Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain

Peripheral Nerve Stimulation for Treatment of Chronic Therapy-refractory Sacroiliac Joint Pain

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.

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)