Status:
RECRUITING
Burst Crossover Trial
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
Norwegian University of Science and Technology
Conditions:
Back Pain with Radiation
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surg...
Eligibility Criteria
Inclusion
- Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
- Minimum pain intensity of 5/10 on the leg pain NRS at baseline
- Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
- Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital
- Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
Exclusion
- Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
- History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
- Abnormal pain behavior and/or unresolved psychiatric illness.
- Unresolved issues of secondary gain or inappropriate medication use.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05372822
Start Date
May 1 2021
End Date
August 15 2025
Last Update
December 24 2024
Active Locations (1)
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1
St Olavs Hospital
Trondheim, Norway