouch JH, Berg B, Pripp AH, Storheim K, Ashton-James CE, Ferreira ML, Grotle M, Ferreira PH. Reducing strain on primary healthcare systems through innovative models of care: the impact of direct access physiotherapy for musculoskeletal conditions-an interrupted time series analysis. Fam Med Community Health. 2024 Sep 24;12(3):e002998. doi: 10.1136/fmch-2024-002998.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Neck Pain, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcomes (time frame: depends upon the registry data, but in general between 2008 and 2022). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.