Constriction, PathologicNCT05817747
Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis
A study testing Dialogue support tool in people with Constriction, Pathologic and Spine Degeneration, run by Sahlgrenska University Hospital at 10 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constriction, Pathologic, Spine Degeneration, Surgery
- What is being tested?
- Dialogue support tool
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 10 sitesSweden
- Study dates
- 1 Mar 2022to 1 Mar 2029
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Sweden10 sites, 8 recruiting
- Recruiting
Aleris Ortopedi Ängelholm
Ängelholm, Skåne County, 26252
Anders Kjellin, MD, anders.kjellin@aleris.se
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 41346
Catharina Parai, MD, PhD, 0046313421000, catharina.parai@vgregion.se
- Recruiting
Spine Center Göteborg
Gothenburg, Västra Götaland County, 421 30
Kajsa Rennerfelt, MD, PhD, kajsa.rennerfelt@spinecenter.se
- Active, not recruiting
Aleris Ortopedi Malmö
Malmö, Skåne County, 21532
- Recruiting
Ryggkirurgiskt Centrum
Stockholm, 114 33
Per Svedmark, MD,PhD, Per.Svedmark@rkc.se
- Recruiting
Spine Center Stockholm
Stockholm, 194 89
Konstantinos Pazarlis, MD, konstantinos.pazarlis@spinecenter.se
- Recruiting
Sundsvalls sjukhus
Sundsvall
Björn Knutsson, MD, PhD
- Recruiting
Norrland University Hospital
Umeå, 90737
Johan Wenman, MD, PhD, 0046702698300, johanwenman@hotmail.com
- Recruiting
Uppsala University Hospital
Uppsala, 751 85
Anna Mac Dowall, MD, PhD, anna.mac.dowall@akademiska.se
- Active, not recruiting
Aleris Elisabethsjukhuset
Uppsala, 752 26
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Constriction, Pathologic, Spine Degeneration, Surgery, Radiculopathy
- Being tested
- Dialogue support tool
- Keywords
- Spine, Cervical radiculopathy, Lumbar spinal stenosis, Surgery, Neck, Prognostic model, External validation
- Medical subject headings
- Constriction, Pathologic, Radiculopathy, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialogue support toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Participants will after the dialogue support tool has been undergo surgery. Receives: Other: Dialogue support tool |
| Non-surgery | Placebo comparator | Participants will after the dialogue support tool has been used not undergo surgery. Receives: Other: Dialogue support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment (GA)
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).
Measured: One year post surgery
Secondary outcomes (5)
Oswestry Disability Index (ODI)
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).
Measured: One year post surgery
Neck Disability index (NDI)
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
Measured: One year post surgery
Euroqol-5-Dimensions quality of life questionnaire (EQ-5D)
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).
Measured: One year post surgery
Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS)
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
Measured: One year post surgery
Mortality
The number of participants that have died within one year of surgery
Measured: One year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Mar 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2029 (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 Constriction, PathologicStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- On all participants the dialogue support tool will be used and will thereafter be put into either of two treatment-arms (surgical, or non-surgical treatment)
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catharina Parai, MD, PhD, Sahlgrenska University Hospital
- Investigators
- Catharina Parai, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817747
- Sponsor's protocol ID
- 2022-2025
- Status last verified
- May 2025
- First submitted
- 19 Mar 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Enger EB, Valentin-Askman L, Hagg O, Fritzell P, Parai C. The strategic use of Big Data - A study protocol for a multicenter clinical trial testing if the use of the Swespine Dialogue Support alter outcomes in degenerative spine surgery. BMC Musculoskelet Disord. 2024 Aug 21;25(1):654. doi: 10.1186/s12891-024-07714-5.
PubMed 39169349
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis
- ClinicalTrials.gov ID
- NCT05817747
- Acronym / sponsor ID
- 2022-2025
- Conditions
- Constriction, Pathologic, Spine Degeneration, Surgery, Radiculopathy
- Keywords
- Spine, Cervical radiculopathy, Lumbar spinal stenosis, Surgery, Neck, Prognostic model, External validation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 18 Apr 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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- On all participants the dialogue support tool will be used and will thereafter be put into either of two treatment-arms (surgical, or non-surgical treatment)
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Other: Dialogue support toolParticipants will after the dialogue support tool has been undergo surgery. |
| Non-surgery | Placebo comparator | Other: Dialogue support toolParticipants will after the dialogue support tool has been used not undergo surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialogue support toolThe 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. | Other | Non-surgery, Surgery |
Primary outcome
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).
5 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: One year post surgery
Neck Disability index (NDI)
Time frame: One year post surgery
Euroqol-5-Dimensions quality of life questionnaire (EQ-5D)
Time frame: One year post surgery
Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS)
Time frame: One year post surgery
Mortality
Time frame: One year post surgery
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 13 May 2025.
- Derived from this study: PubMed 39169349Enger EB, Valentin-Askman L, Hagg O, Fritzell P, Parai C. The strategic use of Big Data - A study protocol for a multicenter clinical trial testing if the use of the Swespine Dialogue Support alter outcomes in degenerative spine surgery. BMC Musculoskelet Disord. 2024 Aug 21;25(1):654. doi: 10.1186/s12891-024-07714-5.
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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.
Catharina Parai, MD, PhD principal investigator
Sahlgrenska University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialogue support tool in people with Constriction, Pathologic and Spine Degeneration, run by Sahlgrenska University Hospital at 10 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Sweden. 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. Some participants in this study may receive a placebo. 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?
Contact Catharina Parai, MD, PhD (0046313421000, catharina.parai@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Assessment (GA) (time frame: One year post surgery). 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 NCT05817747, 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 13 May 2025.