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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Experimental | Participants will after the dialogue support tool has been undergo surgery. |
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| Non-surgery | Placebo Comparator | Participants will after the dialogue support tool has been used not undergo surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | One year post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | One year post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catharina Parai, MD, PhD | Contact | 0046313421000 | catharina.parai@vgregion.se | |
| Eric Brisby Enger, MD | Contact | 0046735716723 | ericbrisbyenger@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Catharina Parai, MD, PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aleris Ortopedi Ängelholm | Recruiting | Ängelholm | Skåne County | 26252 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39169349 | Derived | 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. |
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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)
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| 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 | 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). | 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 | One year post surgery |
| Mortality | The number of participants that have died within one year of surgery | One year post surgery |
| Aleris Ortopedi Malmö | Active, not recruiting | Malmö | Skåne County | 21532 | Sweden |
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Västra Götaland County | 41346 | Sweden |
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| Spine Center Göteborg | Recruiting | Gothenburg | Västra Götaland County | 421 30 | Sweden |
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| Ryggkirurgiskt Centrum | Recruiting | Stockholm | 114 33 | Sweden |
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| Spine Center Stockholm | Recruiting | Stockholm | 194 89 | Sweden |
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| Sundsvalls sjukhus | Recruiting | Sundsvall | Sweden |
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| Norrland University Hospital | Recruiting | Umeå | 90737 | Sweden |
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| Uppsala University Hospital | Recruiting | Uppsala | 751 85 | Sweden |
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| Aleris Elisabethsjukhuset | Active, not recruiting | Uppsala | 752 26 | Sweden |
| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| D011843 | Radiculopathy |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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