Actively Recruiting
Led by Sahlgrenska University Hospital · Updated on 2025-05-13
900
Participants Needed
10
Research Sites
104 weeks
Total Duration
Researchers are evaluating whether using a digital tool called the Dialogue Support tool can change patient-reported outcomes and satisfaction after surgery for lumbar spinal stenosis or cervical radiculopathy. The study aims to see if this tool affects patients' reports of leg pain and satisfaction in lumbar spinal stenosis, arm pain and satisfaction in cervical radiculopathy, and quality of life in patients who do not have surgery after assessment compared to those who do. Participants will be assessed using the Dialogue Support tool alongside the usual surgeon evaluation to help decide the best treatment approach. Study groups include those who proceed with surgery after the tool's use and those who do not. The tool provides predicted postoperative outcomes to help guide treatment decisions. During the study, researchers will follow participants and compare their outcomes to matched controls from the Swedish Spine Register. Assessments include general patient-reported outcomes one year after surgery, such as pain levels, disability indexes, quality of life questionnaires, and mortality. The study will last long enough to collect one-year postoperative data for these outcomes.
CONDITIONS
Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo surgery or non-surgical management following the use of a dialogue support tool to decide the optimal treatment.
1 baseline visit and periodic follow-up visits during treatment
Duration - Up to 1 year post treatment
Participants are assessed for outcomes such as disability, quality of life, pain, and mortality up to one year after surgery or treatment decision.
Approximately 1 visit at one year post treatment
Total: 10 locations
1
Aleris Ortopedi Ängelholm
Ängelholm, Skåne County, Sweden, 26252
Actively Recruiting
2
Aleris Ortopedi Malmö
Malmö, Skåne County, Sweden, 21532
Active, Not Recruiting
3
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 41346
Actively Recruiting
4
Spine Center Göteborg
Gothenburg, Västra Götaland County, Sweden, 421 30
Actively Recruiting
5
Ryggkirurgiskt Centrum
Stockholm, Sweden, 114 33
Actively Recruiting
6
Spine Center Stockholm
Stockholm, Sweden, 194 89
Actively Recruiting
7
Sundsvalls sjukhus
Sundsvall, Sweden
Actively Recruiting
8
Norrland University Hospital
Umeå, Sweden, 90737
Actively Recruiting
9
Uppsala University Hospital
Uppsala, Sweden, 751 85
Actively Recruiting
10
Aleris Elisabethsjukhuset
Uppsala, Sweden, 752 26
Active, Not Recruiting
C
Catharina Parai, MD, PhD
E
Eric Brisby Enger, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Eric Brisby Enger, Ludvig Valentin-Askman, Olle Hägg...
https://pubmed.ncbi.nlm.nih.gov/39169349