Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain
Not Applicable
Recruiting
- Conditions
- Sacroiliac Joint Pain
- Registration Number
- NCT05357300
- Lead Sponsor
- PD Dr. med. Simon Bayerl
- 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 treatment.
Randomization 4:3 to operative (PNS=Peripheral Nerve Stimulation) arm or conservative (BMT= Best Medical Treatment) arm with crossover possibility for the BMT group after 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- 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 Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change of chronic sacroiliac joint pain 6 months Change of pain measured with a numeric rating scale ranking from minimum 0 to maximum 100 where higher numbers mean a worse outcome
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Charité - Universitätsmedizin Berlin, Department of Neurosurgery
🇩🇪Berlin, Germany
Charité - Universitätsmedizin Berlin, Department of Neurosurgery🇩🇪Berlin, GermanySimon H Bayerl, MDContact+49(0)30 450560789simon.bayerl@charite.deDimitri Tkatschenko, MDContact+49(0)30 450560789dimitri.tkatschenko@charite.de