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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05817747
Other study ID # 2022-2025
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date March 1, 2029

Study information

Verified date April 2024
Source Sahlgrenska University Hospital, Sweden
Contact Catharina Parai, MD, PhD
Phone 0046313421000
Email catharina.parai@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 900
Est. completion date March 1, 2029
Est. primary completion date March 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Dialogue support tool
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.

Locations

Country Name City State
Sweden Aleris Ortopedi Ängelholm Ängelholm Skåne
Sweden Spine Center Göteborg Göteborg Västra Götaland
Sweden Sahlgrenska University Hospital Gothenburg Västra Götaland
Sweden Aleris Ortopedi Malmö Malmö Skåne
Sweden Ryggkirurgiskt Centrum Stockholm
Sweden Spine Center Stockholm Stockholm
Sweden Norrland University Hospital Umeå
Sweden Aleris Elisabethsjukhuset Uppsala
Sweden Uppsala University Hospital Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Mortality The number of participants that have died within one year of surgery One year post surgery
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