Status:
COMPLETED
Objective Data on Daily Activity in Patients Treated with SCS: the Intellis Study
Lead Sponsor:
Sahlgrenska University Hospital
Conditions:
Failed Back Surgery Syndrome
Eligibility:
All Genders
18-70 years
Brief Summary
In spinal cord stimulation (SCS), most outcome data are based on patient questionnaires. The lack of tools for objective evaluation of the effects of SCS on chronic pain has posed a barrier for provid...
Detailed Description
Although the interaction between chronic pain and physical functioning is a well-accepted paradigm, objective data on how pain affects individuals' daily life is scanty. Most data are based on patient...
Eligibility Criteria
Inclusion
- Refractory chronic pain in low-back and/or legs that persists for at least 6 months following the most recent spinal surgery
- 18-70 years of age. Patients \>70 years will not be included due to the reduction in general activity level that is usually seen in older patient cohorts.
- Mean pain intensity should be 5 or higher measured on a Visual Analogue Scale (VAS).
- Patient has been informed of the study procedures and has given written informed consent.
Exclusion
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, rheumatoid arthritis
- Addiction to drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Active malignancy
- Life expectancy \< 1 year
- Local infection or other skin disorder at site of incision
- Pregnancy
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04710355
Start Date
August 1 2020
End Date
July 31 2024
Last Update
January 16 2025
Active Locations (7)
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1
AZ Delta Hospital
Roeselare, Belgium
2
Aalborg University Hospital
Aalborg, Denmark
3
Rijnstate Hospital
Arnhem, Netherlands
4
MCL Leeuwarden
Leeuwarden, Netherlands