Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain (SIlencing)

PD Dr. med. Simon Bayerl

Status

Enrolling

Conditions

Sacroiliac Joint Pain

Treatments

Device: Peripheral Nerve Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05357300

128236

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)