Status:
UNKNOWN
Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain
Lead Sponsor:
PD Dr. med. Simon Bayerl
Conditions:
Sacroiliac Joint Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective randomized controlled study, primary objective: Pain reduction in patients with chronic Sacroiliac joint pain after therapy either with Peripheral Nerve Stimulation or with best medical tr...
Eligibility Criteria
Inclusion
- Subject is at least 18 years old
- Subject with chronic sacroiliac joint pain refractory to conservative treatment
- Subject with NRS of at least 60/100
- Subject with temporary pain reduction of at least 50% (NRS) after fluoroscopy guided SIJ infiltration
- Subject received conservative treatment for at least three months including physiotherapy and pain medication
- Subject is able to understand the study and Impulse generator programming
Exclusion
- Pregnancy
- Subject is under age
- Acute traumatic injury of the ISG
- Active inflammation or neoplastic infiltration of the SIJ
- Neoplastic diseases of the spine
- Spinal surgery within the last three months
- The SIJ pain is not the leading symptom
- Contraindication for Neuromodulation Device (severe psychiatric disease, severe coagulation disorder, acute infection, active autoimmune disease with immunosupression)
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05357300
Start Date
April 26 2022
End Date
April 1 2025
Last Update
May 6 2022
Active Locations (1)
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1
Charité - Universitätsmedizin Berlin, Department of Neurosurgery
Berlin, Germany, 12203