Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
900 (estimated)
Sponsor
Sahlgrenska University Hospital · Other
Who this trial is looking for
This trial is looking for adults who are considering surgery for back or neck pain. Participants will receive a prediction of their recovery outcomes to see if it helps their satisfaction after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years of age or older
I have been diagnosed with lumbar spinal stenosis or cervical radiculopathy
I have had an MRI in the last 12 months that confirms my diagnosis
I am visiting a participating clinic for surgery
I can give informed consent
You may not be able to join if
I have another condition that explains my symptoms
I cannot give informed consent
I need more tests that delay my participation by more than one month
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Sati…
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.
Trial Locations
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State
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Status
Eligibility Criteria
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 refe…
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.
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