Status:
COMPLETED
Clinical Decision Support System (CDSS) in Neurostimulation Therapy
Lead Sponsor:
General University Hospital of Valencia
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Failed Back Surgery Syndrome
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
Chronic pain is correlated with alterations in the structure and function of the brain, developed according to the phenotype of pain. Still today, the data on functional connectivity (FC), on chronic ...
Detailed Description
Primary objective:To develop a predictive model integrated in a clinical decision support system (CDSS) feed by neuroimaging quantitative information objectively extracted from Magnetic Resonance (MR)...
Eligibility Criteria
Inclusion
- Patients presenting pain of more than 6 months in duration
- VAS Score at baseline ≥ 5
- Patients with degenerative spine pain. Non specific low-back pain, nociceptive pain / mixed neuropathic
- Post-operative spine pain, failed back surgery syndrome, mixed pain
- Low consumption of analgesic and adjuvant drugs.
- Pure radiculopathy
- No suffering other serious chronic diseases.
- No history of drug or alcohol.
Exclusion
- Having implanted pacemakers, stimulators or hearing aids incompatible with MR imaging.
- Patients presenting psychiatric illness or significant cognitive deficits.
- Psychological instability.
- History of alcohol and drugs.
- Severe coagulopathy.
- Pending Surgery.
Key Trial Info
Start Date :
November 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04735159
Start Date
November 20 2016
End Date
June 30 2019
Last Update
February 4 2021
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